CN115078743A

CN115078743A - Quality inspection control equipment, quality inspection management and control system for biological in-vitro samples

Info

Publication number: CN115078743A
Application number: CN202210182157.5A
Authority: CN
Inventors: 段飞蝶; 汉雨生; 范忍; 林晓雯; 段军莉; 张之宏
Original assignee: Guangzhou Burning Rock Dx Co ltd
Current assignee: Guangzhou Burning Rock Dx Co ltd
Priority date: 2021-03-16
Filing date: 2022-02-25
Publication date: 2022-09-20
Also published as: CN115083525A

Abstract

The application discloses quality inspection control equipment, a quality inspection control system and a quality inspection management system for biological in-vitro samples, wherein the equipment comprises a quality inspection workbench which is provided with a transportation area and a plurality of working areas; the transfer device is arranged adjacent to the transportation area and the plurality of working areas and is used for transferring the carrier containing the biological in-vitro sample among the transportation area or the plurality of working areas; the identification device is used for identifying order information of the biological in-vitro sample; a quality control device for detecting the biological in-vitro sample to generate quality control data; the conveying device is used for conveying the carrier of the sample to be detected to the quality inspection workbench or conveying the sample carrier which is subjected to quality inspection out of the quality inspection workbench; the quality control equipment is communicated with the quality control management system through the communication device, and the quality control equipment associated with the quality control management system can further improve the detection accuracy of the automatically processed samples while realizing the automatic processing of the samples and reducing the detection error rate of the samples.

Description

Quality inspection control equipment, quality inspection management and control system for biological in-vitro samples

Technical Field

The application relates to the field of biological sample processing, in particular to quality control equipment, a quality control system and a quality control management system for biological in-vitro samples.

Background

In medical testing, the testing process performed on a sample basis includes pre-analysis, in-analysis, and post-analysis; in which about 68% of the total number of detection accidents are caused by the occurrence of a sample error in the pre-analysis stage, and the detection error may cause an improper examination or improper treatment of a patient, and therefore, how to reduce the error rate of sample processing in the pre-analysis stage is of great significance to the sample-based medical examination.

Generally, the current flow before sample analysis is realized by manual participation, particularly in the detection process of a mixed sample, the detection items required by a large number of samples are different, the corresponding flow and standard before sample analysis are also different, the process is complicated, the test dependency in manual treatment is high, for example, whether the quality of a blood sample to be detected is qualified or not is realized based on manual evaluation, instruments on the sample need to be manually realized in the process of transferring a plurality of flows, in addition to the problem that detection errors are easy to occur in the process, the problem of low efficiency also exists, the flow time before sample analysis is too long, the period of the whole detection flow is inevitably increased, and the time cost and the labor cost are both consumed greatly.

Disclosure of Invention

In view of the above-mentioned shortcomings of the related art, an object of the present application is to provide a quality control device, a quality control system, and a quality control management system for a biological ex-vivo sample, which do not depend on human intervention, so as to solve the problems of high failure rate and low efficiency in sample pre-analysis processing in the prior art.

To achieve the above and other related objects, the present application discloses a quality control apparatus for a biological in vitro sample, comprising: the quality inspection workbench is provided with a transportation area and a plurality of working areas; the transfer device is arranged adjacent to the transportation area and the plurality of working areas and is used for transferring the carrier containing the biological in-vitro sample among the transportation area or the plurality of working areas; the identification device is used for identifying order information of the biological in-vitro sample transferred by the transfer device; the quality inspection device is used for detecting the biological in-vitro sample in the quality inspection working area to generate quality inspection data; the conveying device is used for conveying the carrier of the biological in-vitro sample to be detected to the quality inspection workbench or conveying the carrier of the biological in-vitro sample which is subjected to quality inspection out of the quality inspection workbench; and the communication device is in communication connection with a quality inspection management system to send and receive information, and the sent information comprises the order information and the quality inspection data.

The application also discloses a quality inspection management system, includes: the communication module is used for being in communication connection with a quality inspection control device to send and receive information; the storage module is used for prestoring order information of the in-vitro biological sample and identity information corresponding to the order information; and storing at least one quality inspection rule; the verification module is used for acquiring the order information of the pre-stored biological in-vitro sample from the storage module, comparing the received order information identified by the quality control equipment with the pre-stored order information to obtain an order information verification result of the biological in-vitro sample, and outputting first shunt information to the transfer device of the quality control equipment; the quality inspection module is used for judging whether quality inspection data output by a quality inspection device of the quality inspection control equipment is qualified or receiving a quality inspection result output by the quality inspection device, and outputting second shunt information to a transfer device of the quality inspection control equipment; and the report generation module is used for receiving the quality inspection result and generating a quality inspection report of the biological in-vitro sample comprising the quality inspection result according to the order information and the identity information.

The application further discloses a quality control system of biological separation sample, include: the quality control equipment for the biological in-vitro sample; and the quality inspection management system is in communication connection with the quality inspection control equipment to send and receive information.

To sum up, quality control equipment, quality control system, quality control management system of this application have following beneficial effect: the sample processing process performed by the quality inspection control equipment can be realized based on the information provided by the quality inspection management system, the determined detection rule or the determined detection flow; by associating the sample processing process with the quality inspection management system, the quality inspection management system can determine how to adjust the processing flow, such as increase and decrease adjustment or sequence adjustment of the processing procedures, and the information provided by the quality inspection management system can assist in determining the detection mode, detection result or transfer mode of the sample in each processing procedure, so that the detection accuracy of the automatically processed sample can be further improved by the quality inspection control equipment associated with the quality inspection management system while the sample is automatically processed to improve the sample processing efficiency and reduce the sample detection error rate; furthermore, this application provides the position relation between structure composition, function and the structure of quality control equipment for realize handling the automation of sample under the sample processing procedure of predetermineeing, through forming the standardized processing procedure to the sample, improved the treatment effeciency.

Drawings

The invention to which this application relates is particularly characterized as set forth in the appended claims. The features and advantages of the invention to which this application relates will be better understood by reference to the exemplary embodiments described in detail below and the accompanying drawings. The drawings are briefly described as follows:

fig. 1 is a block diagram of a quality inspection control apparatus and a quality inspection management system according to an embodiment of the present invention.

Fig. 2 is a schematic device layout diagram of the quality inspection control apparatus according to an embodiment of the present disclosure.

Fig. 3 is a schematic device layout diagram of the quality inspection control apparatus according to another embodiment of the present application.

Fig. 4a is a schematic diagram of a label style in an embodiment of the present application.

Fig. 4b is a schematic diagram of another embodiment of the present application.

Fig. 4c shows a schematic view of a labeled test tube pattern according to an embodiment of the present application.

Fig. 5 is a schematic diagram of a collection area in the quality control device of the present application in one embodiment.

Fig. 6a is a schematic diagram of a carrier in a collection area of a quality control apparatus according to an embodiment of the present invention being removable.

Fig. 6b is a schematic diagram of a carrier in a collection area of a quality control apparatus according to an embodiment of the present invention being removable.

Fig. 7 is a schematic view of a transfer device according to an embodiment of the present disclosure.

Fig. 8 is a schematic structural diagram of a carrier according to an embodiment of the present invention.

Fig. 9 is a schematic structural diagram of a conveying device of the quality control apparatus according to an embodiment of the present disclosure.

Fig. 10 is a schematic structural diagram of a conveying robot of the conveying device according to an embodiment of the present disclosure.

Fig. 11 is a schematic diagram of a quality control apparatus according to an embodiment of the present invention for taking samples from a screening area.

Fig. 12 is a schematic diagram illustrating a sample identification by the quality control apparatus according to an embodiment of the present disclosure.

Fig. 13 is a schematic diagram of the quality control apparatus of the present application for placing a sample in a quality control work area according to an embodiment of the present application.

Fig. 14 is a schematic diagram of the quality control apparatus of the present application showing a sample being placed in a collection region in one embodiment.

Fig. 15 is a schematic diagram of the quality control apparatus of the present application in one embodiment showing placement of a sample at an identification device.

FIG. 16 is a schematic diagram of a quality control apparatus according to an embodiment of the present disclosure for placing a sample in a non-defective placement area.

Fig. 17 is a schematic diagram of the quality control apparatus of the present application for placing a sample in a transfer buffer according to an embodiment.

Detailed Description

The following description of the embodiments of the present application is provided for illustrative purposes, and other advantages and capabilities of the present application will become apparent to those skilled in the art from the present disclosure.

In the following description, reference is made to the accompanying drawings that describe several embodiments of the application. It is to be understood that other embodiments may be utilized and that mechanical, structural, electrical, and operational changes may be made without departing from the spirit and scope of the present disclosure. The following detailed description is not to be taken in a limiting sense, and the scope of embodiments of the present application is defined only by the claims of the issued patent. The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the application. Spatially relative terms, such as "upper," "lower," "left," "right," "lower," "below," "lower," "above," "upper," and the like, may be used herein to facilitate describing one element or feature's relationship to another element or feature as illustrated in the figures.

Although the terms first, second, etc. may be used herein to describe various elements or parameters in some instances, these elements or parameters should not be limited by these terms. These terms are only used to distinguish one element or parameter from another element or parameter. For example, the first non-defective placement area may be referred to as a second non-defective placement area, and similarly, the second non-defective placement area may be referred to as a first non-defective placement area, without departing from the scope of the various described embodiments. The first non-defective placement area and the second non-defective placement area are both describing a non-defective placement area, but they are not the same non-defective placement area unless the context clearly dictates otherwise.

Also, as used herein, the singular forms "a", "an" and "the" are intended to include the plural forms as well, unless the context indicates otherwise. It will be further understood that the terms "comprises," "comprising," "includes" and/or "including," when used in this specification, specify the presence of stated features, steps, operations, elements, components, items, species, and/or groups, but do not preclude the presence, or addition of one or more other features, steps, operations, elements, components, items, species, and/or groups thereof. The terms "or" and/or "as used herein are to be construed as inclusive or meaning any one or any combination. Thus, "A, B or C" or "A, B and/or C" means "any of the following: a; b; c; a and B; a and C; b and C; A. b and C ". An exception to this definition will occur only when a combination of elements, functions, steps or operations are inherently mutually exclusive in some way.

In a medical setting, collecting a patient sample and analyzing the sample to determine a treatment regimen for the patient is a common procedure for many types of diagnosis. As described in the background art, the processing process can be divided into pre-analysis, during-analysis and post-analysis, and in the current medical examination based on a sample, the pre-analysis stage of the sample needs to be completed manually, and this stage is also the stage where detection errors occur most easily, and the detection errors may cause improper examination or improper treatment of patients, so that the foregoing accidents are avoided, and it is of great significance to improve the accuracy of the sample before analysis.

The work before the analysis of the sample usually involves a plurality of complicated processes, and in the existing sample pretreatment scheme, the transfer between each process or a specific link in each process needs to be realized by manpower, so that detection errors can be caused, and the mode of manual participation consumes a great deal of time and cost.

In the examples provided herein, "ex vivo" refers to the separation of in vivo components, such as tissues or cells, from an animal or human into an in vitro environment, such as by surgery or sampling, etc.

"biological sample" may refer to samples of biological macromolecules, cells, tissues and organs (including, for example, human organ tissue, whole blood, plasma, serum, bodily fluids (urine, saliva, cerebrospinal fluid, etc.) and derivatives thereof (including, for example, DNA, RNA, proteins, etc.) of healthy and diseased organisms (including, for example, human organism tissue, whole blood, plasma, serum, plasma, pleural fluid, ascites, pericardial fluid, sweat, tears, ear fluid, sputum, lymph, bone marrow suspension, lymph, urine, saliva, semen, vaginal fluid, stool, transcervical lavage, cerebrospinal fluid, brain fluid, breast milk, vitreous fluid, aqueous humor, sebum, endolymphatic, peritoneal fluid, pleural fluid, cerumen, epicardial fluid, and secretions of the respiratory, intestinal, and genitourinary tracts, etc.; biological ex vivo samples may also be re-located in blood or tissues, etc. obtained directly from an organism Samples obtained are for example proteins, antibodies, nucleic acid samples etc.

In certain embodiments, the ex vivo biological sample is used to perform molecular diagnostics. The quality control device is used for realizing the analysis pretreatment of the sample, and for the biological in-vitro samples for realizing different analyses, the specific detection flow and detection mode of the biological in-vitro samples before the analysis may be different. The molecular diagnosis technology is a technology for diagnosing human body states and diseases by using DNA and RNA as diagnosis materials and detecting existence, defects or expression abnormality of genes by using a molecular biology technology, and correspondingly, the biological in vitro sample is usually a sample for obtaining the DNA or RNA diagnosis materials.

In the examples provided herein, the biological ex-vivo sample is also referred to as "sample", and the term "sample" in the examples is "biological ex-vivo sample" in the present application unless otherwise specified.

In the examples provided in the present application, the term "carrier of a biological ex-vivo sample" or "carrier" refers to a carrier containing a biological ex-vivo sample therein, rather than merely the carrier itself as a container, unless otherwise specified.

The carrier of the biological in-vitro sample is a container for holding the biological in-vitro sample, and the specific form of the carrier can be different in different application scenarios. When the conveying device conveys the carrier of the biological in-vitro sample, the carrier of the biological in-vitro sample is generally moved by driving the carrier of the carrier to move together with the carrier of the biological in-vitro sample. Correspondingly, a limiting structure matched with the carrier shape can be arranged in the carrier to ensure that the carrier of the biological in-vitro sample is stably conveyed when the conveying device operates.

In some embodiments, the carrier of the biological ex-vivo sample is a test tube-type container. The test tube type container is generally composed of a test tube as a container and a test tube stopper or a test tube cap. The outer wall of the test tube can be used for attaching the information carrier of the order information or the label of the identity information and the like. In one embodiment, the test tube is, for example, a blood collection tube, and more specifically, the test tube is, for example, a Streck blood collection tube with a height of 105mm and a body diameter of 15.5 mm. Of course, in some other embodiments, the sample carrier is also, for example, a loading tube/dish for a urine collection tube or other case specimen, etc.

In the embodiments provided in the present application, the term "carrier" refers to a carrying structure for carrying a carrier of a bio-ex-vivo sample within a quality inspection station and during transportation by a transportation device, and generally, the carrier has a certain limiting effect on the carrier of the bio-ex-vivo sample so that the area where the bio-ex-vivo sample is located can be determined or moved by determining or moving the position of the carrier. In some embodiments provided herein, the carrier is a carrier plate, a well rack, or the like, which holds the test tubes. In an embodiment where the carrier is a test tube type container, the carrier of the carrier may be a hole plate, and the hole plate may be a bearing plate having a predetermined number of limiting holes for accommodating the test tube type container. The hole plate is also provided with a clamping hole structure used for fixing the loaded test tube type container, the clamping hole structure is a clamping jaw arranged in the limiting hole, and when the test tube type container is placed in the limiting hole, the clamping jaw is abutted against the outer side of the test tube type container so as to limit the test tube type container to displace, such as incline, shake and the like in the limiting hole.

In some embodiments, the carrier is provided with a buffer layer for contacting a tube-type container of the biological ex-vivo sample; in some examples, the material of the test tube type container has a hard brittleness, and the carrier may further include a buffer layer at least at a portion contacting the test tube type container for protecting the test tube type container from being damaged during the transferring process. The buffer layer is made of elastic rubber, silica gel or other materials with elastic deformation, damping property or buffering property.

To this end, the application provides a quality control equipment of biological separation sample, quality control equipment communication connection quality control management system, quality control equipment includes: the quality inspection device comprises a quality inspection workbench, a transfer device, an identification device, a quality inspection device, a conveying device and a communication device, wherein the quality inspection workbench is provided with a transportation area and a plurality of working areas; the transfer device is arranged adjacent to the transportation area and the plurality of working areas and is used for transferring the carrier containing the biological in-vitro sample among the transportation area or the plurality of working areas; the identification device is used for identifying order information of the biological in-vitro sample transferred by the transfer device; the quality testing device is used for testing the biological in-vitro sample in the quality testing working area to generate a quality testing result; the conveying device is used for conveying the carrier of the biological in-vitro sample to be detected to the quality inspection workbench or conveying the carrier of the biological in-vitro sample which is subjected to quality inspection out of the quality inspection workbench; the communication device is used for being in communication connection with a quality inspection management system to send and receive information, and the sent information comprises the order information and quality inspection data.

The communication device of the quality control equipment is in communication connection with the quality control management system, the communication device can be in communication connection with the quality control management system to send and receive information, the sent information comprises the order information and the quality control data, and therefore the sample processing process performed by the quality control equipment can be realized based on the information provided by the quality control management system, the determined detection rule or the determined detection flow. By associating the sample processing process with the quality inspection management system, in some embodiments of implementing automated sample processing, the quality inspection control device can determine how to adjust the processing flow, such as increase and decrease adjustment or sequential adjustment of the processing procedures, through the quality inspection management system, and the information provided by the quality inspection management system can assist in determining the detection mode, detection result or transportation mode of the sample in each processing procedure, so that the quality inspection control device associated with the quality inspection management system can further improve the detection accuracy of the automatically processed sample while implementing automated sample processing to improve the sample processing efficiency and reduce the sample detection error rate; furthermore, this application provides the position relation between structure composition, function and the structure of quality control equipment for realize handling the automation of sample under the sample processing procedure of predetermineeing, through forming the standardized processing procedure to the sample, improved the treatment effeciency.

In an embodiment, the communication device is communicatively connected to a quality control management system, where the communication connection is a connection mode that establishes a connection between different devices based on a certain communication protocol or another matching rule and implements data transmission and information exchange, and includes a connection established by pairing identification information between a remote terminal and a target object terminal. The communication protocol determines rules to be followed for realizing communication or service between the devices, and the protocol defines the format of a data unit, the connection mode of an information unit and the sending and receiving time sequence of the information so as to ensure the identification and transmission of the information between the devices; the communication protocols include TCP/IP, NETBEUI and IPX/SPX. The identification information is used for determining attributes of different terminal devices, such as unique device identification codes, so as to determine that the connection terminal is correctly corresponding, and then realize data transmission between subsequent terminal devices.

In some embodiments provided herein, the quality control device is a series of detection operations for implementing a pre-analysis stage of the sample, such as quality inspection of the sample, information detection of the sample; wherein the quality inspection is used to achieve quality (quality) control or quality (quality) assurance of the sample. The sample is a bio-sample, and accordingly, the quality control device of the present application is generally associated with medical applications such as use in assisting in developing diagnostic opinions for patients, treatment plans, or biologically-relevant medical research such as pharmaceutical research and development or scientific research. In some scenarios, the quality control device is also an instrument system for implementing sample preprocessing and quality inspection.

In the embodiments provided in the present application, the quality control management system communicatively connected to the communication device of the quality control apparatus may be a system applied in different scenarios, such as a detection laboratory or a hospital, the quality control management system includes, but is not limited to, an electronic device, a server cluster, a cloud server system, and the like, and the quality control management system may also be a combination of software and hardware; the quality control device is connected with the quality control management system in a communication mode such as network connection.

In a first aspect, a quality inspection control device is provided, please refer to fig. 1, which shows a schematic frame diagram of a quality inspection management system in an embodiment, in which the quality inspection control device is communicatively connected to the quality inspection management system. As shown in the figure, the quality control device 1 is connected to the quality control management system 2 through a network, where the network may be the internet, a mobile network, a Local Area Network (LAN), a wide area network (WLAN), a storage local area network (SAN), one or more intranets, or the like, or a suitable combination thereof, and in the embodiments provided in the present application, the types of the client and the server, or the types or protocols of the communication networks between the publisher terminal and the server, and between the responder terminal and the server, or the like, are not limited.

The quality control device 1 needs to be in communication connection with the quality control management system 2 to realize interaction of information or instructions and the like when realizing automatic processing of samples, and correspondingly, a functional module which is suitable for the operation requirement of the quality control device 1 can be configured in the quality control management system 2. The functional modules are cooperatively implemented by various types of devices (such as terminal devices, servers, server clusters, or cloud server systems), or computing resources such as processors, communication resources (such as those for supporting communications in various manners such as optical cables and wireless communications), for example. In some examples, the functional modules in the quality inspection management system 2 may be embedded in a software system of the electronic device, and the software system of the electronic device may obtain the order information or the quality inspection rule from a storage medium of the electronic device or other devices, servers, etc. in network communication with the electronic device.

In an embodiment, the quality control management system 2 includes a communication module 20, a storage module 21, a verification module 22, and a quality control module 23.

In an embodiment, the storage module 21 may be configured to store order information of the in-vitro biological sample and identity information corresponding to the order information, so that after the quality inspection control device 1 transmits the order information of the in-vitro biological sample obtained by the identification device to the quality inspection management system 2, the verification module 22 obtains pre-stored order information from the storage module, and compares the pre-stored order information with the received order information identified by the quality inspection control device 1 to generate a verification result for the order information. The quality control device 1 receives the order information verification and may determine a subsequent transport or detection action for the bio-ionic sample based thereon.

The storage module 21 may further include at least one quality inspection rule, for example, the quality inspection device of the quality inspection control apparatus 1 may perform quality inspection on the bio-ionic sample based on the at least one quality inspection rule, and compare the quality inspection data obtained by the quality inspection device with the qualified standard determined by the quality inspection rule to generate a quality inspection result. The quality inspection rule is, for example, a parameter to be inspected (to be measured) for inspecting a biological sample in vitro and a corresponding quality inspection means, and it should be understood that when the parameter to be inspected is different for the sample, corresponding devices, equipment, or inspection steps for obtaining a measurement value are different.

The quality inspection module 23 in the quality inspection management system 2 can be used to perform the comparison between the quality inspection data and the quality inspection qualified standard to determine the quality inspection result (e.g. the determination result of whether the bio-ionic sample is qualified for quality inspection), or generate the shunting information based on the determined quality inspection result to control the subsequent transportation or detection of the bio-ionic sample by the quality inspection control device 1. In some embodiments, the quality control module may be further configured to associate quality control data with an identity information.

Of course, the functional modules of the quality inspection management system 2 are not limited to these, for example, the quality inspection management system 2 may further be configured with a report generation module 24, and the report generation module 24 may generate a quality inspection report of the biological ex-vivo sample including the quality inspection result according to the order information and the identity information.

In some embodiments, the quality control management system of the present application may also refer to embodiments provided in applicant's prior patent publication CN104899697B (titled: a laboratory process quality control management and reporting automation system and method), i.e., the functional modules that the quality control management system is also configurable in some embodiments may refer to functional modules in the laboratory process quality control management and reporting automation system described in the patent publication, such as a received sample confirmation module, a sample information entry module, a detection application submission module, and the like.

In various embodiments provided by the first aspect of the present application, the quality inspection control apparatus includes a quality inspection workbench, a transferring device, an identifying device, a quality inspection device, and a conveying device to cooperatively realize automatic detection and conveying of a sample.

It should be understood that in order to realize the automatic processing of the sample, devices for realizing different functions need to be arranged, the quality inspection workbench can realize the arrangement of different devices, and comprises a transportation area and a plurality of working areas, the working areas comprise an identification working area and a quality inspection working area, which correspond to an identification device and a quality inspection device respectively, and the transportation area is an area in the quality inspection workbench, which is associated with the transportation device. The quality inspection workbench can be set into different shapes according to sample processing requirements, and the application is not limited.

The transfer device transfers the carrier containing the biological in-vitro sample between a transport area or a plurality of working areas according to a detection process, for example, the carrier containing the biological in-vitro sample is transferred to an identification working area, the identification device can identify order information of the biological in-vitro sample and transmit the order information to a quality inspection management system, and therefore correlation between the order information of the biological in-vitro sample and information in the quality inspection management system can be achieved.

In the quality inspection working area, the quality inspection device detects the biological in-vitro sample to generate a quality inspection result, the parameters specifically detected by the quality inspection device can be determined based on quality inspection rules, and correspondingly, the quality inspection device can be configured based on preset quality inspection rules; after the detection process is finished, the conveying device can convey the carrier of the biological in-vitro sample out of the quality inspection workbench; or, the conveying device is used for conveying the carrier of the biological in-vitro sample into the quality inspection workbench.

The transfer device and the conveying device of the quality inspection control equipment can realize the automatic conveying of the biological ion samples cooperatively according to the detection flow, and the quality inspection control equipment can realize the automatic processing of the biological ion samples so as to improve the processing efficiency and reduce the detection error rate; meanwhile, the quality control equipment is in communication connection with the quality inspection management system, information transmission can be realized between the quality inspection control equipment and the quality inspection management system, correspondingly, the quality inspection control equipment has higher adaptability to the processing mode of the biological isolated sample, for example, quality inspection operation is executed based on the quality inspection rule determined by the quality inspection management system, the quality inspection device can realize quality inspection operation corresponding to one or more quality inspection rules, and the subsequent processing of the biological isolated sample can be determined based on the quality inspection result; for another example, the identification device can identify the order information of the biological in-vitro sample and transmit the identification result to the quality inspection management system, the biological in-vitro sample often undergoes a plurality of transfer processes in practical application, detection errors caused by order information errors can be avoided by identifying the order information, or specific processing processes required by the biological in-vitro sample are determined by determining the order information, so that the detection error rate is further reduced.

For convenience of describing the structure and layout of the quality control apparatus of the present application, please refer to fig. 2, which is a schematic diagram of the device layout of the quality control apparatus of the present application in one embodiment. It should be noted that fig. 2 is only shown in an implementable manner, and the specific structure and the positional relationship between the structures of the quality inspection control device provided by the present application are not limited thereto.

As shown in fig. 2, the quality inspection control apparatus 1 includes a quality inspection work table 10, and the quality inspection work table 10 is provided with a transportation area 101 and a plurality of work areas 100. The transport area 101 is also an area in the quality control workbench 10 associated with the transport device 14, that is, the transport area 101 may be a location area where the transport device 14 transports the carrier of the biological ex-vivo sample to be tested to the quality control workbench 10, or a location area where the transport device 14 starts transporting the carrier of the biological ex-vivo sample from the quality control workbench 10. In the embodiment, the working area 100 corresponding to the recognition device 12, the quality inspection device 13, and the transfer device 11 is provided in the quality inspection table 10 of the quality inspection control apparatus 1.

For convenience of describing the working flow and the device cooperation mode, the structural composition and the layout of the quality control device 1 provided by the present application, the following description will be given by taking the quality control flow or the quality control method of the quality control device 1 in an embodiment as an example, to describe the device and the working principle for executing each step of the quality control flow. It should be understood that, in practical scenarios, the quality control flow according to which the quality control apparatus 1 processes the bio-isolated sample is not limited thereto. In an embodiment provided by the present application, the quality control process executed by the quality control apparatus 1 includes the following steps:

conveying the carrier containing the biological in-vitro sample to a quality inspection workbench 10; in an embodiment, the transfer device 11 obtains the carrier of the biological ex-vivo sample conveyed to the quality inspection workbench 10 by the conveying device 14, transfers the carrier of the biological ex-vivo sample to a working area corresponding to the identification device 12, so that the identification device 12 identifies order information on the carrier of the biological ex-vivo sample, and transmits the order information identified by the identification device 12 to the quality inspection management system 2, that is, it can be determined whether the order information matches with order information pre-stored in the quality inspection management system 2, thereby determining first shunting information for the biological ex-vivo sample. The shunting information is information for determining the transfer of the biological ex-vivo sample from the identification device 12 to the next working area or placement area.

The identification device 12 is disposed in an identification work area of the quality control workbench 10, and is used for identifying order information of the biological in-vitro sample transferred by the transfer device 11 to transmit to the quality control management system 2. In practical scenarios, such as sample testing performed inside a hospital or sample testing performed in a central laboratory, the obtained bio-body samples are all associated with certain order information to ensure that the bio-body samples match the corresponding users, such as the person providing the sample or the patient from which the sample is collected. In each stage of the medical verification, before, during and after the analysis, it is necessary to ensure that the sample corresponds to the user to perform the detection based on the user's needs and to provide the detection result to the user. The identification device 12 may be configured to identify order information of the in-vitro biological sample and transmit the identified order information to the quality inspection management system 2, and the quality inspection management system 2 may compare the received order information with pre-stored order information to determine whether the order information of the in-vitro biological sample is correct. The quality inspection management system 2 is in communication connection with the quality inspection control device 1, so that the quality inspection management system can be respectively arranged in different occasions or application environments, correspondingly, the quality inspection control device 1 can check order information in different application environments, and the adaptive application scenes are wide and high in adaptability.

In an implementation scenario, before the carrier of the bio-vitro sample is transferred to the quality inspection workbench 10, an information carrier for associating or loading order information, such as a bar code, a two-dimensional code, or a number field, is configured in advance, the identification device 12 identifies the information carrier to obtain the order information associated or loaded with the information carrier, and matches the order information obtained based on the identification with information in an order information database pre-stored in the quality inspection management system 2 to determine whether the load or associated order information on the carrier of the bio-vitro sample is correct. Taking the information carrier as a bar code as an example, in some examples, the position of the bar code on the carrier of the biological in-vitro sample is not fixed, that is, when the bar code is attached, the bar code does not need to be in a fixed position and an attaching direction; in other examples, the information carrier on the carrier of the biological isolated sample may be provided in a plurality of information carriers, for example, order information collected in different scenes, such as different hospitals; here, when the identification device 12 identifies the information carriers, it may identify each information carrier attached at different positions and in different directions, and when it is determined that at least one of the order information corresponding to all the information carriers on the carrier of the biological in-vitro sample matches the order information in the order information database pre-stored in the quality control management system 2, it may be determined that the order information of the biological in-vitro sample is correct to perform a subsequent detection process.

In some embodiments, the order information includes traceability information of the biological in-vitro sample, the traceability information including at least one of user identification information, communication information, biometric information, and order number information. In an embodiment, the source tracing information is used to determine user information corresponding to the order, such as user identification information, communication information, biometric information, order number information, and the like of the user, which are generally unique (i.e., not repeated). The types of the user identification information that can be obtained include the system-defined identification number, or the third-party-defined identification number, etc. of the de-identified identification information, for example: user codes, user identification codes, bar codes based on the user codes, two-dimensional codes and the like; the communication information is, for example, a communication identification number such as a mobile phone number, a fixed number, a mailbox address and the like of the user; the biological characteristic information is, for example, portrait information, iris information and fingerprint information of the user, and the specific user corresponding to the order can be determined according to the uniqueness of the biological characteristic information; generally, under a predetermined order number rule, the order number is also unique information, and corresponding order information can be searched and matched in an order system based on the order number.

In some embodiments, the quality inspection management system 2 has an order system therein, and after the identification device 12 identifies the order information on the biological in-vitro sample and transmits the order information to the quality inspection management system 2, the quality inspection management system 2 searches the matching pre-stored order in the order system by using the tracing information in the received order information as an index, and can compare the order information of the pre-stored order with the order information identified and obtained by the quality inspection control device 1 to determine whether there is an order information error. In some embodiments, the traceability information is further associated with the detection item information of the biological in-vitro sample and the sample information; wherein the sample information includes at least one of a collection time of the bio-ex-vivo sample, a collection sample amount, a sample type, and a number of sample carriers.

In some scenarios, the order is generated by further including the detection requirement of the user, such as detection item information, and the related information of the sample attribute, such as the acquisition time, the amount of the acquired sample, the type of the sample, the number of sample carriers, and the like. The sample collecting quantity is the quality or volume of the collected sample, the type of the sample is blood or tissue fluid, and the number of the sample carriers is the number of the carriers containing the samples corresponding to the same order.

The inspection item information and the sample information are associated with the traceability information, for example, the traceability information and the inspection item information and the sample information are included in the order information pre-stored in the order system of the quality inspection management system 2. In this example, the order information on the bio-ex vivo sample may be part of the order information, such as traceability information therein.

In the embodiments provided in the present application, the order information on the biological in-vitro sample can be used to refer to the order information content loaded on the carrier, for example, the order number presented in the form of a digital symbol, and can also be used to refer to the information obtained by reading the information carrier on the carrier, such as an information code, a label, a code, and the like.

The order information may be attached to the carrier of the biological in-vitro sample in different presentation forms or information carriers, and correspondingly, the identification device 12 may be configured as, for example, an RFID device, an NFC device, or a code scanning device, and the like, only when the identification device 12 is enabled to identify the order information associated with obtaining the biological in-vitro sample.

In some embodiments, the identification device 12 is a code scanning device, and is configured to identify an information code on a carrier of the in-vitro biological sample to obtain the order information, and compare the order information with information pre-stored in the quality inspection management system 2 to obtain a verification result. For example, in the embodiment shown in fig. 2, the identification device 12 is a code scanning device, and a corresponding code scanning station is disposed in the quality inspection work area. In an embodiment, the code scanning device is, for example, a line scan camera.

When the order information is attached to the carrier of the biological in-vitro sample by using the information code as the information carrier, correspondingly, the identification device 12 may be configured as a code scanning device, and the order information associated with the information code is obtained by reading the information code on the carrier. The order information obtained by scanning the code is compared with the order information prestored in the quality inspection management system 2, so that the verification result of the order information of the biological ion sample can be obtained. When the types of the information carriers of the order information are different, the correspondingly configured code scanning devices may be different, for example, a bar code scanner or a two-dimensional code scanner, and the specific specification and the product type of the code scanning device are not limited in the present application.

In some scenes, when the order information of the biological in-vitro sample is determined to be qualified, the transfer device 11 transfers the biological in-vitro sample to the next working area; and when the order information of the biological in-vitro sample is determined to be unqualified, transferring the biological in-vitro sample to a corresponding collection area for placing the biological in-vitro sample with unmatched order information. The qualification standard for whether the order information is qualified is, for example, whether the attaching position of the information code is qualified, whether the information codes are overlapped and covered with each other or not when a plurality of information codes are attached to the carrier, or whether the information codes are covered by other labels and cannot be identified, or whether the obtained order information can be matched with the pre-stored order information or not.

In some embodiments, the quality control workstation 10 is provided with a relay buffer 102 for placing a plurality of carriers of biological in-vitro samples corresponding to the same order information. Referring to fig. 2, in the embodiment shown in fig. 2, a transfer buffer 102 is disposed in the quality inspection workbench 10.

In some examples, the number of carriers of the biological ex-vivo samples collected when the samples are collected based on the same order is 2 or more, and when a plurality of samples are associated with each other to be recorded in the same order information, the same order information corresponds to carriers of a plurality of biological ex-vivo samples. In the detection process, after the information code loaded on the carrier of the bio-in-vitro sample is identified to obtain the corresponding order information, it is determined that the order information corresponds to the carriers of the plurality of bio-in-vitro samples, the carriers of the bio-in-vitro samples are transferred to the transfer buffer 102, and after it is determined that the carriers of the plurality of bio-in-vitro samples corresponding to the order information are all detected and identified (i.e., are collected), the carriers of the plurality of bio-in-vitro samples are subsequently transferred.

The relay buffer 102 may be used to assist in determining quantity information, and in some embodiments, determining the quantity information of the bio-in-vitro sample in the relay buffer 102 includes:

the method comprises the steps of identifying order information of biological in-vitro samples based on the identification device 12, placing the biological in-vitro samples in a transfer temporary storage area 102 and determining the order information as order information to be detected when the order information is determined to correspond to a plurality of biological in-vitro sample carriers, enabling the identification device 12 to continuously identify the order information of a preset number of biological in-vitro samples, and determining that the number information is correct when other biological in-vitro samples corresponding to the order information to be detected are determined to be contained in the preset number of biological in-vitro samples. For example, when order information identification is performed on a biological sample, and the number of biological samples corresponding to the order information is found to be multiple, the carrier of the biological ex-vivo sample is transferred to the transfer buffer 102, after which a number of further samples are processed, for example, to continue processing other samples or a certain number of threshold, e.g., 20 samples, within the same carrier, and determine whether there are any bio-body samples therein with the same order information, when the rest samples corresponding to the order information are detected and found in the preset number of biological in-vitro samples, that is, it can be determined that the quantity information of the in-vitro biological samples is correct, otherwise, when the remaining samples corresponding to the order information are not detected in the preset quantity of in-vitro biological samples (for example, the remaining samples are lost or recorded incorrectly), it is determined that the quantity information of the in-vitro biological samples in the transfer buffer 102 is incorrect. In the case that the quantity information of the bio-ex-vivo samples is determined to be correct, after all the carriers of the plurality of bio-ex-vivo samples corresponding to the order information are detected, the plurality of bio-ex-vivo samples may be removed from the relay buffer 102 for subsequent processing.

In some embodiments, the transfer buffer 102 is further associated with an alarm device (not shown) that is triggered when the transfer buffer 102 is in the unloading state, and an operator can select manual processing of the bio-body sample in the transfer buffer 102. In an embodiment, the alarm device is, for example, a buzzer or a signal light, and the alarm device can also be used for triggering the device to pause so as to facilitate manual handling or troubleshooting.

In an embodiment, the to-be-unloaded state may be customized, for example, the state of each storage position on the transfer buffer 102 loaded with the carrier of the bio-in-vitro sample may be defined as a full state, and the alarm device is triggered when the transfer buffer 102 reaches the full state; for another example, a triggering rule may be set based on the storage position of the transfer buffer 102, for example, when a part of the storage positions in the transfer buffer 102 are in a loading state, an alarm device may be triggered.

In the embodiment shown in fig. 2, the storage locations of the transfer buffer 102 are arranged in a 3 × 8(3 rows × 8 columns) arrangement, and the transfer buffer 102 can be loaded with 24 carriers of the bio-ex-vivo samples at most, and when it is determined that the number of carriers of the bio-ex-vivo samples placed in any row of the transfer buffer 102 exceeds 8, or when it is determined that the number of carriers of the bio-ex-vivo samples placed in any column of the transfer buffer 102 exceeds 3, the alarm device can be triggered. Of course, it should be noted that the specification of the transfer buffer 102 is not limited thereto; accordingly, the rules for triggering the alarm device are not limited thereto.

In some embodiments, the quality control apparatus 1 further comprises a housing (not shown), which may be configured to cover the quality control platform 10, for example, to avoid interference from the external environment with the operation of the apparatus in the quality control platform 10 and to provide a sterile working environment. In some implementations, the housing may also be configured with one or more transparent windows through which an operator may immediately visit the operating conditions within the quality inspection station 10.

In some embodiments, a protective pad (not shown) is further disposed in the quality inspection working table 10, and the protective pad is made of a material with a buffering property, such as a foam material or rubber, or a flexible structure with a buffering function, such as a cloth pad. In the embodiment shown in fig. 2, a protective pad is provided in the quality control platform 10 to prevent or reduce the hard contact between the carrier or the transfer device 11 and the surface of the quality control platform 10 during the transfer of the in vitro biological sample.

After the order information of the biological in-vitro sample is identified, the carrier transfer of the biological in-vitro sample can be transferred to the next working area according to the detection process. Typically, the bio-ionic sample may be quality tested after the order information identification is passed.

Referring to fig. 2, as shown in the figure, a quality inspection device 13 is disposed in the quality inspection workbench 10, and the quality inspection device 13 inspects the in-vitro biological sample in the quality inspection working area to generate quality inspection data, based on which a quality inspection result can be generated. In some embodiments, the quality inspection result is generated from the quality inspection data by: comparing quality inspection data obtained by inspecting the biological in-vitro sample by the quality inspection device 13 based on a quality inspection qualified standard to obtain a quality inspection result; the quality inspection qualified standard is an industry standard, a user-defined standard or a standard determined by the quality inspection management system 2.

The quality inspection qualification standard is, for example, to define a qualification value range for a parameter value for a quality inspection parameter to be measured, and after the quality inspection device 13 detects and obtains quality inspection data, determine whether the measurement of the quality inspection data is within the qualification value range, thereby determining a quality inspection result. The quality inspection qualified standard may be an industry standard, for example, a default qualified range preset in the quality inspection control device 1; the method can also be used for self-defining standards, such as manually setting quality inspection parameters or qualified value ranges; in some examples, the quality inspection qualification criteria may also be determined by the quality inspection management system 2, and in an implementation scenario, for example, quality inspection data may be transmitted to the quality inspection management system 2, and the quality inspection result may be determined by the quality inspection management system 2.

In some embodiments, the quality inspection parameters used to form the quality inspection qualification criteria include: one or more of sample weight, sample volume, and sample gravimetric density. For example, testing determines the net weight of the sample and relates the net weight of the sample to an acceptable range of sample weights in a quality acceptance criterion, such as greater than, less than, or within an acceptable range of values, and the like. Wherein the net weight of the sample is determined, for example, computationally, by predetermining the empty carrier weight of the bio-ex-vivo sample, thereby determining the net weight of the sample based on actual weighing data (i.e. the total weight of the carrier loaded with the bio-ex-vivo sample) and the empty carrier weight computationally. Of course, in another embodiment, the total weight of the carrier and the sample of the in vitro biological sample can be compared with the total weight qualified range of the sample and the carrier in the preset quality testing qualified standard to determine the quality testing result.

In some embodiments, the quality acceptance criteria include sample acceptance criteria for one or more sample types. For example, the qualified ranges corresponding to the quality control parameters are set for different types of samples, and when determining whether the quality control result is qualified based on the quality control data, the type of the sample can be determined based on the order information of the biological in-vitro sample, and the quality control data is compared with the qualified label of the sample corresponding to the type of the sample to obtain the quality control result.

When the detection items or subsequent processing operations corresponding to the in vitro biological samples are different and the requirements for the quality of the samples meeting the standard are different, the specific quality inspection modes performed on the samples before analysis may be different, and the quality inspection rules and the quality inspection methods determined based on the detection requirements, such as methods for determining the amount of the samples, such as weighing, sample volume identification, and the like. The quality inspection device 13 is configured to perform quality inspection of the pre-analysis bio-ex-vivo sample based on a quality inspection rule. The detection items include, for example, conventional pathological detection, qPCR (Quantitative PCR), nucleic acid molecular hybridization such as FISH (Fluorescence in situ hybridization), Sanger, biochip, NGS (Next generation sequencing), mass spectrometry, and the like, and the subsequent processing operations include, for example, nucleic acid extraction, protein purification, and the like.

In some embodiments, the quality inspection device 13 includes a weighing device for detecting the weight of the ex-vivo biological sample, and comparing the detected weight of the ex-vivo biological sample with the quality inspection standard of the quality inspection management system 2 to generate the quality inspection result. For example, in the embodiment shown in fig. 2, the quality inspection device 13 includes a weighing device, and a corresponding weighing station is provided in the quality inspection work area. The weighing device is used for determining the sample volume, and in some examples, the determination of the liquid volume can be performed by other devices, such as visual identification to determine the sample volume. The application provides an embodiment for determining the sample size by weighing, and the sample size can be determined by weighing the sample and the carrier thereof, so that the infection of the sample caused by the process of determining the sample size is avoided. The weighing device has a measurement accuracy, in one example, within ± 0.01g to ensure accurate detection of the sample size.

In some examples, the weighing device has a position-limiting structure 130 for placing the carrier of the biological ex-vivo sample, for example, in the embodiment shown in fig. 2, the position-limiting structure 130 for placing the carrier of the biological ex-vivo sample is configured in the weighing device, thereby achieving accurate placement of the carrier of the biological ex-vivo sample on the weighing device to ensure that the carrier is stably placed at the preset position. The stop structure may be configured to match the geometry of the carrier of the biological sample, for example, when the carrier of the biological sample is a test tube type container, and correspondingly, the stop structure 130 is, for example, a cylinder structure or a groove structure matching the size of the test tube.

In some examples, when the device for determining the amount of the sample is a volume measuring device, a device with a preset volume measuring accuracy may be configured, for example, the volume measuring accuracy is within ± 0.05 ml.

In some scenarios, different types of biological samples are included in the samples to be tested in the operating state of the quality control apparatus 1. The quality standard of the liquid amount is different when the initial amount of detection required in the analysis may be different corresponding to different liquid types of the biological in vitro samples. In some embodiments, the quality inspection device 13 performs quality inspection on the bio-sample to obtain quality inspection data, and compares the quality inspection data with a quality inspection qualification standard corresponding to a liquid type of the bio-sample to generate a quality inspection result. Wherein the fluid type of the ex-vivo biological sample can be determined by the quality control management system 2, for example, the fluid type of the ex-vivo biological sample is obtained during the collection phase of the sample, and the fluid type information is stored in the quality control management system 2. Based on different types of sample liquid, the quality inspection qualified standard of the sample under the corresponding liquid type is determined, for example, the standard weight (or volume) intervals corresponding to different types of sample liquid are different, the quality inspection device 13 performs weighing or volume inspection on the bio-ionic sample, and compares the inspection result with the standard weight or volume corresponding to the liquid type to generate the quality inspection result. In some examples, the corresponding standard weights (or volumes) of the bio-ex vivo samples of different liquid types may also be the same.

After the quality inspection device 13 obtains the quality inspection data, a quality inspection result can be generated based on the quality inspection data, and the quality inspection management system 2 associates the quality inspection result with identity information. Wherein, the quality inspection result may be generated by the quality inspection control device 1 or the quality inspection management system 2; the quality inspection device 13 is configured to obtain quality inspection data of the bio-analyte sample, and in an example, after the quality inspection control device 1 receives the quality inspection rule, it may determine whether the quality inspection data meets a quality inspection qualified standard based on the quality inspection rule to generate a quality inspection result; in another example, the quality control apparatus 1 transmits the quality inspection data detected by the quality inspection device 13 to the quality inspection management system 2, and the quality inspection management system 2 determines whether the detected data meets the quality inspection qualified standard to generate a quality inspection result.

In some examples, the identity information has a correspondence with order information of the bio-ex vivo sample, e.g., the identity information may serve as an index for retrieving orders in an order system. In an implementation manner, the quality inspection management system 2 associates the quality inspection result with the identity information, or associates the quality inspection result with the order information of the biological in-vitro sample, and associates the quality inspection result with the identity information by using the corresponding relationship between the order information and the identity information. And after the quality inspection result of the biological in-vitro sample is determined, the subsequent transport region of the biological in-vitro sample can be determined. In some examples, the biological in-vitro sample can be transported to a qualified product placement area after the quality inspection of the biological in-vitro sample is determined to be qualified, and the biological in-vitro sample is transported to a collection area for placing the unqualified sample when the quality inspection of the biological in-vitro sample is determined to be unqualified.

In some embodiments, the communication device is configured to receive identity information of the ex-vivo biological sample from the quality control management system 2; please refer to fig. 3, which is a schematic device layout diagram of the quality inspection control apparatus according to another embodiment of the present application. As shown in the figure, the quality control device 1 further comprises an identification means 15 for identifying the identity information on the carrier of the bio-isolated sample.

In the embodiment shown in fig. 3, after the order information identification and quality inspection of the bio-ex-vivo samples are completed, the bio-ex-vivo samples are transported to a subsequent checking device, for example, a testing device for analysis, that is, the bio-ex-vivo samples are transferred to another analysis environment, and in a different analysis environment, the identity information of the bio-ex-vivo samples is checked in order to identify the required testing operation for each bio-ex-vivo sample or to correlate the analysis result to the order information of the bio-ex-vivo samples. Generally speaking, the traceability information in the order information may be used as an identity information, but when the analysis environment sets an identity information format or rule for the biological in-vitro sample, the identity information of the biological in-vitro sample needs to be identified on the carrier according to the identity information format in the analysis environment.

In some examples, the identity information is information obtained by converting order information of the biological in-vitro sample into a certain format, for example, converting sample type information in the order information into codes and symbols by words, converting traceability information of the order information into information codes, and the like.

In a possible implementation manner, the identification of the identity information of the ex-vivo biological sample may be performed after the ex-vivo biological sample is delivered to an analysis environment, for example, order information of a load of the ex-vivo biological sample is identified in the analysis environment, and the identity information corresponding to the order information is identified on a carrier of the ex-vivo biological sample.

Here, the present application provides an embodiment in which the quality control device 1 identifies the identity information of the carrier of the biological in-vitro sample, and by means of the order information determined in the detection process, the identification device 15 can directly identify the identity information corresponding to the order information on the carrier of the biological in-vitro sample, so that the whole-process transfer efficiency of the medical examination based on the sample can be improved, and the repeated examination of the information is avoided.

In some embodiments, the information identified on the carrier of the biological ex-vivo sample by the identification device 15 includes number information, wherein the number information is number information acquired from the quality control system 2 or number information generated based on the information acquired from the quality control system 2.

In certain embodiments, the identity information of the ex-vivo biological sample obtained from the quality control management system 2 includes numbering information determined by the quality control management system 2 based on numbering rules. Under the numbering rule, the identity information and the numbering information can be set to be unique, so that each piece of numbering information has uniquely corresponding order information, and the order information corresponding to the biological in-vitro sample and the detection result obtained in the advanced detection process can be determined based on the identity information.

The numbering rule may be in an identity information format corresponding to the detection system configured in the analysis environment, and in the detection system, the analysis process to be performed on the sample may be determined by reading the identity information identified on the carrier of the in vitro biological sample. The numbering rule may be determined by the quality inspection management system 2, in an actual scenario, the quality inspection management system 2 may be, for example, a management system of a detection system configured in the analysis environment, or the quality inspection management system 2 is in communication connection with the detection system configured in the analysis environment, when the quality inspection management system 2 determines an identity information format for identifying a sample in a subsequent analysis environment or other sample processing operations, the numbering rule may be formed based on the identity information format, the numbering information corresponding to the sample is determined for the biological sample based on the numbering rule, and the quality inspection control device 1 in communication connection with the quality inspection management system 2 may identify the numbering information on the carrier of the biological sample.

In some embodiments, the number information is number information generated based on information acquired from the quality inspection management system 2. For example, the quality inspection system obtains pre-stored information, such as the traceability information of the sample, from the quality inspection management system 2 which is in communication connection with the quality inspection system. Order number information, and the like, and forming a number based on the acquired information according to a certain numbering rule. For another example, the number may also be used to represent information such as the number of samples, the types of samples, and detection items, so that when the number information is read, for example, in a subsequent analysis environment, the detection item information, the sample information, and the like corresponding to the samples may be clarified by reading the number information.

In some embodiments, the number information is formed in a manner including any one of:

in one implementation, the identity information is based on a number field of a predetermined format, which is characterized by a preset number rule in the quality inspection management system 2. The preset numbering rule is, for example, a numbering rule configured in the quality inspection management system 2, that is, the numbering rule is determined by the quality inspection management system 2, and the quality inspection management system 2 may determine information to be used for numbering in pre-stored order information such as sample type, sample number, sample collection time, detection item information, and the like, and form a field of numbering information to be identified based on the numbering rule. The number field of the predetermined format determines the number length and the number of the representation form, for example, a number with a certain length, for example, by the quality inspection management system 2; when the numbering rule includes a classification rule, the numbering field of the predetermined format is, for example, a field characterizing the sample type as a number or a letter, in which case the same sample type field is present in the numbering corresponding to the ex-vivo biological samples of the same sample type, and the sample type of the ex-vivo biological sample can be determined in the subsequent transport by identifying the sample type field in the identifier attached to the carrier. That is, in some embodiments, the number field is associated with shunting information of the bio-ex-vivo sample, which may be used, for example, to determine whether the bio-ex-vivo sample is qualified and a qualified type or an unqualified type, such that shunting information of the bio-ex-vivo sample may be determined based on the number field, for example, placement location information based on a subsequent pending procedure or a determination of a target area to be shunted.

In another implementation, a numbering rule that determines the identity information is customized to determine the number fields used to form the numbering information. In this example, the information for numbering and the numbering rule of the information may be selected in a customized manner, for example, an operator may set the numbering rule in a customized manner based on the information acquired by the quality inspection control device 1, and for each biological in-vitro sample, the identity information of the biological in-vitro sample is represented as a numbering field under the customized numbering rule to obtain the numbering information of the biological in-vitro sample.

In certain embodiments, the identification means 15 generates (prints) a label based on the identity information and marks the label on the carrier of the bio-ex vivo sample. The label can be used as a carrier of the identity information, for example, when the identity information is number information, the label can be a label with number content, and the identity information can be determined by reading the label; or, the label is associated with the identity information, and when the label is identified by the external device, the corresponding identity information can be obtained.

In an implementation, the identification device 15 may print a label associated with the identity information generated based on the identity information acquired from the quality control management system 2, for example, and attach the printed label to a carrier of the biological in-vitro sample. The process of generating the electronic label to be printed based on the identity information may be performed by the quality inspection management system 2 or the quality inspection control device 1, and the identification device 15 prints the label based on the electronic label and attaches the label to the carrier of the biological in-vitro sample.

For example, in the embodiment shown in fig. 3, a label printer 150 for generating labels and a labeling station for performing label attachment are provided in the quality control workbench 10. In an embodiment, the labeling assembly 150 is disposed in the identification device 15, and the carrier of the in-vitro biological sample is placed in the labeling position shown in the figure, so that the labeling assembly 150 can perform the operation of attaching the label to the carrier. Of course, the structure and layout of the equipment for realizing the labeling function can be changed.

As shown in fig. 3, the identification device 15 has a labeling assembly 150, in a working scenario, the transfer device 11 transfers the carrier of the in-vitro biological sample to a labeling site, the labeling site may further be configured with a positioning structure for placing the carrier of the in-vitro biological sample, and the labeling assembly 150 may label the carrier of the in-vitro biological sample placed in the labeling site.

In some examples, the identification device 15 may generate a label according to a predetermined standard and mark the label at a predetermined position of the carrier of the biological ex-vivo sample. In a specific use, the content and format of the predetermined label, such as a printed label, can be adjusted according to requirements, wherein the content of the label can be the content determined by the quality inspection management system 2, and the format of the label can be customized based on the printing requirement or determined by the quality inspection management system 2; alternatively or additionally, the content of the tag is determined by the quality control system. When the label is marked on the carrier of the biological in-vitro sample, the label can be attached to the carrier at a preset position based on the preset labeling requirement. For example, the labeling requirements may include an upper position and a lower position of the label on the carrier, such as a distance from the bottom of the carrier, an application direction of the label, such as a vertical direction or a horizontal direction, and a label flatness (e.g., flatness of the applied label, such as whether the applied label has wrinkles or whether bubbles affect subsequent identification) associated with an identification rate of the label, and the like. In some examples, when multiple labels are required to be attached to the carrier of the same biological isolated sample, the labeling requirement may further include a requirement for the positional relationship of the attachment between the multiple labels, for example, the multiple labels are required to be attached in a non-overlapping state before.

The material of the label can be determined according to the subsequent storage requirement or the detection environment requirement of the biological in-vitro sample, for example, in one example, the label is synthetic paper or coated paper. Please refer to fig. 4a and 4b, wherein fig. 4a is a schematic diagram illustrating a label style in an embodiment of the present application; FIG. 4b is a schematic view of another embodiment of the present application showing a label style; FIG. 4c is a schematic view of a labeled test tube format of the present application in one embodiment; the label is in a label mode as shown in fig. 4a or fig. 4b, the distance between labels on the label paper in fig. 4a is 2mm, and the label paper is made of Elite PET synthetic paper; the width of the label paper in fig. 4a and 4b is 27mm, the distance between the labels on the label paper in fig. 4b is 3mm, and the label is made of alli coated paper; in an embodiment, each label in the label paper has a size of 24mm × 15mm, and the information contained therein is, for example, an order code or a management code, a test item, a patient name, and the like (the identity information described in the foregoing embodiment can be referred to in detail). In an example, after the information associated with the tag is correctly identified, the tag may be docked with the quality inspection management system 2, so as to complete matching of the information, so as to determine that the order information of the biological in-vitro sample is correct for performing a subsequent detection process. In this example, the information carrier, such as a barcode or a two-dimensional code, attached to the carrier, such as a blood collection tube, is shown in fig. 4c, and fig. 4c is a schematic diagram of the information carrier attached to the carrier, such as a blood collection tube, in an embodiment of the present application.

In some embodiments, the quality control apparatus 1 further comprises a marker verification device (not shown) for identifying the label to determine the position of the marker on the carrier of the biological ex-vivo sample; or the tag is used for identifying the tag to obtain identity information corresponding to the tag or/and quality control information associated with the identity information.

In one example, the label verifying device is configured to determine whether the identification device 15 attaches a label to the carrier of the in-vitro biological sample according to a predetermined labeling requirement, and when it is determined that the labeling position of the identification device 15 meets the labeling requirement, the carrier of the in-vitro biological sample with the identification information being completed can be transferred to a next working area or a transportation area 101 determined according to the detection process; or, when the label verifying device determines that the labeling position of the identification device 15 does not meet the labeling requirement, the identification information is determined to be unqualified, and in some examples, the transfer device 11 transfers the biological in-vitro sample with unqualified identification information to the identification error area in the quality inspection workbench 10.

In an example, the tag verification device may be further configured to identify the tag to obtain identity information corresponding to the tag or/and quality control information associated with the identity information. The label verifying device can determine whether the labeled identity information can be identified and whether the identified content is consistent with the preset identity information content through identifying the identity information corresponding to the label. For example, the tag verification device recognizes the tag to obtain identity information, compares the obtained identity information with the identity information identified by the identification device 15, and determines that the identity information is incorrect when the two contents cannot be matched.

In some embodiments, the tag verification device may be further configured to identify the tag to determine quality inspection information associated with the identity information, for example, the identity information identification operation on the carrier of the biological sample is performed after the quality inspection operation, so that the tag verification device can verify whether the association between the identity information and the quality inspection information is correct, and thus, whether there is a case where the identity information corresponding to the tag is identified as another identity information can be verified. In some scenarios, the bio-ex-vivo sample may also be placed in sections by identifying the tag with the obtained quality inspection information. The quality inspection information and the identity information are associated, for example, in a manner that the identity information and the order information have a corresponding relationship, the quality inspection information and the order information are associated, and the quality inspection information and the identity information are associated by the order information.

In some embodiments, the marker verification device comprises a visual recognition device 12. The visual recognition device 12 determines whether the label position meets the labeling requirement or whether the identity information content corresponding to the label can be correctly read, for example, by an image recognition method. The visual recognition device 12 includes, for example, an image acquisition device such as a camera and an image analysis device such as a processor and a text recognition module; in some examples, the visual recognition device 12 in the quality inspection control apparatus 1 may be configured to include only the image acquisition device, and to perform the recognition process by transmitting the acquired image to the image analysis device of another terminal and acquiring the analysis result determined by the image analysis device.

In some embodiments, the way that the tag verifying device identifies the tag to determine the location of the tag or determine whether the tag-related information is correct can be set as a sampling form, for example, the carrier of the biological isolated sample to be sampled can be determined according to a preset rule such as a certain number interval or a time interval. In an implementation scene, a carrier of a biological in-vitro sample which does not need to be marked and verified can be placed in a corresponding qualified product area or a corresponding unqualified product area after order information identification, quality inspection and identification operations are carried out on the carrier; the carrier of the biological in-vitro sample needing the marking verification is subjected to order information identification, quality inspection and identification operation, then the marking verification (namely the verification of the identity information identification) is carried out, and the carrier of the biological in-vitro sample is shunted based on the marking verification result.

In some embodiments, after the biological sample to be tested is conveyed to the quality inspection workbench 10, the recognition device 12, the quality inspection device 13 and the identification device 15 sequentially perform recognition, quality inspection and identification operations on the biological sample. In some examples, the detection process in the quality inspection workbench 10 is to perform order information identification on a biological in-vitro sample to be inspected, then perform quality inspection operation, and then perform identity information identification operation after the quality inspection operation is finished; or, the detection process in the quality inspection workbench 10 is to perform order information identification on the biological in-vitro sample to be inspected, then perform identity information identification, and then perform quality inspection operation.

In one implementation, the identification of the identity information of the bio-in-vitro sample can be performed before the identification of the order information, but in the embodiment of performing the identification of the order information in advance, the quality inspection management system 2 can determine the association relationship between the identity information and the order information in advance, so that the quality inspection control device 1 identifies the identity information corresponding to the order information on the carrier of the bio-in-vitro sample.

In some examples, the detection process in the quality inspection workbench 10 is to perform order information identification on the biological in-vitro sample to be detected, perform first shunt placement on the biological in-vitro sample based on the identification result of the order information, that is, transfer the biological in-vitro sample with order information qualified for inspection to the next detection working area, such as the quality inspection device 13, and transfer the biological in-vitro sample with order information unqualified for inspection to the collection area for placing the unqualified sample; performing quality inspection and identity information identification on the biological in-vitro samples qualified in order information verification, and then performing secondary distribution placement; the biological in-vitro samples with unqualified quality inspection results or wrong identity information can be transferred to the corresponding collecting regions, and the biological in-vitro samples with qualified quality inspection results and correct identity information identifications are transferred to the qualified product placing regions.

The operation procedures in the detection process can be adjusted according to the use requirement, and in some implementations, when the displacement range of the transfer device 11 includes each working area, the adjustment or modification of the detection process can be implemented according to the instruction control of the transfer device 11 and the recognition device 12, the identification device 15 and the quality inspection device 13. The actual processing flow of the sample in the quality inspection workbench 10 can be changed by changing the detection flow determined by the control management system or changing the detection flow preset in the quality inspection control device 1.

In some embodiments, after the biological in-vitro sample to be detected is conveyed to the quality inspection workbench 10, the identification device 12, the quality inspection device 13, and the identification device 15 sequentially perform identification, quality inspection, and identification operations on the biological in-vitro sample, wherein the identification device 15 marks a label generated based on the identity information and the quality inspection result of the biological in-vitro sample on a carrier of the biological in-vitro sample.

In some embodiments, when the identity information is identified on the carrier of the biological ex-vivo sample, the order information of the biological ex-vivo sample and the information obtained in the preceding order information identification and quality inspection can be identified on the carrier of the biological ex-vivo sample together, so as to assist in the second shunting of the biological ex-vivo sample.

After the order information recognition, quality inspection and identification information identification of the bio-ex sample are completed in the quality inspection workbench 10, the second shunting of the bio-ex sample may be performed, in some examples, the second shunting of the bio-ex sample may be, for example, transferring the bio-ex sample determined to be unqualified to the collection area 103 corresponding to the unqualified product, and transferring the qualified product in which each quality inspection control process is completed in the working area 100 to the corresponding placement area, and by identifying the information obtained in the preceding order information recognition and quality inspection on the carrier of the bio-ex sample, when the label attached to the carrier of the bio-ex sample is recognized, the transfer area of the bio-ex sample may be determined, and the second shunting of the bio-ex sample may be assisted.

In some examples, when the placement area for the non-defective products is configured to include a plurality of areas for respectively placing the bio-ex-vivo samples of different non-defective types, or/and when the collection area 103 for the non-defective products includes a plurality of areas for respectively placing the bio-ex-vivo samples of different non-defective types, the label generated by the identification device 15 can also be used to characterize the non-defective type or/and the non-defective type of the bio-ex-vivo sample. For example, by characterizing the eligibility type as a suffix field or other field of numbering information in the tag, the next placement area for the bio-ionic sample can be determined upon identification of the tag.

In one scenario, before labeling the biological in-vitro sample, the biological in-vitro sample with wrong quantity information is recorded and transferred to the collection area 103 of the corresponding sample with wrong quantity after labeling, the biological in-vitro sample with unqualified quality inspection result is recorded and transferred to the collection area 103 of the corresponding sample with wrong quality inspection after labeling, the biological in-vitro sample with qualified order information and quality inspection result is labeled and verified after labeling, the biological in-vitro sample with correct labeling and verification result is transferred to the placement area for placing the qualified product, and the biological in-vitro sample with wrong verification result is transferred to the collection area 103 with corresponding wrong labeling (or wrong identity information).

In some embodiments of the quality control apparatus 1 provided by the present application, the carrier of the in-vitro biological sample may be further configured to undergo three shunting judgments, wherein each shunting judgment includes a determination process for a next to-be-flowed region, for example, a first shunting process is performed on the carrier of the in-vitro biological sample based on a verification result of the order information, and the carrier of the in-vitro biological sample with qualified order information is transported to a next to-be-detected station; after order information identification, quality inspection and identity information identification of the bio-in-vitro sample are completed in the quality inspection workbench 10, second shunting processing of the bio-in-vitro sample can be executed, carriers of the bio-in-vitro sample with unqualified quality inspection results are transferred to corresponding placement areas, marking and checking are carried out on the order information and the carriers of the bio-in-vitro sample with qualified quality inspection, third shunting judgment is carried out based on the marking and checking results, namely the carriers of the bio-in-vitro sample with qualified marking and checking results are transferred to corresponding qualified areas, and the carriers of the bio-in-vitro sample with unqualified marking and checking results are transferred to corresponding unqualified placement areas.

In some embodiments, the quality control workstation 10 further comprises at least one non-defective placement area 104 for placing a biological ex vivo sample that is qualified for testing. In some embodiments, after each testing operation, such as identifying order information and quality testing, is completed on the bio-specimen sample in the quality testing station 10, the bio-specimen sample is determined to be a qualified product and then placed in the corresponding qualified product placement area 104. The quality inspection workbench 10 may be provided with one or more qualified product placement areas 104, which may be specifically determined based on the need for placing qualified products, for example, one qualified product placement area 104 may be provided in the quality inspection workbench 10 to place biological in-vitro samples qualified for inspection in the qualified product placement area 104; also, for example, a plurality of non-defective product placement areas 104 may be provided in the quality control workbench 10 for placing different types of non-defective products. Wherein the number of the non-defective placement areas 104 may be determined based on whether non-defective products of the bio-ex vivo sample are placed on a category-based partition basis.

For example, when the biological in-vitro sample qualified for detection is not placed in a classified manner, the corresponding qualified product placement area 104 is one, and therefore, the qualified product placement area 104 is not necessarily a continuous area, and may be a plurality of partitions, for example; in some embodiments, the specimen of the biological ex-vivo sample is classified without depending on location, for example, based on identification such as a label, an information code, a number, etc., in which case the specimen housing area 104 may be regarded as one in number; alternatively, when the samples of the biological samples are all regarded as the same type of qualified product, the qualified product placement area 104 is regarded as one in number.

In some embodiments, the at least one non-defective placement area 104 is disposed in the transportation area 101, and the transportation device 14 transports the ex-vivo biological sample from the non-defective placement area 104 to the quality control platform 10.

The at least one qualified product placement area 104 is disposed in the conveying area 101, after a series of detection processes of the biological in-vitro sample are completed in the quality inspection workbench 10, the carrier of the biological in-vitro sample determined to be qualified for detection is placed in the qualified product placement area 104, and the conveying device 14 can subsequently convey the carrier of the biological in-vitro sample out of the quality inspection workbench 10.

Of course, in other embodiments, the non-defective placement area 104 may be placed in a manually blankeable area.

In some embodiments, the quality control workstation 10 has a plurality of non-defective placement areas 104, and the plurality of non-defective placement areas 104 are used for placing different types of non-defective biological samples determined according to a predetermined classification rule.

In some embodiments, the number of the at least one qualified product placement region 104 corresponds to the number of qualified product categories, which are determined according to a predetermined classification rule, which may be a fixed rule or a user-defined rule.

In an implementation scenario, the at least one qualified product placement area 104 includes a first qualified product placement area, a second qualified product placement area, and a third qualified product placement area, which are respectively used for placing the first qualified product, the second qualified product, and the third qualified product determined according to the preset classification rule. Of course, the classification of the qualified products is not limited to the classification into three categories, and correspondingly, the qualified product placement region 104 is not necessarily limited to three or three categories of qualified product placement regions, for example, six categories or eight categories, but is not limited thereto, for example, in the embodiment shown in fig. 2, a plurality of qualified product placement regions are also provided in the quality inspection workbench 10. In an actual application scenario, the qualified product placement area 104 may set different numbers or types of areas for the classification of the qualified products according to different rule requirements.

In some scenes, the living body separated samples qualified for detection are placed in a classified manner, so that qualified products of the living body separated samples of different types can be classified and processed, for example, the living body separated samples of different types are blanked to different areas, and then different types of detection items are performed on the living body separated samples.

In some embodiments, the classification rules are obtained from the quality control management system 2 or defined according to information obtained from the quality control management system 2. The classification rules are used for classifying qualified products of the biological in-vitro samples into different categories so as to carry out different subsequent treatments on the biological in-vitro samples of different categories.

The classification manner of the qualified products of the biological in-vitro sample may be customized by acquiring information from the quality inspection management system 2, for example, the quality inspection management device customizes and determines key information for distinguishing the types of the qualified products, and acquires the key information from the quality inspection management system 2 to form a classification rule; alternatively, the quality inspection management system 2 determines a classification rule, for example, a classification rule for a non-defective product is established in the quality inspection management system 2, and the quality inspection management apparatus receives the classification rule determined by the quality inspection management system 2 to place the non-defective product in a partition. For example, the classification rule may be to distinguish between corresponding test items, test devices, or sample types in subsequent tests of the bio-isolated sample.

For example, the classification rule is, for example, based on the subsequent processing method to be performed on the sample, for example, when the biological in-vitro sample is a liquid sample to be centrifuged, and the centrifugation manner required for different samples is different, the samples need to be classified and transferred to the processing positions of the corresponding centrifugation processes. The conveying area 101 in the quality inspection workbench 10 is disposed in the conveying device 14, in the illustrated embodiment, eight types of qualified product placement areas are configured in the conveying area 101, wherein different types of qualified products are distinguished according to the carrier specification of the biological in-vitro sample, and the subsequent processing procedure or processing equipment, such as a centrifugation method, for example, determined by different centrifugation procedures, and the carrier specification is, for example, Streck blood collection tubes, Faclon centrifuge tubes, etc. with different materials or volumes. As yet another example, classification rules may also be defined for sample characteristics such as sample volume (weight scale), sample type, and the like.

In some embodiments, after the classification rule is used for classifying the qualified product, the processing of the biological in-vitro sample may be to attach a label, assign a number, and the like to a carrier of the biological in-vitro sample, in addition to the above-described partitioned placement.

In one scenario, the classification rule may also be, for example, a predetermined label or field, for example, to characterize the sample type and the detection item information of the in-vitro biological sample as a field, in an implementation manner, for example, the in-vitro biological sample with the same field value is determined as the same qualified type, for each in-vitro biological sample, the field value is determined based on the sample type and the detection item information, and when the in-vitro biological sample that is qualified for detection is placed in the qualified area, the qualified type of the in-vitro biological sample is determined by obtaining the field information, so that the in-vitro biological sample is transferred to the corresponding qualified product placement area 104.

In certain examples, as in the previous embodiments, before the second shunting of the bio-ex-vivo sample, its corresponding eligibility type may be characterized by the marking of the identification means 15 on the carrier of said bio-ex-vivo sample. In some embodiments, the non-defective product placement area 104 is provided with an information code associated with the non-defective category corresponding to the non-defective product placement area 104. The information code may be provided on the carrier 3 of the carrier for loading the biological ex-vivo sample in the non-defective product placement area 104, for example, and after the carrier 3 in the non-defective product placement area 104 is transferred out of the quality inspection workbench 10, the non-defective type of the biological ex-vivo sample loaded in the carrier 3 may be determined by identifying the information code on the carrier 3. The information code is, for example, a bar code or a two-dimensional code.

In some scenarios, after the carriers 3 in the qualified product placement area 104 are transferred out of the quality control workbench 10, the carriers of the biological in-vitro samples loaded on the carriers 3 are blanked, and after the blanking is finished, the carriers 3 are transferred to the storage areas of the carriers 3 corresponding to the qualified categories. In this process, the information code loaded on the empty vehicle 3 can also be identified again to determine its corresponding qualified category.

In some embodiments, a screening area 105 is further disposed in the quality inspection workbench 10 for placing a carrier of a biological isolated sample to be inspected. By placing the biological in-vitro sample to be detected in the screening area 105 of the quality inspection workbench 10, the transfer device 11 can obtain the biological in-vitro sample from the screening area 105 for detection. It should be understood that the type of sample deposited in the screening area 105 is not limited to blood.

In some embodiments, when the quality testing platform 10 is provided with a placement area for placing the bio-sample that has been subjected to the testing process or has performed a certain testing operation, such as the qualified product placement area 104 described in the previous embodiments, the bio-sample that has been tested can be distinguished from the bio-sample that has not been tested based on the placement area by placing the bio-sample to be tested in the screening area 105.

In some embodiments, the screening area 105 is located in the transport area 101, and the transport device 14 transports carriers of biological ex-vivo samples to be tested from the loading area 106 to the screening area 105, or transports carriers 3 empty in the screening area 105 to the loading area 106.

By arranging the screening area 105 in the transportation area 101, automatic feeding of the biological ex-vivo samples to be detected can be realized, for example, in one case, the conveying device 14 conveys the biological ex-vivo samples to the screening area 105, and the transfer device 11 obtains the biological ex-vivo samples from the screening area 105 to convey the biological ex-vivo samples to each working area for detection; alternatively, the empty carriers 3 in the screening area 105 can be transported to the loading area 106 by the transporting device 14 or the carriers 3 in the screening area 105 can be transported to the qualified product placing area 104 in the quality inspection workbench 10, thereby realizing the reuse of the carriers 3. In the embodiments of the present application, the terms "empty carrier" or "empty carrier" are used to describe a carrier 3 that does not carry a biological ex-vivo sample.

Of course, in some scenarios, the conveying device 14 can simultaneously perform the above two functions, that is, conveying the carrier of the biological in-vitro template to be detected from the loading area 106 to the screening area 105, and conveying the empty carrier 3 in the screening area 105 to the loading area 106, so as to realize the recycling of the carrier 3.

In some embodiments, the quality control workstation 10 further comprises at least one collection region 103 for placing the biological ex-vivo sample determined as failing to be detected. As described in the foregoing embodiment, when the quality control apparatus 1 processes the bio-isolated sample based on the quality control process, the bio-isolated sample is split for the first time and split for the second time to place the unqualified sample and the qualified sample determined in the test in a partition manner. The collecting region 103 is used for placing unqualified biological in-vitro samples, so that the qualified biological in-vitro samples and the unqualified biological in-vitro samples can be distinguished in regions, and the subsequent treatment corresponding to the qualified biological in-vitro samples is conveniently carried out.

In certain embodiments, the detecting failure comprises at least one of the order information, identity information, and quality inspection results being failed; the collection area 103 comprises at least one of a code scanning error area for placing the biological in-vitro sample with wrong order information or wrong quantity information, a liquid quantity error area for placing the biological in-vitro sample with wrong quality inspection result, and an identification error area for placing the biological in-vitro sample with wrong identity information.

The standard for determining whether the biological in-vitro sample is qualified or not can be customized, for example, the quality control system 2 defines the qualified standard, or the quality control device 1 establishes the qualified standard after acquiring information from the quality control system 2; the quality inspection control device 1 detects the biological sample to obtain the detection information to determine whether the detection information meets the qualification standard, so as to obtain the judgment result of whether the biological sample is qualified. In some embodiments, the detecting fails comprises failing at least one of the order information, identity information, and quality inspection results.

The order information is unqualified, for example, the order information loaded on the biological in-vitro sample and related to the order information cannot be identified or the order information obtained after identification cannot be matched with the pre-stored order information in the quality inspection management system 2, for example, the number of carriers does not match, the identity information in the order information does not match, the position where the information code is attached is wrong, and the like.

The unqualified identity information includes, for example, an error in the position of label attachment related to the identity information, an error in format, and an error in association between the identity information and other information, for example, a mismatch between the order information obtained by the quality inspection control device 1 by inspecting the same bio-sample and the corresponding relationship between the identity information and the order information and the identity information in the quality inspection control system.

The quality inspection result is not qualified, for example, the result obtained by performing the quality inspection on the biological sample does not meet the quality inspection qualified standard.

The at least one collection area 103 is used for placing the biological in-vitro sample determined to be unqualified for detection, and the collection area 103 comprises at least one of a code scanning error area or a quantity information error area for placing the biological in-vitro sample with wrong order information, a liquid quantity error area for placing the biological in-vitro sample with wrong quality detection result, and an identification error area for placing the biological in-vitro sample with wrong identity information.

Referring to fig. 5, a schematic view of a collection area of a quality inspection stage of the quality inspection control apparatus according to an embodiment of the present invention is shown. As shown in the figure, the collection area 103 is divided according to the type of the defect, for example, when the order information of the biological ex-vivo sample is detected to be wrong, the biological ex-vivo sample is placed in the code scanning error area 1031 or the quantity information error area 1033 according to the wrong category; the sample placed in the code scanning error zone 1031 is, for example, a sample that cannot obtain corresponding order information after identifying an information code loaded on a carrier of the biological in-vitro sample, or a position error of the information code load is identified, and a matching error between the obtained order information and information in pre-stored order information is detected; the number of the samples, for example, carriers of the in-vitro biological sample in actual detection, placed in the number information error area 1033 is not matched with the number of the carriers in the order information pre-stored by the quality inspection management system 2, for example, the number of the carriers of the in-vitro biological sample corresponding to a certain user in the pre-stored order information is 2, and the number of the in-vitro biological samples corresponding to the order information detected by the quality inspection control device 1 is 1, which is considered as a mismatch condition.

The sample placed in the liquid volume error zone 1032 is, for example, a biological isolated sample whose weight is determined to be not in accordance with the standard weight interval after the quality inspection performed by the quality inspection device 13. The weight of the sample may also be expressed in terms of the volume of the sample, both to illustrate the amount of sample carried within the carrier. It should be noted that the quality inspection method for the bio-analyte sample is not limited to weight determination, and the specific quality inspection to be performed on the sample in the pre-analysis stage is different in different detection items, so that the liquid volume error zone 1032 described in this application can be adapted to the requirements of the application scenario in some embodiments, and can also be used as other types of placement zones, such as a placement zone for hemolyzed sample, a sample placement zone with an incorrect volume, and the like.

The sample placed corresponding to the identification error area (not identified in fig. 5) for placing the biological in-vitro sample with the wrong identity information is a sample with unqualified identity information, and the unqualified identity information is, for example, the marking mode of the information carrier corresponding to the identity information does not meet the preset marking rule, the content of the identity information is wrong, and the like.

It should be noted that, in practical applications, when the specific quality inspection rule and the specific identification method for the bio-in-vitro sample are changed and the corresponding qualification standards of the sample are different, the error type of the bio-in-vitro sample placed in the collection region 103 is also changed, and the invention is not limited to the above embodiments. In another embodiment, the carriers in the collection region 103 do not define different error regions, and in use, the error types of the bio-ex vivo samples can be customized and the corresponding placement region of each error type of the bio-ex vivo samples can be determined.

In some embodiments, the collection area 103 further includes a spare area 1034, when a carrier of a certain unqualified collection area 103, such as the code scanning error area 1031, is unloaded and is not placed back to the carrier 3 in the code scanning error area 1031, the unqualified sample with the code scanning error in the detection can be placed in the spare area 1034, so that the normal operation of the detection process can be ensured, and the waiting time can be avoided.

In some embodiments, each of the plurality of collection regions 103 has a different identifiable designation, each designation characterizing a rejected type of collection region 103.

It should be understood that when the quality inspection control apparatus 1 has a plurality of collection areas 103 therein for placing different types of rejects, respectively, the plurality of rejection areas should be identifiable to enable placing of rejects in corresponding areas based on the type of reject when they are detected. In some embodiments, the biological isolated sample determined as being unqualified for detection is placed in the corresponding collection area 103 by the transfer device 11, the plurality of collection areas 103 correspond to different location areas, and the different marks can be regarded as different coordinates (areas) corresponding to the plurality of collection areas 103, and the transfer device 11 achieves the placement of the unqualified product based on the coordinates (areas).

In some embodiments, the plurality of collection zones 103 are identified by different markings so that different zones can be manually identified to facilitate the blanking and subsequent processing of particular types of rejects by an operator.

For example, in some embodiments, the indicia is formed by any one of:

in one embodiment, the marker is formed by the assigned placement bits and corresponding codes of the plurality of collection zones 103. In this embodiment, in order to distinguish the regions corresponding to the collection areas 103, codes are assigned to the collection areas 103 based on their assigned positions, and the reject types corresponding to the collection areas 103 can be determined by identifying the codes. Such as numbers, symbols, text, coordinates, matrices, etc. In scenarios where it is desirable to make the collection region 103 of the corresponding type manually identifiable, the code may be marked on the vehicle 3 of the vehicle within the collection region 103, for example by marking the code on the vehicle within the collection region 103.

In another embodiment, the indicia are formed by a plurality of collection regions 103 being set to different colors to create a color difference gradient between adjacent regions for machine vision identification or operator identification of the different regions. In the present embodiment, the color can be used as the mark of the collection area 103 by setting the collection areas 103 to have different colors so that a recognizable color difference gradient is formed between the collection areas 103, and the collection areas 103 can be distinguished in the plurality of collection areas 103 by recognizing the color of the collection area 103. In a scenario where a color difference gradient is formed between the collection areas 103, the transfer device 11 may be implemented to place the rejected sample in its corresponding collection area 103, for example, by visual recognition; in a scene of blanking unqualified products in the collection area 103, different collection areas 103 can be identified through colors, so that blanking processing of the collection area 103 with a specific unqualified type can be realized.

In yet another embodiment, the mark is formed by providing identifiable marks at the intersection of the plurality of collection areas 103, and the marks include at least one of a magnetic strip and a reflective strip. In some scenarios in the present embodiment, determining each of the collection areas 103 may be achieved by identifying the boundary of the collection area 103, and identifiable marks are disposed at the boundaries of a plurality of collection areas 103, such as magnetic strips, reflective strips, and the like, so as to distinguish the plurality of collection areas 103 by identifying the boundaries of the collection areas 103, thereby achieving correspondence of each collection area 103 to a reject type. The form of the mark is not limited to a magnetic stripe or a reflective stripe, and for example, a protrusion or a depression structure may be provided at the boundary of each collection area 103, so that the boundary between different collection areas 103 can be identified.

In each of the above examples, the identifier of the collection area 103 is used to establish the correspondence relationship between the collection area 103 and the type of the failure, and therefore, the present application is not limited to the specific presentation form of the identifier, only when the identifier is used to implement or assist in implementing the correspondence relationship between the collection area 103 and the type of the failure.

Referring to fig. 6a, a carrier in a collection area of the present application is shown in a schematic view with one embodiment removed. As shown, the collection zone 103 is provided with a displacement device 1030, the displacement device 1030 is used for arranging the carrier 3 of the carrier of the bio-ex-vivo sample, and the carrier 3 is moved to transport the unqualified carrier of the bio-ex-vivo sample out of the quality inspection workbench 10.

In some examples, in order to facilitate the blanking or the subsequent transportation of the ex-vivo sample in the collection area 103, a displacement device 1030 is disposed in the collection area 103, and the carrier 3 of the carrier of the ex-vivo sample is disposed in the displacement device 1030, so that the carrier 3 and the ex-vivo sample carried by the carrier can move out of the quality testing workbench 10 based on the degree of freedom formed by the displacement device 1030.

The displacement device 1030 may include, for example, a limiting structure and a driving mechanism for determining a displacement path, the carrier 3 is disposed on the limiting structure, and the driving mechanism drives the carrier 3 to move along the displacement path determined by the limiting structure, so that the carrier 3 in the collection area 103 can be transported. For example, in the embodiment shown in fig. 6a, the carrier 3 is moved by a rail-type displacement mechanism, i.e., can be moved out of the quality inspection workbench 10. In this embodiment, the limiting structure is, for example, a guide rail or a guide groove, and the driving mechanism includes, for example, a driving mechanism of a servo motor. Of course, in some cases, the driving mechanism is not necessarily configured, and the carrier 3 may be moved out of the quality inspection table 10 by manual work.

In some embodiments, when a plurality of collecting regions 103 are disposed in the quality inspection workbench 10, each collecting region 103 may be configured with a shifting mechanism, so that when any collecting region 103 is in a full-load state or other predetermined condition requiring blanking, the collecting region 103 can be blanked separately.

In some embodiments, the shifting device includes a rail mechanism disposed on the quality inspection workbench 10 and extending outside the quality inspection workbench 10 for disposing the carrier 3.

By means of the limiting effect of the guide rail mechanism, the carrier 3 arranged on the guide rail mechanism can move along the direction of the guide rail, the guide rail mechanism is arranged to extend out of the quality inspection workbench 10, and the carrier 3 can move out of the quality inspection workbench 10 to realize the blanking process.

In some embodiments, the collecting area 103 includes a storage station and at least one standby station, and the carriers 3 disposed on the storage station and the at least one standby station are respectively movable along the shifting device. The carrier 3 of the carrier of the biological isolated sample can be placed on each station of the storage station and the at least one standby station, and the carrier 3 on any station can be driven to move independently, or the loading or loading and unloading operation of the carrier 3 can be carried out independently on any station. As shown in fig. 6a, each collection area 103 comprises a storage station 103a and a standby station 103b, i.e. the two stations shown in fig. 6 a.

In practical operation, when any

station

103a or 103b in the collection area 103 corresponding to the same unqualified type is in a full-load state, such as a storage station, the station needs to be transferred out of the quality inspection workbench 10 for blanking, or when any station in the collection area 103 is transferred out of the quality inspection workbench 10 based on operation requirements, in the process, the quality inspection control device 1 can continue to perform sample detection and place the biological isolated sample determined to be unqualified in detection in another station, such as a standby station, of the collection area 103, so that detection time consumption for operations such as blanking of the collection area 103 and loading of the carrier 3 can be avoided, and the efficiency of the quality inspection control device 1 for automatically processing the sample can be further improved.

In some embodiments, the movement of the carrier 3 placed in the collection area 103 may be automatic, manual, or compatible with both of the automatic and manual movement; in practical operation, when the carriers 3 in the collecting area 103 are in a full-load state, that is, carriers of biological in-vitro samples are placed at all loading positions on the carriers 3, the carriers 3 can be automatically transferred out of the quality inspection workbench 10 to realize blanking of unqualified samples and supplement loading of empty carriers 3; in the implementation scenario of manually selecting the carrier 3 to be transferred, the operator may determine the transfer timing of the carrier 3, for example, when the carrier 3 is not fully loaded, the operator may select to transfer the carrier 3 out of the quality inspection workbench 10 to perform the subsequent unloading operation.

In some embodiments, the collecting region 103 is further configured with a sensing device (not shown) for detecting the carrier 3 to move the carrier 3 to a predetermined position. For example, the sensing device is a photoelectric sensor, and when the carrier 3 moves along the displacement mechanism, the photoelectric sensor can sense and determine whether the carrier 3 moves to a preset position, so as to achieve accurate positioning of the carrier 3.

In some embodiments, the sensor may also be a distance measuring sensor, and here, for example, the distance detecting direction of the distance measuring sensor may be set as the moving direction of the vehicle 3, and the distance measuring sensor may be, for example, an infrared distance measuring sensor, a laser distance sensor, an ultrasonic sensor, a radar sensor, and the like.

In some embodiments, when it is determined that the vehicle 3 moves to the preset position, the vehicle 3 may also be fixed such that the vehicle 3 is maintained at the preset position. For example, when the carrier 3 includes a material having ferromagnetic property, the carrier 3 can be locked and fixed at a predetermined position by a magnet.

In some embodiments, the detection process according to which the transfer device 11 transfers the carrier of the biological isolated sample is a detection process determined by the quality control system 2 or a detection process preset in the quality control device 1.

In another embodiment, the

storage stations

103a and 103b of the carriers in the collection area 103 can also be arranged in an upper-lower double-layer manner, for example, a lifting or lowering driving mechanism is used to implement the placement or removal of the carriers, as shown in fig. 6b, which is a schematic diagram of the carriers in the collection area of the present application that can be removed in another embodiment.

It should be understood that in the pre-analysis stage of the sample, the sample needs to be processed in multiple ways, and thus has a corresponding detection process. Generally, the detection process may be determined according to the requirements before the analysis of the sample, for example, for the bio-isolated samples corresponding to different detection devices or detection items, the pretreatment process for the bio-isolated samples may be different; as another example, when the processing scenario of the bio-analyte sample is different in the analysis, such as in-hospital analysis or in a testing laboratory, the specific testing procedure to be performed on the bio-analyte sample before the analysis may be different.

In an implementation, the detection process may be determined by the quality control management system 2, and the transfer device 11 moves the biological ex-vivo sample according to the detection process; it should be understood that the quality control device 1 is connected to the quality control management system 2 in communication, the quality control management system 2 determines the detection process, and the quality control device 1 can generate the control command for the transfer device 11 based on the detection process. Or, the detection process is a detection process preset in the quality inspection control device 1, and in some scenarios, the detection process preset in the quality inspection control device 1 may be modified. Generally, the quality control apparatus 1 further comprises a control device, the control device can be connected to each detection device, such as the identification device 12, the quality detection device 13, the conveying device 14 and the transfer device 11, and the control device can control the transfer device 11 based on a preset detection process, so as to realize automatic transfer of the sample and control of the operation performed by each detection device according to the detection process.

For example, in one scenario, the detection process includes performing order information identification on the bio-isolated sample, then transferring the bio-isolated sample to a quality inspection work area for quality inspection, and transferring the bio-isolated sample to the transportation area 101 for blanking after the quality inspection is finished. It should be noted that the detection process that can be used to implement the pre-analysis processing on the sample is not unique, for example, in some embodiments, the order information of the sample may be identified after the quality inspection is performed, but the order information corresponding to the biological in-vitro sample is determined by the detection, and the obtained detection result may be associated with the order information of the biological in-vitro sample in the subsequent various detections, so that the processing efficiency may be further improved by designing the detection process.

Referring to fig. 7, which is a schematic view of an embodiment of the transfer apparatus of the present application, the transfer apparatus 11 includes a multi-axis robot assembly 110. The end effector 111 of the multi-axis robot assembly 110 may be used to grasp the sample a, and the end effector 111 may transfer the sample a between the transportation area 101 and/or the working area 100 in a state of grasping the sample a by the multi-axis formed degree of freedom. In this embodiment, the sample a is the above-mentioned biological ex-vivo sample or a carrier of the biological ex-vivo sample.

As shown in fig. 7, the multi-axis robot assembly 110 is a four-axis robot assembly. The area for automatically transferring the biological in-vitro sample A can be determined by determining the motion range of the four-axis manipulator assembly, in one scene, the four-axis manipulator assembly can obtain the biological in-vitro sample A to be detected in a screening area 105 in a quality inspection workbench 10, convey the captured biological in-vitro sample A to a recognition device 12 and a quality inspection device 13 according to a detection process, transfer the biological in-vitro sample A after the quality inspection is completed to a qualified product placing area 104 in the quality inspection workbench 10, or transfer the biological in-vitro sample A determined to be unqualified in the inspection workbench 10 to a collecting area 103 in the quality inspection workbench 10, and then obtain another biological in-vitro sample A to be detected in the screening area 105 to repeat the process.

In some embodiments, the end effector 111 of the multi-axis manipulator assembly 110 is further provided with a holding structure for the carrier of the bio-ex vivo sample a to protect the carrier and reduce damage to the carrier during the transfer process.

The end effector 111 is provided with a supporting structure (not shown), which can support the bottom of the carrier of the bio-in-vitro sample a during the transfer process, thereby protecting the carrier; meanwhile, the supporting structure can also be arranged to move relative to the carrier clamped by the end effector 111, so that the supporting structure rotates along the shaft to enable the carrier to be separated from the supported state. In some scenarios, for example when weighing and quality testing the bio-isolated sample a, the transfer device 11 transfers the carrier of the bio-isolated sample a to the quality testing device 13 and rotates the holding structure to release the carrier of the bio-isolated sample a, so that the weighing component can perform the weight test on the sample a.

In some embodiments, the support structure may also be configured with a buffer structure of flexible material to protect the carrier grasped by the end effector 111.

In certain embodiments, the transfer device 11 is provided with braking means to protect the carrier of the biological ex-vivo sample a. In an embodiment, the braking device is, for example, a band-type brake, which limits the excessive displacement of the end effector 111 to prevent the carrier 11 from being damaged during the process of grasping and transferring the carrier of the bio-isolated sample a.

In some scenarios, the braking device may also serve as a protection device in case of an abnormal or faulty condition of the apparatus, for example, by configuring the multi-axis robot assembly with the braking device in the plumb line direction to limit the displacement range, it is possible to avoid the multi-axis robot assembly from falling to damage the sample a or to cause impact damage to the apparatus internal device in an abnormal condition such as power failure of the apparatus.

In some embodiments, the braking device comprises a power-off protection device for controlling the end effector 111 of the transfer device 11 such that in a power-off state the end effector 111 maintains a clamped state on the carrier of the biological ex-vivo sample a.

A power-off protection device is configured for the transfer device 11 to control the stressed state of the end effector 111 in the power-off state to control the clamping force to the carrier, so as to avoid the damage of the sample a and the interference to the environment of the quality inspection workbench 10 caused by a fault or an undetected environmental factor. For example, in one implementation, the power-off protection device has a spring that can control the end effector 111 to determine the stiffness or strength of the end effector 111 in a certain clamping dimension, such as the opening and closing dimensions of the jaws of the end effector 111, so as to determine that when the carrier of the biological ex-vivo sample a is clamped in the power-off state, the stiffness and strength of the clamping are controllable, and the carrier is kept in the clamped state.

In some embodiments, the transfer device 11 has a rotatable end effector 111 to rotate a carrier of the biological ex-vivo sample a along a central axis of the carrier when grasping the carrier.

When the carrier contains the biological in-vitro sample a, the carrier is placed in a form that the biological in-vitro sample a is prevented from overflowing from a container opening of the carrier, so that a central shaft of the carrier is usually required to be in a vertical state. The end effector 111 may drive the carrier to rotate along a central axis of the carrier when the carrier of the biological isolated sample a is grabbed, that is, the carrier is made to rotate along an axis in a plumb line direction, in some scenarios, for example, when the end effector 111 of the transfer device 11 grabs the carrier of the biological isolated sample a to allow the identification device 12 to identify the order information loaded on the carrier, when the order information is an information code or a chip associated to the carrier, the end effector 111 drives the carrier to rotate along the central axis thereof, and the identification device 12 may realize identification of a full angle, that is, 360 degrees; in another aspect, when the end effector 111 grabs the carrier of the biological isolated sample a for the labeling process of the carrier by a device for labeling the carrier, such as the identification device 15, the end effector 111 drives the carrier to rotate along its central axis, and the identification device 15 can determine the labeling position in all angular orientations of the carrier.

In some embodiments, the transfer device 11 is configured to maintain the carrier of the bio-ex-vivo sample a in a vertical state while transferring the carrier of the bio-ex-vivo sample a. In order to avoid spillage of the bio-ex-vivo sample a from the mouth of the container of the carrier in the state in which said carrier of the bio-ex-vivo sample a is transferred, the present application also provides an embodiment in which the transfer device 11 is configured to keep the carrier of the bio-ex-vivo sample a in an upright state when transferring the carrier. For example, in one embodiment, the multi-axis manipulator assembly 110 of the transfer device 11 moves the end effector 111 in a planar rotation or a vertical lifting motion, so as to prevent the carrier of the biological ex-vivo sample a from tilting or overturning.

In some examples, the quality control apparatus 1 is configured with a visual recognition device (not shown), after the transfer device 11 transfers the bio-specimen between the work areas according to the detection process to complete the detection, the transfer device 11 further places the bio-specimen in a non-defective product placement area 104 or a collection area 103 for placing a non-defective product in the quality control workbench 10 based on the detection result, and the visual recognition device can determine the position of each area or the non-defective type and the non-defective type corresponding to each area, that is, the transfer device 11 can achieve the partition placement of the bio-specimen according to the detection result. The visual recognition device is, for example, an image capture device such as a camera device arranged on the transfer device 11.

In some implementations, the visual recognition device is configured to determine at least one of the working area 100, the conveying area 101, and the placement area in the quality inspection workbench 10 through image analysis, for example, by determining the detection positions corresponding to the recognition device and the quality inspection device 13 in the working area 100 respectively, so as to enable the transfer device 11 to perform the transfer of the carrier of the bio-ionic sample according to the detection positions; or, the vision recognition device recognizes the carrier 3 of the carrier of the bio-vitro sample in the quality inspection workbench 10, and obtains the carrier of the bio-vitro sample by determining the loading position and the loading state of the carrier 3 or places the carrier of the bio-vitro sample at a preset loading position.

In some implementations, the visual recognition device is configured to determine the position of the carrier of the biological ex-vivo sample through image analysis, and the transfer device 11 can grip the carrier of the biological ex-vivo sample according to a predetermined gripping position when gripping the carrier of the biological ex-vivo sample. For example, the position where the end effector 111 grips the sample is below the cover of the container of the carrier. The mode of the visual recognition device acquiring the image may be camera or video camera imaging, and the shooting device for acquiring the image includes but is not limited to: a camera, a video camera, an image pickup module in which a lens and a CCD are integrated, an image pickup module in which a lens and a CMOS are integrated, or the like.

In the example of fig. 2 or fig. 3, the transfer device 11 may determine a transfer path to the carrier of the bio-ionomer sample based on the positions of the working area 100, the qualified product placement area 104, and the collection area 103 in the quality inspection station 10, for example, a control instruction to the transfer device 11 may be generated based on the coordinates of each working area, placement area, and collection area 103, so that the transfer device 11 may transfer the carrier of the bio-ionomer sample according to the transfer path determined by the control instruction; the transfer path may be updated in real time, for example, the transfer device 11 first transports the carrier of the to-be-tested biological in-vitro sample in the quality inspection workbench 10 to the working area corresponding to the identification device 12, and determines a subsequent transfer path to the carrier of the biological in-vitro sample based on the inspection result of the identification device 12 on the order information, for example, transfers the biological in-vitro sample that is qualified for the inspection to the quality inspection working area corresponding to the quality inspection device 13, and transfers the biological in-vitro sample that is not qualified for the inspection to the corresponding collection area 103.

In some examples, the transfer device 11 is configured to precisely hold, transfer and place the carrier of the biological sample between the working areas, a PLC (Programmable Logic Controller) control system is configured to control a transfer path of the transfer device 11, and a register is configured for each placement area and the carrier 3 of the transfer area, based on a loading state displayed by the register, the PLC control system can determine a full loading position where the transfer device 11 can clamp the carrier in the carrier 3 or an empty loading position where the carrier can be placed, and the transfer device 11 can precisely position and hold or place the carrier of the biological sample at the predetermined position according to an instruction of the PLC control system. Of course, the Control System for configuring the registers for the vehicles 3 and controlling the movement path of the transfer device 11 is not limited to a PLC Control System, and may be a DSC (Distributed Control System), an FCS (Fieldbus Control System), or the like.

As shown in fig. 4c, the carrier is a test tube type container, and referring to fig. 8, the carrier is a schematic structural diagram of the carrier of the present application in an embodiment, as shown in the figure, the carrier 3 is configured in a panel-type structure, a register is configured for each loading position (i.e. hole position) 30 of the carrier 3, when the carrier carrying the bio-isolated sample in the hole position, the corresponding register is shown in a full-load state, otherwise, when the hole position is empty, the corresponding register is shown in an empty-load state. Meanwhile, in some examples, the status of the register may also be used to determine the conveying control of the conveying device 14 to the conveying area 101, for example, when each register on the carrier 3 in the screening area 105 is displayed as an empty status, it may be determined that the carrier 3 is entirely in an empty status, and accordingly, the empty carrier 3 may be transferred out of the quality inspection workbench 10.

In the foregoing steps, the identification device 12, the quality inspection device 13 and the identification device 15 realize continuous processing of the sample, and inevitably, the transfer device 11 transfers the carrier of the biological in-vitro sample among the working areas, and the detection device configured in each working area can execute the corresponding detection program; meanwhile, when the in vitro biological samples are continuously transferred between the placing areas in the quality testing workbench 10, the carrier 3 needs to be transported inside and outside the quality testing workbench 10 to ensure that the quality testing control process is continuously performed, for example, the in vitro biological samples to be tested are transported into the quality testing workbench 10, and the carrier 3 loaded with the in vitro biological samples to be tested in the quality testing workbench 10 is transported out of the quality testing workbench 10.

The conveying device 14 can be used for transferring the carrier 3 loaded with the biological in-vitro sample to be detected into the quality inspection workbench 10, or transferring the carrier of the biological in-vitro sample which is detected in the quality inspection workbench 10 out of the quality inspection workbench 10 through the carrier 3, so that the automatic operation of sample treatment can be realized.

Specifically, the conveying device 14 is, for example, a conveying line overlapping with the quality control workbench 10 or penetrating through the quality control workbench 10, and the conveying line can be driven to move the carrier 3 of the carrier of the bio-separated sample placed on the conveying line to a preset fixed point position.

The conveyor line may be configured to match the carriers 3 of the carriers, so that the carriers 3 may be kept stationary relative to the conveyor line after being loaded on the conveyor line, and thus the conveying path for the carriers 3 may be determined by controlling the displacement of the conveyor line. The conveying line is provided with a driving device, and under the working state of the quality inspection control equipment 1, the motion state of the conveying line can be controlled based on the conveying requirement of the biological sample in the quality inspection workbench 10. The carrier 3 may be a carrier loaded with a biological in-vitro sample, for example, when the screening area 105 in the quality inspection workbench 10 needs to be supplemented with a biological in-vitro sample to be inspected, the conveyor line is controlled to convey the carrier 3 loaded with the biological in-vitro sample to the screening area 105; in some examples, the carrier 3 may be an empty carrier 3, for example, when the quality inspection workbench 10 needs to be supplemented with an empty carrier 3 in the non-defective product placement area 104 where the inspected sample is placed, the conveying device 14 conveys the empty carrier 3 to the non-defective product placement area 104.

In some embodiments, the transport device 14 includes a loading area 106 located outside the quality control workstation 10 for placing carriers of the ex-vivo biological samples to be transported to the quality control workstation 10. In the process of detecting the bio-isolated sample in the quality inspection workbench 10, the bio-isolated sample to be detected needs to be continuously or at certain intervals conveyed into the quality inspection workbench 10 to ensure that the detection process in the quality inspection workbench 10 operates normally. The feeding area 106 is used for placing a carrier of the biological in-vitro sample to be conveyed into the quality inspection workbench 10, and the conveying device 14 can convey the carrier of the biological in-vitro sample in the feeding area 106 into the quality inspection workbench 10 during operation.

In some embodiments, the loading area 106 is further provided with an empty carrier buffer area for placing the carrier 3 to be loaded with the biological ex-vivo sample. The empty tool buffer area can pre-store a certain number of empty tools 3, so that when the quality inspection workbench 10 of the quality inspection control device 1 performs the loading operation and the unloading operation (or detection operation), the loading speed and the unloading speed (or detection speed) can be allowed to be not completely consistent, and when the device is in operation, for example, when the unloading speed (or detection speed) is greater than the loading speed, the empty tools can be stored in the empty tool buffer area, so that the quality inspection control device 1 can keep normal operation. The empty tool buffer area can be set as a loading buffer area for loading samples or an empty tool 3 to be temporarily stored and transferred to the quality inspection workbench 10.

In the embodiment shown in fig. 2 or 3, the loading area 106 is further provided with a sterilizing device 16, and the sterilizing device 16 is used for sterilizing the empty carriers carrying the bio-body samples. In the operation process of the quality control device 1, the carrier 3 can be repeatedly used by determining the transfer path of the carrier 3 for loading the carrier of the biological in-vitro sample, and in order to avoid the gradual accumulation of infection or pathogenic viruses, bacteria and the like of the carrier 3 in the operation process of repeated use, the application also provides an embodiment that the sterilizing device 16 is arranged in the loading area 106, the loading area 106 is provided with an ultraviolet sterilizing lamp, so that the carrier 3 comprises the sterilizing area corresponding to the sterilizing device 16 in the operation path, and the sterilizing device 16 can realize the sterilizing treatment of the carrier 3.

In one implementation scenario, the conveying device 14 conveys the empty carriers 3 in the screening area 105 of the quality inspection workbench 10 out of the quality inspection workbench 10, and conveys the empty carriers 3 to the disinfection area corresponding to the disinfection device 16 for disinfection, and the empty carriers 3 can be reused after disinfection, for example, conveyed to the qualified product placement area 104 of the quality inspection workbench 10.

In some implementations, the specific type of the disinfection device 16 can be determined based on disinfection requirements and at least one of the material of the carrier 3, disinfection duration requirements, structural layout requirements of the conveyor 14. In some embodiments, the disinfection device 16 comprises an ultraviolet disinfection device 16.

In practical application, the area connected with the feeding area 106 can be determined according to the application environment of the quality inspection control device 1; for example, the loading area 106 is generally required to perform the operation of loading the carrier 3 with the carrier of the bio-ex-vivo sample, and accordingly, the loading area 106 may be configured to be connected to a storage chamber or a receiving chamber of the bio-ex-vivo sample.

In some embodiments, the conveying device 14 further includes a blanking area 107 located outside the quality testing station 10, for transporting the biosorption sample determined to be qualified for testing from the quality testing station 10 to the blanking area 107.

In an implementation manner, the conveying line of the conveying device 14 may be configured to include a conveying section located outside the quality inspection workbench 10, and the qualified product placement area 104 for placing the tested qualified product in the quality inspection workbench 10 is disposed in the conveying area 101, and the conveying line is driven to operate, so that the carrier 3 loaded with the carrier of the biological isolated sample in the qualified product placement area 104 is transferred to the conveying section, that is, the biological isolated sample determined to be qualified for testing is transported from the quality inspection workbench 10 to the blanking area 107.

In some embodiments, when the quality inspection workbench 10 is provided with a plurality of non-defective product placing areas 104, the blanking area 107 may be further configured to have a plurality of blanking partitions corresponding to the plurality of non-defective product placing areas 104, respectively. The conveying device 14 conveys the carrier 3 of the bio-isolated samples which are detected in the quality inspection workbench 10 and placed in the qualified product placement area 104 to the corresponding blanking subareas, so that specific types of bio-isolated samples can be obtained at different blanking subareas, and different operations or detections and other treatments on the bio-isolated samples based on the types of the samples can be favorably carried out subsequently. For example, a first type of qualified product placing area, a second type of qualified product placing area, and a third type of qualified product placing area are provided in the transportation area 101 on the quality inspection workbench, and correspondingly, a blanking area 107 of the conveying device 14 is provided with a blanking partition area for placing the first type of qualified product, the second type of qualified product, and the third type of qualified product.

In certain embodiments, the blanking area 107 is connected to a designated circulation area that is determined based on the need to transport the sample after testing has been completed.

In some embodiments, the conveying device 14 is configured to convey the carrier of the bio-specimen placed in the loading area 106 to the screening area 105 in the quality inspection workbench 10, convey the carrier of the bio-specimen with the finished quality inspection from the quality inspection workbench 10 to the unloading area 107, convey the empty carrier 3 in the screening area 105 to the sterilizing device 16 for sterilization and then convey the carrier to the loading area 106 for standby, or convey the empty carrier 3 after sterilization to the qualified product placement area 104 in the quality inspection workbench 10.

The conveying device 14 may be configured to convey the carrier of the biological in-vitro sample in the feeding area 106 outside the quality inspection workbench 10 to the screening area 105 in the quality inspection workbench 10 based on the feeding and discharging requirements in the quality inspection workbench 10, so that the transfer device 11 can obtain the biological in-vitro sample from the screening area 105 for detection; meanwhile, in the process of detection in the quality inspection workbench 10, the biological in-vitro sample which is detected is gradually loaded to the carrier 3 of the qualified product placement area 104, and when the carrier 3 of the qualified product placement area 104 is in a full-load state, the conveying device 14 conveys the carrier of the biological in-vitro sample which is detected according to the detection process from the quality inspection workbench 10 to the blanking area 107; meanwhile, in order to realize the reuse of the carriers 3, after all the biological in vitro samples loaded on the carriers 3 in the screening area 105 are transferred to other areas, the carriers 3 with no load in the screening area 105 are transported to the disinfection device 16 for disinfection treatment, and the disinfected no-load devices 3 can be transported to the qualified product placement area 104 to place carriers of the detected biological in vitro samples or transported to the loading area 106 for standby.

In certain embodiments, the conveyor 14 is a fixed point conveyor line robot. Please refer to fig. 9, which is a schematic structural diagram of a conveying device of the quality inspection control apparatus according to an embodiment of the present disclosure. In one example, the conveyor 14, which is a fixed point conveyor line robot, includes: a transfer line 140, a transfer robot 141, and a rail mechanism 142.

The conveying line 140 is used for carrying a carrier 3 of a carrier of a biological in-vitro sample; the conveying line 140 is provided with a feeding area 106 outside the quality inspection workbench 10, a transportation area 101 inside the quality inspection workbench 10, and a discharging area 107 outside the quality inspection workbench 10. The conveying robot 141 is disposed on the rail mechanism 142, and is configured to move the carrier 3 between different positions/different zones on the conveying line 140 by moving linearly on the rail mechanism 142.

In one implementation, the loading area 106 is configured with a conveyor belt, and the carriers 3 in the loading area 106 are conveyed to an end of the loading area 106 close to the quality inspection workbench 10 by the conveyor belt, so that the transfer path length of the conveying robot 141 can be effectively reduced. The length of the conveyor belt in the loading area 106 can be used to determine the number of carriers 3 buffered in the loading area 106, and in an embodiment, the conveyor belt in the loading area 106 can be further configured to be independent from the conveying robot 141, so that when the number of the conveyor belt buffers in the loading area 106 reaches a preset threshold, the loading operation in the loading area 106 can be suspended independently, and the continuous circulation of other parts of the conveying line 140, such as the transportation area 101, is not affected.

The conveying line 140 can be used for loading the carriers 3 of the carriers of the biological in-vitro samples, and the conveying robot 141 can convey the carriers 3 among different locations by dividing the conveying line 140 into different locations, so that the conveying function of the conveying device 14 can be cooperatively realized. The functional area of the conveying line 140 can be set according to the requirement of the quality control apparatus 1, for example, referring to the foregoing embodiment, the screening area 105 and the qualified product placing area 104 in the quality inspection workbench 10 can be disposed in the conveying area 101 of the conveying line 140, so that the conveying robot 141 can convey the carrier of the biological in vitro sample in the feeding area 106 outside the quality inspection workbench 10 to the screening area 105 in the quality inspection workbench 10; meanwhile, the conveying robot 141 may convey the carriers 3 in the non-defective product placement area 104 of the quality inspection workbench 10 to the blanking area 107, or/and convey the empty carriers 3 in the screening area 105 to the carrier buffer area 108.

In some examples, the carrier buffer 108 may be configured as a dual-layer or multi-layer structure, for example, a single layer of the well plate buffer may be configured with 2 carriers 3, and the carrier 3 buffer 108 is configured as a total of 5 layers, thereby providing the carrier storage capacity of the carrier buffer 108 and effectively utilizing the equipment space.

In some embodiments, the guide rail mechanism 142 of the fixed point conveying line 140 determines the moving direction of the conveying manipulator 141, i.e., the direction of the conveying line 140. Here, the direction of the conveying line 140 is an arrangement direction of different locations on the conveying line 140, and may also be regarded as a direction of a shortest distance between the different locations. The present application provides an embodiment in which the guide rail mechanism 142 is disposed along the direction of the conveying line 140, so that the transfer path can be effectively shortened when the conveying robot 141 moves along the guide rail mechanism 142, and the conveying efficiency can be improved. In one implementation, to realize the transportation robot 141 to transfer the carrier 3 between different locations, the rail mechanisms 142 are disposed across two ends of the quality inspection workbench 10 to ensure that the transportation robot 141 can move a distance to cover each location on the transportation line 140.

In some embodiments, the rail mechanism 142 is mounted above the conveying line 140, and the conveying robot 141 further includes a lifting assembly to control the position of the end effector in the lifting direction. In an implementation scenario, the lifting assembly determines the position of the end effector in the lifting direction to realize the grabbing, conveying and placing actions of the carrier 3 on the conveying line 140, for example, the end effector is lowered to a preset position to ensure that the carrier 3 can be grabbed, and then the end effector is controlled to lift the grabbed carrier 3 by a certain height for conveying, so that collision and interference of different parts in the conveying process can be avoided, and when the conveying manipulator 141 conveys the carrier 3 to a position above a target position, the end effector is controlled to drive the carrier 3 to descend to a predetermined position and then release the carrier 3, so as to ensure that the carrier 3 is stably placed.

In the embodiment shown in fig. 9, a plurality of qualified product placing areas 104 are disposed in the transportation area 101, and the blanking area 107 is used for placing or conveying the carrier 3 of the bio-isolated sample conveyed from the quality inspection workbench 10 by the plurality of qualified product placing areas 104, and the carrier 3 is also a qualified product carrier. As shown in fig. 9, the blanking area 107 is disposed on the conveyor belt, a certain number of carriers 3 can be placed on the conveyor belt, and when the conveyor belt of the blanking area 107 is stationary, the blanking area 107 can be used as a temporary storage area for carriers of the qualified products; meanwhile, the conveyor belt can be driven to move, the conveying manipulator 141 transports the qualified product carriers in the qualified product placing area 104 to the blanking area 107, and the conveyor belt in the blanking area 107 can drive the carriers 3 borne by the conveyor belt to move, so that the bearing position of the conveyor belt is fully utilized.

In an implementation scenario, when the carrier 3 in the non-defective product placement area 104 is in a full-load state, the conveying manipulator 141 transfers the carrier 3 to a predetermined placement area on the conveyor belt, and after the carrier 3 is stably placed on the conveyor belt, the conveyor belt drives the carrier 3 to move a certain distance to the discharging end, so that the predetermined placement area determined by the moving range of the conveying manipulator 141 is in a non-full-load state, that is, a storage space of a next carrier is reserved; for example, each time a carrier is placed on the conveyor belt of the blanking area 107, the conveyor belt is driven to move a position of the carrier toward the blanking end, when the carrier placed on the conveyor belt contacts the blanking end, the corresponding alarm device is triggered, and when the alarm device is triggered, the conveying manipulator 141 can be made to suspend transferring the carrier of the qualified product placement area 104 to the blanking area 107, and perform blanking on the carrier of the conveyor belt of the blanking area 107, such as manual transferring the carrier carrying the qualified product.

Fig. 10 is a schematic structural diagram of a conveying robot of the conveying device according to an embodiment of the present disclosure. As shown, the end effector of the transport robot 141 is a clamping jaw adapted to the carrier 3 of the carrier of the biological isolated sample, the clamping jaw includes a first clamping jaw 1411 and a second clamping jaw 1412 which are oppositely arranged, and the clamping jaw spacing is adjusted by driving at least one of the first clamping jaw 1411 and the second clamping jaw 1412, so that the carrier 3 can be grabbed and released by the clamping jaw.

As shown in fig. 9, the quality control apparatus 1 is further provided with a positioning detection device 144 for detecting the moving position of the carrier 3 by the conveying robot 141 to determine that the carrier 3 is moved to a predetermined position. In an embodiment, the positioning detection device 144 is a camera, which includes but is not limited to: a camera, a video camera, an image pickup module in which a lens and a CCD are integrated, an image pickup module in which a lens and a CMOS are integrated, or the like.

To achieve accurate positioning of the carrier 3, the transfer process of the carrier 3 by the conveying robot 141 may be detected or monitored based on the positioning detection device. In one example, the positioning detection device may detect the carrier position at regular time intervals, or detect the carrier position when the end effector of the conveying robot 141 moves above the target area to perform a lowering operation, or detect the carrier position when the end effector of the conveying robot 141 releases the carrier; in another example, the positioning detection device may continuously monitor the conveying process to determine that the conveying robot 141 is moving in a predetermined path.

In some embodiments, the delivery device may also be a double layer fixed point delivery device (not shown). It should be understood that the screening area and the qualified product placement area in the quality inspection workbench are both determined positions, and in order to realize that the carrier of the biological in-vitro sample is driven to a preset fixed-point position based on the conveying device, the application also provides an embodiment that the conveying device is set as a double-layer fixed-point conveying device. In this example, the conveying device has a higher degree of freedom for the conveying path of the carried carrier, i.e., the conveying operation can be performed based on the feeding and discharging requirements in the quality inspection workbench; meanwhile, the double-layer fixed-point conveying device can reduce the equipment space occupied by the quality inspection control equipment. The conveying device is a double-layer fixed-point conveying device with an upper conveying line and a lower conveying line.

In some embodiments, the upper layer conveying line of the double-layer fixed-point conveying device is used for fixing carriers of the bio-in-vitro sample, loading the samples and unloading the samples, and the lower layer conveying line is used for conveying the carriers of the bio-in-vitro sample to different positions. For example, the empty carrier may be fixed to the upper conveyor line at the upper conveyor line in the loading area, and the sample loading operation may be performed on the empty carrier at the upper conveyor line in the loading area; unloading operation of the samples is carried out on the carriers at an upper layer conveying line of the blanking area; the screening area and the qualified product placing area in the quality inspection workbench can be arranged on an upper conveying line of the conveying device, carriers in the screening area are in sample unloading, and carriers in the qualified product placing area are in sample loading in the process of detection operation in the quality inspection workbench.

In some embodiments, to achieve precise positioning and fixing of the carriers, the conveying device is further provided with a locking mechanism, such as a cylinder, for fixing the carriers at a predetermined loading position. In one embodiment, the carrier is loaded on a conveyor device equipped with a cylinder for fixing the carrier.

The lower layer conveying line is used for conveying carriers of the biological in-vitro samples to different positions, and when the operations such as loading and unloading of the samples are carried out at the upper layer conveying line, the lower layer conveying line can carry out no-load conveying of the carriers which are loaded with the samples or unloaded with the samples, so that the conveying device can carry out different circulation processing on the biological in-vitro samples at the same time.

And the lifting mechanism is arranged between the upper-layer conveying line and the lower-layer conveying line and used for transferring the carrier positioned on the upper-layer conveying line to the lower-layer conveying line so as to convey the carrier, or transferring the carrier positioned on the lower-layer conveying line to the upper-layer conveying line so as to load or unload the sample of the carrier. In some implementations, each location of the upper layer conveying line is set as a fixed functional location, and a preset process for a sample or a carrier is performed at each functional location; the lifting mechanism is used for realizing the switching of the carrier between the upper-layer conveying line and the lower-layer conveying line, so that the replacement and the updating of the carrier can be kept at the functional area of the upper-layer conveying line. In some implementation scenarios, a plurality of lifting mechanisms may be disposed in the conveying device to realize the switching of the carriers 3 between the upper conveying line and the lower conveying line at a plurality of positions.

In some embodiments, the quality control management system 2 is a management system of a testing laboratory. The quality inspection management system 2 is in communication connection with the quality inspection control device 1 and is used for providing instructions or information for the quality inspection control device 1. Depending on the specific application scenario, the quality inspection management system 2 may be a system built in different ways or a system configured in different use environments, and in some embodiments, the quality inspection management system 2 is a management system of a detection laboratory. The testing laboratory is a testing environment in which a sample is subjected to an analytical operation, and testing equipment is generally provided therein. In the embodiment where the quality control system 2 is a management system of a testing laboratory, the specific processing flow and processing method of the quality control device 1 for the bio-isolated sample can be determined based on the requirements of the testing laboratory, for example, the identification information identified on the carrier of the bio-isolated sample can be the number information determined by the transportation rule of the testing laboratory.

In some scenarios, the management system of the detection laboratory includes a sample management module, by which the management system is communicatively connected with the quality inspection control device 1 to implement instruction or information interaction.

In some embodiments, other structures may be added to or used with the quality control apparatus 1 of the present application, for example, when the biosome sample is a blood sample, the quality control apparatus 1 may further include a centrifuge device for centrifuging the biosome sample after the quality control is completed, and the blanking region 107 of the conveying device 14 may be configured to interface with the centrifuge device.

In some embodiments, the quality control apparatus 1 is further provided with a control device, which is connectable to the identification device 12, the quality inspection device 13, the transfer device 11, and the transport device 14 to generate a control command to the identification device 12, the quality inspection device 13, the transfer device 11, and the transport device 14 or receive detection information. The control device may also be arranged in communication with the quality control system 2, whereby the control device may obtain information in the quality control system 2 and transmit data obtained by each of the identification devices 12, the quality inspection devices 13, etc. to the quality control system 2 to associate the detection data or detection results for the bio-ionic sample to the quality control system 2 or to determine a specific treatment for the bio-ionic sample based on the information of the quality control system 2.

In some embodiments, the control device is configured to enable the identification device 12, the quality inspection device 13, etc. in the quality inspection workbench 10 to obtain data, so as to realize timely interaction with the quality inspection management system 2, and at the same time, the control device can record the corresponding processing time of the sample in the detection process. The control device may include, for example: a memory unit, a processing unit, and an interface unit, etc.

The storage unit includes high speed random access memory and may also include non-volatile memory, such as one or more magnetic disk storage devices, flash memory devices, or other non-volatile solid state storage devices. In certain embodiments, the storage unit may also include memory that is remote from the one or more processors, such as network-attached memory accessed via RF circuitry or external ports and a communication network (not shown), which may be the internet, one or more intranets, local area networks, wide area networks, storage area networks, and the like, or suitable combinations thereof. The memory controller may control access to the memory by other components of the device, such as the CPU and peripheral interfaces.

The processing unit includes one or more general purpose microprocessors, one or more application specific processors (ASICs), one or more field programmable logic arrays (FPGAs), or any combination thereof. The processing unit is operatively coupled with memory and/or non-volatile storage. More specifically, the processor may execute instructions stored in the memory and/or non-volatile storage device to perform operations in the computing device, such as generating and/or transmitting quality inspection results to the quality inspection management system 2. For example, when the processing unit controls the transferring device 11 to transfer the carrier of the bio-isolated sample in the quality inspection workbench 10, the processing unit enables the recognition device 12 and the quality inspection device 13 to perform corresponding recognition and quality inspection on the bio-isolated sample when the bio-isolated sample is transferred to the corresponding workbench, and controls the transferring path of the transferring device 11 to the bio-isolated sample based on the recognition and quality inspection results, and controls the conveying device 14 to control the conveying device 14 to convey the carrier of the bio-isolated sample or the carrier 3 inside and outside the quality inspection workbench 10 according to the conveying requirement of the bio-isolated sample in the quality inspection workbench 10.

The interface unit comprises a plurality of interfaces, each interface is respectively connected with the identification device 12, the quality inspection device 13, the transfer device 11 and the conveying device 14, and the processing unit is operatively coupled with each interface, so that the control device can interact with each device connected with the interface.

The application also provides an embodiment that the identification device 15 is configured in the quality inspection workbench 10 to assist in realizing the shunting of the sample or providing the sample with a recognizable serial number in the subsequent link processing, so that the detection accident caused by the sample transfer in the medical verification process can be further reduced, and the transfer efficiency can be effectively improved.

The application also provides an embodiment that the transfer device 11, the recognition device 12, the quality inspection device 13 and the conveying device 14 cooperate to realize automatic detection and conveying of the sample, and the position relationship and the processing flow of each device are configured to ensure that the quality inspection control equipment can realize automatic processing and continuous operation of the sample.

Here, the quality control apparatus provided by the first aspect of the present application, wherein the transfer device, the identification device, the quality inspection device, and the transport device are configured to realize automated processing of the sample; the quality control equipment is in communication connection with the quality control management system, so that control over a detection process in the quality control equipment can be realized in a assisting manner or a detection result can be generated in a assisting manner, and the quality control equipment has higher adaptability to a processing mode of the bio-ionomer sample through information interaction between the quality control management system and the quality control management equipment, for example, order information verification of the bio-ionomer sample is realized through the identification device, so that errors before sample analysis caused by sample flow in an actual application environment can be effectively reduced; if the specific quality inspection mode of the sample and the quality inspection qualification judgment mode of the sample can be adjusted based on the information provided by the quality inspection management system, the quality inspection control equipment can be applied to sample analysis pretreatment of various detection items.

In the embodiment provided by the second aspect of the present application, there is also provided a quality control device for a biological isolated sample, the quality control device being communicatively connected to a quality control management system 2. In an embodiment, the quality control device is a series of detection operations for implementing a pre-analysis stage of the sample, such as quality inspection of the sample, information detection of the sample; wherein the quality inspection is used to achieve quality (quality) control or quality (quality) assurance of the sample. The sample is a bio-sample, and accordingly, the quality control device of the present application is generally associated with medical applications such as use in assisting in developing diagnostic opinions for patients, treatment plans, or biologically-relevant medical research such as pharmaceutical research and development or scientific research. In some scenarios, the quality control device is also an instrument system for implementing sample preprocessing and quality inspection.

In the embodiment provided in the second aspect of the present application, the quality control management system 2 communicatively connected to the quality control device may be a system applied in different scenarios, such as a detection laboratory or a hospital, the quality control management system 2 includes, but is not limited to, an electronic device, a server cluster, a cloud server system, and the like, and the quality control management system 2 may also be a combination of software and hardware; the quality control device and the quality control management system 2 may be connected in a communication manner through a network, where the network may be an internet, a mobile network, a local area network, a wide area network, a storage local area network, one or more intranets, or the like, or a suitable combination thereof, and the embodiments of the present application do not limit the types of the client and the server, or the types or protocols of the communication networks between the publisher terminal and the server, and between the responder terminal and the server, or the like in the present application.

The quality control equipment needs to be in communication connection with the quality control management system 2 to realize interaction of information or instructions and the like when realizing automatic processing of samples, and correspondingly, a functional module which is suitable for the operation requirement of the quality control equipment can be configured in the quality control management system 2. The functional modules are cooperatively implemented by various types of devices (such as terminal devices, servers, server clusters, or cloud server systems), or computing resources such as processors and communication resources (such as those for supporting communications in various manners such as optical cables and cellular). In some examples, each functional module in the quality inspection management system 2 may be embedded in a software system of the electronic device, and the software system of the electronic device may obtain the order information or the quality inspection rule from a storage medium of the electronic device or other devices, servers, and the like in network communication with the electronic device.

In the embodiment shown in fig. 1, the functional modules of the quality inspection management system 2 include a storage module 21, an authentication module 22, and a quality inspection module 23.

The storage module 21 may be configured to store order information of the biological in-vitro sample and identity information corresponding to the order information, so that after the quality inspection control device transmits the order information of the biological in-vitro sample obtained by the identification device 12 to the quality inspection management system 2, the verification module 22 obtains pre-stored order information from the storage module and compares the pre-stored order information with the received order information identified by the quality inspection control device to generate a verification result for the order information. The quality control device receives the order information verification and may determine a subsequent transport or testing action for the bio-ionic sample based thereon.

The storage module 21 may further include at least one quality inspection rule, for example, the quality inspection device 13 of the quality inspection control device may perform quality inspection on the bio-ionic sample based on the at least one quality inspection rule, and compare the quality inspection data obtained by the quality inspection device 13 with the qualified standard determined by the quality inspection rule to generate a quality inspection result.

The quality control module 23 in the quality control management system 2 may be configured to perform the comparison between the quality control data and the qualified standard determined by the quality control rule, or generate the shunting information based on the determined quality control result to control the subsequent transportation or detection of the bio-ionic sample by the quality control device. The quality inspection module may be further configured to associate quality inspection data with an identity information.

Of course, the functional modules of the quality control management system 2 are not limited to these, for example, the quality control management system 2 may further include a report generation module 24, and the report generation module 23 may generate a quality control report of the biological ex-vivo sample including the quality control result according to the order information and the identity information.

In some embodiments, the quality control device communicatively connected quality control management system 2 provided in the second aspect of the present application may also refer to embodiments provided in applicant's prior patent publication such as CN104899697B, i.e., the functional modules that the quality control management system 2 is also configurable in some embodiments may refer to functional modules in the laboratory process quality control management and report automation system described in the patent publication, such as a received sample confirmation module, a sample information entry module, a detection application submission module, and the like.

In the embodiment shown in fig. 2 or fig. 3, the quality inspection control apparatus includes: a quality inspection table 10, a transfer device 11, a recognition device 12, a quality inspection device 13, a communication device, a marking device 15, and a conveying device 14. The quality inspection workbench 10 is provided with a transportation area 101 and a plurality of working areas 100; the transfer device 11 is arranged adjacent to the transportation area 101 and the plurality of working areas 100, and is used for transferring the carrier containing the biological in-vitro sample among the plurality of working areas 100 or the transportation area 101 according to a detection process; the identification device 12 is used for identifying order information of the biological in-vitro sample transferred by the transfer device 11; the transfer device 11 transfers the carrier of the biological in-vitro sample with unqualified check result to the collection area 103, or transfers the carrier of the biological in-vitro sample with qualified check result to the quality inspection working area; the quality inspection device 13 is used for detecting the biological in-vitro sample in the quality inspection working area according to a quality inspection rule preset in the quality inspection management system 2 so as to generate quality inspection data; the transfer device 11 transfers the carrier of the biological in-vitro sample which is subjected to the quality inspection to the information identification area; the communication device is in communication connection with a quality inspection management system 2 to send and receive information, the sent information comprises the order information, quality inspection data and identity information of the biological in-vitro sample, and the received information comprises a verification result of the order information; the identification device 15 is used for identifying the identity information of the biological in-vitro sample acquired from the quality inspection management system 2 on a carrier of the biological in-vitro sample, and the transfer device 11 transfers the carrier of the biological in-vitro sample with qualified information identification to the qualified product placement area 104 or transfers the carrier of the biological in-vitro sample with unqualified information identification or unqualified quality inspection result to the corresponding collection area 103; the conveying device 14 is used for conveying the carrier of the biological in-vitro sample to be detected to the quality inspection workbench 10 and conveying the carrier of the biological in-vitro sample which is subjected to quality inspection from the qualified product placing area 104 out of the quality inspection workbench 10.

In an embodiment, the quality control apparatus according to the second aspect of the present application performs a pre-analysis processing procedure on the bio-plasma sample as follows: the conveying device 14 is configured to convey the carrier of the biological in-vitro sample placed in the loading area 106 to the screening area 105 in the quality inspection workbench 10, convey the carrier of the biological in-vitro sample subjected to the quality inspection from the quality inspection workbench 10 to the unloading area 107, and convey the empty carrier 3 in the screening area 105 to the carrier buffer area 108, or convey the empty carrier 3 to the non-defective product placement area 104 in the quality inspection workbench 10.

Referring to fig. 11, which is a schematic diagram illustrating a quality inspection control apparatus according to an embodiment of the present invention, a sample is taken from a screening area, as shown in the figure, the conveying device 14 performs sample transportation, and conveys a sample in a loading area to the screening area 105, the transferring device 11 in the quality inspection workbench 10 obtains a carrier of a to-be-inspected bio-in-vitro sample from the screening area 105 according to an inspection process, transfers the carrier of the bio-in-vitro sample between the working area 100 and the conveying area 101, which are provided with a transfer temporary storage area 102, a collecting area 103, or/and a qualified product placement area 104, to complete inspection, and places the qualified sample, which is completed inspection, in the qualified product placement area 104 in the quality inspection workbench 10. Wherein, the detection process comprises:

the transfer device 11 in the quality inspection workbench 10 transports the captured carrier of the biological in-vitro sample to be inspected to the identification working area according to the inspection process to identify the identification device 12, please refer to fig. 12, which is a schematic diagram of the quality inspection control device of the present application for identifying the sample in one embodiment, as shown in the figure, in the identification working area corresponding to the identification device 12, order information identification is performed on the carrier of the biological in-vitro sample to obtain the verification result of the order information; the identification process is performed by, for example, a carrier of the biological in-vitro sample being grasped by the transferring device 11, but an information carrier such as an information code associated with order information is attached to the carrier, and the corresponding identifying device 12 may be configured as a code scanning device, and in the code scanning process, the transferring device 11 may drive the carrier of the biological in-vitro sample to rotate so as to scan the carrier by 360 degrees.

After the order information is obtained through identification, the order information can be transmitted to the quality inspection management system 2 through the communication device, whether the order information loaded on the carrier of the biological in-vitro sample is correct or not can be determined through comparing the order information obtained through identification with the order information pre-stored in the quality inspection management system 2, the communication device can receive the verification feedback of the order information from the quality inspection management system 2, the transfer device 11 is controlled based on the feedback result to transfer the carrier of the biological in-vitro sample with the qualified result of the order information verification to the quality inspection device 13 in the quality inspection working area for quality inspection, and the quality inspection control device is shown in fig. 13, and fig. 13 is a schematic diagram that the sample is placed in the quality inspection working area in one embodiment of the quality inspection control device. In an embodiment, the order information is, for example: one or more of sample type, detection item, detection content, split information, sample number, and sample ID; in another embodiment, the order information is, for example, traceability information such as user certificate information, communication information, and the like; in yet another embodiment, the order information may further include characteristic information of the sample, such as a type of the sample, a sample amount, a sample collection time, and the like, or information of a detection item to be performed on the sample.

The transfer device 11 transfers the biological in-vitro sample qualified by order information verification to a quality inspection working area, the quality inspection device 13 performs quality inspection on the biological in-vitro sample to generate quality inspection data, and the quality inspection data is compared with a quality inspection qualified standard to determine a quality inspection result of the biological in-vitro sample. In some examples, the structure and the quality testing manner of the quality testing device 13 may be determined according to the quality testing requirement of the sample, and in some examples, the quality testing device 13 is a weighing device that weighs to determine whether the sample amount of the biological in-vitro sample meets a quality testing qualified standard, and the quality testing qualified standard may be further determined by the quality testing management system 2. In some scenarios, the quality qualification criteria may also be determined by the type of sample, which may be obtained from the quality control management system 2, for example.

When the order information is not qualified, the carrier of the bio-isolated sample is transferred to the collection area 103 for placing the unqualified sample by the transfer device 11, as shown in fig. 14, where fig. 14 is a schematic diagram illustrating that the quality inspection control device of the present application places the sample in the collection area in one embodiment. Alternatively, when the quality inspection result of the quality inspection device 13 is that the quality inspection qualification standard is not satisfied, the carrier of the biological ex-vivo sample is transferred by the transfer device 11 to the collection region 103 for placing the unqualified sample.

In an embodiment, after the quality inspection is finished, the transferring device 11 may transfer the carrier of the bio-ex-vivo sample to the identification device 15, and the identification device 15 identifies the identity information of the bio-ex-vivo sample acquired from the quality inspection management system 2 on the carrier of the bio-ex-vivo sample. For example, the identification device 15 generates a label associated with the content of the identity information based on the identity information obtained from the quality control system 2, and attaches the label to the carrier of the biological in-vitro sample. Referring now to fig. 15, fig. 15 illustrates a schematic view of the quality control apparatus of the present application in one embodiment of placing a sample at an identification device.

Referring to fig. 16, fig. 16 is a schematic diagram illustrating the quality control apparatus of the present application placing a sample in a non-defective placement area according to an embodiment of the present application. The transfer device 11 then transfers the carrier of the biological in-vitro sample with qualified information identification to the qualified product placement area 104, or transfers the carrier of the biological in-vitro sample with unqualified information identification or unqualified quality inspection result to the corresponding collection area 103; the determination of whether the information identifier is qualified is, for example, whether the identity information obtained by identifying the tag is consistent with the identity information preset and associated with the tag when the tag is generated is determined by identifying the tag, and when the quality inspection result of the biological in-vitro sample and the information identifier are both determined to be qualified, the carrier of the biological in-vitro sample can be transferred to the qualified product placement area 104 for placing the qualified sample after the detection is completed; and when any one of the quality detection result and the information mark is unqualified, transferring the carrier of the biological in-vitro sample to the corresponding collection area 103.

Thus, the quality testing workbench 10 performs the testing of the biological in-vitro sample according to the testing process, and based on the testing result, the carrier of the biological in-vitro sample obtained from the screening area 105 is placed in the qualified product placing area 104 or the collecting area 103 for placing the unqualified product; meanwhile, the conveying device 14 conveys the biological in-vitro sample to be detected to the screening area 105, and conveys the biological in-vitro sample of the qualified product placing area 104 out of the quality inspection workbench 10 so as to be conveyed from the quality inspection workbench 10 to the blanking area 107, so that the automatic processing of the sample can be realized, and the continuity of the operation of the equipment can be determined.

In some examples, the number of carriers of the biological ex-vivo samples collected when the samples are collected based on the same order is 2 or more, and when a plurality of samples are associated with each other to be recorded in the same order information, the same order information corresponds to carriers of a plurality of biological ex-vivo samples. In the detection process, after the information code loaded on the carrier of the bio-in-vitro sample is identified to obtain the corresponding order information, it is determined that the order information corresponds to the carriers of the plurality of bio-in-vitro samples, the carriers of the bio-in-vitro samples are transferred to the transfer buffer 102, and after it is determined that the carriers of the plurality of bio-in-vitro samples corresponding to the order information are all detected and identified (i.e., are collected), the carriers of the plurality of bio-in-vitro samples are subsequently transferred. Referring now to fig. 17, fig. 17 is a schematic diagram of the quality control apparatus of the present application, in one embodiment, placing a sample in a transfer buffer.

The quality control equipment provided by the second aspect of the application can effectively reduce the error rate of sample analysis pretreatment and obviously improve the sample processing efficiency.

Referring back to fig. 1, in a third aspect, the present application further provides a quality inspection management system 2, where the quality inspection management system 2 includes: a communication module 20, a storage module 21, a verification module 22, a quality inspection module 23, and a report generation module 24. Wherein, the communication module 20 is configured to be in communication connection with the quality inspection control device 1 according to any one of the embodiments provided in the first aspect of the present application to send and receive information; the storage module 21 is configured to store order information of the in-vitro biological sample and identity information corresponding to the order information; and storing at least one quality inspection rule; the verification module 22 is configured to obtain order information of a pre-stored biological in-vitro sample from the storage module 21, compare the received order information identified by the quality control device 1 with the pre-stored order information to obtain an order information verification result of the biological in-vitro sample, and output first shunt information to the transfer device 11 of the quality control device 1; the quality inspection module 23 is configured to determine whether the quality inspection data output by the quality inspection device 13 of the quality inspection control apparatus 1 is qualified or receive the quality inspection result output by the quality inspection device 13, and output second shunt information to the transfer device 11 of the quality inspection control apparatus 1; and the report generating module 24 is configured to receive the quality inspection result output by the quality inspection module 23, and generate a quality inspection report of the biological in-vitro sample including the quality inspection result according to the order information and the identity information. In some embodiments, the quality inspection module 23 is further configured to associate an identity information based on the quality inspection result.

The communication module 20 is configured to be in communication connection with the quality control device 1 to send and receive information, and for example, may be configured to form an interface for the quality control device 1 to be in communication connection with the quality control management system 2, where the communication connection is, for example, a network connection, where the network may be the internet, a mobile network, a local area network, a wide area network, a storage local area network, one or more intranets, and the like, or a suitable combination thereof, and the embodiments of the present application are not limited in the present application to the types of clients and servers, or the types or protocols of the communication networks between the issuer terminal and the server, and between the responder terminal and the server.

The storage module 21 of the quality control management system 2 includes, for example, high-speed random access memory, and may also include non-volatile memory, such as one or more magnetic disk storage devices, flash memory devices, or other non-volatile solid-state storage devices. In certain embodiments, the memory module 21 may include memory for one or more processors, such as network attached memory accessed via RF circuitry or external ports and a communications network, which may be the internet, one or more intranets, local area networks, wide area networks, storage area networks, and the like, or suitable combinations thereof. The storage module 21 controller may control the access of other components of the device, such as a CPU and a peripheral interface, to the memory, for example, so that the quality control device 1, which is in communication connection with the quality control management system 2, may obtain order information stored in the storage module 21 and identity information corresponding to the order information through the peripheral interface. In some embodiments, the storage module 21 may also be a storage module 21 configured in a cloud.

The storage module 21 is, for example, a storage module of an order system, wherein the order information of the biological in-vitro sample pre-stored in the order system is, for example, information of a user when generating an order, such as an order number, user identity information (traceability information), sample information, detection item information, and the like.

In an example, the verification module 22 is configured to, after acquiring the order information obtained by identifying the carrier of the bio-vitro sample by the quality control device 1, use part or all of the order information as an index, acquire the order information of the pre-stored bio-vitro sample in the storage module 21, and determine whether the order information acquired by retrieving from the storage module 21 matches the order information acquired by identifying the quality control device 1, thereby acquiring a verification result of the order information. The order information verification result generated by the verification module 22 can also be transmitted to the quality inspection control device 1, so that the transferring device 11 in the quality inspection control device 1 can obtain the first shunt information conveyed to the bio-isolate sample based on the order information verification result.

In the process of communication connection with the quality control device 1, the quality control management system 2 may further receive quality control data obtained by performing quality control on the bio-ionic sample by the quality control device 1, and the quality control module 23 may be configured to determine whether the quality control data is qualified; in an implementation manner, the quality inspection module 23 obtains a corresponding quality inspection rule from the storage module 21 to determine whether the quality inspection data is qualified based on the quality inspection rule. In an implementation manner, the quality inspection module 23 may further determine a sample type of the in-vitro biological sample corresponding to the quality inspection data based on the acquired quality inspection data and order information associated with the quality inspection data, and determine a quality inspection rule for performing qualification judgment on the quality inspection data based on the sample type.

In some examples, the quality inspection module 23 may further associate the quality inspection data with identity information, which may be set to have an association relationship with the order information in the storage module 21, for example, the identity information corresponds to the order information of the biological in-vitro sample one to one.

The report generation module 24 in the quality inspection management system 2 may generate a detection report based on the detection data in the quality inspection control device 1 and the order information of the in-vitro biological sample, and in an example, the report generation module 24 generates a quality inspection report of the in-vitro biological sample including the quality inspection result according to the order information and the identity information. The quality inspection report can be an electronic report or an entity report obtained based on data (such as a paper report), and the specific presentation form is not limited in the application.

In some embodiments, other functional units formed by software, hardware or a combination of software and hardware may also be configured in the quality inspection management system 2, for example, the quality inspection management system 2 may be a management system for an inspection laboratory, in this example, the storage module 21, the verification module 22, the quality inspection module 23 and the report generation module 24 may be sample management units in the quality inspection management system 2. In some embodiments, the quality control management system 2 may also refer to embodiments provided in applicant's prior patent publication documents such as CN104899697B, i.e., the functional modules that the quality control management system 2 may also configure in some embodiments refer to functional modules in the laboratory process quality control management and report automation system described in this patent publication, such as a received sample validation module, a sample information entry module, a detection application submission module, and the like.

The functional modules configured in the quality inspection management system 2 are cooperatively implemented by, for example, various types of devices (such as terminal devices, servers, server clusters, or cloud server systems), or computing resources such as processors, and communication resources (such as those used to support various modes of communication such as optical cables and cells). In some examples, each functional module in the quality inspection management system 2 may be embedded in a software system of the electronic device, and the software system of the electronic device may obtain the order information or the quality inspection rule from a storage medium of the electronic device or other devices, servers, and the like in network communication with the electronic device.

In some embodiments, the quality control management system 2 may also be a cloud server system, which may be arranged on one or more physical servers according to various factors such as functions, loads, and the like. When distributed in a plurality of entity servers, the server may be composed of servers based on a cloud architecture. For example, the cloud-based server includes a public cloud server and a private cloud server, wherein the public or private cloud server includes Software-as-a-Service, Platform-as-a-Service, and Infrastructure-as-a-Service. The private cloud service end comprises an Arlison cloud computing service platform, an Amazon cloud computing service platform, a Baidu cloud computing platform, a Tencent cloud computing platform and the like. The server may also be formed by a distributed or centralized cluster of servers. For example, the server cluster is composed of at least one entity server. Each entity server is provided with a plurality of virtual servers, each virtual server runs at least one functional module of the quality inspection management system 2, and the virtual servers are communicated with each other through a network.

The present application also provides, in a fourth aspect, a quality control system for a biological isolated sample, the quality control system including at least one quality control device according to any one of the embodiments provided in the first or second aspect of the present application, and a quality control management system provided in the third aspect above and communicatively connected to the at least one quality control device.

The quality control device 1 in the quality control system is in communication connection with the quality control management system, that is, the quality control device 1 can be made to execute the pre-analysis processing on the bio-ionic sample, and in an implementation scenario, the quality control device 1 and the quality control management system can be configured in the same environment, for example, in the same laboratory; of course, in other implementations, the quality control apparatus 1 and the quality control system may be disposed in different areas and may be connected in communication.

The quality inspection control system can be a combination of hardware and software, in one example, the quality inspection control device 1 is a hardware module in the quality inspection control system, and the quality inspection management system is a software module in the quality inspection control system or a module combining software and hardware; in some embodiments, the quality control system may also be a sub-module in a software system of the quality control system, such as a sample management module in the quality control system.

The quality control device 1 may be connected to the quality control management system in a communication manner, where the network may be the internet, a mobile network, a local area network, a wide area network, a storage local area network, one or more intranets, or the like, or a suitable combination thereof, and the embodiments of the present application do not limit the types of the client and the server, or the types or protocols of the communication networks between the publisher terminal and the server, and between the responder terminal and the server.

Here, for specific structures, layouts, and operation procedures of the quality inspection control device 1 and the quality inspection management system in the quality inspection control system for the in vitro biological sample provided by the present application, reference may be made to the embodiments provided in the first aspect and the second aspect of the present application, and details are not repeated herein.

The present application provides, in a fourth aspect, a quality inspection management system including: a communication module 20, a storage module 21, a verification module 22, a quality inspection module 23, and a report generation module 24.

The communication module 20 is configured to be in communication connection with the quality inspection control device 1 according to any one of the embodiments provided in the first aspect of the present application to send and receive information.

The storage module 21 is configured to store order information of the in-vitro biological sample and identity information corresponding to the order information; and storing at least one quality inspection rule.

The verification module 22 is configured to obtain order information of a pre-stored biological in-vitro sample from the storage module 21, compare the received order information identified by the quality control device 1 with the pre-stored order information to obtain an order information verification result of the biological in-vitro sample, and output first shunt information to the transfer device 11 of the quality control device 1.

The quality inspection module 23 is configured to determine whether the quality inspection data output by the quality inspection device 13 of the quality inspection control apparatus 1 is qualified or receive the quality inspection result output by the quality inspection device 13, and output second shunt information to the transfer device 11 of the quality inspection control apparatus 1.

The report generating module 24 is configured to receive the quality inspection result output by the quality inspection module 23, and generate a quality inspection report of the biological in-vitro sample including the quality inspection result according to the order information and the identity information.

In some embodiments, the quality inspection module 23 is further configured to associate an identity information based on the quality inspection result;

the communication module 20 is configured to be in communication connection with the quality control device 1 to send and receive information, and for example, may be configured to form an interface for the quality control device 1 to be in communication connection with a quality control management system, where the communication connection is, for example, a network connection, where the network may be the internet, a mobile network, a local area network, a wide area network, a storage local area network, one or more intranets, and the like, or a suitable combination thereof, and the types or protocols of the client and the server, or the types or protocols of the communication networks between the issuer terminal and the server, and between the responder terminal and the server in the embodiments of the present application are not limited in the present application.

The storage module 21 of the quality control management system comprises, for example, high-speed random access memory, and may also comprise non-volatile memory, such as one or more magnetic disk storage devices, flash memory devices, or other non-volatile solid-state storage devices. In certain embodiments, the memory module 21 may include memory for one or more processors, such as network attached memory accessed via RF circuitry or external ports and a communications network, which may be the internet, one or more intranets, local area networks, wide area networks, storage area networks, and the like, or suitable combinations thereof. The storage module 21 controller may control the access of other components of the device, such as the CPU and the peripheral interface, to the memory, for example, so that the quality control device 1, which is in communication connection with the quality control management system, may acquire the order information stored in the storage module 21 and the identity information corresponding to the order information through the peripheral interface.

In some embodiments, the storage module 21 may also be a storage module 21 configured in a cloud.

In an example, the verification module 22 is configured to, after obtaining order information obtained by identifying the carrier of the bio-vitro sample by the quality control device 1, obtain, as an index, part or all of the order information, obtain, in the storage module 21, order information of a pre-stored bio-vitro sample, and determine whether the order information obtained by retrieving from the storage module 21 matches the order information obtained by identifying the quality control device 1, thereby obtaining a verification result of the order information. The order information verification result generated by the verification module 22 can also be transmitted to the quality inspection control device 1, so that the transferring device 11 in the quality inspection control device 1 can obtain the first shunt information conveyed to the bio-isolate sample based on the order information verification result.

In the process of communication connection with the quality control device 1, the quality inspection management system can also receive quality inspection data obtained by quality inspection of the bio-ionic sample by the quality inspection control device 1, and the quality inspection module 23 can be used for judging whether the quality inspection data is qualified; in an implementation manner, the quality inspection module 23 obtains a corresponding quality inspection rule from the storage module 21 to determine whether the quality inspection data is qualified based on the quality inspection rule. In an implementation manner, the quality inspection module 23 may further determine a sample type of the in-vitro biological sample corresponding to the quality inspection data based on the acquired quality inspection data and order information associated with the quality inspection data, and determine a quality inspection rule for performing qualification judgment on the quality inspection data based on the sample type.

The report generation module 24 in the quality inspection management system may generate a detection report based on the detection data in the quality inspection control device 1 and the order information of the in-vitro biological sample, and in an example, the report generation module 24 generates a quality inspection report of the in-vitro biological sample including the quality inspection result according to the order information and the identity information. The quality inspection report may be an electronic report or an entity report obtained based on data, and the specific presentation form is not limited in the application.

In some embodiments, other functional units formed by software, hardware or a combination of software and hardware may be configured in the quality inspection management system, for example, the quality inspection management system may be a management system for an inspection laboratory, and in this example, the storage module 21, the verification module 22, the quality inspection module 23 and the report generation module 24 may be sample management units in the quality inspection management system. In some embodiments, the quality control management system may also refer to embodiments provided in applicant's prior patent publication documents such as CN104899697B, i.e., the functional modules that the quality control management system may also configure in some embodiments refer to functional modules in the laboratory process quality control management and reporting automation system described in this patent publication, such as a received sample validation module, a sample information entry module, a detection application submission module, and the like.

The functional modules configured in the quality inspection management system are cooperatively implemented by various types of devices (such as terminal devices, servers, server clusters, or cloud server systems), or computing resources such as processors, and communication resources (such as those used for supporting communications in various manners such as optical cables and cells). In some examples, each functional module in the quality inspection management system may be embedded in a software system of the electronic device, and the software system of the electronic device may obtain the order information or the quality inspection rule from a storage medium of the electronic device or other devices, servers, and the like in network communication with the electronic device.

In some embodiments, the quality control management system may also be a cloud server system, which may be arranged on one or more physical servers according to various factors such as function, load, and the like. When distributed in a plurality of entity servers, the server may be composed of servers based on a cloud architecture. For example, the cloud-based server includes a public cloud server and a private cloud server, wherein the public or private cloud server includes Software-as-a-Service, Platform-as-a-Service, and Infrastructure-as-a-Service. The private cloud service end comprises an Array cloud computing service platform, an Amazon cloud computing service platform, a Baidu cloud computing platform, a Tencent cloud computing platform and the like. The server may also be formed by a distributed or centralized cluster of servers. For example, the server cluster is composed of at least one entity server. Each entity server is provided with a plurality of virtual servers, each virtual server runs at least one functional module of the quality inspection management system, and the virtual servers are communicated with each other through a network.

To sum up, quality control equipment, quality control system, quality control management system of this application have following beneficial effect: the sample processing process performed by the quality inspection control equipment can be realized based on the information provided by the quality inspection management system, the determined detection rule or the determined detection flow; by associating the sample processing process with the quality inspection management system, the quality inspection management system can determine how to adjust the processing flow, such as increase and decrease adjustment or sequence adjustment of the processing procedures, and the information provided by the quality inspection management system can assist in determining the detection mode, detection result or transfer (conveying) mode of the sample in each processing procedure, so that the detection accuracy of the automatically processed sample can be further improved by the quality inspection control equipment associated with the quality inspection management system while the sample is automatically processed to improve the sample processing efficiency and reduce the sample detection error rate; furthermore, this application provides the position relation between structure composition, function and the structure of quality control equipment for realize handling the automation of sample under the sample processing procedure of predetermineeing, through forming the standardized processing procedure to the sample, improved the treatment effeciency.

The above embodiments are merely illustrative of the principles and utilities of the present application and are not intended to limit the present application. Any person skilled in the art can modify or change the above-described embodiments without departing from the spirit and scope of the present application. Accordingly, it is intended that all equivalent modifications or changes which can be made by those skilled in the art without departing from the spirit and technical concepts disclosed in the present application shall be covered by the claims of the present application.

Claims

1. A quality control device for a biological in-vitro sample, comprising:

the quality inspection workbench is provided with a transportation area and a plurality of working areas;

the transfer device is arranged adjacent to the transportation area and the plurality of working areas and is used for transferring the carrier containing the biological in-vitro sample among the transportation area or the plurality of working areas;

the identification device is used for identifying order information of the biological in-vitro sample transferred by the transfer device;

the quality inspection device is used for detecting the biological in-vitro sample in the quality inspection working area to generate quality inspection data;

the conveying device is used for conveying the carrier of the biological in-vitro sample to be detected to the quality inspection workbench or conveying the carrier of the biological in-vitro sample which is subjected to quality inspection out of the quality inspection workbench; and

and the communication device is used for being in communication connection with a quality inspection management system to send and receive information, and the sent information comprises the order information and the quality inspection data.

2. The quality control apparatus of the ex-vivo biological sample according to claim 1, wherein the communication device is configured to receive identity information of the ex-vivo biological sample from the quality control management system; the quality inspection control equipment further comprises an identification device for identifying the identity information on the carrier of the biological in-vitro sample.

3. The quality control apparatus of the ex-vivo biological sample according to claim 2, further comprising a marker verifying device for recognizing a label marked on the carrier of the ex-vivo biological sample to determine a position of the marker on the carrier of the ex-vivo biological sample; or the tag identification module is used for identifying the tag to obtain identity information corresponding to the tag or/and quality control information associated with the identity information.

4. The apparatus of claim 1, wherein the testing platform further comprises at least one qualified product placement area for placing the biological ex-vivo sample qualified for testing.

5. The apparatus for controlling quality of a biological ex-vivo sample according to claim 1, wherein the quality inspection stage further comprises a screening area for placing a carrier of the biological ex-vivo sample to be inspected.

6. The apparatus for quality control of ex-vivo biological sample according to claim 5, wherein the screening zone is disposed in the transportation zone; the conveying device comprises a feeding area positioned outside the quality inspection workbench and is used for placing a carrier of the biological in-vitro sample to be conveyed to the quality inspection workbench; the conveying device conveys a carrier of a biological in-vitro sample to be detected to the screening area from the feeding area, or conveys a carrier positioned in the screening area in an idle load to the feeding area.

7. The device for controlling the quality of a biological ex-vivo sample according to claim 1, 4 or 5, wherein the quality inspection workbench further comprises at least one collection area for placing the biological ex-vivo sample determined as being unqualified for inspection.

8. The device as claimed in claim 7, wherein the collecting region is provided with a displacement device for arranging a carrier of the bio-ex-vivo sample, and moving the carrier to transport the unqualified carrier of the bio-ex-vivo sample out of the quality control workbench.

9. The apparatus of claim 8, wherein the displacement device comprises a guide mechanism disposed on the quality testing platform and extending outside the quality testing platform for disposing the carrier.

10. The apparatus of claim 8, wherein the collection area comprises a storage station and at least one standby station, and the carriers disposed on the storage station and the at least one standby station are respectively movable along the displacement device.

11. The apparatus of claim 8, wherein the collection region is further configured with a sensor device for detecting the carrier to move the carrier to a predetermined position.

12. The device for controlling the quality inspection of the in-vitro biological samples according to claim 1, wherein the quality inspection workbench further comprises a transfer buffer for placing a plurality of carriers of the in-vitro biological samples corresponding to the same order information.

13. The apparatus of claim 1, wherein the transfer device comprises a multi-axis manipulator assembly.

14. The apparatus for quality control of ex-vivo biological sample according to claim 1 or 13, wherein the transfer device is provided with a brake device to protect the carrier of the ex-vivo biological sample.

15. The apparatus for quality control of ex-vivo biological samples according to claim 14, wherein the brake device comprises a power-off protection device for controlling the end-effector of the transfer device such that the end-effector maintains a clamping state on the carrier of the ex-vivo biological sample in a power-off state.

16. The apparatus according to claim 1 or 13, wherein the transfer device has a rotatable end effector for rotating the carrier along a central axis of the carrier when grasping the carrier of the bio-ex-vivo sample.

17. The quality control apparatus of the ex-vivo biological sample according to claim 13, wherein the transfer device maintains the carrier of the ex-vivo biological sample in a vertical state while transferring the carrier of the ex-vivo biological sample.

18. The quality control device of the ex-vivo biological sample according to claim 1, wherein the identification means is a code scanning means for determining that an information code on a carrier of the ex-vivo biological sample can be read to obtain a verification result; or the code scanning device is used for identifying the information code on the carrier of the biological in-vitro sample to obtain the order information, and comparing the order information with the information prestored in the quality inspection management system to obtain an inspection result.

19. The device for controlling the quality of the ex-vivo biological sample according to claim 1, wherein the quality inspection device comprises a weighing device for detecting the mass of the ex-vivo biological sample, and comparing the detected mass of the ex-vivo biological sample with the quality inspection qualified standard to generate the quality inspection result.

20. The apparatus of claim 19, wherein the weighing device has a position-limiting structure for placing the carrier of the bio-ex-vivo sample.

21. The device for controlling the quality of the ex-vivo biological sample according to claim 1, wherein the conveying device comprises a feeding area located outside the quality inspection workbench and used for placing a carrier of the ex-vivo biological sample to be conveyed to the quality inspection workbench.

22. The apparatus of claim 21, wherein the transport device further comprises an empty buffer outside the quality control platform for placing a carrier to be loaded with the bio-ex vivo sample.

23. The apparatus as claimed in claim 22, wherein the empty carrier buffer is further provided with a sterilizing device for sterilizing a carrier carrying the carrier of the ex-vivo biological sample.

24. The device for controlling the quality of the bio-ex-vivo sample according to claim 23, wherein the conveying device further comprises a blanking area located outside the quality inspection workbench, and is used for transporting the bio-ex-vivo sample judged to be qualified for detection from the quality inspection workbench to the blanking area.

25. The apparatus for controlling quality inspection of a bio ex vivo sample according to claim 1, wherein the conveyor is a fixed point conveyor line robot comprising:

the conveying line is used for carrying a carrier of a biological in-vitro sample; the conveying line comprises a feeding area outside the quality inspection workbench, a conveying area inside the quality inspection workbench and a discharging area outside the quality inspection workbench;

and the conveying manipulator is used for transferring the carriers among different areas on the conveying line.

26. The apparatus of claim 25, wherein the conveying device further comprises a guide mechanism for disposing the conveying robot, and the guide mechanism determines a moving direction of the conveying robot to be parallel to the conveying line direction.

27. The apparatus of claim 26, wherein the rail mechanism is mounted above the conveyor line, and the conveyor robot further comprises a lifting assembly to control a position of the end effector in a lifting direction.

28. The apparatus of claim 25, further comprising a positioning detection device for detecting a moving position of the carrier by the transport robot to determine that the carrier is moved to a predetermined position.

29. The apparatus for controlling quality of a bio-ex-vivo sample according to claim 1, wherein the carrier of the bio-ex-vivo sample is a test tube type container.

30. The apparatus of claim 29, wherein the carrier of the carrier is a well plate, and the well plate is provided with a hole clamping structure for fixing a test tube type container of the biological isolated sample.

31. The apparatus for quality control of an ex-vivo biological sample according to claim 1, wherein the ex-vivo biological sample is a liquid sample.

32. The device for controlling quality inspection of a bio-ex vivo sample according to claim 1, wherein the device for controlling quality inspection and the system for managing quality inspection form a system for controlling quality inspection, and wherein the system for managing quality inspection comprises:

the storage module is used for prestoring order information of the biological in-vitro sample and identity information corresponding to the order information;

the verification module is used for acquiring the order information of the pre-stored biological in-vitro sample from the storage module, comparing the received order information identified by the quality inspection control equipment with the pre-stored order information to obtain an order information verification result of the biological in-vitro sample, and outputting first shunt information to the quality inspection control equipment;

the quality inspection module is used for judging whether the quality inspection data of the quality inspection device of the quality inspection control equipment is qualified or not and outputting a quality inspection result to the quality inspection control equipment or receiving the quality inspection result of the quality inspection device of the quality inspection control equipment; and

and the report generation module is used for receiving the quality inspection result and generating a quality inspection report of the biological in-vitro sample comprising the quality inspection result according to the order information and the identity information.

33. A quality control management system, comprising:

the communication module is used for being in communication connection with a quality inspection control device to send and receive information;

the storage module is used for prestoring order information of the biological in-vitro sample and identity information corresponding to the order information; and storing at least one quality inspection rule;

the verification module is used for acquiring the order information of the pre-stored biological in-vitro sample from the storage module, comparing the received order information identified by the quality control equipment with the pre-stored order information to obtain an order information verification result of the biological in-vitro sample, and outputting first shunt information to the transfer device of the quality control equipment;

the quality inspection module is used for judging whether quality inspection data output by a quality inspection device of the quality inspection control equipment is qualified or receiving a quality inspection result output by the quality inspection device, and outputting second shunt information to a transfer device of the quality inspection control equipment; and

34. A quality control system for a biological in-vitro sample, comprising:

a quality control device for an ex vivo biological sample according to any one of claims 1 to 32; and

the quality control system of claim 33, wherein the quality control system is communicatively coupled to the quality control device to send and receive information.