CN118262851A - Judgment method, module, system and operation method thereof - Google Patents

Judgment method, module, system and operation method thereof Download PDF

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Publication number
CN118262851A
CN118262851A CN202410418218.2A CN202410418218A CN118262851A CN 118262851 A CN118262851 A CN 118262851A CN 202410418218 A CN202410418218 A CN 202410418218A CN 118262851 A CN118262851 A CN 118262851A
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module
nucleic acid
scanner
pcr amplification
reagent
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舒畅
孟石
郁强
杨星
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Jiaxing Aikono Biotechnology Co ltd
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Jiaxing Aikono Biotechnology Co ltd
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    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
    • C12Q1/00—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
    • C12Q1/68—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving nucleic acids
    • C12Q1/6844—Nucleic acid amplification reactions
    • C12Q1/686—Polymerase chain reaction [PCR]
    • G—PHYSICS
    • G06—COMPUTING; CALCULATING OR COUNTING
    • G06K—GRAPHICAL DATA READING; PRESENTATION OF DATA; RECORD CARRIERS; HANDLING RECORD CARRIERS
    • G06K17/00—Methods or arrangements for effecting co-operative working between equipments covered by two or more of main groups G06K1/00 - G06K15/00, e.g. automatic card files incorporating conveying and reading operations
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H10/00—ICT specially adapted for the handling or processing of patient-related medical or healthcare data
    • G16H10/40—ICT specially adapted for the handling or processing of patient-related medical or healthcare data for data related to laboratory analysis, e.g. patient specimen analysis

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  • Genetics & Genomics (AREA)
  • Measuring Or Testing Involving Enzymes Or Micro-Organisms (AREA)
  • Apparatus Associated With Microorganisms And Enzymes (AREA)

Abstract

The invention provides a judging method, a judging module, a judging system and an operating method thereof. The judging method is based on the scanning result of the scanner to the mark, judges whether the module contains the specific object, and judges whether the module contains the specific object when the scanning result is unidentified, and judges that the module does not contain the specific object when the scanning result is identified. The judging method can effectively judge whether the module contains the specific object or not, and avoid idle work of the system and the module caused by forgetting, forgetting to place or misplacement of the specific object.

Description

Judgment method, module, system and operation method thereof
Technical Field
The present invention relates to the field of in vitro diagnostics. Specifically, the invention provides a judging method, a judging module, a judging system and an operating method thereof.
Background
In vitro diagnosis is to obtain clinical diagnosis information by detecting a human body sample (blood, body fluid, tissue, etc.) outside the human body. Since in vitro diagnosis can be rapidly and accurately diagnosed in early stages of diseases, it plays an increasingly important role in the fields of clinical medicine and related medical research.
The existing in vitro diagnostic methods, devices and methods of operation are still not optimized. For example, when a user uses an in vitro diagnostic device, the user often forgets, forgets to place or misplaces a sample container, a reagent container, a reaction container, a pipette tip, and the like, making the in vitro diagnostic device do no work. Therefore, there is a need for improvements in vitro diagnostic methods, devices, and methods of operation.
Disclosure of Invention
The invention provides a judging method, a judging module, a judging system and an operating method thereof.
Specifically, the invention provides a judging method, which is based on a scanning result of a scanner on a mark, and judges whether a specific object is contained in a module or not, wherein the specific object is contained in the judging module when the scanning result is unidentified, and the specific object is not contained in the judging module when the scanning result is identified.
Preferably, the judgment method of the present invention is applicable to the field of in vitro diagnosis. The determination method of the present invention is not limited to the field of in vitro diagnosis, and is general. The determination method of the present invention can be employed in any field where it is desired to determine whether a specific article is contained in a module.
According to one aspect of the present invention, the specific items in the judgment method of the present invention include, but are not limited to, sample containers, reagent containers, reaction containers, and/or pipette tips, etc. The module has a compartment adapted to receive a specific item, the module is provided with a logo, the logo being at least partially obscured after placement of the specific item on the module, the logo being at least partially obscured from recognition by the scanner. Preferably, the identification is provided on a compartment of the module.
According to one aspect of the invention, the judgment method of the invention can be used in a fully automatic nucleic acid detection analysis system. The module is a reagent consumable module, a nucleic acid extraction module and/or a PCR amplification module; the specific articles placed by the reagent consumable module are various reagent tubes and/or consumables for nucleic acid detection and analysis; the specific article placed by the nucleic acid extraction module is a nucleic acid extraction reagent strip; the specific article placed by the PCR amplification module is a PCR tube.
The invention also provides a module having a compartment adapted to receive a specific item, the module being provided with a marking, the marking being at least partially obscured and the at least partially obscured marking being unrecognizable to a scanner upon receiving the specific item on the module. Preferably, the identification is provided on a compartment of the module.
According to one aspect of the invention, the specific item is a sample container, a reagent container, a reaction container and/or a pipette tip.
According to one aspect of the invention, the module is suitable for in vitro diagnostics. It should be noted that the module of the present invention is not limited to the field of in vitro diagnosis, and has versatility and is applicable to any field in which a specific article needs to be placed on the module.
The invention also provides a system which comprises the module and a scanner. Likewise, the system is not limited to use in the field of in vitro diagnostics, and the system has versatility and is applicable to any field.
According to one aspect of the present invention there is also provided a system comprising a module and a scanner, the module having a compartment adapted to hold a particular item, the module being provided with an identification; the module is a reagent consumable module, a nucleic acid extraction module and/or a PCR amplification module; the identification of the reagent consumable module is arranged on a compartment of the reagent consumable module or a specific article placed on the compartment; the identification of the nucleic acid extraction module is arranged on a specific article on which the nucleic acid extraction module is placed; the identity of the PCR amplification module is provided on the compartment of the PCR amplification module or on the particular item on which it is placed.
The indicia provided on the compartments of the module of the present invention are preferably provided on the upper surface of the compartments.
In the invention, the identification comprises a bar code, a two-dimensional code and the like.
In the present invention, the scanner includes a scanner and the like.
Preferably, the system is a fully automated nucleic acid detection analysis system. The full-automatic nucleic acid detection analysis system can integrate the functions of sample processing, nucleic acid extraction, PCR amplification, detection analysis and the like, and can realize the rapid and accurate detection of nucleic acid in an automatic and high-flux mode.
According to one aspect of the invention, the specific items placed by the reagent consumable module are various reagent tubes and/or consumables for nucleic acid detection analysis, such as pipette tips and the like.
According to one aspect of the invention, in the case that the mark of the reagent consumable module is disposed on the compartment of the reagent consumable module, after a specific article is placed on the reagent consumable module, the mark is at least partially blocked, and the mark at least partially blocked cannot be recognized by the scanner. When a specific object is not placed on the reagent consumable module, the mark is not shielded. In the case that the identification of the reagent consumable module is disposed on a specific article (reagent tube and/or consumable) on which the reagent consumable module is placed, the identification can be recognized by the scanner after the specific article is placed on the reagent consumable module.
According to one aspect of the invention, the specific item on which the nucleic acid extraction module is placed is a nucleic acid extraction reagent strip, the nucleic acid extraction module being for extracting nucleic acids in a sample. The sample may include various samples of human genital secretions, respiratory swabs, serum/plasma, feces, urine, and the like. The fully automatic nucleic acid detection analysis system can process a plurality of samples by physical grinding and cracking. The nucleic acid extraction module utilizes magnetic bead adsorption extraction, and the extraction efficiency is high. The nucleic acid extraction reagent strip sequentially comprises a binding tube, a cleaning tube and an eluting tube. The binding tube, the cleaning tube and the eluting tube are covered with sealing films. Preferably, the label on the nucleic acid extraction strip is located on the upper surface of the nucleic acid extraction strip and the sealing membrane is located on the same side. Preferably, the label and elution tube are located at each end of the nucleic acid extraction reagent strip.
According to one aspect of the invention, the nucleic acid extraction module has N compartments adapted to house N nucleic acid extraction reagent strips. N is a natural number greater than or equal to 1. Preferably, N is 8-12. The scanner scans the identifier on the nucleic acid extraction reagent strip.
According to one aspect of the invention, each nucleic acid extraction reagent strip is provided with a label.
According to one aspect of the present invention, the identifier of the nucleic acid isolation reagent strip includes information on the type of the nucleic acid isolation reagent, the expiration date of the reagent, and the like.
According to one aspect of the invention, the specific item placed by the PCR amplification module is a PCR tube, and the PCR amplification module is used for PCR amplification and detection of nucleic acid in a sample.
According to one aspect of the invention, the scanner may scan the identity on the compartment of the PCR amplification module or on the PCR tube.
According to one aspect of the invention, the PCR amplification module has N compartments adapted to house N PCR tubes. N is a natural number greater than or equal to 1. Preferably, N is 8-12.
Preferably, the scanner scans the identity on the compartment of the PCR amplification module. A label is provided on the compartment of each PCR amplification module.
According to one aspect of the invention, in the case that the identifier of the PCR amplification module is disposed on the compartment of the PCR amplification module, the identifier is at least partially blocked and the at least partially blocked identifier cannot be recognized by the scanner after the specific article is placed on the PCR amplification module. When a specific object is not placed on the PCR amplification module, the mark is not shielded. Under the condition that the mark of the PCR amplification module is arranged on the PCR tube, the mark can be identified by the scanner after the PCR tube is arranged on the PCR amplification module.
According to one aspect of the invention, the fully automated nucleic acid detection analysis system further comprises an automated pipetting device. The automatic pipetting device comprises a pipetting gun. The automatic pipetting device is used for sample pipetting, nucleic acid extraction, PCR sample loading and the like in response to control of software.
According to one aspect of the invention, the scanner is disposed on the automatic pipetting device. The scanner moves following the movement of the automatic pipetting device. In the invention, the scanner is used for scanning the identification in response to the control of software. The scanner of the invention can rapidly and accurately scan the identification, and realize real-time communication and data transmission with software.
According to one aspect of the invention, the fully automated nucleic acid detection analysis system further comprises a power supply component, a control component, a housing, and the like.
According to an aspect of the present invention, the control unit of the present invention is a computer-based automatic control unit capable of receiving an operation instruction from software and performing a corresponding operation, including a detection control operation such as displacement control, temperature control, or the like.
According to one aspect of the invention, the fully automated nucleic acid detection analysis system further comprises a sample injection module. The sample injection module is provided with a sample tube. The sample tube adopted by the invention is an original tube, and the original tube is directly connected to the machine without manual sample adding. The sample tube may be a standard sample tube or a non-standard sample tube. The sample tube of the present invention is placed on a sample rack. The sample rack is provided with 8-16 sample tubes, preferably 12 sample tubes.
According to one aspect of the invention, the sample tube or sample holder of the invention may be attached with a label. The identification can be scanned by the scanner of the invention or by an external scanner.
According to one aspect of the invention, the fully automated nucleic acid detection analysis system further comprises software. The software is used for managing the full flow of the operation and the operation of the full-automatic nucleic acid detection analysis system.
The software of the fully automatic nucleic acid detection analysis system of the present invention is preferably embedded software.
The invention also provides an operation method of the system, which comprises the following steps:
s1: a self-checking step;
S2: setting and loading;
S3: and (3) a detection step.
Preferably, the system is an in vitro diagnostic system. Further preferably, the above system is a fully automated nucleic acid detection analysis system.
The self-checking step S1, the setting step S2 and the loading step S3 may be performed automatically in sequence, or may be performed after the user manually triggers the steps sequentially.
According to one aspect of the invention, the scanner is operated in both the self-test step S1 and the setup and load step S2.
According to one aspect of the present invention, the self-test step S1 and the setup and load step S2 each include a step of scanning the identity of the PCR amplification module by a scanner.
According to one aspect of the invention, in the self-test step S1, a step of scanning the identity of the PCR amplification module by a scanner is included. When the scanner scans the identifier of the PCR amplification module in the self-checking step S1, and when the identifier is positioned on the compartment of the PCR amplification module and the scanning result of the scanner is identified, the software judges that the placement mode of the PCR tube is correct (no PCR tube is forgotten in the PCR amplification module, and no PCR tube is placed on the PCR amplification module at the moment), and the subsequent operation is continued; when the scanning result is unidentified, the software judges that the placement mode of the PCR tube is incorrect (the PCR tube is forgotten in the PCR amplification module, and the unclean PCR tube is placed on the PCR amplification module at the moment), and prompts the user to clean the PCR tube and confirm, and the follow-up operation is continued after the cleaned PCR tube is confirmed. When the identification is positioned on the PCR tube and the scanning result of the scanner is unidentified, continuing the subsequent operation; when the scanning result is that the PCR tube is identified, the software prompts the user to clean the PCR tube and confirms that the PCR tube is cleaned, and then the subsequent operation is continued.
According to one aspect of the invention, in the setting and loading step S2, a step of scanning the identity of the reagent consumable module, the nucleic acid extraction module and/or the PCR amplification module by a scanner is included. Optionally, in the setting and loading step S2, a step of scanning the identity of the nucleic acid extraction module and/or the PCR amplification module by a scanner is included.
When the scanner scans the mark of the reagent consumable module in the setting and loading step S2, and the mark is positioned on the reagent consumable module compartment, if the scanning result of the scanner is unidentified, the software judges that the placement is correct, and then the subsequent operation is continued. In the case that the mark is positioned on a specific article (various reagent tubes or consumable materials) placed by the reagent consumable material module, when the scanning result of the scanner is recognized, the software judges that the placement is correct, and then the subsequent operation is continued. Optionally, the reagent consumable module compartment includes a compartment in which the reagent tube is placed, a compartment in which the consumable is placed, and the like.
When the scanner scans the identifier of the nucleic acid extraction module in the setting and loading step S2, the scanner scans the identifier on the nucleic acid extraction reagent strip.
According to one aspect of the invention, if the user confirms on the software that the nucleic acid extraction reagent strip has been placed correctly, the software continues with subsequent operations. If the user does not confirm on the software that the nucleic acid extraction reagent strip has been placed correctly, the user adds the nucleic acid extraction reagent strip, the scanner rescans the identity of the nucleic acid extraction reagent strip, and after the user confirms on the software that the nucleic acid extraction reagent strip has been placed correctly, the software continues with subsequent operations.
According to one aspect of the invention, preferably, the scanner scans the identity of the nucleic acid extraction reagent strip, and if the identification is unsuccessful, the software prompts the user to correctly place the nucleic acid extraction reagent strip. After the identification of the nucleic acid extraction reagent strip is successful, the software prompts the relevant information of the identification of the nucleic acid extraction reagent strip, and if the relevant information is wrong, the user replaces the nucleic acid extraction reagent strip and rescans. After the relevant information of the nucleic acid extraction reagent strip mark is correct, the user confirms that the nucleic acid extraction reagent strip is correctly placed on the software, and the software continues the subsequent operation.
When the scanner scans the identifier of the PCR amplification module in the setting and loading step S2, and when the identifier is located on the compartment of the PCR amplification module, and the scanning result of the scanner is unidentified, the software judges that the placement mode of the PCR tube is correct (the PCR tube is placed in the PCR amplification module), and continues the subsequent operation, and when the scanning result is identified, the software judges that the placement mode of the PCR tube is incorrect (the PCR tube is not placed in the PCR amplification module), and the software prompts the user to correctly place the PCR tube and confirms that the PCR tube is correctly placed, and then continues the subsequent operation after confirming that the PCR tube is correctly placed. And under the condition that the mark is positioned on the PCR tube, if the scanning result of the scanner is recognized, continuing the subsequent operation, and if the scanning result is not recognized, prompting the user to correctly place the PCR tube by the software and confirming that the PCR tube is correctly placed, and continuing the subsequent operation after confirming that the PCR tube is correctly placed.
According to one aspect of the invention, in a self-test step S1, a step of scanning an identifier on a PCR amplification module compartment by a scanner is included; the setting and loading step S2 includes a step of scanning the identifier on the nucleic acid extraction reagent strip and the identifier on the PCR amplification module compartment by a scanner, or includes a step of scanning the identifier on the reagent consumable module compartment, the identifier on the nucleic acid extraction reagent strip, and the identifier on the PCR amplification module compartment by a scanner. In the self-checking step S1, when the scanning result of the scanner scanning the mark on the PCR amplification module compartment is recognized, the software judges that the placement mode of the PCR tube is correct, and the subsequent operation is continued. In the setting and loading step S2, when the scanning result of the scanner scanning the identifier on the PCR amplification module compartment is unidentified, the software judges that the placement mode of the PCR tube is correct, and the subsequent operation is continued.
According to one aspect of the invention, the setting and loading step S2 may comprise the steps of:
S21: after the self-checking step is completed, the software prompts the user to set the sample and the detection information on the software.
S22: and after the sample and the detection information are set, starting a loading step.
S22-1: the software prompts the user to load the consumable, and the consumable is loaded and enters the next step after being confirmed on the software. Or the scanner scans the mark on the compartment where the reagent consumable module is placed on the consumable, or the mark on the consumable, and the consumable enters the next step after being placed correctly.
S22-2: the scanner scans the identification of the PCR amplification module, the identification is arranged on a compartment of the PCR amplification module or a PCR tube, and the PCR tube enters the next step after being placed correctly.
S22-3: the scanner scans the identity of the nucleic acid extraction reagent strip and the nucleic acid extraction reagent strip is placed correctly and then proceeds to the next step.
S22-4: the software prompts the user to load the reagent tube, which is loaded and confirmed on the software to proceed to the next step. Or the scanner scans the mark on the compartment where the reagent consumable module is placed on the reagent tube, or the mark on the reagent tube, and the reagent tube enters the next step after being placed correctly.
S22-5: the software prompts the user to load the sample tube, which is loaded and confirmed on the software before proceeding to the next step. Or the scanner scans the mark of the sample tube or the sample rack, and the sample tube is placed correctly and then enters the next step.
In the present invention, after the completion of the setting and loading step S2, the nucleic acid detection step S3 is started.
According to one aspect of the invention, the software of the fully automatic nucleic acid detection analysis system of the invention has the function of prompting the user to clean the PCR tube during the self-checking step and/or prompting the user to correctly place the PCR tube during the setting and loading steps.
According to one aspect of the invention, the software of the fully automated nucleic acid detection analysis system of the invention has the function of prompting the user to clean the PCR tube during the self-test step and/or prompting the user to properly place the PCR tube and the nucleic acid extraction reagent strip during the setup and loading steps.
According to one aspect of the invention, the software of the fully automatic nucleic acid detection analysis system has the functions of prompting a user to clean the PCR tube in a self-checking step and/or prompting the user to correctly place the PCR tube and/or correctly place the nucleic acid extraction reagent strip in a setting and loading step according to the scanning result of the scanner.
According to one aspect of the invention, the software of the full-automatic nucleic acid detection analysis system can also have the functions of prompting a user to set a sample and detection information, prompting the user to load consumable materials and confirm, prompting the user to load a reagent tube and confirm and/or prompting the user to load the sample tube and confirm and the like.
According to one aspect of the invention, the software of the fully automated nucleic acid detection analysis system of the invention may have one or more of the following functions: the method comprises the steps of (1) prompting a user to clean a PCR tube and confirm, (2) prompting the user to set sample and detection information, (3) prompting the user to load consumable and confirm, (4) prompting the user to correctly place the PCR tube and confirm, (5) prompting the user to correctly place a nucleic acid extraction reagent strip, (6) prompting the user to correctly place relevant information of a nucleic acid extraction reagent strip mark and confirm, (7) prompting the user to load the reagent tube and confirm, (8) prompting the user to load the sample tube and confirm, and (9) starting detection after all loading is confirmed to be successful.
The invention has at least the following advantages or beneficial effects:
The judging method can effectively judge whether the module contains the specific object or not, and avoid idle work of the system and the module caused by forgetting, forgetting to place or misplacement of the specific object. The judging method has low cost and high efficiency. When the mark is arranged on the compartment of the module, the mark can be repeatedly used without replacement, and the operation is simple and convenient.
When the system is a full-automatic nucleic acid detection analysis system, the mark is arranged on the reagent consumable module and/or the PCR amplification module, and the mark arrangement mode is skillfully designed, so that the problem of useless detection of the system caused by forgetting a user or not placing the reagent consumable and/or the PCR tube is effectively solved, the detection efficiency is improved, and the design is skillful and practical. Through setting up the sign on nucleic acid extraction reagent strip, can contain information such as nucleic acid extraction reagent kind, reagent expiration date in the sign, when the scanner scans the sign of nucleic acid extraction reagent strip, if discernment is unsuccessful or information is wrong, the user can correct in time, just find after avoiding detecting the step to accomplish and do idle work, improved full-automatic nucleic acid detection analysis system's availability factor and result validity. The operation method of the full-automatic nucleic acid detection analysis system can realize effective self-detection of the system before nucleic acid detection, and avoid the situations of invalid detection and the like caused by uncleaned PCR tubes. Moreover, all consumables, reagent tubes, PCR tubes, nucleic acid extraction reagent strips and the like can be ensured to be loaded correctly, and the effectiveness of nucleic acid detection is ensured efficiently.
Drawings
FIG. 1 is a top view of a scanner and PCR amplification module of an exemplary system of the present invention.
FIG. 2 is a partial schematic diagram of an exemplary system of the present invention without a PCR tube.
FIG. 3 is a partial schematic view of an exemplary system of the present invention for placing PCR tubes.
FIG. 4 is a flow chart of one method of operation of an exemplary system of the present invention.
Wherein reference numerals are as follows:
1. A scanner;
2. Identification;
3. A PCR tube;
4. An automatic pipetting device;
5. a compartment.
Detailed Description
The following description of the embodiments of the present invention will be made clearly and fully with reference to the accompanying drawings, in which it is evident that the embodiments described are only some, but not all embodiments of the invention. All other embodiments, based on the embodiments of the invention, which are apparent to those of ordinary skill in the art without inventive faculty, are intended to be within the scope of the invention.
The technical solutions of the embodiments of the present invention may be combined with each other, but it is necessary to base the implementation of those skilled in the art, and when the combination of the technical solutions contradicts or cannot be implemented, it should be considered that the combination of the technical solutions does not exist and is not within the scope of protection claimed by the present invention.
The technical scheme of the invention is exemplified by a full-automatic nucleic acid detection analysis system in the specific embodiment of the invention. However, the technical scheme of the invention is a general scheme, and can be applied to the field of full-automatic nucleic acid detection and analysis, other in-vitro diagnosis fields and any field in which whether a specific object is contained in a module needs to be judged.
In one embodiment, an exemplary fully automated nucleic acid detection analysis system includes a nucleic acid extraction module (not shown), a PCR amplification module, an automated pipetting device 4, a scanner 1, and software.
In one embodiment, the exemplary fully automated nucleic acid detection analysis system further comprises a power supply component, a control component, and a housing. The control part is an automatic control part based on a computer and can receive operation instructions from software and execute corresponding operations, including detection control operations such as displacement control, temperature control and the like.
In one embodiment, the exemplary fully automated nucleic acid detection analysis system further comprises a reagent consumable module. The reagent consumable module houses various reagent tubes and/or consumables for nucleic acid detection analysis, such as a pipette tip, and the like.
In one embodiment, the exemplary fully automated nucleic acid detection analysis system further comprises a sample injection module. The sample injection module is used for placing a sample tube. The adopted sample tube is an original tube, and the original tube is directly connected to a machine without manual sample adding. The sample tube may be a standard sample tube, such as a standard blood collection tube or BD sample tube. Sample tubes suitable for the device of the present invention may be any commercially available sample tube such as, but not limited to, 12/13 x 75mm glass blood collection tube, 12/13 x 75mm plastic blood collection tube, 13 x 100mm blood collection tube, 16 x 75mm blood collection tube, 16 x 100mm BD sample tube, etc. The sample tube may also be a non-standard sample tube. The sample tube of the present invention is placed on a sample rack. The sample rack is provided with 8-16 sample tubes, preferably 12 sample tubes.
In one embodiment, a nucleic acid extraction module is used to extract nucleic acids in a sample, the nucleic acid extraction module having N compartments adapted to hold N nucleic acid extraction reagent strips. N is a natural number greater than or equal to 1. In one embodiment, N is 8-12. The nucleic acid extraction reagent strip sequentially comprises a binding tube, a cleaning tube and an eluting tube. The binding tube, the cleaning tube and the eluting tube are covered with sealing films.
In one embodiment, the sample may include various samples of human genital secretions, respiratory swabs, serum/plasma, feces, urine, and the like. The invention can process various samples by physical grinding and cracking. The nucleic acid extraction module utilizes magnetic bead adsorption extraction, and the extraction efficiency is high.
In one embodiment, the PCR amplification module is used to PCR amplify and detect nucleic acids in a sample.
In one embodiment, the PCR amplification module is a module suitable for performing PCR amplification in any manner, including but not limited to qPCR (fluorescent quantitative PCR), RT-PCR, hot start PCR, nested PCR, multiplex PCR, recovery condition PCR, dsRNA synthesis, COLD-PCR, digital PCR, and the like. In one embodiment, the PCR amplification module is configured for fluorescent quantitative PCR of DNA and RNA.
FIGS. 1-3 describe in detail the case where the identity of the PCR module is disposed on a compartment of the PCR module. The situation that the mark of the PCR module is arranged on the PCR tube, the mark of the reagent consumable module is arranged is similar to the situation.
As shown in fig. 1-3, in one embodiment, the scanner 1 is provided on an automatic pipetting device 4. The automatic pipetting device 4 is used for sample pipetting, nucleic acid extraction, PCR sample loading and the like in response to control of software. The scanner 1 moves following the movement of the automatic pipetting device 4. The automatic pipetting device 4 is provided with a pipetting gun. The PCR amplification module has N compartments 5 suitable for placing N PCR tubes. N is a natural number of 1 or more, preferably N is 8 to 12. The PCR amplification module is provided with a label 2. The identification 2 may be a bar code or a two-dimensional code, etc. The scanner 1 may be a scanner or the like. In one embodiment, the label 2 of the PCR amplification module is disposed on the upper surface of the compartment 5 of the PCR amplification module. The compartment 5 of each PCR amplification module is provided with one label 2. When the PCR tube 3 is not placed on the PCR amplification module compartment, no shielding exists at the mark 2 on the PCR amplification module compartment. After the PCR tube 3 is placed on the PCR amplification module compartment, the mark 2 on the PCR amplification module compartment is at least partially blocked. The identity 2 on the at least partially obscured PCR amplification module compartment is not recognizable by the scanner 1.
In one embodiment, the software is embedded software for managing the full flow of operation and operation of the fully automated nucleic acid detection analysis system. In one embodiment, the software confirms whether the placement of the PCR tube 3 is correct by scanning the PCR amplification module's logo 2. If the placement mode of the PCR tube 3 is correct, the subsequent operation is continued.
In one embodiment, the PCR tube 3 is a reaction cup with a cover, the bottom end of the cup body is in a conical structure, and the upper end of the cup body is in a cylindrical shape. The effective volume of the PCR tube 3 is usually about 1 to 100. Mu.l, preferably about 10 to 50. Mu.l, more preferably about 30. Mu.l.
As shown in fig. 4, in one embodiment, the method of operation of an exemplary fully automated nucleic acid detection analysis system comprises the steps of:
Firstly, opening software, entering a self-checking step S1, scanning an identifier of a PCR amplification module (the identifier is positioned on a compartment of the PCR amplification module) by a scanner, and prompting a user to clear a PCR tube by the software when the scanning result is unidentified, and continuing the follow-up operation after the user confirms that the PCR tube is cleared; and when the scanning result is that the scanning is recognized, continuing the subsequent operation.
And S2, entering a setting and loading step, wherein the software prompts a user to set samples and detection information on the software. After the sample and the detection information are set, the software prompts the user to load the consumable and confirms that the consumable is loaded, and the user enters the next step after confirming on the software.
The scanner scans the identification of the PCR amplification module (the identification is positioned on a compartment of the PCR amplification module), when the scanning result is unidentified, the next step is carried out, and when the scanning result is identified, the software prompts the user to correctly place the PCR tube, and after the user confirms that the PCR tube is correctly placed, the next step is carried out.
The scanner scans the identity of the nucleic acid extraction reagent strip. Each nucleic acid extraction reagent strip is provided with a mark. The label of the nucleic acid extraction reagent strip is positioned on the upper surface of the nucleic acid extraction reagent strip, and the sealing film is positioned on the same side. The label and the elution tube are respectively positioned at two ends of the nucleic acid extraction reagent strip. The label of the nucleic acid isolation strip contains information such as the type of the nucleic acid isolation reagent and the expiration date of the reagent. When the scanning result of the identification of the nucleic acid extraction reagent strip is that the identification is already recognized, the software prompts the user of relevant information of the identification of the nucleic acid extraction reagent strip; when the scanning result is unrecognized, the software prompts the user to correctly place the nucleic acid extraction reagent strip, and when the user correctly places the nucleic acid extraction reagent strip and the identification of the nucleic acid extraction reagent strip is recognized, the software prompts the user about information of the identification of the nucleic acid extraction reagent strip. If the related information is wrong, the user repositions the nucleic acid extraction reagent strip and the scanner rescans the identification of the nucleic acid extraction reagent strip, after the related information of the identification of the nucleic acid extraction reagent strip is correct, the user confirms on the software that the nucleic acid extraction reagent strip is correctly positioned, and the software continues the subsequent operation.
The software prompts the user to load the reagent tube and confirms that the reagent tube is loaded and proceeds to the next step after confirmation on the software.
The software prompts the user to load the sample tube and confirm. In one embodiment, the sample tube or sample holder may be attached with an identification. The identification can be scanned by the scanner 1 of the invention or by an external scanner. The nucleic acid detection step S3 is started after the sample tube has been loaded and validated on the software.
In one embodiment, the method for operating the full-automatic nucleic acid detection and analysis system according to the present invention may be performed automatically in sequence after the software is turned on, or may be performed after the user manually triggers the step S1, the step S2 of setting and loading, and the step S3 of detecting.
In the description of the present invention, the term "module" is used to refer to a unit or combination of units configured to operate together to implement one or more subsystem functions of the system of the present invention. It should be understood that each unit within a module need not be directly connected or in direct communication with each other unit. Moreover, the connection or communication of the units may be implemented with the aid of units or elements external to the module, such as a processor.
In the description of the present invention, the terms "in accordance with an aspect of the present invention," "under an embodiment," and the like are intended to describe further specific features, structures, materials, or characteristics, etc., and are not limited to the different embodiments, but may be combined in any suitable manner in any one or more of the embodiments.
The above is only a preferred embodiment of the present invention, and is not intended to limit the embodiment of the present invention, and various modifications and variations of the embodiment of the present invention will be apparent to those skilled in the art. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the embodiments of the present invention should be included in the protection scope of the embodiments of the present invention.

Claims (10)

1. A judging method is characterized in that: based on the scanning result of the scanner to the mark, the judging method judges whether the module contains the specific object, when the scanning result is unidentified, the judging module contains the specific object, and when the scanning result is identified, the judging module does not contain the specific object.
2. A module, characterized in that: the module has a compartment adapted to receive a specific item, the module is provided with a logo, the logo being at least partially obscured after placement of the specific item on the module, the logo being at least partially obscured from recognition by the scanner.
3. A module according to claim 2, characterized in that: the specific item is a sample container, a reagent container, a reaction container, and/or a pipette tip.
4. A module according to claim 2, characterized in that: the module is suitable for in vitro diagnostics.
5. A module according to claim 2, characterized in that: the logo is disposed on a compartment of the module.
6. A system, characterized by: the system comprising the module of any one of claims 2-5 and a scanner.
7. A system, characterized by: the system comprises a module and a scanner, the module having a compartment adapted to hold a specific item, the module being provided with an identification; the module is a reagent consumable module, a nucleic acid extraction module and/or a PCR amplification module; the identification of the reagent consumable module is arranged on a compartment of the reagent consumable module or a specific article placed on the compartment; the identification of the nucleic acid extraction module is arranged on a specific article on which the nucleic acid extraction module is placed; the identity of the PCR amplification module is provided on the compartment of the PCR amplification module or on the particular item on which it is placed.
8. The system according to claim 7, wherein: the specific articles placed by the reagent consumable module are various reagent tubes and/or consumables for nucleic acid detection and analysis; the specific article placed by the nucleic acid extraction module is a nucleic acid extraction reagent strip; the specific article placed by the PCR amplification module is a PCR tube.
9. The system according to claim 7 or 8, characterized in that: in the case that the mark of the reagent consumable module is arranged on the compartment of the reagent consumable module, after a specific object is placed on the reagent consumable module, the mark is at least partially blocked, and the mark which is at least partially blocked cannot be identified by the scanner; and/or, in the case that the mark of the PCR amplification module is arranged on the compartment of the PCR amplification module, after the specific object is placed on the PCR amplification module, the mark is at least partially shielded, and the mark at least partially shielded cannot be recognized by the scanner.
10. A method of operating a system as claimed in any one of claims 7 to 9, characterized in that: the method comprises the following steps:
s1: a self-checking step;
S2: setting and loading;
S3: and (3) a detection step.
CN202410418218.2A 2024-04-08 2024-04-08 Judgment method, module, system and operation method thereof Pending CN118262851A (en)

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