CN111796106A - Quality control/calibration test method, sample analyzer, and computer-readable storage medium - Google Patents
Quality control/calibration test method, sample analyzer, and computer-readable storage medium Download PDFInfo
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Abstract
The embodiment of the invention discloses a quality control/calibration test method, a sample analyzer and a computer readable storage medium, wherein the sample analyzer comprises a reagent bin which is provided with a plurality of reagent storage positions and used for refrigerating reagents, and a quality control/calibration quality storage position is also arranged in the reagent bin, and the quality control/calibration test method comprises the following steps: acquiring a quality control/calibration test instruction of a quality control/calibration product to be tested; acquiring characteristic information of a quality control/calibration product to be tested and position information of a quality control/calibration product storage bit where the quality control/calibration product to be tested is located; controlling the sample sucking needle to move to a quality control/calibration product storage position where the quality control/calibration product to be detected is located to suck a specified amount of quality control/calibration product to be detected according to the characteristic information and the position information; and performing quality control/calibration test by using the specified quantity of quality control/calibration products to be tested.
Description
Technical Field
The present invention relates to the field of in vitro diagnostics, and in particular, to a quality control/calibration test method, a sample analyzer, and a computer-readable storage medium.
Background
In order to ensure the accuracy of the detection result of the in vitro diagnostic apparatus, a traceable standard is generally used to calibrate the in vitro diagnostic apparatus and track the stability of the detection result of the apparatus. Taking a full-automatic chemiluminescence analyzer as an example, when a new batch of reagents are used on the machine, a calibrator is required to be used for correcting the instrument and a reagent system so as to ensure the correctness of the detection output result of the instrument; meanwhile, in order to monitor the working state of the full-automatic chemiluminescence analyzer, a department is generally required to perform daily quality control on the analyzer in laboratory management specifications, that is, the stability and consistency of detection results of the analyzer within a certain period of time are evaluated by performing daily test on a stable standard substance with certain traceability. In addition to the above scenarios, when the environment of the apparatus changes, such as transportation, and temperature and humidity change significantly, quality control products and calibration products are used to determine whether the performance of the apparatus deviates and correct.
The quality control product or calibrator generally has a certain bioactivity, and in order to ensure the quality stability of the quality control product or calibrator, the quality control product or calibrator is usually stored in a refrigerator for refrigeration (e.g., 2-8 ℃). When the quality control product and the calibration product are required to be used, the quality control product and the calibration product are taken out of the refrigerator and placed on a sample position of an analyzer, the position of the quality control product or the position of the calibration product is set or obtained through bar code scanning, and then a quality control program or a calibration program is selected to be executed, so that the quality control monitoring or the calibration of the instrument is completed. After the instrument test is finished, the quality control product or the calibration product needs to be taken out and packaged, and then the quality control product or the calibration product needs to be put back into a refrigerator for storage, so that the operation process is complicated; and because the chemiluminescence analyzer has different test time for different items, an operator easily forgets to take out the quality control product or the calibrator after quality control/calibration test, or takes out the quality control product or the calibrator after placing the chemiluminescence analyzer in the instrument for a long time, and the quality control product or the calibrator is easy to deteriorate after being placed in an open room for a long time, so that the test result is inaccurate, and even the whole bottle of the quality control product or the calibrator is scrapped.
Disclosure of Invention
In order to solve the above technical problems, embodiments of the present invention are directed to a quality control/calibration testing method, a sample analyzer, and a computer storage medium, which can simplify a quality control/calibration testing process and improve accuracy of a testing result.
The embodiment of the invention provides a quality control/calibration test method, which is applied to a sample analyzer, in particular to a biochemical analyzer or a chemiluminescence immunoassay analyzer, wherein the sample analyzer comprises a reagent bin which is provided with a plurality of reagent storage positions and is used for refrigerating reagents, and a quality control/calibration product storage position is also arranged in the reagent bin, and the method comprises the following steps:
acquiring a quality control/calibration test instruction of a quality control/calibration product to be tested;
acquiring characteristic information of a quality control/calibration product to be tested and acquiring position information of a quality control/calibration product storage bit where the quality control/calibration product to be tested is located;
controlling the sample sucking needle to move to a quality control/calibration product storage position where the quality control/calibration product to be detected is located to suck a specified amount of quality control/calibration product to be detected according to the characteristic information and the position information;
and performing quality control/calibration test by using the specified quantity of quality control/calibration products to be tested.
In the above method, the control/calibrator storage space may be constituted as at least one reagent storage space of the plurality of reagent storage spaces, or may be constituted as a storage space independent from the plurality of reagent storage spaces.
In the above method, the step of obtaining the characteristic information of the quality control/calibration product to be tested may include:
obtaining characteristic information of a quality control/calibration product to be tested through man-machine interaction; alternatively, the first and second electrodes may be,
and scanning the identification part of the container of the quality control/calibration product to be detected through a scanning device to obtain the characteristic information of the quality control/calibration product to be detected.
In the above method, the step of obtaining the position information of the quality control/calibration product storage bit where the quality control/calibration product to be tested is located may include:
presetting a quality control/calibrator storage position of the quality control/calibrator to be tested through man-machine interaction, so as to obtain the position information; alternatively, the first and second electrodes may be,
and obtaining the position information of the quality control/calibration product storage bit of the quality control/calibration product to be tested through a scanning device.
In the method, the characteristic information of the quality control/calibration product to be tested may include at least one of a name of the quality control/calibration product, a production date, an expiration date, and a total amount.
In the above method, after the controlling the sample aspirating needle to aspirate the specified amount of the quality control/calibration product to be tested, the method may further include:
and acquiring and storing the residual information of the quality control/calibration product to be tested.
In the above method, the step of obtaining and storing the remaining amount information of the quality control/calibration product to be tested may include:
determining and storing the residual amount information in association with the characteristic information of the quality control/calibration product to be tested through the total amount of the quality control/calibration product to be tested and the specified amount; or
Determining and storing the residual amount information in association with the characteristic information of the quality control/calibration product to be detected by detecting the current liquid level height of the quality control/calibration product to be detected.
In the above method, after obtaining and storing the remaining amount information of the quality control/calibration product to be tested, the method may further include:
judging whether the quality control/calibration product to be tested is enough to be used for the next quality control/calibration test or not according to the surplus information;
and when the quality control/calibration product to be tested is not enough for the next quality control/calibration test, outputting an alarm signal of the quality control/calibration product shortage and/or outputting prompt information for replacing the quality control/calibration product to be tested.
In the above method, the step of obtaining the quality control/calibration test instruction for the quality control/calibration product to be tested may include:
presetting the quality control/calibration test time of the quality control/calibration product to be tested;
obtaining a system time of the sample analyzer;
and when the system time of the sample analyzer is detected to reach the quality control/calibration time, acquiring the quality control/calibration test instruction.
In the above method, after obtaining the characteristic information of the quality control/calibration product to be tested, and before controlling the sample aspirating needle to aspirate the quality control/calibration product to be tested, the method may further include:
obtaining a system time of the sample analyzer;
determining whether the quality control/calibration product to be tested is in the valid period or not according to the system time and the production date and the valid period in the characteristic information of the quality control/calibration product to be tested;
and when the quality control/calibration product to be tested is not in the validity period, outputting an alarm signal of the expiration of the quality control/calibration product to be tested and/or outputting a prompt for replacing the quality control/calibration product to be tested.
An embodiment of the present invention further provides a sample analyzer, in particular a biochemical analyzer or a chemiluminescent immunoassay analyzer, including:
the reagent bin is provided with a plurality of reagent storage positions and forms a reagent bin for refrigerating the reagents, wherein the reagent bin is also internally provided with a quality control/calibrator storage position for refrigerating and storing a quality control/calibrator;
the sample sucking needle is used for sucking and discharging a sample;
and the control device is used for controlling the sample sucking needle to move to the quality control/calibration product storage position where the quality control/calibration product to be tested is located to suck the specified quantity of quality control/calibration product to be tested when a quality control/calibration test instruction for the quality control/calibration product to be tested is received, so that the specified quantity of quality control/calibration product to be tested is utilized to carry out quality control/calibration test.
In the above sample analyzer, the reagent cartridge may include: a reagent disk and a refrigeration device, wherein the reagent disk can comprise a plurality of reagent holding positions.
In the above sample analyzer, the control/calibrator storage space may be constituted as at least one reagent storage space of the plurality of reagent storage spaces, or may be constituted as a storage space independent from the plurality of reagent storage spaces.
In the sample analyzer, a protection device for preventing the liquid from volatilizing may be disposed on the container port of the quality control/calibration product to be measured.
In the above sample analyzer, the sample analyzer may further include a scanning device, and the scanning device is configured to obtain characteristic information of the quality control/calibration product to be tested and position information of a quality control/calibration product storage location where the quality control/calibration product to be tested is located.
In the sample analyser described above, the processor is arranged to perform any of the methods described above.
The embodiment of the invention also provides a quality control/calibration test device, which is applied to a sample analyzer, in particular to a biochemical analyzer or a chemiluminescence immunoassay analyzer, and comprises the following components: a processor, a memory and a computer program stored on the memory and executable on the processor, which when executed by the processor implements the method as defined in any one of the above.
An embodiment of the present invention further provides a storage medium, on which a computer program is stored, for application to a sample analyzer, wherein the computer program, when executed by a processor, implements the method according to any one of the above-mentioned methods.
According to the invention, the quality control/calibration product storage position is arranged in the reagent bin of the sample analyzer, and the reagent bin of the sample analyzer has a refrigeration function, so that the quality control/calibration product can be prevented from deteriorating when being placed in the reagent bin of the sample analyzer, the accuracy of a test result is further improved, the quality control/calibration product does not need to be taken out again after the quality control/calibration test is finished, and the quality control/calibration product cannot be forgotten to be in a normal temperature environment for a long time but is in refrigeration when a user forgets to take out the product. Therefore, according to the invention, the quality control/calibration product is placed at the quality control/calibration product storage position arranged in the reagent bin, when the sample analyzer receives the quality control/calibration test instruction, the sample sucking needle is directly instructed to move to the quality control/calibration product storage position to obtain the quality control/calibration product, and the subsequent quality control/calibration test process is completed, so that the quality control/calibration test process is simplified.
Drawings
Fig. 1 is a schematic top view of a sample analyzer according to an embodiment of the present invention;
FIG. 2 is a schematic top view of the sample reagent loading device of the sample analyzer of FIG. 1;
FIG. 3 is an exploded schematic view of the sample reagent loading device shown in FIG. 2;
FIG. 4 is a schematic view of a scanning identification code of the scanning device in the sample reagent loading device shown in FIG. 2;
FIG. 5 is a schematic flow chart of a quality control/calibration testing method according to an embodiment of the present invention;
FIG. 6 is a schematic flow chart illustrating the establishment of correspondence between quality control/calibration material and quality control/calibration material storage bits through human-computer interaction according to an embodiment of the present invention;
FIG. 7 is a schematic flowchart of the embodiment of the present invention for establishing a mapping relationship between a quality control/calibration material and a storage bit of the quality control/calibration material by a scanning device;
fig. 8 is a schematic structural diagram of a quality control/calibration testing apparatus according to an embodiment of the present invention.
Detailed Description
The technical solution in the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings in the embodiments of the present invention.
The numbering of the components as such, e.g., "first", "second", etc., is used herein only to distinguish the objects as described, and does not have any sequential or technical meaning. The term "connected" and "coupled" as used herein includes both direct and indirect connections (couplings), unless otherwise specified. In the description of the present invention, it is to be understood that the terms "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "clockwise", "counterclockwise", and the like, indicate orientations or positional relationships based on those shown in the drawings, and are only for convenience of description and simplicity of description, but do not indicate or imply that the referenced devices or elements must have a particular orientation, be constructed and operated in a particular orientation, and thus, are not to be construed as limiting the present invention.
In the present invention, unless otherwise expressly stated or limited, the first feature "on" or "under" the second feature may be directly contacting the first and second features or indirectly contacting the first and second features through an intermediate. Also, a first feature "on," "over," and "above" a second feature may be directly or diagonally above the second feature, or may simply indicate that the first feature is at a higher level than the second feature. A first feature being "under," "below," and "beneath" a second feature may be directly under or obliquely under the first feature, or may simply mean that the first feature is at a lesser elevation than the second feature.
Referring to fig. 1, an embodiment of the present invention provides a sample analyzer, especially a chemiluminescence immunoassay analyzer, which is used for analyzing and detecting a sample to be detected to obtain a corresponding detection result, so as to meet a use requirement. The sample analyzer includes: the reagent bin is provided with a plurality of reagent storage positions and forms a reagent bin for refrigerating the reagents, wherein the reagent bin is also internally provided with a quality control/calibrator storage position for refrigerating and storing a quality control/calibrator; the sample sucking needle is used for sucking and discharging a sample; and the control device is used for controlling the sample sucking needle to move to the quality control/calibration product storage position where the quality control/calibration product to be tested is located to suck the specified quantity of quality control/calibration product to be tested when a quality control/calibration test instruction for the quality control/calibration product to be tested is received, so that the specified quantity of quality control/calibration product to be tested is utilized to carry out quality control/calibration test.
Specifically, in the present invention, a sample analyzer, particularly a chemiluminescent immunoassay analyzer, may include a sample reagent loading device 1, an incubation photometric device 2, a dispensing device 3, a magnetic separation cleaning device 4, a reaction vessel grasping device 5, a homogenizing device 6, a waste liquid discharge device 7, a reaction vessel loading device 8, a control device (not shown), and the like. The sample reagent loading apparatus 1 is used for loading a sample and a reagent. Specifically, the sample reagent loading device 1 can store a plurality of samples. The sample reagent loading device 1 can also load various reagents required for sample detection, so that the required reagents can be conveniently selected, and the reagent suction efficiency is improved. The dispensing device 3 includes a sample and/or reagent aspirating needle (not shown) for aspirating and discharging samples and reagents to effect transfer of the samples and reagents into reaction vessels. The blending device 6 is used for supporting the reaction vessel. It is understood that the empty reaction vessel is transferred to the mixing device, the dispensing device 3 transfers the sample and the reagent to the reaction vessel, respectively, and the reaction vessel is transferred to the incubation photometry device 2 after the sample and the reagent are uniformly mixed by the mixing device 6. The incubation photometric device 2 is used for incubation and luminescence detection, and the magnetic separation cleaning device 4 is used for separation cleaning. After the reaction container is transferred to the incubation photometric device 2, the incubation photometric device 2 can incubate the sample and the reagent in the reaction container, the incubated reaction container is transferred to the magnetic separation cleaning device 4 for separation and cleaning, and the cleaned reaction container is transferred back to the incubation photometric device 2 for luminescence detection to obtain the corresponding parameters of the sample. The reaction vessel gripping device 5 is used for transferring the reaction vessels among the blending device 6, the incubation photometric device 2 and the magnetic separation cleaning device 4. The waste liquid discharge device 7 is used for discharging waste liquid in the reaction vessel after detection, and when the waste liquid is discharged, the waste liquid discharge device 7 can also shade the reaction vessel for luminescence detection in the incubation photometric device 2. The reaction container loading device 8 is used for loading a reaction container for reacting a sample and a reagent.
As shown in fig. 2 to 4, the sample reagent loading device 1 according to the present invention includes a sample loading mechanism 11 for loading a sample and a reagent loading mechanism 12 for loading a reagent, the sample loading mechanism 11 is sleeved outside the reagent loading mechanism 12, and the sample loading mechanism 11 and the reagent loading mechanism 12 rotate independently of each other. The sample loading mechanism 11 can store a sample to be tested, and the reagent loading mechanism 12 stores various reagents required for testing of the sample.
According to the invention, at least one quality control/calibration product storage location is provided in the reagent magazine 121, in particular in the reagent tray 122, for storing quality control/calibration products. Because reagent storehouse 121 has the cold-stored function, so place quality control/calibrator in reagent storehouse 121 can prevent quality control/calibrator to go bad, and then improve the accuracy of test result, also need not to take out it again after quality control/calibration test finishes yet, also can not lead to the quality control/calibrator to forget for a long time and forget under the normal atmospheric temperature environment when at least the user takes out, but in refrigerating. Therefore, according to the present invention, the quality control/calibration product is placed at the quality control/calibration product storage location provided in the reagent chamber 121, and when the chemiluminescence analyzer receives a quality control/calibration test command, the chemiluminescence analyzer directly instructs the sample suction needle of the dispensing device 3 to move to the quality control/calibration product storage location to obtain the quality control/calibration product, and completes the subsequent quality control/calibration test process, thereby simplifying the quality control/calibration test process.
In the present invention, the control/calibrator storage space may be constituted as at least one reagent storage space among the plurality of reagent storage spaces, or may be constituted as a storage space independent of the plurality of reagent storage spaces.
Furthermore, a protective device for preventing liquid from volatilizing is arranged on a container port of the quality control/calibration product to be tested, and the protective device can be matched with the action of the sample sucking needle to realize the functions of opening, closing, sample sucking and sealing protection. Illustratively, a rubber film with a cross-shaped cut is arranged at the container port of the quality control/calibration product, and the cross-shaped cut of the rubber film is pushed open when a sample sucking needle is inserted; after the needle is removed, the cross incision is restored and the incision is closed.
The reagent storage driving structure 126 may include a reagent storage driving motor, a synchronous belt structure and a rotating shaft, the rotating shaft extends into the reagent chamber 121, the synchronous belt structure is in transmission connection with the reagent storage driving motor and the rotating shaft, and the reagent disk 122 is installed on the rotating shaft. The reagent storage driving motor drives the rotating shaft to rotate through a synchronous belt structure, and then the rotating shaft drives the reagent disk 122 to rotate, so that a reagent container or a quality control/calibration product container to be sucked in the reagent disk 122 is transferred to a reagent sucking station, and a reagent needle or a sample sucking needle of the dispensing device 3 sucks a reagent or a quality control/calibration product and transfers the reagent or the quality control/calibration product to a reaction container; after the reagent needle or the sample sucking needle of the dispensing device 3 sucks the reagent or the quality control/calibration product, the reagent storage driving structure 126 may drive the reagent disk 122 to rotate again, so that the next to-be-detected reagent container rotates to the reagent sucking station.
Alternatively, the reagent aspirating station and the reagent storage driving structure may not be provided, but the control device may directly control the dispensing device 3 to move the reagent needle or the sample aspirating needle to the position where the reagent or the quality control/calibration product is located, aspirate the reagent or the quality control/calibration product, and transfer the reagent or the quality control/calibration product to the reaction vessel.
The sample aspirating needle and the reagent needle may be the same element or may be two different elements.
Further, the reagent loading mechanism 12 may further include a reagent chamber cover 123, and the reagent chamber cover 123 is covered on the reagent chamber 121. The reagent bin cover 123 can avoid the loss of cold energy in the reagent bin 121, guarantee the refrigeration effect and save the cost. Also, the reagent chamber cover 123 may have a plurality of reagent inhalation holes 1231, and the reagent needle may be inserted into any of the reagent inhalation holes 1231 to inhale the reagent.
Further, the reagent loading mechanism 12 may further include an opening and closing cover 124, the reagent compartment cover 123 has a placing and taking opening for placing or taking out the reagent container, and the opening and closing cover 124 is openably and closably located in the placing and taking opening of the reagent compartment cover 123. When the reagent in a certain reagent container on the reagent tray 122 needs to be replenished, the switch cover 124 is opened, the reagent container is taken out through the placing and taking opening, and after the reagent is replenished, the reagent container is placed on the reagent tray 122 through the placing and taking opening. Thus, the use of operators can be facilitated, and the loss of cold in the reagent bin 121 can be avoided.
In addition, the sample reagent loading device 1 further includes a scanning device 13 for scanning the identification code, and the sample loading mechanism 11 is provided with a scanning notch 1111. The scanner 13 can scan the identification code of the sample container on the sample loading mechanism 11, and the scanner 13 can scan the identification code of the reagent container and the quality control/calibrator container on the reagent loading mechanism 12 through the scanning notch 1111. The control device is electrically connected to the scanning device 13, the control device is configured to control the scanning device 13 to perform a scanning operation and store various items of information obtained by the scanning device 13, such as information about a position of the sample and an item to be detected, and information about a position and a type of the reagent and the quality control/calibration product, and the scanning device 13 can transmit basic information about the sample, the reagent and the quality control/calibration product, such as the position and the item to be detected, to the control device.
In other words, the scanning device 13 may be configured to obtain characteristic information of the quality control/calibration product to be tested, which may include at least one of a name of the quality control/calibration product, a production date, an expiration date, and a total amount, and position information of a quality control/calibration product storage bit in which the quality control/calibration product to be tested is located.
In addition, the reagent loading mechanism 12 further includes a refrigerating device (not shown) for refrigerating the inside of the reagent chamber 121, so that the inside of the reagent chamber 121 is in a low-temperature environment, thereby facilitating preservation of reagents and quality control/calibration products. The refrigerating device can be arranged at the lower part of the reagent tray. Furthermore, the cooling device may comprise a semiconductor cooling plate or a compressor. In addition, the chemiluminescent immunoassay analyzer may include a display interface for displaying the results of the sample analysis and/or displaying information related to the reagents and/or quality control/calibrators, such as characteristic information, type information, location information, etc., as well as for receiving user settings and control instructions, such as quality control/calibration test instructions.
As shown in fig. 5, the embodiment of the present invention provides a quality control/calibration test method applied to a sample analyzer, especially a biochemical analyzer or a chemiluminescent immunoassay analyzer, especially according to the present invention, the sample analyzer includes a reagent chamber 121 having a plurality of reagent storage sites and configured to store reagents for refrigeration, and a quality control/calibration product storage site is further disposed in the reagent chamber 121, the method includes:
s101, obtaining a quality control/calibration test instruction of a quality control/calibration product to be tested.
The quality control/calibration test method provided by the embodiment of the invention is suitable for a scene that a quality control/calibration product storage position is arranged in a reagent bin of a sample analyzer for storing a quality control/calibration product.
In the embodiment of the present invention, the sample analyzer includes a reagent chamber 121 having a refrigeration function, and a plurality of reagent storage locations are disposed in the reagent chamber. At least one reagent holding site of the plurality of reagent holding sites may be set as a control/calibrator holding site, that is, the control/calibrator holding site is configured as at least one reagent holding site of the plurality of reagent holding sites; alternatively, a control/calibrator holding site independent of the plurality of reagent holding sites may be previously constructed in the sample analyzer, that is, the control/calibrator holding site may be constructed as a holding site independent of the plurality of reagent holding sites. The specific configuration is set according to the actual situation, and the embodiment of the present invention is not particularly limited.
In the embodiment of the invention, the quality control/calibration test instruction can be given by a user in a man-machine interaction mode on a display operation interface of the sample analyzer. For example, the user may preset the quality control/calibration test time of the quality control/calibration product to be tested in the sample analyzer, and obtain the system time of the sample analyzer, and when the sample analyzer detects that the system time of the sample analyzer reaches the quality control/calibration time, obtain the quality control/calibration test instruction; or the user may perform a touch operation for triggering the quality control/calibration test on the display operation interface of the sample analyzer, and at this time, the sample analyzer acquires the quality control/calibration test instruction. The specific choice is made according to the actual situation, and the embodiment of the present invention is not particularly limited.
It can be understood that because the quality control/calibration product to be tested and the reagent are simultaneously stored in the reagent bin of the sample analyzer, the quality control/calibration test time can be preset according to the idle time of the department, the daily quality control/calibration test can be automatically completed, and the workload and the working time of the department are further saved.
S102, acquiring characteristic information of the quality control/calibration product to be tested and acquiring position information of a quality control/calibration product storage bit where the quality control/calibration product to be tested is located.
In the embodiment of the invention, the sample analyzer can obtain the characteristic information of the quality control/calibration product to be detected through man-machine interaction; or the sample analyzer can automatically obtain the characteristic information of the quality control/calibration product to be detected by scanning the identification part of the quality control/calibration product to be detected through the scanning device, and the characteristic information is specifically selected according to the actual situation, and the embodiment of the invention is not specifically limited.
In the embodiment of the present invention, the characteristic information of the quality control/calibration product to be tested includes at least one of a name of the quality control/calibration product, a production date, an expiration date, and a total amount, which is specifically selected according to an actual situation, and the embodiment of the present invention is not specifically limited.
In the embodiment of the invention, the quality control/calibration product to be tested is stored in the quality control/calibration product container, the quality control/calibration product container is provided with the identification part, the identification part bears the characteristic information of the quality control/calibration product to be tested, and the sample analyzer scans the identification part of the quality control/calibration product container through the scanning device to obtain the characteristic information of the quality control/calibration product to be tested.
In the embodiment of the invention, the sample analyzer can preset the quality control/calibrator storage position of the quality control/calibrator to be tested through human-computer interaction, so as to obtain the position information, for example, a user can set a certain reagent storage position or a certain independent quality control/calibrator storage position as the quality control/calibrator storage position of a certain quality control/calibrator on the display operation interface of the sample analyzer, so as to obtain the position information of the quality control/calibrator storage position; alternatively, the sample analyzer may obtain the position information of the quality control/calibrator storage location where the quality control/calibrator to be measured is located, through the scanning device. The specific choice is made according to the actual situation, and the embodiment of the present invention is not particularly limited.
In the embodiment of the invention, after the sample analyzer acquires the characteristic information of the quality control/calibration product to be detected and the position information of the quality control/calibration product storage bit where the quality control/calibration product to be detected is located, the sample analyzer establishes and stores the corresponding relationship between the characteristic information of the quality control/calibration product to be detected and the position information of the quality control/calibration product storage bit where the quality control/calibration product to be detected is located, so that the sample analyzer can determine the position information of the quality control/calibration product storage bit to be detected where the quality control/calibration product to be detected is located according to the corresponding relationship.
In one embodiment, the sample analyzer obtains the position information of the storage location of the quality control/calibrator to be tested and the characteristic information of the quality control/calibrator to be tested respectively through human-computer interaction on the display operation interface, and then establishes the corresponding relationship between the characteristic information and the position information.
Illustratively, as shown in fig. 6, in step S201, a first quality control/calibration product is first placed on a first reagent position of a reagent chamber; in step S202, a first reagent bin is selected as a storage bit of the first quality control/calibration product on the reagent bin setting interface, so as to obtain position information of the storage bit of the first quality control/calibration product; then in step S203, inputting characteristic information of the first quality control/calibration product, such as the name, item, production date, expiration date, total amount, etc., of the quality control/calibration product on the reagent bin setting interface; finally, in step S204, a corresponding relationship between the characteristic information of the first quality control/calibration product and the position information of the storage bit where the first quality control/calibration product is located is established and stored.
In another embodiment, the sample analyzer may be provided with a scanning device, and the sample analyzer scans the identification portion of the container of the quality control/calibration product to be tested by using the scanning device, and obtains the characteristic information of the quality control/calibration product to be tested and the storage location of the quality control/calibration product to be tested corresponding to the scanning position; and then, establishing a corresponding relation between the characteristic information and the position information.
Illustratively, as shown in fig. 7, in step S301, a first quality control/calibration material is first placed at any one of the holding positions of the reagent cartridge; in step S302, the sample analyzer controls the scanning device to scan each storage location of the reagent compartment to obtain characteristic information of the first quality control/calibration product and position information of the storage location where the first quality control/calibration product is located; finally, in step S303, a corresponding relationship between the characteristic information of the first quality control/calibration product and the position information of the storage bit where the first quality control/calibration product is located is established and stored.
It should be noted that the embodiment of the present invention does not limit the execution sequence of the two steps of step S101, in which the sample analyzer obtains the quality control/calibration test command, and step S102, in which the characteristic information of the quality control/calibration product to be tested is obtained, and the position information of the quality control/calibration product storage bit where the quality control/calibration product to be tested is located is obtained (or the corresponding relationship between the characteristic information of the quality control/calibration product to be tested and the position information of the quality control/calibration product storage bit is set), and the selection is specifically performed according to the actual situation. That is, the sample analyzer may first obtain the characteristic information of the quality control/calibration product to be tested and the position information of the quality control/calibration product storage bit where the quality control/calibration product to be tested is located according to the method shown in fig. 6, and establish the corresponding relationship between the characteristic information and the position information, and then obtain the quality control/calibration test instruction; or the sample analyzer may control the scanning device to scan each storage location of the reagent bin after the quality control/calibration test instruction is obtained, so as to obtain the characteristic information of the first quality control/calibration product and the position information of the storage location where the first quality control/calibration product is located.
It should be noted that, the reagent storage position may include a reagent storage position provided with a blending device and a reagent storage position not provided with a blending device, wherein, the reagent storage position provided with a blending device can perform blending operation on a chemiluminescent magnetic bead reagent, and when the type of the quality control/calibration product to be tested is a blending type, the quality control/calibration product to be tested can be placed on the reagent storage position provided with a blending device in the reagent bin, that is, the reagent storage position provided with a blending device is set as the quality control/calibration product storage position. The blending type is the type that requires blending operations prior to testing.
Further, after the sample analyzer acquires the characteristic information of the quality control/calibration product to be tested, the sample analyzer can judge the type of the quality control/calibration product to be tested, and when the type of the quality control/calibration product to be tested is the blending type, the sample analyzer instructs to place the quality control/calibration product to be tested on the quality control/calibration product storage position to be tested of the blending device.
S103, controlling the sample sucking needle to move to a quality control/calibration product storage position where the quality control/calibration product to be detected is located to suck the specified quantity of the quality control/calibration product to be detected according to the characteristic information and the position information.
After the sample analyzer acquires the characteristic information of the quality control/calibration product to be detected and the position information of the quality control/calibration product storage position where the quality control/calibration product to be detected is located, the sample analyzer controls the sample sucking needle to move to the quality control/calibration product storage position where the quality control/calibration product to be detected is located to suck the specified quantity of the quality control/calibration product to be detected according to the characteristic information and the position information.
In the embodiment of the invention, the sample analyzer controls the sample suction needle to move to the storage position of the quality control/calibration product to be detected, determines the specified quantity for performing the quality control/calibration test from the quality control/calibration test instruction, and then controls the sample suction needle to be inserted into the container for storing the quality control/calibration product to be detected so as to suck the specified quantity of the quality control/calibration product to be detected.
Further, when the quality control/calibration product to be tested is of a blending type, the sample analyzer first utilizes the blending device of the storage location of the quality control/calibration product to be tested to blend the quality control/calibration product to be tested, and then the sample analyzer controls the sample suction needle to suck the specified amount of the quality control/calibration product to be tested.
And S104, performing quality control/calibration test by using the specified quantity of quality control/calibration products to be tested.
After the sample analyzer controls the sample sucking needle to suck the specified amount of quality control/calibration product to be tested at the quality control/calibration product storage position to be tested, the sample analyzer performs quality control/calibration test by using the specified amount of quality control/calibration product to be tested.
In the embodiment of the invention, after the sample sucking needle sucks the specified quantity of the quality control/calibration product to be detected, the sample analyzer controls the sample sucking needle to move to the reaction container, and the sucked quality control/calibration product to be detected is discharged into the reaction container to react with the reagent so as to complete the quality control/calibration test.
Further, after the sample analyzer controls the sample suction needle to suck the specified amount of quality control/calibration product to be detected at the quality control/calibration product storage position to be detected, the sample analyzer can obtain and store the residual amount information of the quality control/calibration product to be detected, and then the sample analyzer can judge whether the quality control/calibration product to be detected is enough for the next quality control/calibration test according to the residual amount information; when the quality control/calibration product to be tested is not enough for the next quality control/calibration test, the sample analyzer outputs an alarm signal indicating that the quality control/calibration product is not enough and/or outputs prompt information for replacing the quality control/calibration product to be tested.
Optionally, the step of acquiring the remaining amount information of the quality control/calibration product to be measured by the sample analyzer may include: the sample analyzer determines and stores the residual amount information in association with the characteristic information of the quality control/calibration product to be detected according to the total amount and the specified amount of the quality control/calibration product to be detected; or, the sample analyzer determines and stores the residual amount information in association with the characteristic information of the quality control/calibration product to be detected by detecting the current liquid level height of the quality control/calibration product to be detected, and specifically selects according to the actual situation, and the embodiment of the present invention is not specifically limited.
Further, after the characteristic information of the quality control/calibration product to be tested is obtained and before the sample sucking needle is controlled to suck the quality control/calibration product to be tested, the sample analyzer can also obtain the system time of the sample analyzer; then the sample analyzer determines whether the quality control/calibration product to be tested is in the valid period according to the system time and the production date and the valid period in the characteristic information of the quality control/calibration product to be tested; when the quality control/calibration product to be detected is not in the validity period, the sample analyzer outputs an alarm signal indicating that the quality control/calibration product to be detected is out of date and/or outputs a prompt for replacing the quality control/calibration product to be detected.
It can be understood that the quality control/calibration material storage position is arranged in the reagent bin of the sample analyzer, and the reagent bin of the sample analyzer has a refrigeration function, so that the quality control/calibration material can be prevented from deteriorating when being placed in the reagent bin, and the accuracy of a test result is improved. The quality control/calibration product is placed at the quality control/calibration product storage position, when the sample analyzer receives a quality control/calibration test instruction, the sample sucking needle is directly instructed to move to the quality control/calibration product storage position to obtain the quality control/calibration product, the subsequent quality control/calibration test process is completed, and the quality control/calibration test process is simplified.
As shown in fig. 8, an embodiment of the present invention provides a quality control/calibration test device, which is applied to a sample analyzer, especially a biochemical analyzer or a chemiluminescence immune analyzer, wherein the quality control/calibration test device 1000 may include:
a memory 1004 for storing instructions and data;
a processor 1002 executing the instructions for: acquiring a quality control/calibration test instruction of a quality control/calibration product to be tested; acquiring characteristic information of a quality control/calibration product to be tested and position information of a quality control/calibration product storage bit where the quality control/calibration product to be tested is located; controlling the sample sucking needle to move to a quality control/calibration product storage position where the quality control/calibration product to be detected is located to suck a specified amount of quality control/calibration product to be detected according to the characteristic information and the position information; and performing quality control/calibration test by using the specified quantity of quality control/calibration products to be tested.
The processor 1002 of the quality control/calibration test Device 1000 is used for controlling the reagent chamber, the pipette tip and the scanning Device to implement corresponding method steps, and the processor 1002 may be at least one of an Application Specific Integrated Circuit (ASIC), a Digital Signal Processor (DSP), a Digital Signal Processing Device (DSPD), a Programmable Logic Device (PLD), a Field Programmable Gate Array (FPGA), a Central Processing Unit (CPU), a controller, a microcontroller and a microprocessor. It is to be understood that the electronic devices for implementing the functions of the processor 1002 may be other devices, and the embodiments of the present invention are not limited in particular.
The memory 1004 of the quality control/calibration test device 1000 is used to store executable program code comprising computer operating instructions, and the memory 1004 may comprise high speed RAM memory and may also include non-volatile memory, such as at least one disk memory. In practical applications, the Memory 1004 may be a volatile Memory (volatile Memory), such as a Random-Access Memory (RAM); or a non-volatile Memory (non-volatile Memory), such as a Read-Only Memory (ROM), a flash Memory (flash Memory), a Hard Disk (HDD), or a Solid-State Drive (SSD); or a combination of the above types of memories and provides instructions and data to the processor 12.
The quality control/calibration test apparatus 1000 may further include a communication bus 1006 for connecting the processor 1002 and the memory 1004 to enable mutual communication between these devices and/or for data transmission with an external network element.
In addition, each functional module in this embodiment may be integrated into one processing unit, or each unit may exist alone physically, or two or more units are integrated into one unit. The integrated unit can be realized in a form of hardware or a form of a software functional module.
Based on the understanding that the technical solution of the present embodiment essentially or a part contributing to the prior art, or all or part of the technical solution may be embodied in the form of a software product stored in a storage medium, and include several instructions for causing a computer device (which may be a personal computer, a server, or a network device, etc.) or a processor (processor) to execute all or part of the steps of the method of the present embodiment. And the aforementioned storage medium includes: various media capable of storing program codes, such as a U disk, a removable hard disk, a ROM, a RAM, a magnetic disk, or an optical disk.
An embodiment of the present invention provides a computer-readable storage medium, on which a computer program is stored, for use in a sample analyzer, where the computer program is executed by the processor 10002 to implement the quality control/calibration testing method described above.
It should be apparent to those skilled in the art that embodiments of the present invention may be provided as a method, server, or computer program product. Accordingly, the present invention may take the form of a hardware embodiment, a software embodiment, or an embodiment combining software and hardware aspects. Furthermore, the present invention may take the form of a computer program product embodied on one or more computer-usable storage media (including, but not limited to, disk storage, optical storage, and the like) having computer-usable program code embodied therein.
The present invention has been described with reference to flowchart illustrations and/or block diagrams of methods, apparatus (servers) and computer program products according to embodiments of the invention. It will be understood that each flow and/or block of the flow diagrams and/or block diagrams, and combinations of flows and/or blocks in the flow diagrams and/or block diagrams, can be implemented by computer program instructions. These computer program instructions may be provided to a processor of a general purpose computer, special purpose computer, embedded processor, or other programmable data processing apparatus to produce a machine, such that the instructions, which execute via the processor of the computer or other programmable data processing apparatus, create means for implementing the functions specified in the flowchart flow or flows and/or block diagram block or blocks.
These computer program instructions may also be stored in a computer-readable memory that can direct a computer or other programmable data processing apparatus to function in a particular manner, such that the instructions stored in the computer-readable memory produce an article of manufacture including instruction means which implement the function specified in the flowchart flow or flows and/or block diagram block or blocks.
These computer program instructions may also be loaded onto a computer or other programmable data processing apparatus to cause a series of operational steps to be performed on the computer or other programmable apparatus to produce a computer implemented process such that the instructions which execute on the computer or other programmable apparatus provide steps for implementing the functions specified in the flowchart flow or flows and/or block diagram block or blocks.
The features mentioned above can be combined with one another as desired, insofar as they are within the scope of the invention. The advantages and features explained for the sample analyzer apply in a corresponding manner to the quality control/calibration test method and to the quality control/calibration test device.
While specific embodiments of the invention have been described above, it will be appreciated by those skilled in the art that these specific embodiments are merely illustrative. Those skilled in the art may make various changes or modifications to these embodiments without departing from the principle of the present invention, and such changes and modifications fall within the scope of the present invention.
Claims (18)
1. A quality control/calibration test method applied to a sample analyzer, wherein the sample analyzer comprises a reagent cabin which is provided with a plurality of reagent storage positions and is used for refrigerating reagents, and a quality control/calibration product storage position for storing a quality control/calibration product is arranged in the reagent cabin, and the method comprises the following steps:
acquiring a quality control/calibration test instruction of a quality control/calibration product to be tested;
acquiring characteristic information of a quality control/calibration product to be tested and acquiring position information of a quality control/calibration product storage bit where the quality control/calibration product to be tested is located;
controlling the sample sucking needle to move to a quality control/calibration product storage position where the quality control/calibration product to be detected is located to suck a specified amount of quality control/calibration product to be detected according to the characteristic information and the position information;
and performing quality control/calibration test by using the specified quantity of quality control/calibration products to be tested.
2. The method of claim 1, wherein the quality control/calibrator storage site is configured as at least one reagent storage site of the plurality of reagent storage sites or as a storage site independent of the plurality of reagent storage sites.
3. The method according to claim 1 or 2, wherein the step of acquiring the characteristic information of the quality control/calibration product to be tested comprises the steps of:
obtaining characteristic information of a quality control/calibration product to be tested through man-machine interaction; alternatively, the first and second electrodes may be,
and scanning the identification part of the container of the quality control/calibration product to be detected through a scanning device to obtain the characteristic information of the quality control/calibration product to be detected.
4. The method according to any one of claims 1 to 3, wherein the step of acquiring the position information of the quality control/calibration product storage bit where the quality control/calibration product to be tested is located comprises:
presetting a quality control/calibrator storage position of the quality control/calibrator to be tested through man-machine interaction, so as to obtain the position information; alternatively, the first and second electrodes may be,
and obtaining the position information of the quality control/calibration product storage bit of the quality control/calibration product to be tested through a scanning device.
5. The method according to any one of claims 1 to 4, wherein the characteristic information of the quality control/calibrator under test includes at least one of a name of the quality control/calibrator, a production date, an expiration date, and a total amount.
6. The method of any one of claims 1 to 5, wherein after controlling the pipetting needle to aspirate a specified volume of the quality control/calibrator under test, the method further comprises:
and acquiring and storing the residual information of the quality control/calibration product to be tested.
7. The method of claim 6, wherein the step of obtaining and storing the remaining amount information of the quality control/calibration material to be tested comprises:
determining and storing the residual amount information in association with the characteristic information of the quality control/calibration product to be tested through the total amount of the quality control/calibration product to be tested and the specified amount; or
Determining and storing the residual amount information in association with the characteristic information of the quality control/calibration product to be detected by detecting the current liquid level height of the quality control/calibration product to be detected.
8. The method of claim 6 or 7, wherein after obtaining and storing the remaining amount information of the quality control/calibration product to be tested, the method further comprises:
judging whether the quality control/calibration product to be tested is enough to be used for the next quality control/calibration test or not according to the surplus information;
and when the quality control/calibration product to be tested is not enough for the next quality control/calibration test, outputting an alarm signal of the quality control/calibration product shortage and/or outputting prompt information for replacing the quality control/calibration product to be tested.
9. The method according to any one of claims 1 to 8, wherein the step of obtaining the quality control/calibration test instruction of the quality control/calibration product to be tested comprises:
presetting the quality control/calibration test time of the quality control/calibration product to be tested;
obtaining a system time of the sample analyzer;
and when the system time of the sample analyzer is detected to reach the quality control/calibration time, acquiring the quality control/calibration test instruction.
10. The method according to any one of claims 1 to 9, wherein after obtaining the characteristic information of the quality control/calibration product to be tested, and before controlling the sample aspirating needle to aspirate the quality control/calibration product to be tested, the method further comprises:
obtaining a system time of the sample analyzer;
determining whether the quality control/calibration product to be tested is in the valid period or not according to the system time and the production date and the valid period in the characteristic information of the quality control/calibration product to be tested;
and when the quality control/calibration product to be tested is not in the validity period, outputting an alarm signal of the expiration of the quality control/calibration product to be tested and/or outputting a prompt for replacing the quality control/calibration product to be tested.
11. A sample analyzer, comprising:
the reagent bin is provided with a plurality of reagent storage positions and forms a reagent bin for refrigerating the reagents, wherein the reagent bin is also internally provided with a quality control/calibrator storage position for refrigerating and storing a quality control/calibrator;
the sample sucking needle is used for sucking and discharging a sample;
and the control device is used for controlling the sample sucking needle to move to the quality control/calibration product storage position where the quality control/calibration product to be tested is located to suck the specified quantity of quality control/calibration product to be tested when a quality control/calibration test instruction for the quality control/calibration product to be tested is received, so that the specified quantity of quality control/calibration product to be tested is utilized to carry out quality control/calibration test.
12. The sample analyzer of claim 11, wherein the reagent cartridge comprises: a reagent disk and a refrigeration device, wherein the reagent disk comprises the plurality of reagent holding positions.
13. The sample analyzer of claim 11 or 12 wherein the control/calibrator storage site is configured as at least one of the plurality of reagent storage sites or as a separate storage site from the plurality of reagent storage sites.
14. The sample analyzer as claimed in any one of claims 11 to 13, wherein the mouth of the container of the quality control/calibration product to be tested is provided with a protection device for preventing liquid from volatilizing.
15. The sample analyzer of any of claims 11-14, further comprising a scanning device for obtaining the characteristic information of the quality control/calibration product to be tested and/or the position information of the quality control/calibration product storage location where the quality control/calibration product to be tested is located.
16. The sample analyzer of any of claims 11 to 15, wherein the control device is configured to perform the method of any of claims 1 to 10.
17. A quality control/calibration test device applied to a sample analyzer, the quality control/calibration test device comprising: a processor, a memory and a computer program stored on the memory and executable on the processor, which when executed by the processor implements the method of any one of claims 1 to 10.
18. A computer-readable storage medium, on which a computer program is stored, for use in a sample analyzer, characterized in that the computer program, when being executed by a processor, carries out the method according to any one of claims 1 to 10.
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN110320378A (en) * | 2019-05-09 | 2019-10-11 | 深圳麦科田生物医疗技术有限公司 | Application method, device, equipment and computer readable storage medium are tested in Quality Control |
| CN114200151A (en) * | 2022-02-17 | 2022-03-18 | 宁波海壹生物科技有限公司 | Full-automatic chemiluminescence immunoassay analyzer management system |
| CN114199948A (en) * | 2021-12-13 | 2022-03-18 | 南京晶捷生物科技有限公司 | Electronic quality control card of dry biochemical analyzer and electronic quality control method thereof |
| CN114694823A (en) * | 2020-12-31 | 2022-07-01 | 科美诊断技术股份有限公司 | Test condition control method and device, electronic equipment and storage medium |
| WO2023131096A1 (en) * | 2022-01-10 | 2023-07-13 | 深圳市帝迈生物技术有限公司 | Reagent loading control method, sample analyzer, computer device and storage medium |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN110320378A (en) * | 2019-05-09 | 2019-10-11 | 深圳麦科田生物医疗技术有限公司 | Application method, device, equipment and computer readable storage medium are tested in Quality Control |
| CN114694823A (en) * | 2020-12-31 | 2022-07-01 | 科美诊断技术股份有限公司 | Test condition control method and device, electronic equipment and storage medium |
| CN114199948A (en) * | 2021-12-13 | 2022-03-18 | 南京晶捷生物科技有限公司 | Electronic quality control card of dry biochemical analyzer and electronic quality control method thereof |
| CN114199948B (en) * | 2021-12-13 | 2023-09-22 | 南京晶捷生物科技有限公司 | Electronic quality control card of dry biochemical analyzer and electronic quality control method thereof |
| WO2023131096A1 (en) * | 2022-01-10 | 2023-07-13 | 深圳市帝迈生物技术有限公司 | Reagent loading control method, sample analyzer, computer device and storage medium |
| CN114200151A (en) * | 2022-02-17 | 2022-03-18 | 宁波海壹生物科技有限公司 | Full-automatic chemiluminescence immunoassay analyzer management system |
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