Test method of calibration sample / quality control sample

Abstract

The invention provides a test method of a calibration sample / quality control sample. The test method comprises the following steps: acquiring a calibration bar code / quality control bar code on a centrifugal tube containing a calibration sample / quality control sample, wherein the calibration bar code / quality control bar code is associated with calibration product parameter information / quality control product parameter information; obtaining a standard bar code on the standard test tube in a vacant state; associating the calibration bar code / the quality control bar code with the standard bar code; transferring the calibration sample / quality control sample in the centrifugal tube into the standard test tube, and feeding the standard test tube into an in-vitro diagnosis analyzer by taking a sample rack as a carrier; the in-vitro diagnosis analyzer obtains the calibration product parameter information / the quality control product parameter information through the standard bar code, and then generates a calibration test task / quality control test task. According to the technical scheme provided by the invention, automatic testing of the calibration sample / quality control sample can be realized.

Description

Technical Field

[0001] The present invention belongs to the field of medical devices, and more specifically, relates to a method for testing calibration samples / quality control samples. Background Art

[0002] In current in vitro diagnostic analyzers, calibrators and quality control products are generally packaged in centrifuge tubes of different specifications. Due to the specifications of the centrifuge tubes, it is impossible to associate the calibration test or quality control test by automatically scanning the barcode. Manual application is the only way to associate the application for calibration test or quality control test by manually specifying the sample rack number and position number. This method requires manual guarantee that the sample rack number and position number specified during manual application are consistent with the sample rack number and position number where the calibrator or quality control product is actually placed, which increases the difficulty of operation and the probability of error, and reduces work efficiency.

[0003] The Chinese invention patent application with publication number CN111381065A can solve the problem of incorrect placement of calibration or quality control materials in the absence of barcode scanning, as well as the problem of using different types of sample racks for routine tests, calibration tests and quality control tests by scanning the sample rack identity and matching it with the calibration test or quality control test manually applied in advance. However, it cannot solve the problem of errors in manual application in advance, that is, the scanned sample position identifier cannot be properly matched and associated with the calibration test or quality control test manually applied in advance, or the sample position identifier is associated with the wrong calibration test item or quality control test item. Once the above problem occurs, it is necessary to re-disassociate, modify the application information and re-establish the association, which increases the difficulty of operation during use and reduces work efficiency and safety. Summary of the Invention

[0004] In view of this, the present invention provides a method for testing a calibration sample / quality control sample, the testing method comprising:

[0005] Obtaining a calibration barcode / quality control barcode on a centrifuge tube containing a calibration sample / quality control sample, wherein the calibration barcode / quality control barcode is associated with calibration material parameter information / quality control material parameter information;

[0006] Obtain the standard barcode on the empty standard test tube;

[0007] Associating the calibration barcode / the quality control barcode with the standard barcode;

[0008] Transferring the calibration sample / quality control sample in the centrifuge tube into the standard test tube, and sending the standard test tube into the in vitro diagnostic analyzer using a sample rack as a carrier;

[0009] The in vitro diagnostic analyzer obtains the calibrator parameter information / the quality control product parameter information through the standard barcode, and then generates a calibration test task / quality control test task.

[0010] Optionally, the in vitro diagnostic analyzer obtains the calibrator parameter information through the standard barcode, and then generates a calibration test task including:

[0011] Get the calibration barcode based on the standard barcode;

[0012] Acquiring calibration parameters according to the calibration barcode, wherein the calibration parameters include a known concentration value of the calibration and batch information of a reagent adapted for the calibration;

[0013] The calibration test task is automatically generated based on the received calibration material parameters and the reagent layout on the instrument side.

[0014] Optionally, the in vitro diagnostic analyzer obtains the quality control product parameter information through the standard barcode, and then generates a quality control test task including:

[0015] Obtain quality control barcodes based on standard barcodes;

[0016] Acquire quality control product parameters according to the quality control barcode, wherein the quality control product parameters include quality control items, quality control levels, standard deviation values, and target values;

[0017] Quality control test tasks are automatically generated based on the received quality control product parameters and the reagent layout on the instrument side.

[0018] The beneficial effects of the present invention are:

[0019] The testing method of the calibration sample / quality control sample of the present invention comprises the following steps: first, obtaining a calibration barcode / quality control barcode on a centrifuge tube containing the calibration sample / quality control sample, wherein the calibration barcode / quality control barcode is associated with calibration product parameter information / quality control product parameter information; second, obtaining a standard barcode on an empty standard test tube; third, associating the calibration barcode / quality control barcode with the standard barcode; third, transferring the calibration sample / quality control sample in the centrifuge tube to the standard test tube, and delivering the standard test tube into an in vitro diagnostic analyzer using a sample rack as a carrier; finally, the in vitro diagnostic analyzer obtains the calibration product parameter information / quality control product parameter information through the standard barcode, thereby generating a calibration test task / quality control test task, and thus realizing automated testing of the calibration sample / quality control sample.

[0020] Other features and advantages of the present invention will be described in detail in the following detailed description. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] The present invention may be better understood by referring to the following description taken in conjunction with the accompanying drawings, in which the same or similar reference numerals are used throughout the drawings to designate the same or similar parts.

[0022] Figure 1 A flowchart illustrating a method for testing calibration samples / quality control samples according to an embodiment of the present invention is shown;

[0023] Figure 2 A structural schematic diagram of an in vitro diagnostic analyzer equipped with a sample pre-processing module according to an embodiment of the present invention is shown, wherein 1 is a sample feeder track, 2 is a sample feeder, 3 is a tray, 4 is a rear-end track change module, 5 is an immunoassay module, 6 is a recovery track, 7 is a sample rack, 8 is a main track, 9 is a sampling track, 10 is a sampling track buffer position, 11 is a sampling track sample adding position, 12 is a push rod motor module, 13 is an emergency position, 14 is a recovery track interface, 15 is a sample bin, and 16 is a sample pre-processing module. DETAILED DESCRIPTION

[0024] In order to enable those skilled in the art to more fully understand the technical solution of the present invention, the exemplary embodiments of the present invention will be described in more comprehensive and detailed in conjunction with the accompanying drawings below. Obviously, the one or more embodiments of the present invention described below are only one or more of the specific ways of implementing the technical solution of the present invention, and are not exhaustive. It should be understood that other ways belonging to a general inventive concept can be used to implement the technical solution of the present invention, and should not be limited by the exemplary embodiments described. Based on one or more embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative work should fall within the scope of protection of the present invention.

[0025] Example: Figure 1 FIG1 shows a flow chart of the test method for calibration samples / quality control samples according to an embodiment of the present invention. Figure 1 The test method of the calibration sample / quality control sample of the embodiment of the present invention includes the following steps:

[0026] Step S100: obtaining a calibration barcode / quality control barcode on a centrifuge tube containing a calibration sample / quality control sample, wherein the calibration barcode / quality control barcode is associated with calibration material parameter information / quality control material parameter information;

[0027] Step S200: obtaining a standard barcode on an empty standard test tube;

[0028] Step S300: Associating the calibration barcode / quality control barcode with the standard barcode;

[0029] Step S400: Transfer the calibration sample / quality control sample in the centrifuge tube to a standard test tube, and then carry the standard test tube into the in vitro diagnostic analyzer using a sample rack as a carrier;

[0030] Step S500: The in vitro diagnostic analyzer obtains calibration material parameter information / quality control material parameter information through a standard barcode, and then generates a calibration test task / quality control test task.

[0031] Furthermore, in step S500 of the embodiment of the present invention, the in vitro diagnostic analyzer obtains calibrator parameter information through the standard barcode, and then generates a calibration test task including:

[0032] Get the calibration barcode based on the standard barcode;

[0033] Obtaining calibrator parameters based on the calibration barcode, including the known concentration value of the calibrator and the reagent batch information adapted for the calibrator;

[0034] The calibration test task is automatically generated based on the received calibration material parameters and the reagent layout on the instrument side.

[0035] Furthermore, in step S500 of the embodiment of the present invention, the in vitro diagnostic analyzer obtains the quality control product parameter information through the standard barcode, and then generates the quality control test task including:

[0036] Obtain quality control barcodes based on standard barcodes;

[0037] Obtain quality control product parameters according to the quality control barcode, which include quality control items, quality control levels, standard deviation values and target values;

[0038] Quality control test tasks are automatically generated based on the received quality control product parameters and the reagent layout on the instrument side.

[0039] Specifically, the calibration sample / quality control sample testing method according to the embodiment of the present invention is implemented based on an in vitro diagnostic analyzer equipped with a sample pre-processing module. Figure 2 FIG2 shows a schematic structural diagram of an in vitro diagnostic analyzer equipped with a sample pre-processing module according to an embodiment of the present invention. Figure 2 In an embodiment of the present invention, an in vitro diagnostic analyzer is composed of a sample pre-processing module, a track module and an immunoassay module. The sample pre-processing module includes a sample waiting area, a standard test tube area, a gripper, a barcode scanner and a sample suction and discharge module, and is mainly used to pack calibration samples or quality control samples in centrifuge tubes of different specifications into corresponding standard test tubes; the track module includes a sample bin and a rear track transmission module. The sample bin is used to store the sample rack to be tested, and the sample feeder scans the standard test tubes on the sample rack and transports the sample rack to the sampling position of the rear track transmission module; the immunoassay module is used to complete the sample testing process and output the test results.

[0040] Furthermore, in an embodiment of the present invention, the sample pre-processing module includes a sample waiting area and a standard test tube area, wherein the sample waiting area includes four trays of 5*10 specifications, which can be compatible with centrifuge tubes of different specifications; the standard test tube area includes four standard test tube trays of 5*10 specifications, each tray has 50 sample positions, and the four trays have a total of 200 sample positions.

[0041] The sample processing methods implemented based on the sample pre-processing module include:

[0042] Step 11: Place the quality control or calibration samples to be tested into the tray in the processing area. Each tray has 50 sample positions and can support up to 200 samples to be processed at the same time.

[0043] Step 12: Place the standard test tubes with associated information barcodes into the tray in the standard test tube area. Each tray has 50 sample positions and can hold up to 200 standard test tubes at the same time.

[0044] Step 13: Sequentially grab the centrifuge tubes and standard test tubes on each sample location in the waiting area and the standard test tube area for barcode scanning. Scan the waiting area first, then the standard test tube area, and automatically identify and skip the idle sample locations.

[0045] Step 14: Match and associate the samples in the waiting area with the test tube positions in the standard test tube area according to the scanned quality control product batch number or calibrator batch number;

[0046] Step 15: Open the lid of the matched standard test tube through the gripper module, and transfer the sample from the area to be processed to the matched standard test tube through the sampling module;

[0047] Step 16: Grab the completed standard test tubes from the tray in the standard test tube area and transfer them to the sample rack;

[0048] Step 17: transport the packaged sample rack to the track sample bin module via the transmission track.

[0049] Furthermore, in an embodiment of the present invention, the track sample bin module includes four tray modules, three emergency position modules, a sample feeder module and a barcode scanner module. Each tray includes 10 sample rack positions and supports up to 40 sample racks and 3 emergency racks for testing. Each sample rack has 5 sample positions.

[0050] The sample rack scheduling method implemented based on the track sample bin module includes the following steps:

[0051] Step 21: Receive the sample racks ready for testing transmitted by the sample pre-processing module and place them in the track sample bin. The sample racks are divided into four types according to different colors, including regular sample racks, emergency sample racks, calibration racks, and quality control racks. Emergency sample racks must be placed in the fixed emergency bin of the track sample bin, and other types of sample racks are placed in the 40 regular sample bins.

[0052] Step 22: After the sample rack is placed in the track sample compartment, the track sample compartment sensor detects the newly placed sample rack, and the sample feeder automatically pulls and scans the barcode information of the sample newly placed in the sample rack;

[0053] Step 23: Automatically obtain or generate sample test information corresponding to each sample position according to the set rules through the scanned sample barcode information;

[0054] Step 24: After the test acquisition or generation on the sample rack is completed, the sample feeder will sequentially transport the sample rack to the sampling position of the rear track transmission module;

[0055] Step 25: After the sample rack arrives at the sampling position, the immune detection module is notified to take samples, complete the entire detection process, and upload the test results.

[0056] Specifically, in the embodiment of the present invention, generating a calibration test task includes two methods: obtaining calibration test information from a third-party platform and automatically generating calibration test information according to locally preset calibration parameter information.

[0057] Obtaining calibration test information from a third-party platform includes the following steps:

[0058] Step 31: The third-party platform includes the LIS system, HIS system, and cloud server platform. The calibrator parameters include the known concentration value of each calibrator and the reagent batch adapted for the calibrator.

[0059] Step 32: The barcode scanned on the sample rack is transmitted to a third-party platform via the hospital network using the HL7 standard transmission protocol;

[0060] Step 33: The third-party platform transmits the calibration parameter information corresponding to the barcode back to the instrument end;

[0061] Step 34: The instrument automatically generates calibration sample test information based on the calibration sample concentration information returned by the third-party platform, the corresponding reagent batch information, and the current reagent layout on the instrument. If there is no matching reagent batch information, no calibration test information will be generated, an alarm will be issued, and an error message will be returned to the third-party platform through the protocol.

[0062] The test scenario design cannot be automatically generated based on the calibrator barcode:

[0063] The calibrator parameter information corresponding to the calibrator barcode was not returned;

[0064] Returns incorrect calibrator parameter information;

[0065] The returned reagent batch information does not exist on the instrument side;

[0066] The returned reagent batch information is not configured or loaded on the instrument side.

[0067] Automatically generating calibration test information based on locally preset calibration parameter information includes the following steps:

[0068] Step 41: In the local software, pre-set the calibration parameter information corresponding to the calibration batch number. The calibration parameter includes the known concentration value of each calibrator and the reagent batch information adapted for the calibrator.

[0069] Step 42: Automatically match the corresponding calibration parameter information locally based on the scanned calibration barcode information;

[0070] Step 43: Automatically generate calibration test information based on the matched calibrator parameter information and the current reagent layout. If there is no matching reagent batch information, no calibration test information will be generated and an alarm will be issued.

[0071] The test scenario design cannot be automatically generated based on the calibrator barcode:

[0072] No matching parameter information was found for the calibrator barcode;

[0073] The wrong calibrator barcode was scanned;

[0074] Matching reagent batch information, not laid out or loaded.

[0075] Specifically, in the embodiment of the present invention, generating a quality control test task includes two methods: obtaining quality control test information from a third-party platform and automatically generating quality control test information according to locally preset quality control parameter information.

[0076] Obtaining quality control test information from a third-party platform includes the following steps:

[0077] Step 51: The third-party platform includes the LIS system, the HIS system, and the cloud server platform. The quality control product parameters include quality control items, quality control levels, standard deviation values, and target values.

[0078] Step 52: The barcode scanned on the sample rack is transmitted to a third-party platform via the hospital network using the HL7 standard transmission protocol.

[0079] Step 53: The third-party platform transmits the quality control product parameter information corresponding to the barcode back to the instrument end;

[0080] Step 54: The instrument automatically generates quality control test information based on the quality control item, quality control level, standard deviation value and target value information returned by the third-party platform, as well as the reagent layout of the current instrument. If there is no matching quality control parameter information, the quality control test information will not be generated, an alarm will be issued, and an error message will be returned to the third-party platform through the protocol.

[0081] The test scenario designed based on the inability to automatically generate a barcode for quality control products is as follows:

[0082] The quality control parameter information corresponding to the quality control product barcode was not returned;

[0083] Returns incorrect quality control parameter information;

[0084] The returned quality control item information does not exist on the instrument side or has not been imported;

[0085] The quality control item information returned is not configured or loaded on the instrument side.

[0086] Automatically generating quality control test information based on locally preset quality control parameter information includes the following steps:

[0087] Step 61: In the local software, pre-set the quality control product parameter information corresponding to the quality control batch number, including quality control items, quality control levels, target values, and standard deviations;

[0088] Step 62: Automatically match the corresponding quality control product parameter information locally according to the scanned quality control product barcode information;

[0089] Step 63: Automatically generate quality control sample test information based on the matched quality control product parameter information and the current reagent layout. If there is no matched quality control parameter information, no quality control test information will be generated and an alarm will be issued.

[0090] The test scenario designed based on the inability to automatically generate a barcode for quality control products is as follows:

[0091] No matching parameter information was found for the quality control product barcode;

[0092] The wrong quality control product barcode was scanned;

[0093] The matching quality control item information is not laid out or loaded.

[0094] Specifically, in an embodiment of the present invention, the local setting automatically matches and generates corresponding test rules, including the following steps:

[0095] In the quality control product barcode, set one or more quality control items supported by the current batch of quality control products;

[0096] In the calibrator barcode, set the known concentration corresponding to the current batch of calibrators, as well as the supported reagent batch information for one or more reagents;

[0097] On the reagent tray, load the reagents corresponding to the quality control items or the batches to be calibrated;

[0098] By scanning the quality control product batch barcode or calibration product batch barcode information, the corresponding quality control items or calibration reagent batch information are automatically matched, and the corresponding quality control test and calibration test information are automatically generated according to the laid out quality control items and reagent batch information.

[0099] The testing method for calibration samples / quality control samples in the embodiment of the present invention is based on the actual usage habits of the client, that is, regular calibration and monthly quality control, and combined with the actual pain points of the client. In order to simplify the user operation process and improve the degree of automation and efficiency, after the instrument recognizes the information of the quality control and calibration materials, it actively judges in combination with the reagent information arranged on the instrument, and automatically generates a test if it meets the test conditions, so as to avoid customers from frequently operating the same test application, improve the processing and detection efficiency of calibration tests and quality control tests, and reduce the error probability of manually applying for samples, thereby improving safety. Automatically generating tests can avoid customers from frequently operating the same test application, improve the processing and detection efficiency of calibration tests and quality control tests, and reduce the error probability of manually applying for samples, thereby improving safety. The embodiment of the present invention mainly relates to a method for automated management of calibration and quality control samples, automatically matching and generating calibration and quality control sample tests, and efficiently completing the full process technical features of automatic identification of calibration and quality control samples, automatic matching and generating tests, automatic sampling and automatic completion of detection in this mode. Sample subpackaging can be automatically performed by a sample pre-treatment module, or other methods can be used for sample subpackaging.

[0100] Although one or more embodiments of the present invention have been described above, it should be understood by those skilled in the art that the present invention can be implemented in any other form without departing from its spirit and scope. Therefore, the embodiments described above are illustrative and not restrictive, and many modifications and substitutions will be apparent to those skilled in the art without departing from the spirit and scope of the present invention as defined in the appended claims.

Claims

1. A method for testing a calibration sample / quality control sample, characterized in that: include: Obtaining a calibration barcode / quality control barcode on a centrifuge tube containing a calibration sample / quality control sample, wherein the calibration barcode / quality control barcode is associated with calibration material parameter information / quality control material parameter information; Obtain the standard barcode on the empty standard test tube; Associating the calibration barcode / the quality control barcode with the standard barcode; Transferring the calibration sample / quality control sample in the centrifuge tube into the standard test tube, and sending the standard test tube into the in vitro diagnostic analyzer using a sample rack as a carrier; The in vitro diagnostic analyzer obtains the calibrator parameter information / the quality control product parameter information through the standard barcode, and then generates a calibration test task / quality control test task.

2. The calibration sample / quality control sample testing method according to claim 1, characterized in that: The in vitro diagnostic analyzer obtains the calibrator parameter information through the standard barcode, and then generates a calibration test task including: Get the calibration barcode based on the standard barcode; Acquiring calibration parameters according to the calibration barcode, wherein the calibration parameters include a known concentration value of the calibration and batch information of a reagent adapted for the calibration; The calibration test task is automatically generated based on the received calibration material parameters and the reagent layout on the instrument side.

3. The calibration sample / quality control sample testing method according to claim 1, characterized in that: The in vitro diagnostic analyzer obtains the quality control product parameter information through the standard barcode, and then generates a quality control test task including: Obtain quality control barcodes based on standard barcodes; Acquire quality control product parameters according to the quality control barcode, wherein the quality control product parameters include quality control items, quality control levels, standard deviation values, and target values; Quality control test tasks are automatically generated based on the received quality control product parameters and the reagent layout on the instrument side.

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