Sample analysis apparatus, method, system and analyser

Abstract

The embodiment of the present application provides a sample analysis device, method, system and analyzer, the device comprises: a sample analysis module and a quality control test module, the sample analysis module is connected with the quality control test module in communication; the sample analysis module is used for analyzing quality control products, and transmitting sample analysis results to the quality control test module;The quality control test module is used for obtaining the quality control information corresponding to the test item of the quality control product according to the configured quality control product library, and combining the sample analysis result, determining the quality control result of the sample analysis device, the reagent used for testing the quality control product and the test item;Wherein, the quality control product library comprises the quality control information configured by the user for any quality control product. The device provided by the embodiment of the present application can effectively and more comprehensively perform quality control test, and then accurately and more comprehensively monitor the precision of the sample analysis device.

Description

Technical Field

[0001] This application relates to the field of quality control technology, and in particular to a sample analysis device, method, system and analyzer. Background Technology

[0002] Currently, internal quality control requires specific quality control products, which are used to conduct daily internal quality control and monitor the precision of the testing system.

[0003] In the process of using quality control products for quality control, the analyzer usually only uses the manufacturer's own (hereinafter referred to as "the manufacturer") closed quality control products. The information of these quality control products has been entered into the system, and automatic quality control can be achieved by recognizing the quality control product information. However, this method is limited to the manufacturer's own quality control products and is not applicable to quality control products from other manufacturers to achieve quality control testing. Quality control testing has limitations.

[0004] Therefore, existing technologies cannot effectively and comprehensively conduct quality control testing, and thus cannot accurately and comprehensively monitor the accuracy of the analyzer. Summary of the Invention

[0005] This application provides a sample analysis device, method, system, and analyzer to overcome the problem that quality control testing cannot be carried out effectively and comprehensively, and therefore the accuracy of the analyzer cannot be monitored accurately and comprehensively.

[0006] In a first aspect, embodiments of this application provide a sample analysis device, including:

[0007] The sample analysis module and the quality control testing module are communicatively connected.

[0008] The sample analysis module is used to analyze the quality control samples and transmit the sample analysis results to the quality control testing module;

[0009] The quality control testing module is used to obtain the quality control information corresponding to the test items of the quality control products according to the configured quality control product library, and, in conjunction with the sample analysis results, determine the sample analysis equipment, the reagents used to test the quality control products, and the quality control results of the test items;

[0010] The quality control product library includes quality control information configured by the user for any quality control product.

[0011] In one possible design, the device further includes a quality control editing module for editing quality control information in the quality control material library.

[0012] In one possible design, the quality control editing module is specifically used for:

[0013] Based on the user's input of editing operations for any quality control product in the quality control product library in the corresponding test item, the quality control product editing information is obtained, and the quality control product editing information includes at least the edited quality control information;

[0014] Add the quality control product editing information to the quality control product library.

[0015] In one possible design, the quality control information includes qualitative reference results and / or test item reference values; the test item reference values ​​are used to support the determination of whether the agglomeration strength meets the requirements.

[0016] In one possible design, the quality control testing module is further configured to perform any of the following operations:

[0017] If the sample analysis results include qualitative results, and the qualitative results meet the qualitative reference results, then the quality control results are determined to be in-control results.

[0018] If the sample analysis results include agglutination strength results, and the agglutination strength results meet the reference values ​​of the test items, then the quality control results are determined to be in-control results.

[0019] If the sample analysis results include qualitative results and agglutination strength results, and the qualitative results satisfy the qualitative reference results and the agglutination strength results satisfy the test item reference values, then the quality control results are determined to be in-control results.

[0020] Secondly, embodiments of this application provide a sample analysis device, including: an information acquisition device, a sample rack, a sample reaction device, a reaction result reading device, and a processing device;

[0021] Information acquisition device, acquiring selected test samples and test items;

[0022] The sample reaction device, according to the selected test sample and test item, grabs the test sample on the sample rack and performs the test reaction, wherein the test sample is a quality control sample;

[0023] A reaction result reading device acquires the test reaction results of the test sample;

[0024] The processing device performs the following processing:

[0025] The test reaction results of the test reaction sample are analyzed to obtain the sample analysis results of the test sample;

[0026] According to the test item, the corresponding quality control information is obtained from the quality control library, the sample analysis results of the test sample are analyzed, and the sample analysis equipment, the reagents used to test the test sample, and the quality control results of the test item are output; wherein, the quality control library includes the quality control information configured by the user for any quality control item.

[0027] In one possible design, the processing device also performs the following processing:

[0028] The quality control product library is updated based on the quality control product editing information obtained by the information acquisition device, or the sample analysis results corresponding to the test samples are added to the quality control product library. The quality control product library includes one or more of the following: quality control product identification, test items, and quality control information.

[0029] Thirdly, embodiments of this application provide a sample analysis method, applied to a sample analysis device as described in either the first or second aspect, the method comprising:

[0030] Analyze the samples to obtain the sample analysis results of the quality control products;

[0031] Based on the configured quality control library, obtain the quality control information corresponding to the test items of the quality control products, and combine it with the sample analysis results of the quality control products to determine the sample analysis equipment, the reagents used to test the quality control products, and the quality control results of the test items;

[0032] The quality control product library includes quality control information configured by the user for any quality control product.

[0033] In one possible design, the method further includes:

[0034] Based on the user's input of editing operations for any quality control product in the quality control product library in the corresponding test item, the quality control product editing information is obtained, and the quality control product editing information includes at least the edited quality control information;

[0035] Add the quality control product editing information to the quality control product library.

[0036] In one possible design, the method further includes:

[0037] Based on the user's input of adding quality control products, obtain the newly added quality control products, the test items of the newly added quality control products, and the corresponding quality control information;

[0038] Add the newly added quality control products, their test items, and corresponding quality control information to the quality control product library.

[0039] In one possible design, the quality control information includes qualitative reference results and / or test item reference values; the test item reference values ​​are used to support the determination of whether the agglomeration strength meets the requirements.

[0040] Fourthly, embodiments of this application provide a sample analysis management system, which includes a display device and a processing device; the processing device displays a quality control management interface through the display device, the quality control management interface including a first display area and a third display area, the first display area displaying quality control product information, the quality control product information including at least one of the following: quality control product identifier, analysis type;

[0041] The processing device responds to the quality control selection information input by the user in the first display area and displays quality control parameter information matching the quality control selection information in the third display area; wherein, the quality control parameter information includes at least one test item and corresponding quality control information.

[0042] In one possible design, the processing device further displays at least one of the following via the display device: a first control for indicating the addition of a quality control item, a second control for indicating the deletion of a quality control item, a third control for indicating the editing of a quality control item, a fourth control for indicating the addition of a test item, a fifth control for indicating the editing of a test item, and a sixth control for indicating the deletion of a test item.

[0043] In one possible design, the processing device is used to perform the steps of the sample analysis method as described in any of the third aspects.

[0044] Fifthly, embodiments of this application provide an analyzer for performing the sample analysis method as described in any of the third aspects.

[0045] This embodiment provides a sample analysis device, method, system, and analyzer. The sample analysis device includes a sample analysis module and a quality control testing module, which are communicatively connected. The sample analysis module analyzes quality control samples and transmits the sample analysis results to the quality control testing module. The quality control testing module obtains the quality control information corresponding to the test items of the quality control samples according to a configured quality control sample library, and determines the sample analysis device, the reagents used to test the quality control samples, and the quality control results of the test items based on the sample analysis results. The quality control sample library includes quality control information configured by the user for any quality control sample. Therefore, by using a sample analysis module to analyze quality control products and obtain sample analysis results, which are then reported to the quality control testing module, the quality control testing module retrieves the required quality control information for the test items of the quality control product from the quality control product library and combines it with the sample analysis results to determine whether it is under control. This enables the sample analysis equipment to both analyze samples (such as quality control products) and support quality control testing, and it supports quality control testing of quality control products provided by any provider. This solves the limitation of existing technologies that only support quality control testing of quality control products from the same manufacturer or preset quality control products, and thus enables effective and comprehensive monitoring of the accuracy of sample analysis equipment (such as analyzers). Attached Figure Description

[0046] To more clearly illustrate the technical solutions in the embodiments of this application or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are some embodiments of this application. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0047] Figure 1 This is a schematic diagram of a scenario provided for an embodiment of this application;

[0048] Figure 2 This is a schematic diagram of the sample analysis device provided in the embodiments of this application;

[0049] Figure 3 This is a schematic diagram of the structure of a sample analysis device provided in another embodiment of this application;

[0050] Figure 4 A schematic flowchart illustrating the sample analysis method provided in this application embodiment;

[0051] Figure 5 This is a schematic diagram of the structure of the sample analysis management system provided in the embodiments of this application;

[0052] Figure 6 This is a schematic diagram of the interface provided for an embodiment of this application;

[0053] Figure 7An interface schematic diagram provided for yet another embodiment of this application;

[0054] Figure 8 An interface schematic diagram provided for yet another embodiment of this application;

[0055] Figure 9 This is a schematic diagram of an interface provided for another embodiment of this application;

[0056] Figure 10 An interface schematic diagram provided for yet another embodiment of this application;

[0057] Figure 11 An interface schematic diagram provided for yet another embodiment of this application;

[0058] Figure 12 This is a schematic diagram of an interface provided for another embodiment of this application. Detailed Implementation

[0059] To make the objectives, technical solutions, and advantages of the embodiments of this application clearer, the technical solutions of the embodiments of this application will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this application, not all embodiments. Based on the embodiments of this application, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this application.

[0060] The terms “first,” “second,” “third,” “fourth,” etc. (if present) in the specification, claims, and accompanying drawings of this application are used to distinguish similar objects and are not necessarily used to describe a particular order or sequence. It should be understood that such data can be interchanged where appropriate so that embodiments of the application described herein can be implemented, for example, in orders other than those illustrated or described herein. Furthermore, the terms “comprising” and “having,” and any variations thereof, are intended to cover a non-exclusive inclusion; for example, a process, method, system, product, or apparatus that comprises a series of steps or units is not necessarily limited to those steps or units explicitly listed, but may include other steps or units not explicitly listed or inherent to such processes, methods, products, or apparatus.

[0061] Currently, in the process of using quality control materials for quality control, there are typically two approaches. One is that the analyzer only uses the manufacturer's own sealed quality control materials. The information of these materials is already entered into the system, and automatic quality control can be achieved by recognizing the quality control material information. However, this method is limited to the manufacturer's own quality control materials and is not applicable to quality control testing using quality control materials from other manufacturers, thus limiting the scope of quality control testing. Another approach is that the instrument lacks quality control functionality. Quality control materials are applied for and tested using a sample testing procedure, and after the results are obtained, the operator judges whether they are out of control. However, manually recording quality control data presents a series of problems, including difficulty in retrieving records, cumbersome operation, and strong subjectivity in human interpretation. Therefore, for existing analyzers, such as blood typing analyzers, current technology cannot effectively and comprehensively perform quality control testing, and consequently, cannot accurately and comprehensively monitor the analyzer's accuracy.

[0062] Therefore, to address the aforementioned issues, this application analyzes samples, such as quality control products, and obtains the sample analysis results, which are then reported for quality control testing. Specifically, it retrieves the required quality control information for the test items of the quality control product from a quality control product library and combines this information with the sample analysis results to determine whether the product is under control. This enables the sample analysis equipment, such as an analyzer, to both analyze samples (e.g., quality control products) and support quality control testing. Furthermore, it supports quality control testing of quality control products provided by any supplier, overcoming the limitation of existing technologies that only support quality control testing of products from the manufacturer or pre-set specifications. This allows for effective and comprehensive monitoring of the accuracy of the sample analysis equipment (e.g., the analyzer).

[0063] In practical applications, this sample analysis device can be an analyzer, such as a blood typing analyzer. Currently, quantitative tests for in vitro diagnostic (IVD) products generally support open quality control settings. However, since blood typing analyzers are qualitative analytical instruments, they currently lack open quality control settings. To enable customized quality control configurations, thereby facilitating automated quality control testing of the user's own closed quality control products while also supporting open quality control systems for other manufacturers' quality control products, this embodiment provides a sample analysis device. This device includes a sample analysis module and a quality control testing module.

[0064] For example, see Figure 1 As shown, Figure 1This is a schematic diagram of a scenario provided in an embodiment of this application. Taking an analyzer as an example, the sample analysis device can use an automatic control system to pick up the quality control sample to be tested onto the analysis table (or sample reaction table) of the sample analysis device. The sample analysis module analyzes the quality control sample and obtains the sample analysis results, which are then reported to the quality control testing module. Using the quality control testing module, the quality control information required for the test items of the quality control sample is obtained from the quality control sample library. Combined with the sample analysis results, the quality control information is determined to be within control of the sample analysis device, the reagents used to test the quality control sample, and the test items. This enables the sample analysis device to both analyze samples (such as quality control samples) and support quality control testing. Furthermore, it supports quality control testing of quality control samples provided by any provider, solving the limitation of existing technologies that only support quality control testing of their own manufacturer or preset quality control samples. This allows for effective and comprehensive monitoring of the accuracy of the sample analysis device (such as an analyzer).

[0065] The technical solutions of this application will be described in detail below with specific embodiments. The following specific embodiments can be combined with each other, and the same or similar concepts or processes may not be described again in some embodiments.

[0066] Figure 2 This is a schematic diagram of the structure of the sample analysis device provided in the embodiment of this application. The device may include: a sample analysis module 21 and a quality control test module 22, and the sample analysis module 21 and the quality control test module 22 are communicatively connected.

[0067] The sample analysis module 21 is used to analyze the quality control samples and transmit the sample analysis results to the quality control testing module.

[0068] The quality control testing module 22 is used to obtain the quality control information corresponding to the test items of the quality control products according to the configured quality control product library, and determine the sample analysis equipment, the reagents used to test the quality control products, and the quality control results of the test items in combination with the sample analysis results.

[0069] The quality control product library includes the quality control information configured by the user for any quality control product.

[0070] Of course, the test samples analyzed by the sample analysis module 21 can be quality control products or ordinary test samples. Ordinary test samples can include blood samples, body fluid samples, etc.

[0071] In this embodiment, the sample is analyzed by the sample analysis module to obtain the sample analysis results, thus enabling the sample analysis device to support the analysis of samples, such as any quality control product with configurable quality control information, that is, it supports the sample analysis of both closed and open quality control products.

[0072] The quality control testing module retrieves the corresponding quality control information for the test items of the quality control products from the configurable quality control product library. Combined with sample analysis results, it determines the sample analysis equipment, the reagents used to test the quality control products, and the quality control results for the test items. The test items here are configurable (e.g., adding new test items or editing existing ones), such as ABO forward and reverse typing and Rh(X1), ABO forward and reverse typing and Rh(CE), etc., and are not specifically limited here.

[0073] Therefore, this sample analysis equipment can support both automatic quality control testing and judgment of closed quality control products, and also support the input of open quality control products and expected results for quality control testing. Here, closed quality control products can refer to the manufacturer's own quality control products, while open quality control products can refer to quality control products developed by other manufacturers; they can be any quality control products.

[0074] The sample analysis device provided in this embodiment includes a sample analysis module and a quality control testing module, which are communicatively connected. The sample analysis module is used to analyze quality control samples and transmit the sample analysis results to the quality control testing module. The quality control testing module is used to obtain the quality control information corresponding to the test items of the quality control samples according to the configured quality control sample library, and, in combination with the sample analysis results, determine the sample analysis device, the reagents used to test the quality control samples, and the quality control results of the test items. The quality control sample library includes the quality control information configured by the user for any quality control sample. Therefore, by using a sample analysis module to analyze quality control products and obtain sample analysis results, which are then reported to the quality control testing module, the quality control testing module retrieves the required quality control information for the test items of the quality control product from the quality control product library. Combined with the sample analysis results, it determines whether the product is under control. This enables the sample analysis equipment to both analyze samples (such as quality control products) and support quality control testing. Furthermore, it supports quality control testing of quality control products provided by any supplier, solving the limitation of existing technologies that only support quality control testing of products from the same manufacturer or preset quality control products. Consequently, it enables simple, flexible, effective, and comprehensive monitoring of the accuracy of sample analysis equipment (such as analyzers).

[0075] In one possible design, the device also includes a quality control editing module for editing quality control information in the quality control material library.

[0076] In this embodiment, in order to support the editing or addition of quality control information, test items, etc., the sample analysis device is equipped with a quality control editing module, through which the quality control information in the quality control library can be edited.

[0077] In one possible design, the quality control editing module is specifically used for:

[0078] Based on the user's input of editing operations for any quality control product in the quality control product library in the corresponding test item, obtain the quality control product editing information, which includes at least the edited quality control information;

[0079] Add the quality control product editing information to the quality control product library.

[0080] In this embodiment, the user can edit the test items of any quality control product in the quality control product library displayed in the editing interface, obtain the edited quality control information, and store it in the quality control product library for updating the library. Therefore, both quality control products and quality control tests are configurable, meaning that quality control products and test items can be edited or added arbitrarily, providing flexibility.

[0081] In one possible design, the quality control editing module is specifically used for:

[0082] Based on the user's input of adding quality control products, obtain the newly added quality control products, the test items for the newly added quality control products, and the corresponding quality control information;

[0083] Add the newly added quality control products, the test items for the newly added quality control products, and the corresponding quality control information to the quality control product library.

[0084] In this embodiment, the user can add applicable items by clicking the "Add" button in the editing interface. Adding applicable items here refers to adding supportable quality control items for the current quality control product. The operation triggered by clicking the "Add" button switches the current editing interface to the "Add" interface. This switching can be achieved by overlaying the current editing interface with the "Add" interface, such as fully or partially overlapping, etc., without specific limitations. Alternatively, it can be a jump, displaying the current editing interface to a completely new interface, such as the "Add" interface. In the "Add" interface, the user enters the identifier of the new quality control product (e.g., the name and / or barcode of the new quality control product), the test items for the new quality control product, and the corresponding quality control information. The system retrieves the new quality control product, the test items for the new quality control product, and the corresponding quality control information, and stores these information in the quality control product library for updating the quality control product library.

[0085] In one possible design, the quality control testing module is also used for:

[0086] In the operation interface corresponding to the current test item, based on the received information indicating the execution of a new test operation, the target quality control information corresponding to the new test operation is obtained from the quality control material library, and the current test item and corresponding quality control information displayed on the operation interface are switched to the target quality control information and corresponding test item.

[0087] In this embodiment, the operation interface of the test item allows switching between different test items. If it is necessary to switch the current test item to another test item, the quality control information to be tested can be selected from the quality control material library through this operation interface. At this time, the operation interface will switch the current test item and its corresponding quality control information to the selected quality control information and its corresponding test item.

[0088] In one possible design, quality control information includes qualitative reference results and / or test item reference values; the test item reference values ​​are used to support the determination of whether the agglomeration strength meets the requirements.

[0089] The sample analysis module is also used to perform agglomeration strength analysis on quality control samples to obtain agglomeration strength results, which are used to represent the agglomeration strength of each well.

[0090] In this embodiment, the quality control information includes: qualitative results and / or test item reference values. The sample analysis module can perform sample analysis through qualitative and / or agglutination intensity to obtain qualitative results and / or agglutination intensity results.

[0091] Here, the reference value for the test item can be a specific value or a region of agglomeration intensity. Specifically, certain well locations can be selected to increase the judgment of agglomeration intensity, unlike existing analyzers that do not have instruments that can both analyze samples and perform quality control tests.

[0092] In one possible design, the quality control testing module is also specifically used to perform any of the following operations:

[0093] If the sample analysis results include qualitative results, and the qualitative results meet the qualitative reference results, then the quality control results are determined to be in-control results.

[0094] If the sample analysis results include agglutination strength results, and the agglutination strength results meet the test item reference values, then the quality control results are determined to be in control results; if the sample analysis results include qualitative results and agglutination strength results, and the qualitative results meet the qualitative reference results and the agglutination strength results meet the test item reference values, then the quality control results are determined to be in control results.

[0095] In this embodiment, the sample analysis device can support quality control judgment based on the final result as well as quality control judgment based on the agglomeration intensity of the pore sites. It can be effectively applied to different practical application scenarios, such as quality control testing based on the rules and habits of laboratory departments.

[0096] Specifically, quality control results can be judged both as an overall result and according to the agglutination intensity range of each well. For example, in editing / adding quality control product information and editing / adding crossmatching, you can choose whether to judge the quality control results based on gel strength. If checked, the final result judgment will only be in control if both the preset final result (here referring to the qualitative reference result) and the preset range of agglutination intensity for each well (i.e., the agglutination intensity result meets the test item reference value); otherwise, it is out of control. If not checked, the final result judgment will be considered in control if the qualitative result is met; otherwise, it is out of control. Alternatively, if checked, qualitative analysis can be omitted, and the final result judgment will be considered in control if the agglutination intensity result meets the test item reference value; otherwise, it is out of control.

[0097] The sample analysis equipment, such as a blood typing analyzer, provides semi-quantitative quality control for blood typing. Results can be derived from the final result, such as positive or negative, A / B / O type, or by analyzing the agglutination intensity range of each well to determine whether the analysis is out of control or in control. However, existing blood typing analyzers provide qualitative quality control interpretation and do not support semi-quantitative quality control interpretation (e.g., agglutination intensity interpretation). Therefore, the sample analysis equipment provided in this application supports qualitative and / or semi-quantitative quality control analysis, enabling effective and comprehensive monitoring of the accuracy of the sample analysis equipment (e.g., the analyzer) according to actual needs.

[0098] Therefore, this application utilizes a sample analysis module to analyze samples and obtain sample analysis results, which are then reported to a quality control testing module. The quality control testing module is used to obtain the expected results from the sample analysis results and quality control product information to determine whether the samples are under control. This enables the analysis equipment to both analyze samples and support quality control testing, and it supports quality control testing of quality control products provided by any provider. This solves the limitation of existing technologies that only support quality control testing of the manufacturer's own or preset quality control products, thereby enabling effective and comprehensive monitoring of the accuracy of the sample analysis equipment.

[0099] Figure 3 This is a schematic diagram of the structure of a sample analysis device provided in another embodiment of this application. The device may include: an information acquisition device 31, a sample rack 32, a sample reaction device 33, a reaction result reading device 34, and a processing device 35.

[0100] Specifically, the sample reaction device 33, according to the selected test sample and test item, grabs the test sample on the sample rack 32 and performs the test reaction;

[0101] The reaction result reading device 34 acquires the test reaction results of the test sample;

[0102] Processing device 35 performs the following processing:

[0103] The test reaction results of the test reaction samples are analyzed to obtain the sample analysis results of the test samples;

[0104] The information acquisition device 31 retrieves the corresponding quality control information from the quality control material library according to the test item, analyzes the sample analysis results of the test sample, and outputs the sample analysis equipment, the reagents used to test the test sample, and the quality control results of the test item; wherein, the quality control material library includes the quality control information configured by the user for any quality control material.

[0105] In this embodiment, the information acquisition device 31 acquires the selected test sample and test item; the sample reaction device 33, according to the selected test sample and test item, picks up the test sample on the sample rack 32 for test reaction. After the test reaction is completed, the reaction result reading device 34 acquires the test reaction result of the test sample. The test reaction result may include qualitative results and / or agglutination strength results. Then, the processing device 35 analyzes the test reaction result of the test sample to obtain the sample analysis result of the test sample; then, according to the test item, the corresponding quality control information is obtained from the quality control material library, and the sample analysis result of the test sample is analyzed to output the quality control results of the sample analysis equipment, the reagents used to test the test sample, and the test item. The test sample on the sample rack 32 can be the sample to be tested or a quality control material.

[0106] The sample analysis device provided in this application analyzes quality control samples to obtain sample analysis results. Based on the obtained sample analysis results and the expected results in the quality control sample information, it determines whether the sample analysis device, the reagents used to test the quality control samples, and the test items are under control. This enables the analysis device to both analyze samples and support quality control testing, and supports quality control testing of quality control samples provided by any provider. It solves the limitation of existing technologies that only support quality control testing of quality control samples from the same manufacturer or preset quality control samples, and thus can effectively and comprehensively monitor the accuracy of the sample analysis device.

[0107] In one possible design, the processing device 35 also performs the following processing:

[0108] The quality control product library is updated based on the quality control product editing information obtained by the information acquisition device 31, or the sample analysis results of the corresponding test samples are added to the quality control product library. The quality control product library includes one or more of the following: quality control product identification, test items, and quality control information.

[0109] In this embodiment, the information reading device may include input devices such as a touch screen and a keyboard. The quality control product editing information can also be obtained through methods such as barcode scanning, near-field communication, and Bluetooth; no specific limitation is made here.

[0110] Updating the quality control product library includes adding or modifying the product library. Before adding a product, the user can be prompted to confirm. If the user confirms the addition, the quality control product editing information or the corresponding test sample analysis results will be added to the quality control product library.

[0111] Therefore, this application analyzes samples and obtains sample analysis results, and then determines whether the sample is under control based on the sample analysis results and the expected results in the quality control information. This enables the analytical equipment to both analyze samples and support quality control testing, and supports quality control testing of quality control products provided by any provider. This solves the limitation of existing technologies that only support quality control testing of the manufacturer's own or preset quality control products, and thus enables effective and comprehensive monitoring of the accuracy of the sample analysis equipment.

[0112] Figure 4 This is a flowchart illustrating a sample analysis method provided in an embodiment of this application. The sample analysis method is applied to the sample analysis device described in the above embodiments and may include:

[0113] S101. Analyze the sample to obtain the sample analysis results of the quality control product;

[0114] S102. Obtain the quality control information corresponding to the test items of the quality control products according to the configured quality control product library, and determine the sample analysis equipment, the reagents used to test the quality control products, and the quality control results of the test items in combination with the sample analysis results of the quality control products.

[0115] The quality control product library includes the quality control information configured by the user for any quality control product.

[0116] In this embodiment, by analyzing quality control samples and combining the sample analysis results of the quality control samples with any configurable quality control information, it is possible to support sample analysis as well as sample analysis of both closed and open quality control samples.

[0117] Specifically, based on the configurable quality control library, the quality control information corresponding to the test items of the quality control products is obtained. Combined with the sample analysis results, the sample analysis equipment, the reagents used to test the quality control products, and the quality control results of the test items are determined. The test items (or detection items) here are configurable (e.g., adding new test items or editing existing test items), such as ABO forward and reverse typing and Rh(X1), ABO forward and reverse typing and Rh(CE), etc., and are not specifically limited here.

[0118] Therefore, this sample analysis method can support both automated quality control testing and judgment of closed quality control products, and also support the input of open quality control products and expected results for quality control testing. Here, closed quality control products can refer to the manufacturer's own quality control products, while open quality control products can refer to quality control products developed by other manufacturers; they can be any type of quality control product.

[0119] The sample analysis method provided in this embodiment analyzes any quality control product and obtains the sample analysis results. Then, it retrieves the quality control information required for the test items of the quality control product from the quality control product library and combines it with the sample analysis results to determine whether it is under control. This achieves both sample analysis (such as quality control products) and support for quality control testing. It also supports quality control testing of quality control products provided by any provider, solving the limitation of existing technologies that only support quality control testing of products from the same manufacturer or preset quality control products. In this way, it can effectively and comprehensively monitor the accuracy of sample analysis equipment (such as analyzers).

[0120] In one possible design, the method can also be implemented through the following steps:

[0121] Step a1: Based on the user's input of the editing operation for any quality control product in the quality control product library in the corresponding test item, obtain the quality control product editing information. The quality control product editing information shall include at least the edited quality control information.

[0122] Step a2: Add the quality control product editing information to the quality control product library.

[0123] In this embodiment, to support the editing or addition of quality control information and test items, the sample analysis method supports editing the quality control information in the quality control library. Specifically, users can edit the test items of any quality control item in the quality control library displayed in the editing interface, obtain the edited quality control information, and store it in the quality control library for updating the library. Therefore, both quality control items and quality control tests are configurable, meaning that quality control items and test items can be edited or added arbitrarily, providing flexibility.

[0124] In one possible design, the method can also be implemented through the following steps:

[0125] Step b1: Based on the user's input of the quality control product addition operation, obtain the newly added quality control product, the test items of the newly added quality control product, and the corresponding quality control information;

[0126] Step b2: Add the newly added quality control products, the test items for the newly added quality control products, and the corresponding quality control information to the quality control product library.

[0127] In this embodiment, the user can click the "Add" button in the editing interface to jump to the "Add" interface. In the "Add" interface, the user can enter the identifier of the new quality control product (such as the name and / or barcode of the new quality control product), the test items for the new quality control product, and the corresponding quality control information. The system then acquires the new quality control product, its test items, and the corresponding quality control information, and stores these information in the quality control product library to update the library.

[0128] In one possible design, the method can also be implemented through the following steps:

[0129] In the current test item's corresponding operation interface, if a new test operation is received indicating that a new test operation will be executed, the interface will display the test items supported by the quality control material or sample corresponding to that new test operation. Here, the new test operation includes test operations for samples and / or quality control materials.

[0130] In this embodiment, the operation interface of the test item can switch between different quality control products or samples for testing. The quality control products or samples can support at least one test item for testing.

[0131] Specifically, when using the entered quality control products for testing, the sample can be switched to the corresponding quality control product on the application interface. At this time, when selecting test items from the drop-down menu, only the test items supported by the selected quality control product will be available. After the test is completed, the system will automatically determine whether the quality control test is out of control or under control based on the entered expected results.

[0132] In one possible design, the method can also be implemented through the following steps:

[0133] In response to the user's operation of switching quality control products, the quality control information and expected results corresponding to the switched quality control products are displayed on the quality control management interface.

[0134] Specifically, during the switching process, the quality control information of the quality control product corresponding to the operation is retrieved from the quality control product library, and the quality control information and expected results, such as qualitative reference results and / or test item reference values, are displayed on the quality control management interface.

[0135] In one possible design, quality control information includes qualitative reference results and / or test item reference values; the test item reference values ​​are used to support the determination of whether the agglomeration strength meets the requirements.

[0136] This method can also be implemented through the following steps:

[0137] Step c1: Perform agglomeration strength analysis on the quality control sample to obtain the agglomeration strength results, which are used to represent the agglomeration strength of each well site;

[0138] Step c2: If the sample analysis results include qualitative results, and the qualitative results meet the qualitative reference results, then the quality control results are determined to be in-control results.

[0139] Step c3: If the sample analysis results include agglutination strength results, and the agglutination strength results meet the reference values ​​of the test items, then the quality control results are determined to be in-control results.

[0140] Step c4: If the sample analysis results include qualitative results and agglomeration strength results, and the qualitative results meet the qualitative reference results and the agglomeration strength results meet the test item reference values, then the quality control results are determined to be in-control results.

[0141] In this embodiment, the quality control information includes: qualitative results and / or test item reference values. The sample analysis module can perform sample analysis through qualitative and / or agglomeration intensity to obtain qualitative results and / or agglomeration intensity results. Here, the test item reference value can be a specific value or a region of agglomeration intensity. Specifically, certain well locations can be selected to increase the determination of agglomeration intensity, unlike existing analyzers that do not have instruments that can both analyze samples and perform quality control tests.

[0142] This sample analysis method can support quality control judgment based on the final results as well as quality control judgment based on the agglomeration intensity of the pore sites. It can be effectively applied to different practical application scenarios, such as quality control testing based on the rules and habits of laboratory departments.

[0143] Specifically, quality control results can be judged both as an overall result and according to the agglutination intensity range of each well. For example, in editing / adding quality control product information and editing / adding crossmatching, you can choose whether to judge the quality control results based on gel strength. If checked, the final result judgment will only be in control if both the preset final result (here referring to the qualitative reference result) and the preset range of agglutination intensity for each well (i.e., the agglutination intensity result meets the test item reference value); otherwise, it is out of control. If not checked, the final result judgment will be considered in control if the qualitative result is met; otherwise, it is out of control. Alternatively, if checked, qualitative analysis can be omitted, and the final result judgment will be considered in control if the agglutination intensity result meets the test item reference value; otherwise, it is out of control.

[0144] Therefore, this application analyzes samples and obtains sample analysis results, and then determines whether the sample is under control based on the sample analysis results and the expected results in the quality control information. This enables the analytical equipment to both analyze samples and support quality control testing, and supports quality control testing of quality control products provided by any provider. This solves the limitation of existing technologies that only support quality control testing of the manufacturer's own or preset quality control products, and thus enables effective and comprehensive monitoring of the accuracy of the sample analysis equipment.

[0145] To implement the sample analysis method, this embodiment provides a sample analysis management system. See also... Figure 5 , Figure 5This is a schematic diagram of the sample analysis management system provided in this application embodiment. The sample analysis management system includes a display device 51 and a processing device 52. The processing device displays a quality control management interface through the display device 51. The quality control management interface includes a first display area and a third display area. The first display area displays quality control product information, which includes at least one of the following: quality control product identifier and analysis type. Of course, the quality control product information displayed in the first display area may also include at least one of the following: batch number, expiration date, etc. The quality control product information displayed in the first display area can be information on all or part of the quality control products obtained from the quality control product library.

[0146] In response to the quality control product selection information entered by the user in the first display area, the processing device 52 displays detailed information of the quality control product matching the selection information in the third display area. The detailed information of the quality control product includes at least quality control product parameter information, which includes at least one test item and corresponding quality control information. The quality control information includes qualitative reference results and / or test item reference values. The test item reference values ​​are used to support the determination of whether the agglomeration strength meets the requirements. The qualitative reference results and test item reference values ​​are the same as described above and will not be repeated. Of course, the detailed information of the quality control product may also include at least one of the following: quality control product identification, barcode, feature code, batch number, expiration date, and analytical type.

[0147] Here, the processing device also responds to the quality control product selection information entered by the user in the first display area, and displays the quality control product information selected by the user in the first display area. For example, the label of the quality control product selected by the user is displayed differently from other quality control product labels in the first display area. Specifically, this can be achieved by highlighting, adding a label line, or a label box, etc., which are not limited in this application.

[0148] Furthermore, for crossmatching, the quality control management interface may also include a second display area to display crossmatching quality control information. Specifically, this second display area includes an entry point for adding a test item, which can be a fixed label, a secondary menu, etc.; the second display area includes an entry point for deleting a test item, which can be a label, a secondary menu, etc.; the second display area also includes an entry point for editing a test item.

[0149] In this embodiment, the quality control product information is displayed in the first display area, such as all the entered quality control products, which is the quality control product library. The detailed information of the quality control products is displayed in the third display area, which may include test items, such as blood type test items, and quality control parameter information corresponding to the test items.

[0150] The first display area shows the specific content of the quality control product information, and includes entry points for adding, deleting, and editing quality control product information. The third display area shows detailed information about the quality control product, supported items, and expected results, such as qualitative reference results and / or test item reference values. Taking cross-matching blood testing as an example, the second display area shows cross-matching quality control information.

[0151] For example, in combination Figure 6 As shown, Figure 6 This is a schematic diagram of the interface provided in an embodiment of this application. Figure 6 The currently displayed interface is the quality control management interface, which includes a first display area, a second display area, and a third display area. The first display area shows the specific content of the quality control products, allowing you to see the information of the quality control products that have been entered into the device, including the entry sequence number, quality control product name (e.g., quality control product 1, quality control product 2, quality control product 3, quality control product 4, quality control product 5), batch number, expiration date, and type (e.g., whole blood). The first display area also provides controls 101 for adding quality control products, 102 for deleting quality control products, and 103 for editing quality control products. By clicking the control 101 for adding quality control products, you can add, modify, or delete quality control products.

[0152] The testing items here take crossmatching as an example. The quality control management interface also displays a corresponding display area for crossmatching to show crossmatching quality control information. For example... Figure 6 As shown, the crossmatch management section displays the configured crossmatch pairings and expected results. The second display area shows the specific details of the test items, including the currently entered crossmatch information, such as the entry sequence number, quality control product name (e.g., quality control product 1, quality control product 2, quality control product 5), type (e.g., whole blood), role (e.g., recipient), and configured quality control products (quality control product 3, quality control product 1). The second display area also provides controls 201 for adding crossmatches, 202 for deleting crossmatches, and 203 for editing crossmatches. Clicking the "Add Crossmatch" control 201 allows for adding test content. The third display area shows quality control product details, including: barcode, feature code (e.g., 1), supported test items, and corresponding quality control information (which may include qualitative reference results and / or test item reference values). The barcode refers to scanning the barcode on the quality control product or sample to obtain the corresponding information.

[0153] For example, the test items and results here can be: Item 1: ABO forward and reverse shaping and Rh(X1), expected result: A / RhD(+), coagulation strength: Hole 1(-A)2+~4+ Hole 5(N)-~-, Hole 2(-B)-~-, Hole 6(Ctr)-~-, Hole 3(-D)2+~4+, Hole 7(Ac)-~-, Hole 4(N)-~-, Hole 8(Bc)2+~4+; Item 2: ABO forward and reverse shaping and Rh(CE), expected result: A / RhD(+) / any result.

[0154] The system includes pre-set information for five quality control products from this manufacturer. When using these products for quality control testing, please refer to [the relevant documentation / reference]. Figure 7 As shown, Figure 7 This is a schematic diagram of an interface provided for another embodiment of this application. The currently displayed interface is the sample application interface, which supports scanning the barcode of quality control products. This sample application interface supports both sample testing and quality control product testing. Taking quality control products as an example, after pushing in the quality control product, scanning the barcode of the quality control product can automatically identify the quality control product information, allowing direct application for the desired quality control item. After the test is completed, an out-of-control / in-control judgment will be automatically performed. The sample application interface displays a control 301 for switching between quality control products and samples by double-clicking the sample position, and a control 302 for adding application items, provided to accommodate clients using open quality control. Simultaneously, the sample application interface also provides a control 303 for starting the test, a control 304 for editing crossmatching, and a control 305 for deleting application items. The sample application interface enables the testing of applied samples or quality control products. In one possible design, the first display area displays at least the quality control product identifier and type; wherein, the processing device also displays at least one of the following in the first display area via the display device: a first control for indicating the addition of a quality control product, a second control for indicating the deletion of a quality control product, a third control for indicating the editing of a quality control product, a fourth control for indicating the addition of a test item, a fifth control for indicating the editing of a test item, and a sixth control for indicating the deletion of a test item.

[0155] These controls can be placed in the first or second display area, or in a new display area, such as the fourth display area. Alternatively, all quality control product information can be displayed centrally through a list, allowing for addition, deletion, and modification. The fourth, fifth, and sixth controls are provided for clients using open quality control systems; please refer to [link / reference needed]. Figure 8 As shown.

[0156] In one possible design, the processing device also responds to the user's adjustment operation in the first display area by adjusting and displaying the corresponding quality control parameter information in the third display area.

[0157] For example, when crossmatching is edited in the second display area, the test information will also be displayed in the third display area.

[0158] For example, by clicking Figure 6 The control 101 for adding quality control items or the control 103 for editing quality control items displays the edit / add quality control item interface. See [link to documentation]. Figure 8 As shown, Figure 8 This is a schematic diagram of an interface provided for another embodiment of the present application. The system also supports manually adding / editing quality control product information. The quality control management interface and the edit / add quality control product interface can be displayed side-by-side or at least partially overlap. The edit / add quality control product interface includes a fourth display area displaying basic information about the quality control product, a fifth display area displaying test items, and a sixth display area displaying quality control information. For example, the fourth area can display the name, batch number, expiration date, barcode, type, and feature code of the quality control product. The fifth display area can display the applicable items supported by the quality control product, a control 401 for adding applicable items, and a control 402 for deleting applicable items. The fifth display area can display the quality control information corresponding to the test item, such as qualitative reference results and / or test item reference values.

[0159] Specifically, in the interface for editing / adding quality control products, users can manually enter the product's name, batch number, expiration date, barcode, type, feature code, supported test items (such as applicable items), item name, and expected results (the expected results may include agglomeration strength results). Adding test items from all currently available systems is supported. When selecting an item, the corresponding detailed information and expected results will switch on the right, eliminating the need for manual searching. For example, the interface for editing / adding quality control products includes a control 401 for adding applicable items and a control 402 for deleting applicable items. Clicking the control 401 adds an applicable item, and selecting an existing applicable item and clicking the control 402 deletes the selected applicable item, thus enabling the editing / adding of quality control products.

[0160] Combination Figure 6 By clicking Figure 6 The control 201 for adding cross-matching or the control 203 for editing cross-matching displays the edit / add cross-matching interface. See [link / reference]. Figure 9 As shown, Figure 9 This is a schematic diagram of an interface provided for another embodiment of this application. The currently displayed first-layer interface is the interface for editing / adding crossmatch blood, and the second-layer interface is... Figure 6The quality control management interface is shown below. The first layer of the interface includes a display area for showing the basic information of the quality control products corresponding to crossmatching, a display area for showing the paired quality control, and the corresponding expected results, i.e., quality control information. The display area for showing the basic information of the quality control products corresponding to crossmatching provides a control for whether to judge based on agglutination strength. If this control is checked, the quality control test can be judged based on agglutination strength.

[0161] Specifically, the interface for editing / adding crossmatching allows users to edit or add crossmatching combinations and expected results. For example, the interface for editing / adding crossmatching provides an entry 501 for selecting the name of the quality control product, an entry 502 for selecting the paired quality control, and an entry 503 for selecting the expected result that matches the test item.

[0162] exist Figure 7 Based on this, by clicking on a sample location, select the quality control sample to be used for the test application (see above). Figure 10 As shown (e.g.) Figure 10 The selected "QC" Figure 10 The diagram provided in another embodiment of this application illustrates the interface. In the sample application interface, when using a self-entered quality control sample for testing, the sample can be switched to the corresponding quality control sample (e.g., by clicking control 301, which supports switching between quality control samples and samples by double-clicking the sample position). At this time, only the test items supported by the selected quality control sample will be available in the drop-down test item selection. Furthermore, the application interface supports simultaneous application for testing of quality control samples and samples, eliminating the need for separate applications. After the test is completed, the system will automatically determine whether the quality control test is out of control or under control based on the entered expected results.

[0163] For example, a user can select a quality control product for testing. In this case, the drop-down list of test items provided to the user will offer all the test items that can be supported for that quality control product. Similarly, a user can select a sample for testing. In this case, the drop-down list of test items provided to the user will offer all the test items that can be supported for that sample. Furthermore, a user can simultaneously select multiple quality control products, multiple samples, or both quality control products and samples for testing. In this case, the drop-down list of test items provided to the user will offer test items that are common to multiple quality control products, or test items that are common to multiple samples, or test items that are common to both quality control products and samples. See also... Figure 11 and Figure 12 As shown, Figure 11 This is a schematic diagram of an interface provided for yet another embodiment of this application. Figure 12 This is a schematic diagram of an interface provided for another embodiment of this application. Figure 8Based on this, by checking the provided control for judging by agglomeration intensity, quality control can determine whether something is in control based on agglomeration intensity. For details, see... Figure 11 As shown, the interface for editing / adding quality control products displays basic information about the quality control product (name, batch number, expiration date, barcode, type, feature code, etc.), the applicable items supported by the quality control product, controls for adding applicable items, and controls for deleting applicable items. It can also display quality control information corresponding to the test item, such as qualitative reference results and / or test item reference values. Specifically, the interface for editing / adding quality control products also provides a control 601 for judging based on agglomeration intensity, meaning that the quality control results can be judged both based on the overall results and based on the agglomeration intensity range of each well.

[0164] exist Figure 9 Based on this, by checking the provided control for judging by agglutination strength, crossmatch testing items can be determined based on agglutination strength to determine whether they are under control. For details, see... Figure 12 As shown, the edit / add crossmatch interface may include a display area for displaying basic information of the quality control materials corresponding to the crossmatch, a display area for displaying the paired quality control, and the corresponding expected results, i.e., quality control information. The display area for displaying the basic information of the quality control materials corresponding to the crossmatch provides a control 602 for judging based on agglutination intensity. This means that the quality control results can be judged both based on the overall result and based on the agglutination intensity range of each well.

[0165] For example, when editing / adding quality control product information (such as...) Figure 11 As shown) and in the Edit / Add crossmatch section, you can choose whether to judge the quality control results based on gel strength (e.g. Figure 12 (As shown). If checked, the final result will be in control only if both the preset final result and the preset range of coagulation intensity for each pore are met; otherwise, it will be out of control.

[0166] In one possible design, the processing device is used to perform the steps of the sample analysis method as described in the above embodiments, which will not be repeated here.

[0167] Therefore, the sample analysis system provided in this application has quality control testing functions, records quality control data, and provides reliable quality control information records; it supports custom quality control products, supporting quality control products used by any hospital department without specific restrictions on the quality control products; it is quick and convenient to use the manufacturer's quality control products, requiring no data entry and allowing direct testing; it supports custom rules for judging out-of-control / in-control quality control, using the final result for judgment or combined with well site agglomeration intensity judgment, meeting the quality control testing requirements of different institutions; it allows for the addition of quality control product items without restrictions on specific items, and all items supported by the instrument can be tested for quality control, ensuring that the quality of the instrument, reagents, and gel cards is under control; and it supports simultaneous application for quality control testing and sample testing, saving time.

[0168] In addition, quality control samples can be used as samples for testing. The test results can be manually recorded or entered into the Laboratory Information Management System (LIS), or the test results can be directly transmitted to the LIS. The results can be manually checked one by one according to the format table in the quality control sample instructions, and recorded manually using paper forms or in the LIS system.

[0169] This application also provides an analyzer, such as a blood typing analyzer, which is used to perform the steps of the sample analysis method as described in the above embodiments, and will not be repeated here.

[0170] The analyzer supports single-entry or batch import of quality control product information; it also supports manually adding quality control product information; and it supports obtaining quality control product information by reading identification codes (quality control product barcodes, QR codes, etc.). The quality control product information may include: quality control product identifier, test items, and expected results; the expected results can be values ​​or ranges; the quality control product information is stored in a quality control product library.

[0171] Therefore, this analyzer is an open quality control system, in which the expected results of quality control tests support qualitative and semi-quantitative judgment; there are no restrictions on the quality control items, and any project can be subject to quality control; when adding new quality control test items, quick navigation is available; quality control test results are automatically judged as out of control or under control; quality control tests and sample tests can be applied for simultaneously.

[0172] This application also provides a computer-readable storage medium storing computer-executable instructions, which, when executed by a processor, implement the above-described method.

[0173] This application also provides a computer program product, including a computer program that, when executed by a processor, implements the above-described method.

[0174] In the several embodiments provided in this application, it should be understood that the disclosed devices and methods can be implemented in other ways. For example, the device embodiments described above are merely illustrative; for instance, the division of modules is only a logical functional division, and in actual implementation, there may be other division methods. For example, multiple modules may be combined or integrated into another system, or some features may be ignored or not executed. Furthermore, the coupling or direct coupling or communication connection shown or discussed may be indirect coupling or communication connection through some interfaces, devices, or modules, and may be electrical, mechanical, or other forms. Additionally, the functional modules in the various embodiments of this application may be integrated into one processing unit, or each module may exist physically separately, or two or more modules may be integrated into one unit. The above-mentioned modular units can be implemented in hardware or in the form of hardware plus software functional units.

[0175] The integrated modules implemented as software functional modules described above can be stored in a computer-readable storage medium. These software functional modules, stored in a storage medium, include several instructions to cause a computer device (which may be a personal computer, server, or network device, etc.) or processor to execute some steps of the methods of the various embodiments of this application. It should be understood that the processor may be a Central Processing Unit (CPU), or other general-purpose processors, digital signal processors (DSPs), application-specific integrated circuits (ASICs), etc. A general-purpose processor may be a microprocessor or any conventional processor. The steps of the methods disclosed in this invention can be directly implemented by a hardware processor, or implemented by a combination of hardware and software modules within the processor.

[0176] The memory may include high-speed RAM, and may also include non-volatile memory (NVM), such as at least one disk drive, and may also be a USB flash drive, external hard drive, read-only memory, disk, or optical disc. The bus may be an Industry Standard Architecture (ISA) bus, a Peripheral Component Interconnect (PCI) bus, or an Extended Industry Standard Architecture (EISA) bus. Buses can be categorized as address buses, data buses, control buses, etc. For ease of illustration, the buses in the accompanying drawings are not limited to a single bus or a single type of bus. The aforementioned storage medium can be implemented by any type of volatile or non-volatile storage device or a combination thereof, such as static random access memory (SRAM), electrically erasable programmable read-only memory (EEPROM), erasable programmable read-only memory (EPROM), programmable read-only memory (PROM), read-only memory (ROM), magnetic storage, flash memory, disk, or optical disc. The storage medium can be any available medium accessible to general-purpose or special-purpose computers.

[0177] An exemplary storage medium is coupled to a processor, enabling the processor to read information from and write information to the storage medium. Alternatively, the storage medium can be an integral part of the processor. Both the processor and the storage medium can reside in application-specific integrated circuits (ASICs). Alternatively, the processor and storage medium can exist as discrete components in an electronic device or host device.

[0178] Those skilled in the art will understand that all or part of the steps of the above-described method embodiments can be implemented by hardware related to program instructions. The aforementioned program can be stored in a computer-readable storage medium. When executed, the program performs the steps of the above-described method embodiments; and the aforementioned storage medium includes various media capable of storing program code, such as ROM, RAM, magnetic disks, or optical disks.

[0179] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of this application, and are not intended to limit them. Although this application has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some or all of the technical features therein. Such modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of this application.

Claims

1. A sample analysis device, characterized in that, include: The system includes a sample analysis module, a quality control testing module, and a quality control editing module, wherein the sample analysis module and the quality control testing module are communicatively connected. The sample analysis module is used to analyze the quality control samples and transmit the sample analysis results to the quality control testing module; The quality control testing module is used to obtain the quality control information corresponding to the test items of the quality control products according to the user-configured quality control product library, and, in conjunction with the sample analysis results, determine the sample analysis equipment, the reagents used to test the quality control products, and the quality control results of the test items; wherein, the quality control product library includes quality control information configured by the user for any quality control product, the quality control information includes qualitative reference results and / or test item reference values, the test item reference values ​​are used to support the determination of whether the agglomeration intensity of each well meets the requirements; The quality control editing module is used to modify the initial quality control information of any test item corresponding to a quality control product in the quality control product library when receiving an editing operation input from the user, and to add a new quality control product, a new test item, and corresponding new quality control information to the quality control product library when receiving a quality control product addition operation input from the user; the quality control testing module is also specifically used to determine the quality control result as an in-control result when the sample analysis result includes a qualitative result and the qualitative result meets the qualitative reference result, and / or when the sample analysis result includes an agglomeration strength result and the agglomeration strength result meets the test item reference value.

2. The sample analysis device according to claim 1, characterized in that, The quality control editing module, when modifying the initial quality control information in the quality control database, is specifically used for: Based on the user's input of editing operations for any quality control product in the quality control product library in the corresponding test item, the quality control product editing information is obtained, and the quality control product editing information includes at least the edited quality control information; The quality control product editing information is added to the quality control product library to update the initial quality control information.

3. The sample analysis device according to claim 1, characterized in that, The quality control editing module, when adding new quality control products, new test items, and corresponding new quality control information, is specifically used for: Based on the user's input of adding quality control products, obtain the newly added quality control products, the test items of the newly added quality control products, and the corresponding quality control information; Add the newly added quality control products, their test items, and corresponding quality control information to the quality control product library.

4. A sample analysis device, characterized in that, include: Information acquisition device, sample rack, sample reaction device, reaction result reading device, and processing device; Information acquisition device, acquiring selected test samples and test items; The sample reaction device, according to the selected test sample and test item, grabs the test sample on the sample rack and performs the test reaction, wherein the test sample is a quality control sample; A reaction result reading device acquires the test reaction results of the test sample; The processing device performs the following processing: The test reaction results of the test sample are analyzed to obtain the sample analysis results of the test sample; According to the test items, the corresponding quality control information is obtained from the quality control library, the sample analysis results of the test samples are analyzed, and the sample analysis equipment, the reagents used to test the test samples, and the quality control results of the test items are output; wherein, the quality control library includes quality control information configured by the user for any quality control item, the quality control information includes qualitative reference results and / or test item reference values, the test item reference values ​​are used to support the determination of whether the agglomeration intensity of each well meets the requirements; When the sample analysis results include qualitative results and the qualitative results meet the qualitative reference results, and / or when the sample analysis results include agglutination strength results and the agglutination strength results meet the test item reference values, then the quality control results are determined to be in-control results; The processing device also performs the following processing: The quality control product editing information obtained by the information acquisition device is used to perform addition and / or modification operations on the quality control product library, or to add the sample analysis results corresponding to the test samples to the quality control product library; wherein, the quality control product editing information includes at least the edited quality control information, and the quality control product library includes one or more of the following: quality control product identification, test items, and quality control information.

5. A sample analysis method, characterized in that, Applied to the sample analysis apparatus as described in any one of claims 1-4, the method comprises: Analyze the samples to obtain the sample analysis results of the quality control products; The quality control information corresponding to the test items of the quality control products is obtained according to the configured quality control product library. Combined with the sample analysis results of the quality control products, the sample analysis equipment, the reagents used to test the quality control products, and the quality control results of the test items are determined. The quality control product library includes quality control information configured by the user for any quality control product. This quality control information includes qualitative reference results and / or test item reference values. The test item reference values ​​are used to support the determination of whether the agglomeration strength meets the requirements. When the sample analysis results include qualitative results and the qualitative results meet the qualitative reference results, and / or when the sample analysis results include agglutination strength results and the agglutination strength results meet the test item reference values, then the quality control results are determined to be in-control results; The method further includes: When an edit operation is received from the user, the initial quality control information of the test item corresponding to any quality control item in the quality control material library is modified. When a user inputs an operation to add quality control products, the system adds the new quality control product, the new test item, and the corresponding new quality control information to the quality control product library.

6. The method according to claim 5, characterized in that, The steps for modifying the initial quality control information in the quality control material library include: Based on the user's input of editing operations for any quality control product in the quality control product library in the corresponding test item, the quality control product editing information is obtained, and the quality control product editing information includes at least the edited quality control information; The quality control product editing information is added to the quality control product library to update the initial quality control information.

7. The method according to claim 5, characterized in that, The steps for adding new quality control products, new test items, and corresponding new quality control information include: Based on the user's input of adding quality control products, obtain the newly added quality control products, the test items of the newly added quality control products, and the corresponding quality control information; Add the newly added quality control products, their test items, and corresponding quality control information to the quality control product library.

8. A sample analysis management system, characterized in that, The sample analysis management system includes a display device and a processing device. The processing device is used to execute the steps of the sample analysis method as described in any one of claims 5 to 7. The processing device displays a quality control management interface through the display device. The quality control management interface includes a first display area and a third display area. The first display area displays quality control product information, which includes at least one of the following: quality control product identification and analysis type. In response to the quality control selection information input by the user in the first display area, the processing device displays quality control parameter information matching the quality control selection information in the third display area; wherein, the quality control parameter information includes at least quality control information corresponding to at least one test item; The processing device also displays at least one of the following via the display device: a first control for indicating the addition of a quality control item, a second control for indicating the deletion of a quality control item, a third control for indicating the editing of a quality control item, a fourth control for indicating the addition of a test item, a fifth control for indicating the editing of a test item, and a sixth control for indicating the deletion of a test item.

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