Method for test item configuration, method for sample analysis and control terminal

Abstract

To provide a method for test item configuration that can improve the convenience of the configuration operation.SOLUTION: A test item configuration method includes: acquiring a first mapping relationship between a test item and a plurality of sub-holes and test target information of each sub-hole, wherein the test target information includes a test target in the test channel of the sample analyzer corresponding to each sub-hole, and the test targets corresponding to the plurality of sub-holes are different; and configuring the test item according to the first mapping relationship and the test target information. In this way, only one experiment item is configured for the test item, so that the input and modification of homogeneous information of the test item only need to be performed for one experiment item, thereby reducing the workload for configuring the test item and improving the convenience.SELECTED DRAWING: None

Description

[Technical Field]

[0001] The present application relates to the technical field of medical equipment, and in particular to a test item setting method, a sample analysis method, and a control terminal. [Background technology]

[0002] With the development of sample analyzer technology, sample analyzers have become important tools in the medical field.

[0003] Depending on the application field and testing principle, sample analyzers can include various types such as immunoassay analyzers, hematology analyzers, biochemistry analyzers, etc. Each type of sample analyzer can be used to test multiple test items, for example, an integrated PCR device can be used to test the nucleic acids of various viruses such as the new coronavirus, influenza virus, AIDS virus, tuberculosis bacillus, E. coli, as well as microorganisms such as bacteria and fungi.

[0004] Based on the above, it is necessary to set the test item information and processing process of the sample analyzer before the test. As of now, no effective solution has been proposed to improve the convenience of setting the test items of the sample analyzer. Summary of the Invention

[0005] In the embodiments of the present invention, a test item setting method, a sample analysis method, a control terminal, a computer-readable storage medium, and a computer program product are provided that can improve the convenience of setting operations.

[0006] According to a first aspect of the present application, there is provided a test item setting method, the method comprising: A step of obtaining a first mapping relationship between test items and a plurality of sub-holes and test object information for each of the sub-holes, wherein the test object information includes test objects for each sub-hole in a test channel of a sample analyzer, and the test objects for the plurality of sub-holes are different; and setting the inspection items based on the first mapping relationship and the inspection object information.

[0007] According to a second aspect of the present application there is provided a method of analyzing a sample, said method comprising: obtaining a sample analysis initiation command, the sample analysis initiation command including test items and sample number; acquiring a plurality of sub-holes corresponding to the test items and test object information for each of the sub-holes, the test object information including the test object of each sub-hole in the test channel of the sample analyzer; determining the number of reaction holes based on the number of samples and the number of subholes for the test items; a step of sending a test control command to a sample analyzer based on the number of reaction holes and the sub-holes corresponding to the test items, the test control command being to control the sample analyzer to prepare test liquids for the corresponding number of reaction holes, obtain the reaction holes corresponding to each sample and the sub-holes of the test items corresponding to the reaction holes, and test the test liquids in each of the reaction holes using a test channel of the sample analyzer to obtain the test results of each reaction hole by the test channel; The method includes a step of obtaining test results for the test items for each sample by analyzing the test results for each reaction hole by the test channel based on the reaction holes corresponding to each sample, the sub-holes for the test items corresponding to each reaction hole, and the test object information for each of the sub-holes.

[0008] According to a third aspect of the present application, there is provided a control terminal comprising a memory in which a computer program is stored and a processor, the computer program being executed by the processor to perform the steps of the method according to each of the above-mentioned embodiments.

[0009] According to a fourth aspect of the present application, there is provided a computer-readable storage medium having a computer program stored thereon, the computer program causing the steps of the method according to each of the above-described embodiments to be performed when the computer program is executed by a processor.

[0010] According to a fifth aspect of the present application, there is provided a computer program product comprising a computer program which, when run on a processor, performs the steps of the method according to each of the above-described embodiments.

[0011] The above-mentioned test item setting method, sample analysis method, control terminal, computer-readable storage medium, and computer program product obtain a first mapping relationship between the test items and multiple sub-holes and test object information for each sub-hole, where the test object information includes the test objects for each sub-hole in the test channel of the sample analyzer. In other words, multiple sub-holes are set for the test items, test objects for each sub-hole in the test channel are set, and the test items are further set based on the first mapping relationship between the test items and the multiple sub-holes and the test object information. As a result, only one experiment item needs to be set for the test items, which can bring about the following effects:

[0012] 1. Since input and modification of similar information related to test items only needs to be performed for one test item, the workload for setting test items is reduced and convenience is improved.

[0013] 2. For multiple objects related to the same sample, only one test item can be created in the host computer software, and only one test item can be displayed for user selection in the sample operation interface, thereby improving the convenience of user operation during the process of using the sample analyzer and improving the efficiency of registration.

[0014] 3. For multiple objects related to the same sample, only one test item is created in the host computer software, and tests for multiple objects are performed in the same batch of experiments, thereby shortening the experimental time and enabling simultaneous output of test results. In addition, only one sample extraction is performed for each test item, and only one extraction plate, one amplification plate, and one quality control item are required, effectively shortening the experimental time and saving resources.

[0015] The details of one or more embodiments of the invention are set forth in the drawings and description that follow so that other features, objects and advantages of the invention will be more clearly understood. [Brief explanation of the drawings]

[0016] In order to more clearly describe the technical solutions of the embodiments of the present invention or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly described below. Needless to say, the drawings described below are only related to some of the embodiments of the present invention, and those skilled in the art can derive other embodiments from these drawings without any creative work. [Figure 1] 1 is a schematic diagram of components of a sample analysis system according to an embodiment of the present invention; [Figure 2] 1 is a flowchart of a test item setting method according to an embodiment of the present invention; [Figure 3] 1 is a flowchart of a step of obtaining a first mapping relationship between an inspection item and a plurality of sub-holes and inspection object information of each of the sub-holes according to an embodiment of the present invention; [Figure 4] 1 is a schematic diagram of a setting interface according to an embodiment of the present invention; [Figure 5] 1 is a schematic diagram of an inspection object setting interface according to an embodiment of the present invention; [Figure 6] 1 is a schematic diagram of a sub-hole setting interface according to an embodiment of the present invention; [Figure 7]1 is a schematic diagram of an object setting interface according to an embodiment of the present invention; [Figure 8] 1 is a schematic diagram of an unconfigured reagent component configuration interface according to an embodiment of the present invention; [Figure 9] 1 is a schematic diagram of an edit reagent component information pop-up window according to an embodiment of the present invention; [Figure 10] 1 is a schematic diagram of a configured reagent component configuration interface according to an embodiment of the present invention; [Figure 11] 1 is a schematic diagram of an inspection object manipulation setting step for a single sub-hole according to an embodiment of the present invention; [Figure 12] FIG. 2 is a schematic diagram illustrating the relationship between setting information of test items according to an embodiment of the present invention; [Figure 13] 1 is a schematic diagram of a flow chart of a method for analyzing a sample according to an embodiment of the present invention; [Figure 14] 1 is a schematic diagram of a test result interface according to an embodiment of the present invention; [Figure 15] FIG. 2 is a schematic diagram illustrating the configuration of a control terminal according to an embodiment of the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0017] Hereinafter, embodiments of the present invention will be described in more detail with reference to the drawings. Although the drawings show several embodiments of the present invention, it should be understood that the present invention can be realized in various forms and should not be construed as being limited to the embodiments described herein. On the contrary, it should be understood that these embodiments are provided to enable a clearer and more complete understanding of the present invention. It should be understood that the drawings and embodiments of the present invention only serve as an example and do not limit the scope of protection of the present invention.

[0018] In vitro diagnostics refers to products and services that obtain clinical diagnostic information and further determine disease or biological function by testing human samples (such as blood, body fluids, and tissues) outside the human body. In vitro diagnostic devices include sample analyzers, including but not limited to integrated PCR analyzers, biochemistry analyzers, chemiluminescence immunoassay analyzers, and coagulation analyzers.

[0019] As shown in FIG. 1, the sample analysis system includes a sample analyzer 10 and a control terminal 20 connected to and communicating with the sample analyzer 10. The control terminal 20 is a host computer for the sample analyzer 10 and can be used to set the test items and / or test programs for the sample analyzer 10, control the test process performed by the sample analyzer, and process the test results performed by the sample analyzer. It should be understood that test items vary between different sample analyses. For example, an integrated PCR analyzer can be used to test for items such as COVID-19, HBV, and HCV. Meanwhile, a biochemistry analyzer can be used to test for items such as liver function, kidney function, blood lipids, and blood glucose. Therefore, before testing a test item with the sample analyzer, the testable items for the sample analyzer can be configured using the control terminal 20. Here, the test item configuration includes, but is not limited to, basic information about the test item, processing process, test program, and result determination rules. The basic information about the test item may include the Chinese and English names and abbreviations of the test item. It should be understood that processing process and test program differ between different test items. Taking an integrated PCR device as an example, the testing program includes an extraction program and an amplification program, and the processing process includes the number of sub-holes, the reagent components and amounts added to each sub-hole, and the test target of each sub-hole.

[0020] Subholes are reaction holes required to perform a test item. The number of subholes is the number of reaction holes, and a single reaction hole can be used to test objects, i.e., target objects. Test objects in a reaction hole must be tested in different test channels of the sample analyzer. Therefore, the number of objects that can be tested in a single reaction hole is related to the number of test channels of the sample analyzer. For example, if a sample analyzer has five test channels, a single reaction hole can test five objects. Therefore, the number of subholes in a processing process is related to the test channels of the sample analyzer and the total number of objects in the test item. Specifically, if the total number of objects in the test item is a multiple of the test channels, the number of subholes is the total number of objects in the test item divided by the number of test channels. If the total number of objects in the test item is not a multiple of the test channels, the number of subholes is the integer part of the quotient obtained by dividing the total number of objects in the test item by the number of test channels + 1. For example, if there are five test channels, the number of objects that can be tested in one subhole is also five. If the total number of objects for one test item is 20 and the test channel number of the sample analyzer is 5, the number of subholes required for the test item is 4, that is, the test item requires 4 reaction holes. If the total number of objects for one test item is 2 and the test channel number of the sample analyzer is 5, the number of subholes required for the test item is 1, that is, the test item requires 1 reaction hole.

[0021] For example, an integrated PCR device can perform tests for COVID-19 and HPV typing, with five test channels. The COVID-19 test has two test targets, ORF1ab and N protein, so one reaction hole is required for the COVID-19 test. The HPV typing test has 10 test targets, so two reaction holes are required for the HPV typing test.

[0022] The number of test channels provided by a sample analyzer is limited and fixed, and the number of objects that can be tested in a single reaction hole must not exceed the number of channels. For example, if a PCR integrated device has five channels, a maximum of five objects can be tested in one reaction hole.

[0023] For a test item related to one sample (e.g., HPV typing), if multiple objects need to be tested and the number of objects exceeds the number of test channels in the sample analyzer, the conventional setup method usually assigns the multiple objects to different experimental items, that is, two experimental items must be created for the test item in the sample analyzer. For example, if an integrated PCR device has only five channels but there are 10 test objects in the sample, the host computer software will create one experimental item for five of the objects and test these five objects in one reaction hole of one amplification plate, while another experimental item will be created for the other five objects and test the other five objects in one reaction hole of another amplification plate.

[0024] In other words, for test items with more test objects than the number of test channels, multiple experimental items must be set up. For example, a test item called HPV typing requires two experimental items: HPV-1 and HPV-10-2. While the two have different Chinese and English names, abbreviations, and addition processes, the extraction and amplification programs are otherwise identical. If a user needs to modify the amplification program, they must modify both experimental items, which is cumbersome and prone to errors. For example, if the HPV-1 amplification program is modified but the HPV-2 amplification program is not, the two amplification programs will not match (though they should theoretically match), leading to further testing errors.

[0025] After the setup is complete, multiple experimental items are listed simultaneously in the sample operation interface. When the user selects and registers the relevant experimental items for the samples waiting to be tested in the interface, it is difficult to distinguish which experimental items to select and bind, which reduces operational efficiency.

[0026] Furthermore, because multiple objects are assigned to multiple experimental items and tested before and after, the test results for multiple objects in the sample are obtained from different batches, which lengthens the test time.In addition, samples are extracted multiple times, which requires the use of multiple extraction plates, multiple amplification plates, and multiple quality control products, resulting in a waste of various resources and affecting the effectiveness of the test.

[0027] To address the above-mentioned problems, the present application provides a test item setting method, which is executed by the control terminal of the sample analysis system shown in FIG.

[0028] As shown in Figure 2, the test item setting method is as follows: Step 202: Obtain a first mapping relationship between test items and a plurality of sub-holes, and test object information for each sub-hole, where the test object information includes the test object for each sub-hole in the test channel of the sample analyzer.

[0029] Here, the term "test items" generally refers to test items used in the medical field to assist in the diagnosis and treatment of diseases. Different types of sample analyzers can perform different test items. For example, PCR-integrated devices are used in clinical molecular biology testing and can test for genes, etc.

[0030] In this embodiment, the difference from the conventional sample analyzer setting method is that multiple sub-holes are set for each test item of the sample analyzer to obtain a first mapping relationship between the test item and multiple sub-holes, that is, one test item corresponds to multiple sub-holes. If the number of test objects for a test item exceeds the number of test channels of the sample analyzer, it is sufficient to set multiple sub-holes for the test item on the control terminal, and there is no need to create multiple experiment items and assign multiple test objects to different experiment items.

[0031] It should be understood that the first mapping relationship between the test item and the multiple sub-holes further includes that the test channels corresponding to the multiple sub-holes of the same test item are at least partially the same, so that when the number of test channels is limited, multiple target test information can be set for the test item.

[0032] The test subject, i.e., the test target, refers to a specific nucleic acid fragment or the like that is the subject of a particular test. For example, in cancer diagnosis, the test subject may be a tumor marker or the like.

[0033] According to different test items, there may be multiple test objects. If the number of test objects for a test item is greater than the number of test channels, it is necessary to set multiple sub-holes for the test item and test object information corresponding to each sub-hole.

[0034] In one embodiment, after creating an inspection item, multiple sub-holes can be set for the inspection item, and inspection object information can be set for each sub-hole.

[0035] Specifically, the test object information includes the test object, the dye, and the corresponding test channel. It should be understood that the number of test channels in a sample analyzer is fixed, and when configuring test objects for each subhole, it is necessary to configure the test objects corresponding to the subhole in each test channel. For example, if there are five test channels and nine test objects for a test item, two subholes must be configured. Furthermore, when configuring the test object for subhole 1, it is necessary to configure the test objects corresponding to the subhole in the five test channels. Similarly, when configuring the test object for subhole 2, it is necessary to configure the test objects corresponding to the subhole in the four test channels.

[0036] Step 204: Inspection items are set based on the first mapping relationship and the inspection object information.

[0037] Specifically, the test item is set based on a first mapping relationship between the test item and the plurality of sub-holes and the test object information of each sub-hole of the test item. Specifically, the database stores the plurality of sub-holes of the test item and the test object information of each sub-hole, and the test object information includes the test object corresponding to each sub-hole in the test channel.

[0038] Therefore, after the testing of one sample is completed, the test results for each test object are obtained by analyzing the test data for each sub-hole of the sample based on the test object information for the test items performed on the sample.

[0039] In the above-mentioned test item setting method, a first mapping relationship between the test item and a plurality of sub-holes and test object information for each sub-hole are obtained, and the test object information includes the test object for each sub-hole in the test channel of the sample analyzer. In other words, a plurality of sub-holes are set for the test item, and the test object for each sub-hole in the test channel is set, and the test item is further set based on the first mapping relationship between the test item and the plurality of sub-holes and the test object information. As a result, only one experiment item needs to be set for the test item, which can bring about the following effects:

[0040] 1. Since input and modification of similar information related to test items only needs to be performed for one test item, the workload for setting test items is reduced and convenience is improved.

[0041] 2. For multiple objects related to the same sample, only one test item can be created in the host computer software, and only one test item can be displayed for user selection in the sample operation interface, thereby improving the convenience of user operation during the process of using the sample analyzer and improving the efficiency of registration.

[0042] 3. For multiple objects related to the same sample, only one test item is created in the host computer software, and tests for multiple objects are performed in the same batch of experiments, thereby shortening the experimental time and enabling simultaneous output of test results. In addition, only one sample extraction is performed for each test item, and only one extraction plate, one amplification plate, and one quality control item are required, effectively shortening the experimental time and saving resources.

[0043] In another embodiment, the step of obtaining the first mapping relationship between the test item and the plurality of sub-holes and the test object information of each sub-hole, as shown in FIG. 3, includes the following steps:

[0044] Step 302: In response to the item creation operation, the test item to be created and basic information about the test item are acquired.

[0045] Specifically, the host computer software of the sample analyzer can provide a user interactive interface. The user operates the user interactive interface in the host computer software to set test items. The item creation operation includes the user creating a new test item through the interactive interface and setting basic information for the newly created test item, and the item creation operation allows the user to obtain the test item to be created and its basic information. Here, the basic information for the test item includes test item identification information.

[0046] In one embodiment, the host computer software may provide a setting interface, which may include multiple areas, one of which may be used as the setting area. It should be understood that the layout of the setting area may be configured depending on the content that needs to be configured for a test item. For example, the setting area may use a single-page layout, where all the content that needs to be configured is displayed on a single page, and the configuration is completed in this manner. On the other hand, if the content and information that needs to be configured for a test item are numerous, multiple setting interfaces may be displayed in the setting area, and each setting interface may be switched using a navigation bar. Each setting interface may be used to set at least one dimension of information, and each setting interface may be switched by operating the navigation bar. For example, the setting interfaces may include a basic information setting page, a reagent composition page, a test object page, etc. The priority of each interface arranged in the navigation bar may be configured based on the priority required by the configuration program. The first interface corresponding to the navigation bar displayed by default in the setting area is typically the basic information setting page. For example, when the setting interface is opened, the basic information setting page is displayed in the setting area.

[0047] In another embodiment, the setting interface may include a test item list area for displaying different types of test items configured for the sample analyzer. In response to selecting one of the test items, the setting information for that test item is displayed in the setting area. For convenience of display, the test item list area and the setting area are configured in a left-right structure, with the left side of the setting interface for displaying the test item list area and the right side for displaying the setting area.

[0048] The basic information setting interface refers to an interface provided to a user for setting basic information of a test item, and the user can input the basic information of the test item in the interface. In one embodiment, a create item button is provided on the basic information setting page, and when the user clicks the create item button, blank information is displayed on the basic information setting page for the user to input the basic information of the test item.

[0049] The basic information for a test item includes the item abbreviation, item name, item type, item number, channel number, number of repetitions, result units, dosage, and display procedure. To facilitate faster and easier user input, in one embodiment, the basic information setting interface provides multiple input operation fields for basic test item information. Some basic test item information can be set as default information, eliminating the need for user input and reducing user input operations. The default information can be pre-set by the system. Some test item information can be set as required input, and the creation of the test item can be saved and completed only after input. After creation is complete, for example, after the user clicks "Save," the system can use the item abbreviation as test item identification information or create an ID number for the item as test item identification information. The test item identification information is then bound to the basic test item information and stored in the database.

[0050] After creating one test item, the newly added test item can be displayed in the test item list.

[0051] Taking a PCR integrated device as an example, as shown in FIG. 4, its setting interface includes a test item list area 401 on the left and a setting area 402 on the right. The test item list area is for displaying different types of test items. The setting area is for setting and displaying the setting interface. The setting interface further includes a navigation bar 403, and the setting area 402 can use the navigation bar 403 to switch and display setting interfaces corresponding to different levels of information, such as a basic information setting page, a reagent composition setting interface, a test object setting interface, and an extraction program setting interface. It should be understood that the setting interface is not limited to the several types described above and can be appropriately adjusted according to the type and setting needs of the sample analyzer, as long as it satisfies the setting needs of multi-dimensional information related to the test items of the sample analyzer.

[0052] Test item types include open and closed types. The open type refers to a test item freely created by the user according to the requirements of the software test item configuration program based on the parameters of the reagent kit from a third-party manufacturer. The closed type refers to a test item preparation program configured on the device's control terminal according to a default program at the time of shipment. The configuration area further includes an item type area 404 for selecting the type of test item. When the open type is selected, open type test items are displayed in the test item list area, and in addition, open type test items can be created and configured in the configuration area. When the closed type is selected, closed type test items are displayed in the test item list area, and in addition, closed type test items can be created and configured in the configuration area.

[0053] In this embodiment, the test item created by manual input in the setting interface in response to the item creation operation is an open-type test item.

[0054] As shown in Figure 4, the basic information page provides a "Create New" button. Users can click the "Create New" button to enter basic information about the item, such as the item abbreviation, nucleic acid dosage, and item type. The item abbreviation and nucleic acid dosage are required fields. For example, for an HPV item requiring two subholes, the item abbreviation is HPV, the nucleic acid dosage is 20, and the item type is qualitative. After creation is complete, for example, after the user clicks "Save," the system can use the item abbreviation as test item identification information.

[0055] Step 304: In response to multiple subhole creation operations for the test item, obtain multiple subholes created for the test item and subhole information for each subhole.

[0056] Complete test item configuration includes the operation of configuring basic test item information, the operation of configuring subholes, the operation of configuring reagent components, the operation of configuring an extraction program, the operation of configuring an amplification program, the operation of configuring result determination rules, etc. Here, the operation of configuring result determination rules is for setting the cycle threshold and the negative positive determination criteria, and it should be understood that the cycle threshold and the negative positive determination criteria will be different for different test subjects. Here, the operation of configuring subholes includes the number of subholes, the reagent components and the amounts added to each subhole, and the test subjects for each subhole.

[0057] Sub-holes are reaction holes required for performing test items. When multiple objects need to be tested for a test item (such as HPV typing) and the number of objects exceeds the number of channels, the conventional method requires multiple experiment items to be set up, and basic information, sub-hole information, processing procedures, etc. must be set for each experiment, which makes the operation complicated and prone to errors.

[0058] On the other hand, in this embodiment, if a test item (e.g., HPV type determination) requires testing of multiple objects and the number of objects exceeds the number of channels, multiple subholes are created and set for the test item by performing multiple subhole creation operations.As a result, one test item corresponds to multiple subholes, and it is no longer necessary to divide one test item into multiple test items and repeatedly set the basic information, processing processes, etc. of the multiple test items.

[0059] In one embodiment, the sub-hole information of the sub-hole is obtained by performing a sub-hole creation operation for the test item multiple times in the test object setting interface, and the sub-hole information includes the sub-hole identification information.

[0060] Taking a PCR integrated device as an example, the subhole creation operation can be realized through the test object setting interface. As shown in FIG. 5, the test object setting interface according to one embodiment provides an "Add Subhole" button, which allows the user to enter the subhole setting interface. As shown in FIG. 6, the subhole setting interface according to one embodiment includes a subhole information input box for setting subhole information. The subhole information includes subhole identification information. After the subhole creation operation is completed, the subhole information will be displayed in the subhole information area shown in FIG. 5. The user can obtain subhole information for multiple subholes by repeating the subhole creation operation described above.

[0061] Step 306: Obtain a first mapping relationship between the test item and the multiple sub-holes based on the basic information of the test item and the sub-hole information of the multiple sub-holes related to the test item.

[0062] After each sub-hole information is saved, the item identification information of the test item is stored in association with the sub-hole identification information of the plurality of sub-holes, thereby obtaining a first mapping relationship between the test item and the plurality of sub-holes.

[0063] Step 308: In response to the inspection object setting operation for each sub-hole, the inspection object information for each sub-hole is obtained.

[0064] A test object setting operation is performed for each of the created subholes to obtain test object information for each subhole. The test object, or test target, refers to a specific nucleic acid sequence or the like that is the target of a specific test. For example, in cancer diagnosis, the test object may be a tumor marker or the like.

[0065] Specifically, the test object information includes the test object, the dye, and the corresponding test channel. The sample analyzer has a fixed number of test channels, and when setting the test object for each subhole, it is necessary to set the test object corresponding to that subhole in the test channel. For example, if there are five test channels, when setting the test object for subhole 1, it is necessary to set the test object corresponding to that subhole in each of the five test channels.

[0066] In one embodiment, as shown in FIG. 5, the test object setting interface provides an "Edit Subhole" button. When the user clicks the "Edit Subhole" button, the user enters the test object setting interface shown in FIG. 7, and further sets information such as the test object corresponding to the subhole in each channel in the test object setting interface.

[0067] As is clear from the above, setting the inspection items includes setting the basic information of the inspection items, setting the sub-hole information, and setting the inspection target of each sub-hole.

[0068] By setting the basic information of the test item and the sub-hole information of the test item, a first mapping relationship between the test item and multiple sub-holes can be obtained. By setting the test object of the sub-hole, the test object information of each sub-hole can be obtained.

[0069] As described above, an open-type inspection item setting method has been provided that allows users to add inspection items using a setting interface. This inspection item setting method allows users to create multiple sub-holes for one inspection item and multiple inspection objects for each sub-hole.

[0070] In another embodiment, the test item settings further include reagent component settings.

[0071] Here, the term "reagent components" refers to the reagents that react with the sample to perform the test. Taking the integrated PCR device as an example, the reagent components include an enzyme solution or a reaction solution. The enzyme solution includes DNA polymerase and thermostable DNA polymerase (Taq enzyme) for catalyzing the DNA synthesis reaction. The reaction solution includes dNTPs (deoxynucleotides), primers, buffer, and other components that may be present, such as MgCl2 (magnesium ion). These reagents are typically used in PCR reactions to perform in vitro DNA replication and amplification. The enzyme solution and reaction solution are essential for PCR reactions, as they ensure the accuracy and reproducibility of the PCR reaction.

[0072] In one embodiment, the setting of the reagent components can be realized when setting the subhole, and in this embodiment, the subhole information further includes the target reagent components of the subhole that are manually input and set by the user.

[0073] In another embodiment, taking into consideration that some reagent components may be the same in multiple subholes for one test item, in order to increase the convenience of setting the target reagent components for each subhole, the reagent components for the test item are set in advance, and when assigned to a subhole, the target reagent component for the subhole can be selected from the reagent components for the test item, thereby eliminating the need for the user to input the reagent components multiple times.

[0074] Specifically, in response to a reagent component setting operation for a test item, at least one reagent component to be set for the test item and the amount of each reagent component to be added are acquired. More specifically, based on reagent component setting needs, a user triggers a reagent component setting operation through a reagent component setting interface to input the reagent components related to the test item and the amount of each reagent component to be added.

[0075] As shown in Figure 8, when the user enters the reagent component setting interface and clicks the "Add" button, the system will display a reagent component information editing pop-up window, as shown in Figure 9, in which the user sets the names of the reagent components and their addition amounts in the pop-up window. Next, when the "Save" button is clicked, the system will automatically associate and save the edited reagent component information with the newly added item, and the reagent components set for that test item will be displayed in the reagent component setting interface, as shown in Figure 10. Here, in the reagent component information editing pop-up window, the reagent component names can be set by selecting them from a reagent component combo box preset in the system, which makes the user's operation easier.

[0076] Correspondingly, in response to a sub-hole creation operation for a test item, a sub-hole to be created for the test item and sub-hole information of the sub-hole are obtained. That is, a single sub-hole creation operation includes, in response to a sub-hole creation operation for a test item, creating a sub-hole and loading a sub-hole information setting interface; and loading the sub-hole information setting interface. The method includes displaying the reaction volume of the subhole on the interface, loading a reagent component list in the subhole information setting interface, and obtaining the selected target reagent component from the reagent component list, where the reagent component list includes all reagent components related to the test item.

[0077] In this embodiment, the subhole information setting interface is loaded in response to a subhole creation operation for a test item. Specifically, the subhole information setting interface is loaded each time a subhole creation operation for a test item is triggered by the user. The subhole information includes subhole identification information, reaction volume, and target reagent components. In one embodiment, the subhole information setting interface is used to set the subhole identification information, reaction volume, and target reagent components, as shown in FIG. 6. Here, the subhole identification information may be the subhole number. For example, the first subhole created has a subhole identification number of 1, and the second subhole created has a subhole identification number of 2.

[0078] The selection of PCR reaction volume depends on various factors. If the volume is too small, addition errors may occur, affecting reaction results and amplification efficiency. On the other hand, if the volume is too large, the reaction cost increases. Reaction volumes are typically 10, 20, 25, 40, 50, or 100 μL. Here, the PCR reaction volume is the sum of the volumes of the added reagents and the reagent components. For example, the PCR reaction volume is the sum of the volumes of the added reagents, enzyme solution, and reaction solution.

[0079] The target reagent component refers to a reagent component required for the reaction in that subhole. In one embodiment, the target reagent component of a single subhole can be selected from the reagent components related to the test item. For example, an enzyme solution, reaction solution 1, and reaction solution 2 are set as reagent components related to the test item. When setting subhole 1, the user can select the enzyme solution and reaction solution 1 from the reagent components related to the test item as the target reagent components of subhole 1, and the enzyme solution and reaction solution 2 from the reagent components related to the test item as the target reagent components of subhole 2.

[0080] As shown in Figure 6, the subhole setting interface in one embodiment includes an input field for multidimensional subhole information, such as subhole identification information, reaction volume, and target reagent components. Here, the subhole identification information is automatically generated from the number of subholes created for the test item in the system, eliminating the need for manual input. For example, if the second subhole of the test item is currently being created, the subhole identification information is set to 2 by default. The user sets the reaction volume of the subhole in the subhole information setting interface.

[0081] The sub-hole setting interface also has a reagent component list loaded that contains all the reagent components related to the test item settings. This allows users to select from the reagent component list according to their needs, eliminating the need to manually enter the components, improving the convenience of the settings.

[0082] The subhole information also includes the premixing addition procedure for the subhole, and this addition procedure is used to instruct the premixing procedure to the addition device of the sample analyzer. Specifically, the addition procedure for the target reagent components of the subhole is obtained based on the reagent component selection operation in the reagent component list. As shown in Figure 6, when an enzyme solution and a reaction solution are selected sequentially for the current subhole, the selected reagent component is displayed in the input frame for the target reagent component, and the addition procedure for the reagent component is displayed in the selected order in the addition procedure field.

[0083] This allows the user to intuitively understand the addition procedure for the selected reagent components by displaying the addition procedure based on the selection operation during the setting process, thereby avoiding setting errors.

[0084] In another embodiment, the premixing sequence may be a fixed sequence, and in some embodiments, when configuring the target reagent components, it is not necessary to set the addition sequence, for example, the default addition sequence for premixing may be to add the enzyme solution followed by the mixture solution.

[0085] In another embodiment, the step of obtaining test object information for a sub-hole in response to a test object setting operation for the sub-hole, i.e., the step of setting test object information for a single sub-hole, includes the following steps, as shown in FIG. 11 .

[0086] Step 1102: Display a channel list corresponding to the sub-holes waiting to be set, where the channel list refers to a list showing multiple test channels of the sample analyzer and the test objects of the sub-holes in each test channel.

[0087] Here, the sub-hole waiting to be set may be a sub-hole currently being created, or a sub-hole selected from multiple sub-holes that have already been created. For ease of setting, the test object setting interface according to one embodiment is composed of two areas, as shown in FIG. 5, one area being a sub-hole list and the other area being a channel list. The sub-hole list displays sub-hole information for the test item, and the channel list displays channel information for the selected sub-hole. The sub-hole list is structured left and right, with the sub-hole list on the left and the channel list on the right, making it easier for the user to operate.

[0088] When a user selects a sub-hole to be set, a channel list for the sub-hole to be set is displayed, where the channel list indicates the multiple test channels of the sample analyzer and the test objects of the sub-holes in each test channel. It should be understood that if no test object information has been set for the sub-hole to be set selected by the user, the channel list will only display the multiple test channels of the sample analyzer.

[0089] Step 1104: The determined channel waiting to be set is obtained from the channel list.

[0090] When the channel selected by the user from the channel list is acquired, this channel is set as a channel waiting to be set.

[0091] Step 1106: In response to an editing operation on the channel waiting to be set, an inspection object setting interface is provided.

[0092] When the user selects a channel to be set, the "Edit Channel" button in the test object setting interface is triggered to display the test object setting interface, which is used to set the test object of the sub-hole in the test channel.

[0093] Step 1108: Obtain the inspection object of the sub-hole in the inspection channel set through the inspection object setting interface.

[0094] The test object setup interface according to one embodiment includes settings for channels, dyes, objects, and internal standards, as shown in FIG.

[0095] Step 1110: Obtain the inspection object information of the sub-hole in the inspection channel set through the inspection object setting interface, where the inspection object information includes the inspection object.

[0096] In one embodiment, a user can set the inspection object information of a sub-hole through the inspection object setting interface shown in Figure 7. After completing the setting of one inspection channel, the inspection object of the channel will be updated in the inspection channel list of the sub-hole.

[0097] This allows the inspection object information of the sub-holes in the inspection channel to be visually and intuitively understood from the channel list, and the method of setting it for each channel makes it possible to clarify the inspection objects of the sub-holes in each inspection channel and avoid confusion.

[0098] Based on the above, if the currently inputted test object overlaps with the inputted test object of the test item, the test object setting interface outputs a test object overlap indication.

[0099] Specifically, if the test object currently being input overlaps with an input test object in a sub-hole waiting for test item setting, a test object overlap indication is output, and at the same time, if the test object currently being input overlaps with an input test object in another sub-hole for which test items have been set, a test object overlap indication is output. This makes it possible to avoid setting overlapping test objects while improving the convenience and accuracy of setting.

[0100] In one embodiment, in addition to interactive setting using an interface, quick setting of test items can also be achieved by table import operation, file import operation, QR code scanning operation, etc.

[0101] In one embodiment, in addition to setting open test items, the system can also support setting closed test items. Closed test items refer to test items designed by the manufacturer of the sample analyzer. For closed test items, sensitive process information is generally not to be obtained by the outside world in order to maintain confidentiality. Here, a closed test item can be selected in the item type area 404 shown in FIG. 4 and set as a closed test item.

[0102] Based on this, the test item setting method acquires test item setting data introduced by the introduction operation in response to an introduction operation of the test item, the introduction operation including any one selected from a table introduction operation, a file introduction operation, and a QR code scanning operation, wherein the introduced table, the introduced file, and the test item setting data enclosed in the QR code are encrypted data, and further includes decrypting and analyzing the test item setting data to acquire a first mapping relationship between the test item and the multiple sub-holes, and information on the test object of each sub-hole.

[0103] Here, the imported table, imported file, and inspection item setting data enclosed in the QR code can be encrypted with a password. When the imported inspection item setting data is acquired, it is decrypted with the corresponding password and analyzed to obtain a first mapping relationship between the inspection items and the multiple sub-holes, and information on the inspection object of each sub-hole.

[0104] Here, the test item setting information can be encrypted and printed on a QR code, which can be attached to the packaging box of the reagent used for the test item. After the user scans the QR code, the control terminal automatically decrypts and analyzes it to obtain the item setting data, and stores the information in a database. This allows information to be entered accurately, quickly, confidentially, and safely.

[0105] In the above-described test item setting method, since a sub-hole creation function is provided, multiple sub-holes can be created for one test item in the host computer software, and test object information for each sub-hole is set for each test channel. Test item setting information according to one embodiment is as shown in FIG. 12. Therefore, if the number of objects exceeds the number of test channels, the host computer software can add sub-holes for this test item and then assign the objects to the different sub-holes created for this test item, eliminating the need to create multiple test items and assign multiple targets to different test items.

[0106] The above-described method can provide the following effects.

[0107] 1. The workload for inputting and correcting information about experimental items is reduced. Although different channels and targets have different reagent components, dosages, and result determination rules, other information (such as extraction programs and amplification programs) is the same. In the host computer software, only one experimental item needs to be created for multiple targets, eliminating the need to create multiple experimental items. In this case, similar information only needs to be input and corrected for one experimental item, reducing the workload and preventing errors.

[0108] 2. Improved efficiency of sample registration by users. For multiple targets related to the same sample, only one experiment item is created in the host computer software, and only one experiment item is displayed for user selection in the sample operation interface. This eliminates problems that users cannot distinguish, improving registration efficiency. For example, when it comes to HPV typing, it is no longer necessary to create HPV-1 and HPV-10-2 as in conventional technology; instead, only one HPV type is required.

[0109] 3. Saving related experimental resources. Only one experimental item is created in the host computer software for multiple targets related to the same sample, and tests for multiple targets are performed in the same batch of experiments, shortening the experimental time and enabling simultaneous output of test results. In addition, only one sample extraction is performed, and only one extraction plate, one amplification plate, and one quality control kit are required, effectively shortening the experimental time and saving resources.

[0110] According to the above-mentioned test item setting method, a first mapping relationship between the test items and the plurality of sub-holes and test object information for each sub-hole can be obtained, where the test object information includes the test object for each sub-hole in the test channel. Based on this, a sample analysis method is further provided, which, as shown in FIG. 13, includes the following steps:

[0111] Step 1302: A sample analysis start command is obtained, and the sample analysis start command includes test items and the number of samples.

[0112] Specifically, the user selects the test item, registers the number of samples, and triggers a sample analysis start command, for example, by clicking Start, and the sample analysis start command is acquired by the control terminal.

[0113] For example, the user selects the corresponding position in the sample interface, inputs the sample number 1-32, selects the sample type, and selects the experiment item "HPV typing" (this can be registered individually or batch processed using the batch registration function). The user then clicks the "Start experiment" button and receives a command to start sample analysis on the control terminal.

[0114] Step 1304: Obtain a plurality of sub-holes corresponding to the test items and test object information for each sub-hole, where the test object information includes the test object for each sub-hole in the test channel of the sample analyzer.

[0115] Here, the sub-holes corresponding to the test items and the test object information for each sub-hole can be obtained by the test item setting method of the present application and stored in a database. After sample analysis is started, multiple sub-holes corresponding to the test items and the test object information for each sub-hole are obtained from the database.

[0116] Step 1306: Determine the number of reaction holes based on the number of samples and the number of sub-holes of the test items.

[0117] Taking an integrated PCR device as an example, the reaction holes here are the reaction holes of the amplification plate, and the number of reaction holes required on the amplification plate = number of samples x number of subholes. For example, if there are two samples and four subholes for the test item, eight reaction holes are required.

[0118] Step 1308: Based on the number of reaction holes and the sub-holes corresponding to the test items, a test control command is sent to the sample analysis device, where the test control command refers to controlling the sample analysis device to prepare test liquids for the corresponding number of reaction holes, obtain the reaction holes corresponding to each sample and the sub-holes of the test items corresponding to the reaction holes, and use the test channels of the sample analysis device to test the test liquids in each reaction hole, thereby obtaining the test results of each reaction hole through the test channels.

[0119] In other words, the control terminal sends a test control command to the sample analyzer, which then creates a reaction hole corresponding to each sample based on the test control command, with the sample's reaction hole corresponding to the sub-hole of the test item. For example, if the number of samples is 5 and the test item is HPV, the number of reaction holes is 5 x 2 = 10. Of the 10 reaction holes, five holes are used for the channel setting information corresponding to sub-hole number 1 of the HPV item, and the other five holes are used for sub-hole number 2 of the HPV item. The sample analyzer uses the test channels to test the test liquid in each reaction hole, thereby obtaining the test results for each reaction hole via the test channels.

[0120] Step 1310: Based on the reaction holes corresponding to each sample, the sub-holes of the test items corresponding to each reaction hole, and the test object information of each sub-hole, the test results of each reaction hole by the test channel are analyzed to obtain the test results of the test items related to each sample.

[0121] Specifically, by determining the reaction hole corresponding to the sample and the sub-holes of the test item corresponding to the reaction hole, it is possible to know which reaction hole corresponds to the sample and which test item each of these reaction holes corresponds to. Furthermore, the test result of the reaction hole by the test channel can be analyzed using the test object information of the sub-hole, thereby obtaining the test result of the test object corresponding to each reaction hole of the test item, and further obtaining the test result of the test item related to the sample.

[0122] Taking the PCR integrated device as an example, the PCR integrated device contains five test channels and performs item testing experiments on samples waiting to be tested with one test item. Taking the test item of HPV type determination, which requires two subholes, as an example, the specific experimental process is as follows:

[0123] 1) The user places the sample tubes in the sample rack, and then inserts the sample rack into the sample storage of the device.

[0124] 2) During the sample rack insertion process, the scanner automatically scans the barcode information of the samples on the rack and the position information of the samples to be placed on the rack, and then transmits the barcode information and the corresponding position information on the rack to the control terminal software, which then associates the sample barcode with the position on the rack and displays it on the "Sample" interface.

[0125] 3) The barcode information of a sample is usually the only sample identification information (i.e., sample number). If a barcode is not attached to a sample tube, the control terminal cannot obtain the sample identification information and cannot complete the association between the sample identification information and the rack position information. In this case, the user can manually edit the sample identification information for a sample with rack position information in the "Sample" interface of the software to complete the association between the sample identification information and the rack position information.

[0126] 4) For samples for which the input of the sample number and the binder of the position information in the rack have been completed, the user sets the test items, for example, the test for HPV type determination (an item requiring two subholes).

[0127] 5) The user shall inspect and replenish each consumable item on the equipment to ensure that there are sufficient consumable items required for the experiment.

[0128] 6) The user clicks the "Start Experiment" button and performs a test experiment corresponding to the HPV item on the sample for which the HPV item has been registered.

[0129] 7) The control terminal determines the number of extraction reagent groups based on the number of samples waiting to be tested and controls the sample analyzer to prepare the extraction reagent groups (in the reagent preparation area). The same number of extraction reagent groups must be prepared as there are samples for which the HPV typing test item will be performed (one extraction reagent group can extract only one sample, and one extraction reagent group contains all the reagent components required to extract one sample). For example, if there are five samples for which the test item will be performed, five extraction reagent groups must be prepared. The extraction reagent groups may be prepared on-site by the analyzer or individually packaged in advance. Individually packaged extraction reagent groups can be used as is, eliminating the need for additional preparation by the analyzer.

[0130] 8) The control terminal controls the sample arm to add the sample to be tested to the extraction reagent group. The extraction reagent group may be stored in a 96-well extraction plate or in a special container. For convenience of the following description, the container in which the extraction reagent group is stored will be referred to as the extraction plate.

[0131] 9) The control terminal then controls the robot grip to transfer the extraction plate to the extraction mechanism for nucleic acid extraction.

[0132] 10) During nucleic acid extraction, the control terminal determines the number of amplification holes based on the number of samples waiting to be tested and the number of subholes for the test item, and controls the subordinate computer to prepare the reagents required for the amplification holes (performed in the reagent preparation area). The number of amplification holes = number of samples waiting to be tested x number of subholes. For example, if the number of samples is 5 and the test item is HPV type determination, the number of amplification holes = 5 x 2 = 10. Of the ten amplification holes, five holes are used for the channel setting information (i.e., target setting information) corresponding to the subhole number 1 for the test item HPV typing. The PCR reagent components added to these five subholes are the PCR reagent components selected when the subhole number 1 was created. For convenience of description, these five holes are named a, b, c, d, and e, respectively; the other five holes are used for the channel setting information (i.e., target setting information) corresponding to the subhole number 2 for the test item HPV typing. The PCR reagent components added to these five subholes are the PCR reagent components selected when the subhole number 2 was created. For convenience of description, these five holes are named A, B, C, D, and E, respectively. After the PCR reagent settings for each amplification hole are complete, they are stored in a consumable item called an "amplification plate." An amplification plate has several amplification holes, which store PCR reagents and nucleic acid mixtures and can be inserted into an amplification module for nucleic acid amplification.

[0133] 11) After sample extraction is complete, the control terminal controls the sample arm to add the nucleic acid obtained by sample extraction to the corresponding hole on the amplification plate. Because the test item "HPV typing" has two subholes, the nucleic acid extracted from each sample is added to two amplification holes to react in the subholes. The PCR reagent components assigned to the two amplification holes are different; otherwise, the effect of testing different targets cannot be achieved. In this example, the amplification holes corresponding to lowercase letters a through e are the amplification holes corresponding to subhole number 1, and the amplification holes corresponding to uppercase letters A through E are the amplification holes corresponding to subhole number 2. Each sample nucleic acid should be added to one amplification hole with a lowercase number and one amplification hole with an uppercase number, respectively. The control terminal also records the association between each sample's nucleic acid and the amplification hole, and the association between the amplification hole and the subhole for the test item "HPV typing."

[0134] 12) Next, the control terminal controls the robot grip to transfer the amplification plate to which the sample nucleic acid has been added to the membrane sealing mechanism and perform membrane sealing.

[0135] 13) Furthermore, the control terminal controls the robotic gripper to transfer the membrane-sealed amplification plate to the amplification module for nucleic acid amplification.

[0136] 14) During the amplification process, the amplification module collects the fluorescent signals from each amplification hole in real time and transmits them to the control terminal, which associates the fluorescent signals with the subhole information for the HPV typing test item and associates the fluorescent signals with the sample number. For each sample, the fluorescent signal data for the two subholes for the HPV typing test item is obtained.

[0137] 15) After the amplification experiment is completed, the control terminal calculates the fluorescence data of the two subholes related to the test item of HPV type determination corresponding to each sample and obtains the result data (such as Ct value).

[0138] In the sample analysis method described above, multiple subholes can be set for a test item in the sample analyzer. Only one experimental item is created in the host computer software for multiple targets associated with the same sample, and only one experimental item is displayed for user selection in the sample operation interface. This eliminates the problem of users being unable to distinguish between them and improves registration efficiency. For example, for HPV typing, there is no need to create HPV-1 and HPV-2 types as in the conventional technology; only one item, i.e., HPV typing, is created. At the same time, only one experimental item is created in the host computer software for multiple targets associated with the same sample, and tests for multiple targets are performed in the same batch, thereby shortening the experiment time and enabling simultaneous output of test results. Furthermore, only one sample extraction is performed, and only one extraction plate, one amplification plate, and one quality control kit are required, effectively shortening the experiment time and saving resources.

[0139] In another embodiment, the sample analysis method further includes: in response to a result inquiry command for the test item, obtaining the test results for the inspection lot number specified in the result inquiry command; and displaying the test results for the inspection lot number in the form of a two-dimensional table on a test result display page based on each subhole corresponding to the test item and the test object corresponding to each subhole, wherein the columns of the two-dimensional table include at least the sample, the test item, the subhole, and the test object.

[0140] Here, the user can trigger a result query on the control terminal, for example, by inputting conditions such as test item and experiment lot number to trigger a result query command. In response to the result query command, the control terminal will display the test result display page for the specified inspection lot number. The sample result list is arranged according to sample, subhole, and target, allowing the user to intuitively check the test results of the multiple subholes related to the sample and the multiple test objects in each subhole.

[0141] In another embodiment, the sample analysis method further includes arranging the test results for the same sample in the two-dimensional table in a line-by-line manner according to the sub-hole identification information of the test items. In other words, the test results for multiple sub-holes corresponding to the same sample are arranged in a line-by-line manner and displayed in the form of a two-dimensional table, thereby making it convenient to centrally and clearly check the test results for multiple targets related to the same sample. A two-dimensional diagram according to one embodiment is shown in Figure 14.

[0142] In one embodiment, the present application further provides a test item setting device, which includes: a setting information acquisition module for acquiring a first mapping relationship between a test item and a plurality of sub-holes and test object information for each of the sub-holes, wherein the test object information includes the test object of each sub-hole in a test channel of a sample analyzer, and the test objects of the plurality of sub-holes are different; and a setting module for setting the inspection items based on the first mapping relationship and the inspection object information.

[0143] In one embodiment, the configuration information acquisition module: a basic information acquisition module for acquiring the test item to be created and basic information of the test item in response to an item creation operation; a sub-hole information acquisition module for acquiring sub-hole information for each of the sub-holes created for the test item in response to a plurality of sub-hole creation operations for the test item; a mapping relationship acquisition module for acquiring a first mapping relationship between the test item and a plurality of subholes based on basic information of the test item and subhole information of a plurality of subholes related to the test item; and an object information acquisition module for acquiring inspection object information of each of the sub-holes in response to an inspection object setting operation for each of the sub-holes.

[0144] In another embodiment, the device further includes a reagent component acquisition module for acquiring at least one reagent component set for the test item and the amount of each reagent component to be added in response to a reagent component setting operation for the test item.

[0145] In response to a subhole creation operation for the test item, the subhole information acquisition module creates a subhole and loads a subhole information setting interface, displays the reaction volume of the subhole in the subhole information setting interface, loads a reagent component list in the subhole information setting interface, acquires the target reagent component selected from the reagent component list, and the reagent component list includes all reagent components related to the test item.

[0146] In another embodiment, the subhole information acquisition module is also used when multiple target reagent components are set for the subhole, and the subhole information also includes the procedure for adding the target reagent components to the subhole.

[0147] In another embodiment, the object information acquisition module displays a channel list corresponding to a sub-hole waiting to be set, where the channel list refers to a list displaying multiple test channels of a sample analysis device and the test objects of the sub-holes in each test channel, acquires a channel waiting to be set determined from the channel list, provides a test object setting interface in response to an editing operation on the channel waiting to be set, and acquires test object information of the sub-holes in the test channel set by the test object setting interface, where the test object information includes the test object.

[0148] In another embodiment, the method further includes a presentation module for outputting a test object overlap presentation in the test object setting interface when the test object currently being input overlaps with the test object already input for the test item.

[0149] In another embodiment, the setting information acquisition module further acquires, in response to an introduction operation of an examination item, examination item setting data introduced by the introduction operation, where the introduction operation includes any one selected from a table introduction operation, a file introduction operation, and a QR code scanning operation, and analyzes the examination item setting data to obtain a first mapping relationship between the examination item and multiple sub-holes, and information on the examination object of each of the sub-holes.

[0150] Further embodiments of the present application provide a sample analysis device, the device comprising: a start-up module for obtaining a sample analysis start-up command, the sample analysis start-up command including test items and sample numbers; a setting information acquisition module for acquiring a plurality of subholes corresponding to the test items and test object information for each of the subholes, the test object information including the test objects for each of the subholes in the test channel of the sample analyzer; a reaction hole determination module for determining the number of reaction holes based on the number of samples and the number of sub-holes of the test items; a control module for sending a test control command to the sample analyzer based on the number of reaction holes and the sub-holes corresponding to the test items, wherein the test control command refers to a control module that controls the sample analyzer to prepare test liquids for the corresponding number of reaction holes, obtain the reaction holes corresponding to each sample and the sub-holes of the test items corresponding to the reaction holes, and test the test liquids in each of the reaction holes using a test channel of the sample analyzer to obtain the test results of each reaction hole by the test channel; and an analysis module for analyzing the test results of each reaction hole by the test channel based on the reaction holes corresponding to each sample, the sub-holes of the test items corresponding to each reaction hole, and the test object information of each of the sub-holes, to obtain the test results of the test items for each sample.

[0151] In another embodiment, a result inquiry module for displaying an inspection result display page of an inspection lot number designated in the result inquiry command in response to a result inquiry command for the inspection item; The system further includes a display module that displays the inspection results of the inspection lot number in the form of a two-dimensional table on the inspection result display page based on each sub-hole corresponding to the inspection item and the inspection object corresponding to each sub-hole, and the columns of the two-dimensional table include at least samples, inspection items, sub-holes, and inspection objects.

[0152] In another embodiment, the display module further arranges the test results of the same sample in the two-dimensional table in separate lines and adjacently according to the subhole identification information of the test items.

[0153] The modules in the test item setting device and sample analyzer described above can be implemented in whole or in part by software, hardware, or a combination thereof. Each module can be implemented in the form of hardware that is embedded in or independent of the processor of the computer device, or in the form of software that is stored in the memory of the computer device, allowing the processor to easily call and execute the operations corresponding to each module.

[0154] In one embodiment, a control terminal is provided, and the internal configuration of such a control terminal is shown in FIG. 15. The computer device includes a processor, memory, a communication interface, a display, and an input device, all connected via a system bus. The processor of the computer device provides calculation and control capabilities. The memory of the computer device includes a non-volatile storage medium and an internal memory. The non-volatile storage medium stores an operating system and a computer program. The internal memory provides an environment for the execution of the operating system and the computer program in the non-volatile storage medium. The communication interface of the computer device is for wired or wireless communication with an external terminal, and wireless communication can be achieved by Wi-Fi, a mobile cellular network, NFC (near field communication), or other technologies. When the computer program is executed by the processor, the test item setting method and the sample analysis method are realized. The display of the computer device may be a liquid crystal display or an electronic ink display, and the input device of the computer device may be a touch layer covered by the display, or a push button, trackball, or touch panel provided on the housing of the computer device.

[0155] It should be understood by those skilled in the art that the configuration shown in Figure 15 is merely a block diagram of a portion of the configuration related to the solution of the present application, and does not limit the computer device to which the solution of the present application can be applied, and that a specific computer device may have more or fewer components than those shown, may combine some components, or may have a different component arrangement.

[0156] An embodiment of the present invention further provides a control terminal, the control terminal including at least one processor and a memory communicatively coupled to the at least one processor, the memory storing a computer program executable by the at least one processor, the computer program, when executed by the at least one processor, causing an electronic device to perform a method according to an embodiment of the present invention.

[0157] An embodiment of the present invention further provides a non-transitory computer-readable medium having a computer program stored thereon, the computer program causing the computer to perform a method according to an embodiment of the present invention when executed by a processor of a computer.

[0158] In accordance with an embodiment of the present invention, there is further provided a computer program product comprising a computer program, which, when run on a processor of a computer, causes the computer to perform a method according to an embodiment of the present invention.

[0159] Those skilled in the art will understand that all or part of the processes in the methods described above can be achieved by instructing relevant hardware through a computer program. The computer program may be stored in a non-volatile computer-readable storage medium, and when executed, the computer program may include the processes in the methods described above. Here, the memory, database, or other media references used in the embodiments provided herein include at least one of non-volatile memory and volatile memory. Non-volatile memory includes read-only memory (ROM), magnetic tape, floppy disk, flash memory, optical memory, high-density embedded non-volatile memory, resistive random access memory (ReRAM), magnetoresistive random access memory (MRAM), ferroelectric random access memory (FRAM), phase change memory (PCM), graphene memory, etc. Volatile memory includes random access memory (RAM) or external cache memory, etc. The following is an illustrative and non-limiting description. RAM may be in various forms, such as static random access memory (SRAM) or dynamic random access memory (DRAM). The databases in the embodiments provided herein include at least one of a relational database and a non-relational database. Non-relational databases include, but are not limited to, distributed databases based on blockchain. The processors in the embodiments provided herein may be, but are not limited to, general-purpose processors, central processors, graphics processors, digital signal processors, programmable logic devices, data processing logic devices based on quantum computing, etc.

[0160] The technical features of the above-described embodiments may be combined in any manner, and for the sake of brevity, not all possible combinations of the technical features of the above-described embodiments will be described. However, any combination of these technical features should be considered to be within the scope of the present specification unless a contradiction arises.

[0161] The above examples only describe some embodiments of the present application, and although the description is specific and detailed, it should not be understood as limiting the patent scope of the present application. It is particularly noted that those skilled in the art can make various modifications and improvements without departing from the concept of the present application, and all of these fall within the scope of protection of the present application. Therefore, the scope of protection of the present application should be governed by the appended claims.

Claims

1. A step of obtaining a first mapping relationship between test items and a plurality of sub-holes and test object information for each of the sub-holes, wherein the test object information includes test objects for each sub-hole in a test channel of a sample analyzer, and the test objects for the plurality of sub-holes are different; and setting the inspection items based on the first mapping relationship and the inspection object information.

2. The step of obtaining a first mapping relationship between the test item and a plurality of sub-holes and test object information of each of the sub-holes includes: acquiring, in response to an item creation operation, a test item to be created and basic information about the test item; In response to a plurality of subhole creation operations for the test item, acquiring a plurality of subholes created for the test item and subhole information for each of the subholes; Obtaining a first mapping relationship between the inspection item and a plurality of subholes based on basic information of the inspection item and subhole information of a plurality of subholes related to the inspection item; and acquiring test object information for each of the sub-holes in response to a test object setting operation for each of the sub-holes.

3. The method further includes acquiring at least one reagent component to be set for the test item and an addition amount of each reagent component in response to a reagent component setting operation for the test item; Correspondingly, the step of acquiring a sub-hole to be created for the test item and sub-hole information of the sub-hole in response to a sub-hole creation operation for the test item includes: In response to a sub-hole creation operation for the test item, creating a sub-hole and loading a sub-hole information setting interface; Displaying the reaction volume of the sub-hole in the sub-hole information setting interface; The method according to claim 2, further comprising: loading a reagent component list in the subhole information setting interface; obtaining a target reagent component selected from the reagent component list; and determining whether the reagent component list includes all reagent components related to the test item.

4. When a plurality of target reagent components are set for the subhole, the subhole information also includes a procedure for adding the target reagent components to the subhole; The method according to claim 3 , further comprising: acquiring a procedure for adding a target reagent component to the subhole based on a selection operation of the reagent component in the reagent component list.

5. The step of acquiring inspection object information of the sub-hole in response to an inspection object setting operation for the sub-hole includes: displaying a channel list corresponding to the subholes waiting to be set, the channel list indicating a plurality of test channels of the sample analyzer and the test objects of the subholes in each test channel; acquiring a channel waiting to be set up from the channel list; providing an inspection object setting interface in response to an editing operation on the waiting-for-setting channel; The method according to any one of claims 2 to 4, further comprising: a step of acquiring inspection object information of the sub-hole in the inspection channel set by the inspection object setting interface, wherein the inspection object information includes an inspection object.

6. 6. The method of claim 5, further comprising: outputting an inspection object overlap indication in the inspection object setting interface when the inspection object currently being input overlaps with the inspection object already input for the inspection item.

7. The step of obtaining a first mapping relationship between the test item and a plurality of sub-holes and test object information of each of the sub-holes includes: In response to an introduction operation of an examination item, the examination item setting data introduced by the introduction operation is acquired, and the introduction operation includes any one selected from a table introduction operation, a file introduction operation, and a QR code scanning operation; The method according to claim 1, 2, 3 or 4, further comprising: analyzing the inspection item setting data to obtain a first mapping relationship between the inspection item and a plurality of sub-holes, and inspection object information for each of the sub-holes.

8. obtaining a sample analysis initiation command, the sample analysis initiation command including test items and sample number; acquiring a plurality of sub-holes corresponding to the test items and test object information for each of the sub-holes, the test object information including the test object of each sub-hole in the test channel of the sample analyzer; determining the number of reaction holes based on the number of samples and the number of subholes for the test items; a step of sending a test control command to a sample analyzer based on the number of reaction holes and the sub-holes corresponding to the test items, the test control command being to control the sample analyzer to prepare test liquids for the corresponding number of reaction holes, obtain the reaction holes corresponding to each sample and the sub-holes of the test items corresponding to the reaction holes, and test the test liquids in each of the reaction holes using a test channel of the sample analyzer to obtain the test results of each reaction hole by the test channel; and obtaining test results for the test items for each sample by analyzing the test results for each reaction hole by the test channel based on the reaction holes corresponding to each sample, the sub-holes for the test items corresponding to each reaction hole, and the test object information for each of the sub-holes.

9. The method comprises: In response to a result inquiry command for the inspection item, obtain the inspection result of the inspection lot number specified in the result inquiry command; 9. The method of claim 8, further comprising: displaying, on the inspection result display page, the inspection results of the inspection lot number in the form of a two-dimensional table based on each subhole corresponding to the inspection item and the inspection object corresponding to each subhole, wherein the columns of the two-dimensional table include at least samples, inspection items, subholes, and inspection objects.

10. 10. The method of claim 9, further comprising: arranging the test results for the same sample in the two-dimensional table in separate lines and adjacently according to subhole identification information of the test items.

11. A control terminal comprising a memory in which a computer program is stored and a processor, A control terminal, characterized in that the processor is configured to carry out the steps of the method according to any one of claims 1 to 4, 8 to 10.

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