A sample analyzer, a server, and an analysis method of a sample to be measured

By combining the sample analyzer and server with the LIS system, the system automatically identifies and performs sample dilution, solving the problem of sample concentrations exceeding the linear range and achieving a more efficient sample analysis process.

CN114487450BActive Publication Date: 2026-04-07SHENZHEN MINDRAY BIO MEDICAL ELECTRONICS CO LTD
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Patent Information

Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
Filing Date
2020-11-13
Publication Date
2026-04-07

AI Technical Summary

Technical Problem

In existing sample testing methods, some sample concentrations exceed the linear range of the measurement system, requiring additional testing and dilution, which increases costs and time.

Method used

By combining a sample analyzer and server with the LIS system, the system automatically determines whether dilution is needed based on the sample's department information, diagnostic information, and historical information, and performs pre-judgment and dilution processing to avoid additional testing.

Benefits of technology

This reduces the need for test strip testing and retesting, shortens reporting time, lowers overall costs, and improves efficiency.

✦ Generated by Eureka AI based on patent content.

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Abstract

The sample analyzer, server, and analysis method for the sample provided by this invention acquire target information of the sample, including at least one of the following: department information of the sample, diagnostic information of the sample, and historical information of the same test items for the corresponding patient; then, based on the target information, it determines whether the sample needs to be diluted; if so, the sample is diluted; and the diluted sample is tested to obtain test data. Therefore, this application pre-determines whether the sample needs to be diluted based on the target information, eliminating the need for test strip testing and waiting for the analysis results before dilution, thus shortening the report generation time, improving efficiency, and reducing the overall cost of sample analysis.
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Description

Technical Field

[0001] This invention relates to the field of medical devices, specifically to a sample analyzer, a server, and a method for analyzing samples to be tested. Background Technology

[0002] In in vitro diagnostics, some test samples have high concentrations. Due to the insufficient linear range of the reagents in the measurement system, the test results of the original sample solution may exceed the upper limit of the linear range. Because clinicians need to assess patient conditions, for some clinical scenarios (such as treatment monitoring), if the results of patient samples exceed the upper limit of the linear range, it is necessary to perform sample dilution tests to obtain accurate results. The main methods currently used by users to determine whether a sample needs dilution and their existing problems are as follows:

[0003] 1. Before testing, use other testing methods to make a preliminary judgment on all samples, such as using test strips to make a preliminary judgment on the HCG concentration in serum based on the color intensity of the bands; this method increases the cost of test strip consumption, and increases the time for issuing reports and the workload of staff.

[0004] 2. All samples are first tested at their original volume using the instrument. Only after confirming that the sample exceeds the upper limit of the measurement range is the dilution test initiated. This method involves an extra test, increasing costs, as well as the time required to issue reports and the workload of staff.

[0005] Therefore, existing sample testing methods generally suffer from problems such as high cost and long report generation time. Summary of the Invention

[0006] This invention mainly provides a sample analyzer, a server, and an analysis method for the sample to be tested, so as to reduce the overall cost of sample analysis.

[0007] One embodiment provides a sample analyzer, comprising:

[0008] The sample reagent component is used to hold the sample to be tested, and after the sample is drawn up, it is provided to the measuring component; the sample reagent component is used to hold the reagent, and after the reagent is drawn up, it is provided to the measuring component; the sample reagent component is used to hold the diluent, and after the diluent is drawn up, it is provided to the measuring component.

[0009] The measuring component is used to perform tests on samples to obtain test data for the items.

[0010] The control unit, which communicates with the sample reagent component and the measurement component, is configured for:

[0011] The sample reagent control unit picks up the sample to be tested and provides the picked-up sample to the measurement unit;

[0012] The target information of the sample to be tested is obtained from the LIS system. The target information includes at least one of the following: the department information of the sample to be tested, the diagnostic information of the sample to be tested, and the historical information of the same test items of the patient corresponding to the sample to be tested.

[0013] Based on the target information, determine whether the sample to be tested needs to be diluted; if so, control the sample reagent component to draw up the diluent and provide the drawn up diluent to the measuring component to dilute the sample to be tested.

[0014] The sample reagent component draws up the reagent and provides the drawn-up reagent to the measuring component;

[0015] The control and measurement unit performs tests on the diluted sample containing the reagent to obtain test data.

[0016] The sample analyzer provided in one embodiment further includes a scanning device; the control device is also used for:

[0017] Before obtaining the target information of the sample to be tested from the LIS system, the control scanning device scans the identification code of the sample to be tested to obtain the test items of the sample to be tested, and determines whether the test items are preset target test items. If so, the target information of the sample to be tested is obtained from the LIS system.

[0018] In one embodiment of the sample analyzer, the target information includes the department information of the sample to be tested; the control device determines whether the sample to be tested needs to be diluted based on the target information, including:

[0019] The purpose of the test is determined based on the department information, and the purpose of the test is divided into two types: treatment monitoring and non-treatment monitoring.

[0020] If the purpose of the test, as determined by the department information, is for treatment monitoring, then the sample to be tested needs to be diluted.

[0021] In one embodiment of the sample analyzer, the target information includes diagnostic information of the sample to be tested; the control device determines whether the sample to be tested needs to be diluted based on the target information, including:

[0022] Based on the diagnostic information, determine whether the patient has a pre-set condition; if so, determine that the sample to be tested needs to be diluted; the pre-set conditions include hepatitis B, intrauterine pregnancy, or placental trophoblastic tumor.

[0023] In one embodiment of the sample analyzer, the target information includes the department information of the sample to be tested; the control device determines whether the sample to be tested needs to be diluted based on the target information, including:

[0024] Determine whether the department information contains and / or does not contain one or more preset first target words; if so, determine that the sample to be tested needs to be diluted.

[0025] In one embodiment of the sample analyzer, the target information includes diagnostic information of the sample to be tested; the control device determines whether the sample to be tested needs to be diluted based on the target information, including:

[0026] Determine whether the diagnostic information contains and / or does not contain one or more preset second target words; if so, determine that the sample to be tested needs to be diluted.

[0027] In one embodiment of the sample analyzer, the target information includes the historical information; the control device determines whether the sample to be tested needs to be diluted based on the target information, including:

[0028] Determine whether the corresponding sample in the historical information has been diluted; if so, determine that the sample to be tested needs to be diluted.

[0029] In one embodiment of the sample analyzer provided, the control device is further configured to:

[0030] If the sample to be tested needs to be diluted, obtain historical information on the same test items for the patients corresponding to the sample to be tested.

[0031] The dilution factor is determined based on the historical information.

[0032] In one embodiment of the sample analyzer, the step of determining the dilution factor based on the historical information is described.

[0033] include:

[0034] The dilution factor used in the project test that generated the historical information is used as the dilution factor of the sample to be tested; or,

[0035] The time interval between the current time and the historical information is calculated based on the time of generation. According to the preset correspondence between the time interval and the dilution factor, the dilution factor corresponding to the current time interval is used as the dilution factor of the sample to be tested.

[0036] In one embodiment of the sample analyzer, the test item and target test item of the sample to be tested are HCG tests, and the target information includes the department information and diagnostic information of the sample to be tested; the control device determines whether the sample to be tested needs to be diluted based on the target information, including:

[0037] Determine whether the department information does not contain the word "gynecology"; determine whether the diagnosis information contains the words "pregnancy", "pregnancy" or "threatened miscarriage" and does not contain the words "ectopic", "fallopian tube" or "extrauterine".

[0038] If the department information does not contain the word "gynecology", and the diagnosis information contains the words "pregnancy", "pregnancy" or "threatened miscarriage" but does not contain the words "ectopic", "fallopian tube" or "extrauterine", then the sample to be tested needs to be diluted.

[0039] In one embodiment of the sample analyzer, the test item and target test item of the sample to be tested are HCG tests; the target information includes diagnostic information of the sample to be tested; the control device determines whether the sample to be tested needs to be diluted based on the target information, including:

[0040] Gestational age data is obtained from the diagnostic information. Based on the preset correspondence between gestational age data and empirical intervals of test results, it is determined whether the empirical interval of test results corresponding to the gestational age data in the diagnostic information exceeds the upper limit of the linear range of the reagent. If so, it is determined that the sample to be tested needs to be diluted.

[0041] In one embodiment of the sample analyzer provided, the control device is further configured to:

[0042] If the sample to be tested needs to be diluted, the dilution factor is determined based on the gestational age data in the diagnostic information.

[0043] In one embodiment of the sample analyzer, the test item and target test item of the sample to be tested are HBsAg testing; the target information includes the department information and diagnostic information of the sample to be tested; the control device determines whether the sample to be tested needs to be diluted based on the target information, including:

[0044] Determine whether the department information contains the words "liver disease" or "infection"; determine whether the diagnosis information contains the words "hepatitis" or "hepatitis B";

[0045] If the department information contains the words "liver disease" or "infection" and the diagnosis information contains the words "hepatitis" or "hepatitis B", then the sample to be tested needs to be diluted.

[0046] One embodiment provides a sample analyzer, comprising:

[0047] The sample reagent component is used to hold the sample to be tested, and after the sample is drawn up, it is provided to the measuring component; the sample reagent component is used to hold the reagent, and after the reagent is drawn up, it is provided to the measuring component.

[0048] The measuring component is used to perform tests on samples to obtain test data for the items.

[0049] The control unit, which communicates with the sample reagent component and the measurement component, is configured for:

[0050] The sample reagent control unit picks up the sample to be tested and provides the picked-up sample to the measurement unit;

[0051] The sample reagent component draws up the reagent and provides the drawn-up reagent to the measuring component;

[0052] The control and measurement unit performs tests on the sample to be tested by adding the reagent, and obtains the test data for the item;

[0053] The test data is processed to obtain the analysis results of the sample to be tested;

[0054] The system retrieves historical information on the same test items for the patients corresponding to the test sample from the LIS system; it determines whether the difference between the analysis result of the test sample and the analysis result in the historical information exceeds the preset range; if so, the test sample is retested.

[0055] One embodiment provides a server, including:

[0056] A communication device for receiving dilution determination requests from a sample analyzer;

[0057] The processor is configured to respond to the dilution determination request, obtain target information of the sample to be tested from the LIS system, the target information including at least one of the following: department information of the sample to be tested, diagnostic information of the sample to be tested, and historical information of the same test items of the patient corresponding to the sample to be tested; determine whether the sample to be tested needs to be diluted based on the target information, and feed back the determination result to the sample analyzer.

[0058] One embodiment provides an analysis method for a sample to be tested, comprising:

[0059] Collect the sample to be tested;

[0060] The target information of the sample to be tested is obtained from the LIS system. The target information includes at least one of the following: the department information of the sample to be tested, the diagnostic information of the sample to be tested, and the historical information of the same test items of the patient corresponding to the sample to be tested.

[0061] Based on the target information, determine whether the sample to be tested needs to be diluted. If so, take out the diluent and use the diluent to dilute the sample to be tested.

[0062] Draw up the reagent and add it to the diluted sample to be tested;

[0063] The diluted sample containing the reagent was then subjected to the test to obtain the test data.

[0064] According to the sample analyzer, server, and analysis method for the sample to be tested described in the above embodiments, target information of the sample to be tested is obtained. This target information includes at least one of the following: department information of the sample to be tested, diagnostic information of the sample to be tested, and historical information of the same test items for the corresponding patient. Then, based on the target information, it is determined whether the sample to be tested needs to be diluted; if so, the sample to be tested is diluted; the diluted sample to be tested is then tested to obtain test data. It is evident that this application pre-determines whether the sample needs to be diluted based on the target information, eliminating the need for test strip testing and waiting for the analysis results before dilution, thus shortening the report issuance time, improving efficiency, and reducing the overall cost of sample analysis. Attached Figure Description

[0065] Figure 1 This is a structural block diagram of an embodiment of the sample analyzer provided by the present invention;

[0066] Figure 2 This is a structural block diagram of another embodiment of the sample analyzer provided by the present invention;

[0067] Figure 3 This is a schematic diagram of the structure of an embodiment of the sample analyzer provided by the present invention;

[0068] Figure 4 A flowchart of an embodiment of the analysis method for the sample to be tested provided by the present invention;

[0069] Figure 5 The structural block diagram of the server provided by this invention;

[0070] Figure 6 This is a flowchart illustrating an embodiment of the present invention where the sample analyzer interacts with a server to complete sample analysis. Detailed Implementation

[0071] The present invention will now be described in further detail with reference to specific embodiments and accompanying drawings. Similar elements in different embodiments are referred to by associated similar element reference numerals. In the following embodiments, many details are described to facilitate a better understanding of this application. However, those skilled in the art will readily recognize that some features may be omitted in different situations, or may be replaced by other elements, materials, or methods. In some cases, certain operations related to this application are not shown or described in the specification. This is to avoid obscuring the core parts of this application with excessive description. For those skilled in the art, detailed description of these related operations is not necessary; they can fully understand the related operations based on the description in the specification and general technical knowledge in the art.

[0072] Furthermore, the features, operations, or characteristics described in the specification can be combined in any suitable manner to form various embodiments. At the same time, the steps or actions in the method description can be rearranged or adjusted in a manner obvious to those skilled in the art. Therefore, the various orders in the specification and drawings are only for the clear description of a particular embodiment and do not imply a necessary order, unless otherwise stated that a particular order must be followed.

[0073] The serial numbers assigned to components in this document, such as "first" and "second," are used only to distinguish the described objects and have no sequential or technical meaning. The terms "connection" and "linkage" used in this application, unless otherwise specified, include both direct and indirect connections (linkages).

[0074] Some embodiments of this invention disclose a sample analyzer for biochemical and immunological analysis, which can be a biochemical analyzer or an immunoassay analyzer, etc. Please refer to... Figure 1 In one embodiment, the sample analyzer may include a sample reagent component, a measuring component 30, and a control device 40; in some embodiments, please refer to Figure 2 The sample analyzer may also include a display unit 50; this will be described in detail below.

[0075] The sample reagent component is used to hold the sample to be tested, reagents, and diluent. After aspirating the sample, it is provided to the measurement component 30; after aspirating the reagents, it is provided to the measurement component 30; and after aspirating the diluent, it is provided to the measurement component 30. In this embodiment, the sample reagent component includes a sample sub-component 10 and a reagent sub-component 20. The sample sub-component 10 is used to hold the sample to be tested and is provided to the measurement component 30 after aspirating the sample. The reagent sub-component 10 is used to hold the reagents and diluent and is provided to the measurement component 30 after aspirating the reagents and diluent. Of course, in some embodiments, the sample sub-component 10 can also aspirate the diluent and provide it to the measurement component 30. In some embodiments, the sample, reagents, and diluent can be aspirated and provided to the measurement component 30 by the same sub-component. That is, the sub-components holding the sample to be tested, reagents, and diluent can be shared by all three, shared in pairs, or three separate sub-components can be provided. The sub-components aspirating the sample to be tested, reagents, and diluent and providing them to the measurement component 30 can also be shared by all three, shared in pairs, or three separate sub-components.

[0076] The sample sub-component 10 is used to hold the sample to be tested, and after the sample is aspirated, it is provided to the measurement component 30. Please refer to... Figure 3 In some embodiments, the sample sub-component 10 may include a sample carrying component 11 and a sample dispensing mechanism 12. The sample carrying component 11 is used to carry samples. In some examples, the sample carrying component 11 may include a sample delivery module (SDM) and a front-end track; in other examples—for example… Figure 3 In such an example, the sample carrier 11 could also be a sample tray, which includes multiple sample positions for placing sample tubes. By rotating its tray structure, the sample can be moved to the appropriate position, such as the position for the sample dispensing mechanism 12 to aspirate the sample. The sample dispensing mechanism 12 is used to aspirate the sample and dispense it into the measurement component 30 (e.g., a reaction cup) to be added. For example, the sample dispensing mechanism 12 may include a sample needle, which is moved in two or three dimensions by a two- or three-dimensional drive mechanism, thereby moving the sample needle to aspirate the sample carried by the sample carrier 11 and to the reaction cup to be added, and to dispense the sample into the reaction cup. In some embodiments, the sample dispensing mechanism 12 can also be used to aspirate diluent and dispense it into the reaction cup to be added with diluent.

[0077] The reagent sub-component 20 is used to hold reagents, which are then drawn up and supplied to the measuring component 30. It also holds diluent, which is drawn up and supplied to the measuring component 30. In some embodiments, the reagent sub-component 20 may include a reagent carrying component 13 and a reagent dispensing mechanism 14. The reagent carrying component 13 is used to hold both reagents and diluent. In one embodiment, the reagent carrying component 13 may include a reagent tray, which is a disc-shaped structure with multiple positions for holding reagent containers. The reagent carrying component 13 is rotatable and can rotate the reagent containers it carries, rotating them to a specific position, such as the position where the reagent is drawn up by the reagent dispensing mechanism 14. In some embodiments, the reagent carrying component 13 also includes a diluent container, which may be mounted on the reagent tray or provided separately.

[0078] The reagent carrying component 13 can be one or more. The reagent dispensing mechanism 14 is used to aspirate reagents and dispense them into the measuring component 30 (e.g., a reaction cup) to which the reagent is to be added. In some embodiments, the reagent dispensing mechanism 14 is also used to aspirate diluent and dispense it into the measuring component 30 (e.g., a reaction cup) to which the diluent is to be added; alternatively, a separate diluent dispensing mechanism can be provided to aspirate diluent and dispense it into the reaction cup to which the diluent is to be added. In one embodiment, the reagent dispensing mechanism 14 may include a reagent needle, which moves in two or three dimensions through a two-dimensional or three-dimensional driving mechanism, thereby moving the reagent needle to aspirate the reagent carried by the reagent carrying component 13, and to move to the reaction cup to which the reagent is to be added, dispensing the reagent into the reaction cup. The reagent needle can also move to aspirate diluent from the diluent container, and to move to the reaction cup to which the diluent is to be added, dispensing the diluent into the reaction cup. Of course, in some embodiments, the sample, reagent, and diluent can also be aspirated and dispensed into the reaction cup through the same dispensing mechanism.

[0079] The measuring component 30 is used to perform tests on the sample to obtain test data. In some embodiments, the measuring component 30 may include a reaction component 15 and a photometric component 16. The reaction component 15 has at least one placement position for placing a reaction cup and incubating the reaction liquid in the reaction cup. For example, the reaction component 15 can be a reaction disk, which is arranged in a disk-shaped structure and has one or more placement positions for placing reaction cups. The reaction disk can rotate and drive the reaction cups in its placement positions to rotate, for distributing the reaction cups and incubating the reaction liquid in the reaction cups within the reaction disk. The photometric component 16 is used to perform photometric measurements on the incubated reaction liquid to obtain the sample's reaction data. For example, the photometric component 16 detects the luminescence intensity of the reaction liquid to be tested, obtains test data, and then calculates the concentration of the analyte in the sample through a calibration curve. In one embodiment, the photometric component 16 is separately disposed outside the reaction component 15.

[0080] The control device 40 is communicatively connected to the sample reagent component, the measuring component 30, and the display component 50. It is configured to control the sample reagent component to aspirate the sample to be tested and provide the aspirated sample to the measuring component 30; and to obtain target information of the sample to be tested from the LIS (Laboratory Information System). This target information includes at least one of the following: department information of the sample to be tested, diagnostic information of the sample to be tested, and historical information of the same test items for the corresponding patient. The control device 40 determines whether the sample to be tested needs dilution based on the target information; if so, it controls the sample reagent component to aspirate diluent and provide the aspirated diluent to the measuring component 30 to dilute the sample to be tested; it also controls the sample reagent component to aspirate reagent and provide the aspirated reagent to the measuring component 30; and it controls the measuring component 30 to perform the test on the diluted sample with added reagent, obtaining the test data for the test item.

[0081] As can be seen, the sample analyzer provided in this application can predict whether the sample needs to be diluted based on the target information, eliminating the need for test strips and waiting for the analysis results before dilution, thus shortening the report issuance time, improving efficiency, and reducing the overall cost of sample analysis.

[0082] The aforementioned functions of the control device 40 can be implemented by the processor of the control device 40 by running a preset computer program.

[0083] The sample analyzer may also include a scanning device, which scans the identification code of the sample to be tested to obtain the identification code, such as a barcode or QR code. The LIS system stores patient information, test items, and target information for each sample. The control device 40 can retrieve the patient information, test items, and target information of the sample to be tested from the LIS system based on the identification code.

[0084] Furthermore, based on the aforementioned sample analyzer, the process of analyzing the sample to be tested is described in detail. For example... Figure 4 As shown in the detailed embodiment, the analysis process of the sample to be tested includes the following steps:

[0085] Step 1: The control device 40 controls the scanning device to scan the identification code of the sample to be tested, thereby obtaining the test items of the sample. In some embodiments, the control device 40 controls the sample distribution module to transport the sample to be tested to the sampling position on the front track, controls the sample dispensing mechanism 12 to pick up the sample to be tested from the sampling position, and injects the picked-up sample into the corresponding reaction cup on the reaction plate. In other embodiments, the control device 40 controls the sample plate to rotate, dispatching the sample to be tested to the sampling position, the sample dispensing mechanism 12 picks up the sample to be tested from the sampling position, and injects the picked-up sample into the corresponding reaction cup on the reaction plate.

[0086] Step 2: The sample analyzer also has a communication device, which can be wired communication, such as various network interfaces, or wireless communication. That is, the sample analyzer communicates with the LIS system (e.g., the server that sets up the LIS system). The control device 40 obtains the target information of the sample to be tested from the LIS system through the communication device.

[0087] The control device 40 can acquire target information for each sample to be tested to determine whether dilution is required, or it can acquire target information only for specific samples to be tested to determine whether dilution is required. Considering that not all test data of the samples to be tested exceed the linear range of the reagent, in this embodiment, before acquiring the target information of the sample to be tested from the LIS system, the control device 40 determines whether the test item is a preset target test item. If so, it acquires the target information of the sample to be tested from the LIS system; otherwise, it proceeds to step 5. In other words, if the test item of the sample to be tested is not a target test item, the subsequent testing process follows the standard sample testing procedure.

[0088] You can preset only one target test item, or you can preset multiple (two or more) target test items. This embodiment will use the latter as an example. There are multiple preset target test items, such as HBsAg (hepatitis B surface antigen), HCG (human chorionic gonadotropin), AFP (alpha-fetoprotein), etc.

[0089] Step 3: The control device 40 determines whether the sample to be tested needs to be diluted based on the target information.

[0090] For example, the target information includes the department information of the sample to be tested. The control device 40 determines the testing purpose based on the department information, which is divided into two types: treatment monitoring and non-treatment monitoring. The target test item can be pre-associated with target department information, such as the target department name. The control device 40 determines whether the department information is the pre-associated target department information, such as the target department name. If so, the testing purpose is determined to be treatment monitoring; otherwise, it is non-treatment monitoring. In addition to using the department name for judgment, keyword matching can also be performed to adapt to different scenarios. Specifically, the control device 40 determines whether the department information contains one or more preset first target words, and / or whether it does not contain one or more preset first target words. If so, the testing purpose is determined to be treatment monitoring; otherwise, the testing purpose is non-treatment monitoring. The first target words can be keywords used to determine the target department name or the testing purpose. If the control device 40 determines the testing purpose to be treatment monitoring based on the department information, it is equivalent to meeting a dilution condition, so the sample to be tested needs to be diluted, and proceeds to step 4; if the control device 40 determines the testing purpose to be non-treatment monitoring based on the department information, the sample to be tested does not need to be diluted, and proceeds to step 5. The target department information is strongly correlated with the target test item. For example, for the HBsAg test, the associated departments include "Infectious Diseases" and "Hepatology." The typical scenarios (purposes) for ordering HBsAg tests include physical examinations, hospital infection prevention and control, prevention and control of mother-to-child transmission, and diagnosis and treatment of HBV-infected individuals. Most hospitals direct HBV (hepatitis B) infected patients to the Infectious Diseases or Hepatology departments for treatment; that is, the purpose of the test is for treatment monitoring. Furthermore, the serum HBsAg concentration in these patients is generally high, exceeding the linear range, requiring dilution. These patients are usually continuously monitored for HBsAg at one hospital, and their historical information is generally present in the laboratory's LIS system. Samples from the first three ordering scenarios come from other departments such as physical examinations and obstetrics and gynecology. These samples do not require dilution, and their purpose is non-treatment monitoring. Therefore, based on the "Infectious Diseases" and "Hepatology" department information, it can be determined whether the sample needs dilution; if the test is requested by other departments, it can be determined that the sample does not need dilution.

[0091] For example, the target information includes the diagnostic information of the sample to be tested, which is the doctor's diagnosis of the patient. The control device 40 determines whether the patient has a preset disease based on the diagnostic information; if so, it determines that the sample to be tested needs to be diluted. Preset diseases include hepatitis B, intrauterine pregnancy, and / or placental trophoblastic tumor, etc. Keyword extraction can be performed on the diagnostic information to determine whether the patient has a preset disease. For example, the control device 40 determines whether the diagnostic information contains one or more preset second target words, and / or whether it does not contain one or more preset second target words; if so, it determines that the patient has a preset disease and the sample to be tested needs to be diluted; otherwise, it determines that the sample to be tested does not need to be diluted. The second target words can be keywords used to determine the type of disease.

[0092] For HCG testing, the common scenarios (purposes) for ordering it include early pregnancy detection, pregnancy monitoring, and diagnosis and monitoring of hydatidiform mole. For the most common scenario, pregnancy monitoring, the serum HCG concentration in pregnant women during normal pregnancies falls within a certain reference range at different gestational weeks:

[0093]

[0094] Furthermore, pregnant women need to monitor changes in their values ​​during regular prenatal checkups, and historical results are stored in the LIS system. Therefore, after acquiring diagnostic information, the control device 40 obtains gestational age data from the diagnostic information. Based on the preset correspondence between gestational age data and the empirical interval of test results (as shown in the table above), it determines whether the empirical interval of the test results corresponding to the gestational age data in the diagnostic information exceeds the upper limit of the linear range of the reagent. If so, it determines that the sample to be tested needs to be diluted and proceeds to step 4; otherwise, it determines that the sample to be tested does not need to be diluted and proceeds to step 5.

[0095] For tests like AFP, the typical ordering scenarios (purposes) include physical examination screening and treatment monitoring for ovarian cancer, breast cancer, lung cancer, hepatobiliary cancer, esophageal cancer, colorectal cancer, gastric cardia cancer, and gallbladder cancer. For the most common cancer treatment monitoring scenario, the diagnostic information, such as the order information, will include a note for "tumor." Therefore, after acquiring the order information, the control device 40 can determine the patient's symptoms based on the order information such as "XX cancer," and determine whether the patient's symptoms correspond to the pre-defined symptoms for the test item. If so, it determines that the sample needs to be diluted; otherwise, it determines that the sample does not need to be diluted.

[0096] For example, the target information includes historical information about the same test items for the patient corresponding to the sample to be tested. If the current test item is HBsAg, then the historical information of the patient's previous HBsAg tests is retrieved. The historical information records whether the sample was diluted, the dilution factor, and the analysis results for the test item. The control device 40 determines whether the sample corresponding to the historical information has been diluted. If so, it determines that the sample to be tested needs to be diluted; otherwise, the sample to be tested does not need to be diluted. That is, if the sample was diluted in the patient's previous test, then the same test now also needs to be diluted.

[0097] The target information includes at least one of the following: the department information of the sample to be tested, the diagnostic information of the sample to be tested, and historical information of the same test item for the patient corresponding to the sample to be tested. That is, the control device 40 can determine whether the sample is diluted based on only one type of target information, or it can determine whether the sample is diluted based on multiple types of target information. There are multiple possible combinations, and the number of judgment conditions can be set according to the user's needs. Of course, the more target information acquired, the more accurate the judgment on whether the sample is diluted. Therefore, this embodiment uses the above three types of target information as an example for explanation. That is, the current sample to be tested is determined to need to be diluted only when all three conditions are met: the purpose of the test is treatment monitoring, the patient has a preset disease, and the sample has been diluted in the historical information. It can be seen that the automatic judgment of whether the sample needs to be diluted in this application is accurate and reliable. Of course, the patient's gender and age can also be used as auxiliary judgment information, which can further increase the reliability of the judgment.

[0098] The following two specific test projects will be used as examples to explain in detail how to determine whether a sample needs to be diluted based on the target information.

[0099] In one example, the test item and target test item for the sample to be tested are HBsAg tests. Elevated HBsAg indicates acute or chronic HBV infection, and HBsAg exceeding the limit is common in patients with chronic active hepatitis B. During antiviral treatment for these patients, clinicians need to continuously monitor the changes in HBsAg levels to monitor the antiviral efficacy, thus requiring dilution and quantification of samples exceeding the limit. Based on the above clinical scenario analysis, samples exceeding the limit and requiring dilution are mainly seen in the antiviral treatment of active hepatitis B. Research on the laboratory LIS database reveals that these individuals are mainly concentrated in hepatology departments, hepatology outpatient clinics, and infectious disease departments. Therefore, the target information includes the department information and diagnostic information of the sample to be tested. After obtaining the target information from the LIS system, the control device 40 determines whether the department information contains the words "liver disease" or "infection"; and whether the diagnostic information contains the words "hepatitis" or "hepatitis B". If the department information contains at least one of the words "liver disease" and "infection," and the diagnosis information contains at least one of the words "hepatitis" and "hepatitis B," then the control device 40 determines that the sample to be tested needs to be diluted. If the words in the target information do not meet the above conditions, then the sample to be tested does not need to be diluted. Using the scheme of this application, applied in a large comprehensive tertiary hospital, the analysis of its LIS database revealed that in a certain year, the hospital issued 64,236 HBsAg tests, of which 1,605 exceeded the limit (exceeding the limit rate of 2.5%). According to the above judgment logic, 744 were retrieved, of which 521 were exceeding the limit. Therefore, the detection rate of this logic rule = 521 / 1605 = 32%; the false detection rate = (744-521) / 64236 = 0.4%. Applied to a tertiary infectious disease hospital, analysis of its LIS database revealed that in a certain year, the hospital issued 36,041 HBsAg tests, of which 17,367 exceeded the limit (an exceedance rate of 48.2%). Following the aforementioned logic, 11,871 results were retrieved, of which 10,068 exceeded the limit. Therefore, the detection rate of this logic rule = 10,068 / 17,367 = 58%; the false positive rate = (11,871 - 10,068) / 36,041 = 5.0%.

[0100] In one example, the test item and target test item for the sample is HCG testing. HCG is mainly secreted by placental trophoblastic cells. Excessive HCG levels are commonly seen in intrauterine pregnancies and placental trophoblastic tumors (hydatidiform mole, choriocarcinoma). Whether in pregnancy management or in the treatment of trophoblastic tumors, clinicians need to continuously monitor changes in the patient's HCG levels to monitor pregnancy outcomes or the effectiveness of tumor treatment. Therefore, samples with excessive levels need to be diluted and quantified. Based on the above clinical scenario analysis, samples with excessive levels requiring dilution are mainly seen in intrauterine pregnancies and trophoblastic tumors. Research on the laboratory LIS database reveals that these individuals are primarily those with intrauterine pregnancies or threatened miscarriages; ectopic pregnancies generally do not show excessive levels, and trophoblastic tumors account for a small percentage, with HCG levels remaining within acceptable limits after treatment. Furthermore, it was found that gynecological HCG testing is often performed on patients with adverse pregnancy outcomes, and HCG levels in these cases are also unlikely to be excessive. Therefore, the corresponding target information includes the department information and diagnostic information of the sample. The control device 40 determines whether the department information does not contain the word "gynecology"; and whether the diagnostic information contains the words "pregnancy," "pregnancy," or "threatened abortion" but does not contain the words "ectopic," "fallopian tube," or "ectopic." If the department information does not contain the word "gynecology," the diagnostic information contains the words "pregnancy," "pregnancy," or "threatened abortion," and the diagnostic information does not contain the words "ectopic," "fallopian tube," or "ectopic," then the sample to be tested needs to be diluted; otherwise, the sample to be tested does not need to be diluted. The proposed solution was applied to a large, comprehensive tertiary hospital. Analysis of its LIS database revealed that in a certain year, the hospital ordered 11,653 HCG tests, of which 5,543 exceeded the limit (an exceedance rate of 47.57%). Following the aforementioned logic, 5,025 results were retrieved, with 3,856 exceeding the limit. Therefore, the detection rate of this logic rule was 3,856 / 5,543 = 69.6%; the false positive rate was (5,025 - 3,856) / 11,653 = 10.0%.

[0101] This application automatically determines dilution, reducing the inconvenience and decreased efficiency caused by manual judgment, manual dilution requests, or retesting. It also reduces reagent waste from test strips or initial test judgments; reduces sample contamination caused by directly inserting test strips into sample tubes; and reduces excessively long result times due to retesting caused by initial test anomalies. Furthermore, this application uses diverse criteria for dilution determination, resulting in high accuracy in determining whether dilution is necessary, effectively reducing the overall testing costs for laboratory departments.

[0102] Step 4: If the control device 40 determines that the sample to be tested needs to be diluted, it controls the sample reagent component to draw up the diluent and inject the diluent into the reaction cup containing the sample to be tested, and uses the diluent to dilute the sample to be tested.

[0103] Specifically, the control device 40 acquires historical information about the same test item for the patient corresponding to the sample to be tested. If the target information contains historical information, it directly uses that historical information; otherwise, it acquires the historical information from the LIS system. The control device 40 determines the dilution factor based on the historical information. For example, the control device 40 uses the dilution factor used in the test that generated the historical information as the dilution factor for the current sample to be tested. This is suitable for tests such as HBsAg. Another example is that the control device 40 calculates the time interval between the historical information generation time and the current time, and uses the dilution factor corresponding to the current time interval as the dilution factor for the current sample to be tested, based on a preset correspondence between the time interval and the dilution factor. This is suitable for tests such as HCG. The correspondence between gestational age and dilution factor can be preset, and the current gestational age can be calculated based on the time elapsed since the historical information, thus obtaining the corresponding dilution factor. Of course, the dilution factor can also be determined based on the gestational age data in the diagnostic information. For example, a pre-set correspondence between the empirical interval of test results and the dilution factor can be established. The control device 40 directly obtains the gestational age data from the diagnostic information, and then obtains the corresponding empirical interval of test results based on the gestational age data in the diagnostic information, and then obtains the corresponding dilution factor based on the obtained empirical interval of test results. Alternatively, a pre-set correspondence between gestational age data and the dilution factor can be established. The control device 40 directly obtains the gestational age data from the diagnostic information, and then obtains the corresponding dilution factor from the above correspondence based on the gestational age data in the diagnostic information. This application automatically determines the dilution factor without manual intervention, shortening the sample analysis time and saving manual operation. Of course, in other embodiments, such as when there is no corresponding historical information in the LIS system, the dilution factor can also be a preset factor, or determined based on user input.

[0104] The control device 40 controls the sample reagent component to draw up the diluent according to the dilution factor of the sample to be tested, and then injects the corresponding dose of diluent into the reaction vessel containing the sample to be tested, thereby diluting the sample. The quantitative injection of diluent can be controlled by a metering pump or by injecting diluent at timed intervals, which are conventional methods and will not be described in detail here.

[0105] Step 5: The control device 40 controls the sample reagent component to draw up the reagent and add it to the sample to be tested. For samples that do not require dilution, the sample reagent component draws up the reagent and injects it into the reaction vessel containing the sample to be tested. For diluted samples, the control device 40 controls the sample reagent component to draw up a certain amount of the diluted sample to be tested and inject it into another reaction vessel, and controls the sample reagent component to draw up the corresponding reagent and inject it into the reaction vessel. The reagent reacts with the diluted sample to form a reaction solution.

[0106] Step 6: The control device 40 controls the measuring component 30 to perform tests on the diluted sample containing reagents, obtaining test data for the test item. For example, the measuring component 30 detects the luminescence intensity of the reaction solution or the refractive index of the reaction solution to obtain test data.

[0107] The control device 40 processes the test data to obtain the analytical results of the sample to be tested; for example, it substitutes the test data into a preset calibration curve to calculate the analytical results of the sample, such as the concentration of the analyte in the sample. The calibration curve reflects the relationship between the test data and the concentration of the analyte.

[0108] The control device 40 is also used to determine whether a sample needs to be retested. This determination can be made after the analysis results for each sample have been obtained; it can also be made for samples undergoing the target test. For example, after obtaining the analysis results through a conventional sample analysis process, or using the aforementioned... Figure 4 After obtaining the analysis results of the sample, if the control device 40 has not acquired historical information, it acquires historical information on the same test item for the patient corresponding to the sample to be tested from the LIS system; it determines whether the difference between the analysis result of the sample to be tested and the analysis result in the historical information exceeds a preset range. If so, the sample to be tested is retested, for example, by directly retesting the sample to be tested, or by displaying a corresponding prompt on the display for the user to confirm whether to retest; if the difference does not exceed the preset range, no retest is required and no action is taken. Typically, the analysis results for the same test item for the same patient will not differ significantly, and the preset range can be set based on the allowable deviation of the analysis results obtained under the same conditions. For the above-mentioned... Figure 4 After obtaining the analysis results of the sample during the sample analysis process, if historical information has been acquired during this period, the control device 40 directly determines whether the difference between the analysis result of the sample to be tested and the analysis result in the historical information exceeds a preset range. Similarly, if it does, the sample to be tested is retested; otherwise, retesting is not required. The LIS system may store multiple historical information for this test item for the patient. Before dilution and / or retesting, the most recent historical information can be obtained. The patient may have last undergone the same test item a long time ago, during which time treatment may have occurred. Therefore, a time range can be set, and historical information within that time range can be acquired. If the time range is exceeded, it is considered that there is no historical information. Through retesting, samples with abnormal analysis results can be automatically identified and automatically retested, thus improving the overall efficiency of sample analysis.

[0109] In the above embodiments, both the dilution determination and the retest determination are performed by the sample analyzer. Of course, the determination can also be performed by devices other than the sample analyzer, such as... Figure 5As shown, the server determines whether to dilute or retest. The sample analyzer only needs to interact with the server to obtain the results of whether to dilute or retest, and then perform the corresponding dilution and retest operations, thus saving the sample analyzer's computational load.

[0110] like Figure 5 As shown, server 60 includes: communication device 610 and processor 620.

[0111] The communication device 610 is used to communicate with the sample analyzer, for example, to receive dilution judgment requests and retest judgment requests from the sample analyzer. The server 60 can be configured with a LIS system, and can also communicate with the LIS system via the communication device 610.

[0112] The processor 620, in response to a dilution judgment request, retrieves target information of the sample to be tested from the LIS system. The target information includes at least one of the following: department information of the sample to be tested, diagnostic information of the sample to be tested, and historical information of the same test items for the patient corresponding to the sample to be tested. Based on the target information, the processor determines whether the sample to be tested needs to be diluted and feeds the judgment result back to the sample analyzer. The processor 620, in response to a retest judgment request, retrieves historical information of the same test items for the patient corresponding to the sample to be tested from the LIS system; determines whether the difference between the analysis result of the sample to be tested and the analysis result in the historical information exceeds a preset range and feeds the judgment result back to the sample analyzer.

[0113] Compared to the embodiment using a sample analyzer, in this embodiment, sample analysis is achieved through information interaction between the sample analyzer and server 60, as follows: Figure 6 As shown, it includes:

[0114] Step 1': The control device 40 controls the sample dispensing mechanism 12 to pick up the sample to be tested from the sampling position and inject the picked-up sample into the corresponding reaction cup on the reaction plate. The specific process is the same as above. Figure 4 Step 1 of the embodiment will not be repeated here.

[0115] Subsequently, the control device 40 communicates with the server 60 through the communication device of the sample analyzer and sends a dilution judgment request.

[0116] Step 2': The communication device 610 of server 60 receives the dilution judgment request. Processor 620 obtains the target information of the sample to be tested from the LIS system through the communication device 610. The specific process is the same as... Figure 4 Step 2 of the embodiment is simply executed by a processor 620 instead of a control device 40, so it will not be described in detail here.

[0117] Step 3': The processor 620 determines whether the sample to be tested needs to be diluted based on the target information. The specific process is the same as above. Figure 4Step 3 of the embodiment is simply executed by a processor 620 instead of a control device 40, so it will not be described in detail here.

[0118] Of course, if the determination result is dilution, the processor 620 determines the dilution factor based on historical information, and the specific process is the same. Figure 4 Examples are not detailed here. After obtaining the dilution factor, the processor 620 feeds back the judgment result (dilution or no dilution) and the dilution factor (if dilution is required) to the sample analyzer via the communication device 610.

[0119] Step 4': If the result indicates dilution, the control device 40 controls the sample reagent component to draw up the diluent according to the dilution factor, injecting the diluent into the reaction vessel containing the sample to be tested, thus diluting the sample. See details below. Figure 4 Example.

[0120] Step 5': The control device 40 controls the sample reagent component to draw up the reagent and add it to the sample to be tested. For samples that do not require dilution, the sample reagent component draws up the reagent and injects it into the reaction vessel containing the sample to be tested. For diluted samples, the control device 40 controls the sample reagent component to draw up a certain amount of the diluted sample to be tested and inject it into another reaction vessel, and controls the sample reagent component to draw up the corresponding reagent and inject it into the reaction vessel. The reagent reacts with the diluted sample to form a reaction solution.

[0121] Step 6': The control device 40 controls the measuring component 30 to perform tests on the diluted sample containing reagents, obtaining test data for the test item. For example, the measuring component 30 detects the luminescence intensity of the reaction solution or the refractive index of the reaction solution to obtain test data.

[0122] The control device 40 sends a retest judgment request to the server 60 through the communication device of the sample analyzer.

[0123] The processor 620 of server 60, based on the retest judgment request, retrieves historical information on the same test items for the patient corresponding to the sample to be tested from the LIS system; determines whether the difference between the analysis result of the sample to be tested and the analysis result in the historical information exceeds a preset range, and feeds back the judgment result to the sample analyzer. The sample analyzer performs a retest based on the retest judgment result, or performs testing on the next sample (without retesting).

[0124] This document describes various exemplary embodiments with reference to them. However, those skilled in the art will recognize that changes and modifications can be made to the exemplary embodiments without departing from the scope of this document. For example, various operational steps and components for performing operational steps can be implemented in different ways depending on the specific application or considering any number of cost functions associated with the operation of the system (e.g., one or more steps can be deleted, modified, or combined with other steps).

[0125] Furthermore, as those skilled in the art will understand, the principles herein can be reflected in a computer program product on a computer-readable storage medium pre-loaded with computer-readable program code. Any tangible, non-transitory computer-readable storage medium may be used, including magnetic storage devices (hard disks, floppy disks, etc.), optical storage devices (CD-ROMs, DVDs, Blu-ray discs, etc.), flash memory, and / or the like. These computer program instructions may be loaded onto a general-purpose computer, a special-purpose computer, or other programmable data processing apparatus to form a machine, such that instructions, which execute on the computer or other programmable data processing apparatus, can generate means for performing a specified function. These computer program instructions may also be stored in a computer-readable storage medium that can instruct the computer or other programmable data processing apparatus to operate in a particular manner, such that instructions stored in the computer-readable storage medium can form an article of manufacture, including means for implementing the specified function. The computer program instructions may also be loaded onto a computer or other programmable data processing apparatus to perform a series of operational steps on the computer or other programmable apparatus to produce a computer-implemented process, such that instructions, which execute on the computer or other programmable apparatus, can provide steps for implementing the specified function.

[0126] While the principles herein have been illustrated in various embodiments, numerous modifications to the structures, arrangements, proportions, elements, materials, and components, particularly suited to specific environments and operational requirements, may be used without departing from the principles and scope of this disclosure. These modifications and other alterations or alterations will be included within the scope of this document.

[0127] The foregoing specific descriptions have been described with reference to various embodiments. However, those skilled in the art will recognize that various modifications and changes can be made without departing from the scope of this disclosure. Therefore, considerations for this disclosure are to be illustrative rather than restrictive, and all such modifications are to be included within its scope. Similarly, advantages, other advantages, and solutions to problems with respect to various embodiments have been described above. However, benefits, advantages, solutions to problems, and any elements that produce these, or make them more explicit, should not be construed as critical, essential, or necessary. The term “comprising” and any other variations thereof as used herein are non-exclusive inclusion, meaning that a process, method, article, or apparatus that includes a list of elements includes not only those elements but also other elements not expressly listed or not part of the process, method, system, article, or apparatus. Furthermore, the term “coupled” and any other variations thereof as used herein refer to physical connections, electrical connections, magnetic connections, optical connections, communication connections, functional connections, and / or any other connections.

[0128] Those skilled in the art will recognize that many changes can be made to the details of the above embodiments without departing from the basic principles of the invention. Therefore, the scope of the invention should be determined according to the following claims.

Claims

1. A sample analyzer, characterized in that, include: The sample reagent component is used to hold the sample to be tested, and after the sample is drawn up, it is provided to the measuring component; the sample reagent component is used to hold the reagent, and after the reagent is drawn up, it is provided to the measuring component; the sample reagent component is used to hold the diluent, and after the diluent is drawn up, it is provided to the measuring component. The measuring component is used to perform tests on samples to obtain test data for the items. Scanning device; The control unit, which communicates with the sample reagent component and the measurement component, is configured for: The control scanning device scans the identification code of the sample to be tested to obtain the test items of the sample; The sample reagent control unit picks up the sample to be tested and provides the picked-up sample to the measurement unit; Determine whether the test item is a preset target test item. If so, obtain the target information of the sample to be tested from the LIS system. The target information includes: the department information of the sample to be tested and the diagnostic information of the sample to be tested. Based on the target information, it is determined whether the sample to be tested needs to be diluted. If the department information of the sample to be tested is the target department information pre-associated with the target test item, and the patient is determined to have a preset disease based on the diagnostic information of the sample to be tested, then it is determined that the sample to be tested needs to be diluted. The sample reagent component draws up the diluent for the test sample that needs to be diluted, and provides the drawn up diluent to the measuring component to dilute the test sample; The sample reagent component draws up the reagent and provides the drawn-up reagent to the measuring component; The control and measurement unit performs tests on the diluted sample containing the reagent to obtain test data.

2. The sample analyzer as described in claim 1, characterized in that, The target information also includes historical information; if the department information of the sample to be tested is the target department information pre-associated with its target test item, and the patient is determined to have a preset disease based on the diagnostic information of the sample to be tested, then the sample to be tested needs to be diluted, including: If the department information of the sample to be tested is the target department information pre-associated with its target test item, and the patient is determined to have a preset disease based on the diagnostic information of the sample to be tested, and the corresponding sample in the historical information is diluted, then it is determined that the sample to be tested needs to be diluted.

3. The sample analyzer as described in claim 1, characterized in that, The preset conditions include hepatitis B, intrauterine pregnancy, or placental trophoblastic tumor.

4. The sample analyzer as described in claim 1, characterized in that, The control device determines whether the sample to be tested needs to be diluted based on the target information, including: Determine whether the department information contains and / or does not contain one or more preset first target words. If so, determine that the department information of the sample to be tested is the target department information pre-associated with its target test item.

5. The sample analyzer as described in claim 1, characterized in that, The control device determines whether the sample to be tested needs to be diluted based on the target information, including: Determine whether the diagnostic information contains and / or does not contain one or more preset second target words; if so, determine whether the patient suffers from a preset disease based on the second target words contained in the diagnostic information.

6. The sample analyzer as described in claim 1, characterized in that, The control device is also used for: If the sample to be tested needs to be diluted, obtain historical information on the same test items for the patients corresponding to the sample to be tested. The dilution factor is determined based on the historical information.

7. The sample analyzer as described in claim 6, characterized in that, Determining the dilution factor based on the historical information includes: The dilution factor used in the project test that generated the historical information is used as the dilution factor of the sample to be tested; or, The time interval between the current time and the historical information is calculated based on the time of generation. According to the preset correspondence between the time interval and the dilution factor, the dilution factor corresponding to the current time interval is used as the dilution factor of the sample to be tested.

8. The sample analyzer as described in claim 1, characterized in that, The test item and target test item of the sample to be tested are HCG tests, and the target information includes the department information and diagnostic information of the sample to be tested. The control device determines whether the sample to be tested needs to be diluted based on the target information, including: Determine whether the department information does not contain the word "gynecology"; Determine whether the diagnostic information contains the words "pregnancy", "pregnancy" or "threatened miscarriage" and does not contain the words "ectopic", "fallopian tube" or "extrauterine". If the department information does not contain the word "gynecology", and the diagnosis information contains the words "pregnancy", "pregnancy" or "threatened miscarriage" but does not contain the words "ectopic", "fallopian tube" or "extrauterine", then the sample to be tested needs to be diluted.

9. The sample analyzer as described in claim 1, characterized in that, The test item and target test item for the sample to be tested are HCG tests; the target information includes the diagnostic information of the sample to be tested. The control device determines whether the sample to be tested needs to be diluted based on the target information, including: Gestational age data is obtained from the diagnostic information. Based on the preset correspondence between gestational age data and empirical intervals of test results, it is determined whether the empirical interval of test results corresponding to the gestational age data in the diagnostic information exceeds the upper limit of the linear range of the reagent. If so, it is determined that the sample to be tested needs to be diluted.

10. The sample analyzer as described in claim 9, characterized in that, The control device is also used for: If the sample to be tested needs to be diluted, the dilution factor is determined based on the gestational age data in the diagnostic information.

11. The sample analyzer as described in claim 1, characterized in that, The test item and target test item for the sample to be tested are HBsAg tests; the target information includes the department information and diagnostic information of the sample to be tested. The control device determines whether the sample to be tested needs to be diluted based on the target information, including: Determine whether the department information contains the words "liver disease" or "infection"; Determine whether the diagnostic information contains the words "hepatitis" or "hepatitis B"; If the department information contains the words "liver disease" or "infection", and the diagnosis information contains the words "hepatitis" or "hepatitis B", then the sample to be tested needs to be diluted.

12. A server, characterized in that, include: A communication device for receiving dilution determination requests from a sample analyzer; The processor is configured to respond to the dilution determination request, obtain target information of the sample to be tested from the LIS system, the target information including: department information and diagnostic information of the sample to be tested; determine whether the sample to be tested needs to be diluted based on the target information, wherein if the department information of the sample to be tested is the target department information pre-associated with the target test item, and the diagnostic information of the sample to be tested determines that the patient may have a preset disease, then the sample to be tested needs to be diluted; and feed the determination result back to the sample analyzer.

13. An analytical method for a sample to be tested, characterized in that, include: Scan the identification code of the sample to be tested to obtain the test items of the sample; Collect the sample to be tested; Determine whether the test item is a preset target test item. If so, obtain the target information of the sample to be tested from the LIS system. The target information includes: the department information of the sample to be tested and the diagnostic information of the sample to be tested. Based on the target information, it is determined whether the sample to be tested needs to be diluted. If the department information of the sample to be tested is the target department information pre-associated with the target test item, and the patient is determined to have a preset disease based on the diagnostic information of the sample to be tested, then it is determined that the sample to be tested needs to be diluted. For test samples that require dilution, dilute the test samples with a diluent; Draw up the reagent and add it to the diluted sample to be tested; The diluted sample containing the reagent was then subjected to the test to obtain the test data.

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