Sample analysis system and sample analysis method

By selecting the target calibration curve based on the intermediate detection information of the pretreated test solution in the sample analysis system, the problem of inaccurate detection results of low-concentration glycated hemoglobin samples in the prior art is solved, and more accurate detection results are achieved.

CN119534865APending Publication Date: 2025-02-28SHENZHEN MINDRAY BIO MEDICAL ELECTRONICS CO LTD
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Patent Information

Application Number
CN202311116804.3
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2023-08-30
Publication Date
2025-02-28

AI Technical Summary

Technical Problem

The prior art is prone to impurities when detecting glycated hemoglobin concentrations, especially low-concentration samples, which leads to inaccurate detection results and affects the clinical diagnosis of diabetes.

Method used

By using preparation components, detection components and controllers in the sample analysis system, the pretreatment test solution and the sample solution to be tested are prepared, and the target calibration curve is selected from at least two calibration curves based on the intermediate detection information of the pretreatment test solution to obtain more accurate detection results.

Benefits of technology

More accurate detection of glycated hemoglobin concentration is achieved, especially in the case of low-concentration samples, reducing the impact of impurities and improving the accuracy and reliability of the detection.

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Abstract

The embodiment of the invention provides a sample analysis system and a sample analysis method. The sample analysis system comprises a preparation assembly, a detection assembly and a controller, the preparation assembly is used for preparing a pretreatment test solution by adopting a sample of a subject and a pretreatment reagent, and preparing a to-be-detected sample solution by adopting a detection reagent and the pretreatment test solution; the detection assembly is used for detecting the to-be-detected sample liquid to obtain detection data; the controller is used for detecting the pretreatment test solution to obtain intermediate detection information; selecting a target calibration curve from the at least two calibration curves according to the intermediate detection information; and obtaining a detection result of the sample according to the detection data and the target calibration curve. According to the method, the corresponding calibration curve is adaptively selected as the target calibration curve according to the intermediate detection information of the pretreatment test solution, so that a relatively accurate detection result is obtained based on the target calibration curve.
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Description

Technical Field

[0001] The present application relates to the technical field of medical equipment, and in particular to a sample analysis system and a sample analysis method. Background Art

[0002] In sample testing, such as glycated hemoglobin testing, the sample measurement results may exceed the effective measurement linear range, which will cause abnormal sample measurement results. For example, when the relevant technology detects the concentration of glycated hemoglobin, the accuracy of samples with higher glycated hemoglobin concentration is better, but for some samples with glycated hemoglobin concentration, the test results are not accurate enough. For example, samples with lower glycated hemoglobin concentration are greatly affected by impurities and the test results are not accurate enough, which will seriously affect the clinical diagnosis of diabetes. Summary of the invention

[0003] The present application provides a sample analysis system and a sample analysis method, which can obtain relatively accurate detection results.

[0004] In a first aspect, an embodiment of the present application provides a sample analysis system, comprising:

[0005] A preparation component, wherein the preparation component is used to prepare a pretreatment test solution using a sample of a subject and a pretreatment reagent, and to prepare a sample solution to be tested using a detection reagent and the pretreatment test solution;

[0006] A detection component, the detection component is used to detect the sample liquid to be tested to obtain detection data;

[0007] A controller, the controller being configured to:

[0008] Testing the pre-treated test solution to obtain intermediate test information;

[0009] selecting a target calibration curve from at least two calibration curves according to the intermediate detection information;

[0010] And obtaining the detection result of the sample according to the detection data and the target calibration curve.

[0011] In a second aspect, an embodiment of the present application provides a sample analysis system, including:

[0012] A preparation component, the preparation component is used to prepare a sample solution to be tested using a sample from a subject and a reagent;

[0013] A detection component, the detection component is used to detect the sample liquid to be tested to obtain detection data;

[0014] A controller, the controller being configured to:

[0015] selecting a target calibration curve from at least two calibration curves according to detection information of a target substance in a sample of the subject;

[0016] And obtaining the detection result of the sample according to the detection data and the target calibration curve.

[0017] In a third aspect, an embodiment of the present application provides a sample analysis system, including:

[0018] A preparation component, the preparation component is used to prepare a sample solution to be tested using a sample from a subject and a reagent;

[0019] A detection component, the detection component is used to detect the sample liquid to be tested to obtain detection data;

[0020] A mode selection module, configured to select a target detection mode from at least two detection modes;

[0021] A controller is used to obtain the concentration of glycated hemoglobin in the sample according to the target detection mode and the detection data, wherein the calibration curves corresponding to at least two of the detection modes are different and the concentrations of hemoglobin in the sample liquid to be tested detected by at least two detection modes are different.

[0022] In a fourth aspect, an embodiment of the present application provides a sample analysis method, including:

[0023] A pretreatment test solution is prepared using a sample of a subject and a pretreatment reagent, and a sample solution to be tested is prepared using a detection reagent and the pretreatment test solution;

[0024] Testing the sample liquid to be tested to obtain test data;

[0025] Testing the pre-treated test solution to obtain intermediate test information;

[0026] selecting a target calibration curve from at least two calibration curves according to the intermediate detection information;

[0027] And obtaining the detection result of the sample according to the detection data and the target calibration curve.

[0028] In a fifth aspect, an embodiment of the present application provides a sample analysis method, including:

[0029] Using the subject's sample and reagents to prepare a sample solution to be tested;

[0030] Testing the sample liquid to be tested to obtain test data;

[0031] selecting a target calibration curve from at least two calibration curves according to detection information of a target substance in a sample of the subject;

[0032] And obtaining the detection result of the sample according to the detection data and the target calibration curve.

[0033] In a sixth aspect, an embodiment of the present application provides a sample analysis method, comprising:

[0034] Using the subject's sample and reagents to prepare a sample solution to be tested;

[0035] Testing the sample liquid to be tested to obtain test data;

[0036] selecting a target detection mode among at least two detection modes;

[0037] The concentration of glycated hemoglobin in the sample is obtained according to the target detection mode and the detection data, the calibration curves corresponding to at least two of the detection modes are different, and the concentrations of hemoglobin in the sample liquid to be tested detected by at least two detection modes are different.

[0038] The sample analysis system and sample analysis method provided in the embodiment of the present application, the preparation component of the sample analysis system is used to prepare a pretreatment test solution using a sample of a subject and a pretreatment reagent, and to prepare a sample solution to be tested using a detection reagent and the pretreatment test solution; the detection component is used to detect the sample solution to be tested to obtain detection data; the controller is used to detect the pretreatment test solution to obtain intermediate detection information; a target calibration curve is selected from at least two calibration curves according to the intermediate detection information; and the detection result of the sample is obtained according to the detection data and the target calibration curve. By adaptively selecting the corresponding calibration curve as the target calibration curve according to the intermediate detection information of the pretreatment test solution, a more accurate detection result can be obtained based on the target calibration curve.

[0039] It should be understood that the above general description and the following detailed description are merely exemplary and explanatory and cannot limit the disclosure of the embodiments of the present application. BRIEF DESCRIPTION OF THE DRAWINGS

[0040] In order to more clearly illustrate the technical solutions of the embodiments of the present application, the drawings required for use in the description of the embodiments will be briefly introduced below. Obviously, the drawings described below are some embodiments of the present application. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative work.

[0041] Figure 1 is a structural schematic diagram of a sample analysis system provided in an embodiment of the present application;

[0042] Figure 2 is a schematic block diagram of a sample analysis system in one embodiment of the present application;

[0043] Figure 3 is a schematic block diagram of a sample analysis system in another embodiment of the present application;

[0044] Figure 4 It is a schematic diagram of using a fixed calibration curve to determine the concentration of glycated hemoglobin in the related art;

[0045] Figure 5 is a schematic diagram of at least two calibration curves in one embodiment of the present application;

[0046] Figure 6 is a structural schematic diagram of a sample analysis system provided by another embodiment of the present application;

[0047] Figure 7 It is a flow chart of a sample analysis method provided in one embodiment of the present application;

[0048] Figure 8 is a flow chart of a sample analysis method provided by another embodiment of the present application;

[0049] Fig. 9 It is a flow chart of a sample analysis method provided in yet another embodiment of the present application.

[0050] Description of reference numerals:

[0051] 110, preparation component; 120, detection component; 130, controller; 140, mode selection module;

[0052] 10. Functional module; 11. Sample component; 12. Sample dispensing mechanism; 13. Reagent component; 14. Reagent dispensing mechanism; 15. Mixing mechanism; 16. Reaction component; 17. Photometric component; 20. Input module; 30. Display module; 40. Memory; 50. Processor; 60. Alarm module. DETAILED DESCRIPTION

[0053] The following will be combined with the drawings in the embodiments of the present application to clearly and completely describe the technical solutions in the embodiments of the present application. Obviously, the described embodiments are part of the embodiments of the present application, not all of the embodiments. Based on the embodiments in the present application, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of this application.

[0054] The flowcharts shown in the accompanying drawings are only examples and do not necessarily include all the contents and operations / steps, nor must they be executed in the order described. For example, some operations / steps may also be decomposed, combined or partially merged, so the actual execution order may change according to actual conditions.

[0055] In conjunction with the accompanying drawings, some embodiments of the present application are described in detail below. In the absence of conflict, the following embodiments and features in the embodiments can be combined with each other.

[0056] See also Figure 1 , Figure 1 It is a structural schematic diagram of a sample analysis system provided in an embodiment of the present application.

[0057] like Figure 1 As shown, the sample analysis system of the embodiment of the present application includes: a preparation component 110 , a detection component 120 , and a controller 130 .

[0058] In some embodiments, the sample analysis system includes at least one sample analyzer, which is used to detect the test items corresponding to the samples. The sample analyzer is used to detect the test items corresponding to the samples and obtain the test results of the samples. After obtaining the test results of each sample, the corresponding test results can be stored and / or output.

[0059] In some embodiments, the sample analyzer includes but is not limited to at least one of the following: a biochemical analyzer, an electrolyte analyzer, an immunoassay analyzer, a coagulation analyzer, and a urine analyzer, wherein the electrolyte analyzer is, for example, an ISE (Ion Selective Electrode) analyzer.

[0060] Exemplarily, the sample analyzer is a biochemical analysis module in a biochemical analyzer, and the biochemical analyzer may further include at least one of an ISE analysis module, an immune analysis module, a coagulation analysis module, a urine analysis module, and the like.

[0061] Before describing the present invention in detail, the structure of a sample analyzer in some embodiments is described first.

[0062] Please refer to Figure 2 , the sample analyzer includes at least one functional module 10 (or one or more functional modules 10).

[0063] Each functional module 10 is used to complete at least one function required in the sample analysis process, and these functional modules 10 work together to complete the sample analysis and obtain the sample analysis results. Figure 3 , is a sample analyzer of an embodiment, in which some examples are given of the functional module 10. For example, the functional module 10 may include a sample component 11, a sample dispensing mechanism 12, a reagent component 13, a reagent dispensing mechanism 14, a mixing mechanism 15, a reaction component 16, and a detection device 17.

[0064] The sample component 11 is used to carry samples. In some examples, the sample component 11 may include a sample delivery module (SDM) and a front track; in other examples, the sample component 11 may also be a sample tray, which includes a plurality of sample positions such as sample tubes, and the sample tray can dispatch samples to corresponding positions, such as positions for the sample dispensing mechanism 12 to absorb samples, by rotating its tray structure.

[0065] The sample dispensing mechanism 12 is used to absorb the sample and discharge it into the reaction cup to be loaded with the sample. For example, the sample dispensing mechanism 12 may include a sample needle, and the sample needle performs two-dimensional or three-dimensional movement in space through a two-dimensional or three-dimensional driving mechanism, so that the sample needle can move to absorb the sample carried by the sample component 11, and move to the reaction cup to be loaded with the sample, and discharge the sample into the reaction cup.

[0066] The reagent component 13 is used to carry the reagent. In one embodiment, the reagent component 13 may be a reagent disk, which is a disk-shaped structure with multiple positions for carrying the reagent. The reagent component 13 can rotate and drive the reagent it carries to rotate, and is used to rotate the reagent to a specific position, such as a position where the reagent is sucked by the reagent dispensing mechanism 14. The number of the reagent components 13 may be one or more.

[0067] Optionally, the sample analysis system may include one or more reagent components 13 . The reagent component 13 may be disposed on one or more sample analyzers, or may be independently disposed on each sample analyzer. Each sample analyzer may use the reagent on the reagent component 13 to perform sample detection.

[0068] The reagent dispensing mechanism 14 is used to absorb the reagent and discharge it into the reaction cup to be added with the reagent. In one embodiment, the reagent dispensing mechanism 14 may include a reagent needle, which is moved in two dimensions or three dimensions in space by a two-dimensional or three-dimensional driving mechanism, so that the reagent needle can move to absorb the reagent, move to the reaction cup to be added with the reagent, and discharge the reagent into the reaction cup.

[0069] It should be noted that, depending on the different test samples and test items, the samples and reagents can be added in different ways, for example, the samples and reagents can be added using a sample needle and a reagent needle respectively, or only the sample can be added using a sample needle, while the reagents can be added using other ways. In some other embodiments, the reagent dispensing mechanism 14 and the sample dispensing mechanism 12 can be the same set of dispensing mechanisms, for example, the sample needle and the reagent needle can use a reusable sampling needle, and the reagent or sample can be transferred after cleaning.

[0070] The mixing mechanism 15 is used to mix the reaction solution in the reaction cup. The number of the mixing mechanism 15 can be one or more.

[0071] The reaction component 16 has at least one placement position, and the placement position is used to place the reaction cup and incubate the reaction liquid in the reaction cup. For example, the reaction component 16 can be a reaction disk, which is arranged in a disc-shaped structure and has one or more placement positions for placing the reaction cup. The reaction disk can rotate and drive the reaction cup in its placement position to rotate, so as to arrange the reaction cup in the reaction disk and incubate the reaction liquid in the reaction cup.

[0072] Exemplarily, the preparation component 110 in the sample analysis system may include Figure 3 The sample part 11 , the sample dispensing mechanism 12 , the reagent part 13 , the reagent dispensing mechanism 14 , the mixing mechanism 15 , and the reaction part 16 are shown.

[0073] The detection device 17 is used to detect the reaction liquid after incubation. For example, the detection device 17 includes a light measuring component, which is used to perform light measurement on the reaction liquid after incubation to obtain the reaction data of the sample. For example, the light measuring component detects the luminescence intensity of the reaction liquid to be measured. The concentration of the component to be measured in the sample can be calculated according to the luminescence intensity of the detected reaction liquid through the calibration curve. In one embodiment, the light measuring component is separately arranged outside the reaction component 16. Of course, it is not limited to this. In other embodiments, the detection device 17 can also include an electrical measurement mechanism (such as an impedance measurement mechanism) or a measurement mechanism based on other principles (such as an imaging measurement mechanism).

[0074] Exemplarily, the detection component 120 in the sample analysis system may include Figure 3 The detection device 17 is shown.

[0075] In some embodiments, the sample analysis system may further include a control device. Exemplarily, the control device includes an input module 20 , a display module 30 , a memory 40 , a processor 50 , and an alarm module 60 ; for example, the controller 130 includes at least the processor 50 .

[0076] Optional, such as Figure 2 As shown, the control device is arranged on one or more sample analyzers in the sample analysis system; of course, it is not limited thereto, for example, the control device may also be arranged independently from each sample analyzer, for example, it may be an independent terminal device such as a computer.

[0077] The input module 20 is used to receive user input. Generally, the input module 20 can be a mouse and a keyboard, etc. In some cases, it can also be a touch screen, which provides functions for user input and content display. Therefore, in this example, the input module 20 and the display module 30 are integrated together. Of course, in some examples, the input module 20 can even be a voice input device that recognizes voice.

[0078] The display module 30 can be used to display information. In some embodiments, the sample analyzer itself can be integrated with a display module. In some embodiments, the sample analyzer can also be connected to a computer device (such as a computer) to display information through a display unit (such as a display screen) of the computer device, which all fall within the scope defined and protected by the display module 30 in this document.

[0079] The processor 50 is used to obtain the test data when the functional module 10 completes the sample analysis, and determine the test result according to the test data; optionally, it can also determine whether the alarm condition is triggered according to the test data or the test result and the alarm condition in the memory 40. In some embodiments, the processor 50 obtains the test data of the sample and determines whether the reaction process of the sample is normal according to the alarm condition.

[0080] The alarm module 60 is used to issue an alarm when the processor 50 determines that an alarm condition is triggered. In some embodiments, when the alarm condition has a corresponding alarm identifier, when the processor 50 determines that the alarm condition is triggered, the alarm module 60 drives the display module 30 to display the alarm identifier corresponding to the alarm condition to issue an alarm. In some examples, the alarm module 60 can be hardware with a display function, and even the alarm module 60 can be integrated with the display module 30 to warn and prompt the user by displaying content.

[0081] Optionally, the sample analysis system may further include a sample scheduling device, which is used to schedule samples to the sample analyzer, or may schedule samples between multiple sample analyzers.

[0082] For the sake of convenience of explanation, the following description will be mainly based on an example in which the sample analyzer in the sample analysis system is a biochemical analyzer.

[0083] See also Figure 1 The preparation component 110 in the sample analysis system is used to prepare a pretreatment test solution using a sample from a subject and a pretreatment reagent, and to prepare a sample solution to be tested using a detection reagent and the pretreatment test solution.

[0084] The sample may be a blood sample, such as a whole blood sample, but is certainly not limited thereto. For example, the sample may also be lymph fluid, cerebrospinal fluid, etc. For ease of explanation, the embodiments of the present application are mainly described using a blood sample as an example.

[0085] For example, the pretreatment reagent includes a hemolytic agent for lysing red blood cells in the blood sample to be tested to release hemoglobin, and may also include an enzyme reagent or an immunoreagent for detecting the hemoglobin content, wherein the enzyme reagent for detecting the hemoglobin content includes, for example, a proteolytic enzyme (which reacts with glycated hemoglobin to produce glycosylated peptides or glycosylated amino acids), and the immunoreagent for detecting the hemoglobin content includes, for example, a glycated hemoglobin-specific antibody. The detection reagent may include an enzyme reagent or an immunoreagent for detecting glycated hemoglobin, wherein the enzyme reagent for detecting glycated hemoglobin includes, for example, a specific oxidase (which reacts with glycosylated peptides or glycosylated amino acids to produce a detectable product, such as hydrogen peroxide), and the immunoreagent for detecting glycated hemoglobin includes, for example, a multi-cluster single antigen carrying several glycated hemoglobin antigenic determinants.

[0086] The detection process of the embodiment of the present application can be applied to a sample analysis system for detecting glycated hemoglobin based on immunoturbidimetry or enzymatic method, but it is certainly not limited thereto, and can also be applied to a sample analysis system based on detection techniques such as immunoaffinity chromatography, ion exchange chromatography, and capillary electrophoresis. The detection reagents of the immunoaffinity chromatography method include aminophenylboronic acid agarose gel, asparagine buffer, and sorbitol buffer (eluent), etc., and accordingly, the detection component 120 includes a detection device based on the immunoaffinity chromatography method; the detection reagents of the ion exchange chromatography method include an equilibrium buffer and an elution buffer, and accordingly, the detection component 120 includes a detection device based on the ion exchange chromatography method.

[0087] See also Figure 1 The detection component 120 in the sample analysis system is used to detect the sample liquid to be detected to obtain detection data, and the controller 130 is at least used to obtain the detection result of the sample according to the detection data.

[0088] For example, the detection component 120 includes a light measurement component, but is not limited thereto. For example, it may also include an electrical measurement mechanism (such as an impedance measurement mechanism) or a measurement mechanism based on other principles (such as an imaging measurement mechanism). For ease of description, the present embodiment of the application mainly uses the light measurement detection component 120 as an example for description. For example, the light measurement detection component can detect the light measurement results of the sample liquid to be tested, such as obtaining absorbance at multiple different times.

[0089] For example, the controller 130 may obtain the reactivity of the sample liquid according to the optical detection result of the sample liquid, and determine the detection result of the sample, such as the concentration of glycated hemoglobin of the sample, according to the reactivity based on a calibration curve.

[0090] In some embodiments, the concentration of glycated hemoglobin in the sample includes the concentration of glycated hemoglobin in the sample in the hemoglobin of the sample. When the controller 130 determines the test result of the sample, it is used to: obtain the concentration of glycated hemoglobin in the sample solution to be tested according to the test data; obtain the test result of the sample according to the concentration of hemoglobin in the sample and the concentration of glycated hemoglobin in the sample solution to be tested. For example, the proportion or percentage content of glycated hemoglobin to hemoglobin can be used as the unit of the test result, such as I FCC (mmol / mol), US NGSP (%), Japanese JDS / JSCC (%) and Swedish MonoS (%) units.

[0091] Specifically, the controller 130 is used to: detect the pre-treated test solution to obtain intermediate detection information; select a target calibration curve from at least two calibration curves according to the intermediate detection information; and obtain the detection result of the sample according to the detection data and the target calibration curve.

[0092] In some embodiments, the test result of the sample includes the test result of the first target substance, and the intermediate test information can characterize the relevant information of the second target substance, wherein the second target substance is a substance that has a deterministic relationship with the first target substance; for example, the test value of the second target substance, such as the concentration of the second target substance, and the concentration of the first target substance usually have a linear relationship. For example, glycated hemoglobin is the product of the continuous and irreversible non-enzymatic protein glycosylation reaction between hemoglobin and glucose in red blood cells, and its concentration is proportional to the concentration of hemoglobin. The first target substance can be glycated hemoglobin, and the second target substance can be hemoglobin.

[0093] Based on the relevant information of the second target substance represented by the intermediate detection information, the range of the detection result of the first target substance can be estimated, for example, whether the concentration of glycated hemoglobin in the sample liquid to be tested is too low or too high can be determined; and based on the estimated range of the detection result of the first target substance, a target calibration curve corresponding to the range is selected from at least two calibration curves; so that when the detection result of the sample is obtained according to the detection data, a more accurate detection result can be obtained based on the target calibration curve.

[0094] Exemplarily, the first target substance is glycated hemoglobin, and the second target substance is hemoglobin; the intermediate detection information includes a detection value related to the hemoglobin concentration of the pretreatment test solution, such as the hemoglobin concentration of the pretreatment test solution. For example, the pretreatment reagent includes a hemolytic agent for lysing the blood sample to be tested, such as red blood cells in a whole blood sample to release hemoglobin. A target calibration curve can be selected from at least two calibration curves based on the detection value related to the hemoglobin concentration of the pretreatment test solution.

[0095] For example, the controller 130 obtains a light signal generated by the reaction between the blood sample of the subject detected by the detection component 120 and the hemolytic agent after being irradiated with light, and obtains the hemoglobin concentration of the pre-treated test solution based on the light signal. Of course, it is not limited to this. For example, the controller 130 obtains an image obtained by a camera shooting the pre-treated test solution, and obtains the hemoglobin concentration of the pre-treated test solution based on the image.

[0096] Exemplarily, the first target substance is glycated hemoglobin, and the second target substance is red blood cells; the intermediate detection information includes a detection value related to the hematocrit of the pretreatment test solution. For example, the pretreatment reagent includes a diluent for diluting the blood sample to be tested to detect the hematocrit. Since the hemoglobin concentration in the blood sample is linearly related to the hematocrit in the blood sample after centrifugation or natural static sedimentation, that is, "hematocrit / total sample volume" (HCT), the target calibration curve can also be selected from at least two calibration curves based on the detection value related to the hematocrit.

[0097] For example, the controller 130 obtains a pulse measurement signal when a detection device such as a resistance measurement device passes through the pre-treatment test solution, and obtains a detection value related to hematocrit based on the pulse measurement signal. Of course, it is not limited to this. For example, an image of a blood sample taken by a camera after centrifugation or natural static sedimentation can be obtained, and the ratio of the hematocrit h to the total volume L of the sample can be determined based on the image to obtain the hematocrit HCT (=h / L) of the first pre-treatment test solution.

[0098] In some embodiments, the pretreatment test solution used to detect the intermediate detection information can be the same as the pretreatment test solution used to prepare the sample solution to be tested, that is, after detecting the intermediate detection information of the pretreatment test solution, the pretreatment test solution can be used to prepare the sample solution to be tested. This can reduce the consumption of reagents, and can also implement the detection process of the embodiment of the present application when the sample analysis system includes a stand-alone sample analyzer.

[0099] Exemplarily, the detection device for detecting the pre-treated test solution to obtain intermediate detection information and the detection device for detecting the sample solution to obtain detection data can be the same detection device in order to reduce costs; of course, they can also be different detection devices, for example, the different detection devices correspond to different detection wavelengths.

[0100] In other embodiments, the pretreatment test solution used to detect the intermediate detection information and the pretreatment test solution used to prepare the sample solution to be tested may also be different pretreatment test solutions; for example, a first pretreatment test solution and a second pretreatment test solution may be prepared separately, the first pretreatment test solution is used to detect the intermediate detection information, and the second pretreatment test solution is used to prepare the sample solution to be tested. Exemplarily, the first pretreatment test solution and the second pretreatment test solution may be prepared and detected by different sample analyzers in the sample analysis system.

[0101] In some embodiments, the intermediate detection information includes the concentration of hemoglobin, and the detection result of the sample includes the concentration of glycated hemoglobin in the sample.

[0102] The concentration of glycated hemoglobin in the sample can be determined based on the concentration of glycated hemoglobin in the sample solution to be tested. For example, the concentration of glycated hemoglobin in the sample includes the concentration of glycated hemoglobin in the sample in the hemoglobin of the sample. For example, when the controller 130 obtains the test result of the sample based on the test data and the target calibration curve, it is used to: obtain the concentration of glycated hemoglobin in the sample solution to be tested based on the test data and the target calibration curve; obtain the test result of the sample based on the concentration of hemoglobin and the concentration of glycated hemoglobin in the sample solution to be tested. Exemplarily, the concentration of glycated hemoglobin in the sample solution to be tested can be determined based on the concentration of glycated hemoglobin in the sample solution to be tested, and the dilution ratio of the pretreatment reagent to prepare the pretreatment test solution and the pretreatment test solution to prepare the sample solution to be tested; the concentration of glycated hemoglobin in the sample in the hemoglobin of the sample can be determined based on the concentration of hemoglobin in the sample and the concentration of glycated hemoglobin in the sample solution to be tested.

[0103] Glycated hemoglobin level is the gold standard for reflecting the long-term blood sugar control level of diabetic patients. When the relevant technology detects the concentration of glycated hemoglobin, the accuracy of samples with higher glycated hemoglobin concentration is better, but for some samples with lower glycated hemoglobin concentration, the test results are not accurate enough. For example, samples with lower glycated hemoglobin concentration are greatly affected by impurities and the test results are not accurate enough, which will seriously affect the clinical diagnosis of diabetes. In the measurement methods such as immunoaffinity chromatography, ion exchange chromatography, capillary electrophoresis, immunoturbidimetry and enzyme method, re-testing may be required due to interference from lipid turbidity samples or test results exceeding the effective measurement range.

[0104] Taking the enzymatic method as an example, biochemical analysis instruments generally use a fixed calibration curve to detect the concentration of glycated hemoglobin, such as Figure 4The figure shows a schematic diagram of the related art using a fixed calibration curve to determine the concentration of glycated hemoglobin in the sample solution to be tested according to the reaction degree corresponding to the test data. Usually, when the concentration of glycated hemoglobin in the sample solution to be tested is not very low, the change of the glycated hemoglobin concentration is linear, and the precision and accuracy of the test results obtained by the test can meet the requirements. However, when the hemoglobin concentration and the glycated hemoglobin concentration of the sample to be tested are low, the glycated hemoglobin test results will be affected by impurities and produce positive deviations when using enzyme methods and other detection methods for glycated hemoglobin detection, that is, the concentration is higher than the actual concentration, which will affect the clinical diagnosis of diabetes in severe cases.

[0105] The embodiment of the present application can estimate the range of glycated hemoglobin in the sample solution to be tested based on intermediate test information such as the test value related to the hemoglobin concentration of the pre-treated test solution and the test value related to the hematocrit; at least when it is estimated that the concentration of glycated hemoglobin in the sample solution to be tested is too low, the problem of the glycated hemoglobin concentration being too high can be solved by switching the calibration curve; for example, the influence of the impurity background on the glycated hemoglobin concentration can be deducted to achieve the expansion of the linear range of the glycated hemoglobin concentration, so that accurate results can be obtained under wide linearity in one test, thereby achieving the effect of obtaining accurate glycated hemoglobin test results in one test, which can be advantageously used to reduce the retesting of glycated hemoglobin test items.

[0106] In some embodiments, the calibration curve is used to characterize the corresponding relationship between the concentration of glycated hemoglobin in the sample solution to be tested and the reactivity of the sample solution to be tested. When the processor obtains the test result of the sample according to the test data and the target calibration curve, it is used to: determine the reactivity of the sample solution to be tested according to the test data, and obtain the test result of the sample according to the reactivity and the target calibration curve.

[0107] Different calibration curves in the at least two calibration curves at least partially do not overlap, that is, the corresponding relationship between the concentration of glycated hemoglobin and the reactivity of the sample solution to be tested in at least some segments of different calibration curves is different. Figure 5 The corresponding relationship between the concentration and reactivity of the glycated hemoglobin in the sample solution to be tested in the high value segment of the first calibration curve is different from the corresponding relationship in the second calibration curve. Figure 4 See also Figure 5 For a test sample liquid with a low glycated hemoglobin concentration, the concentration obtained based on the first calibration curve at the same reactivity is higher than the actual concentration; by selecting the second calibration curve as the target calibration curve when it is estimated based on the intermediate detection information that the glycated hemoglobin concentration of the test sample liquid is low, so that the concentration obtained based on the second calibration curve is closer to the actual concentration or equal to the actual concentration, thereby obtaining a more accurate detection result.

[0108] In some embodiments, the intermediate detection information includes the concentration of hemoglobin. When the processor selects a target calibration curve from at least two calibration curves based on the intermediate detection information, it is used to: when the concentration of hemoglobin is greater than or equal to a first concentration threshold, select the first calibration curve as the target calibration curve; when the concentration of hemoglobin is less than the first concentration threshold, select the second calibration curve as the target calibration curve; the second calibration curve does not overlap at least partially with the first calibration curve. It should be noted that the concentration of hemoglobin in the intermediate detection information can be the concentration of hemoglobin in the pretreatment test solution or the concentration of hemoglobin in the sample of the subject, and different first concentration thresholds can be set accordingly, which is specifically determined by the dilution ratio of the sample when preparing the pretreatment test solution.

[0109] In some other embodiments, the at least two calibration curves may further include a third calibration curve. For example, when the concentration of hemoglobin is greater than or equal to the first concentration threshold and less than or equal to the third concentration threshold, the first calibration curve is selected as the target calibration curve; when the concentration of hemoglobin is greater than the third concentration threshold, the third calibration curve is selected as the target calibration curve.

[0110] For example, when the concentration of hemoglobin is less than the first concentration threshold, it can be estimated that the concentration of glycated hemoglobin in the sample liquid to be tested is low. By selecting the second calibration curve as the target calibration curve, the concentration obtained based on the second calibration curve is closer to the actual concentration or equal to the actual concentration, thereby obtaining a more accurate test result.

[0111] For example, see Figure 5 The first calibration curve and the second calibration curve overlap in a range where the hemoglobin concentration is greater than or equal to a first concentration threshold, and do not overlap in a range where the hemoglobin concentration is less than the first concentration threshold.

[0112] Preferably, within the range where the hemoglobin concentration is less than the first concentration threshold, the ratio of the glycated hemoglobin concentration to the corresponding reactivity in the second calibration curve is greater than the ratio of the glycated hemoglobin concentration to the corresponding reactivity in the first calibration curve. Figure 5 The concentration of glycated hemoglobin corresponding to the hemoglobin of the first concentration threshold has the same reactivity in the first calibration curve and the second calibration curve; within the range where the hemoglobin concentration is less than the first concentration threshold, the slope of the second calibration curve is greater than the slope of the first calibration curve.

[0113] Preferably, see Figure 5, within the range where the concentration of hemoglobin is less than the first concentration threshold, the concentration of glycated hemoglobin corresponding to at least one reactivity in the second calibration curve is less than the concentration of glycated hemoglobin corresponding to the same reactivity in the first calibration curve.

[0114] By estimating that the concentration of glycated hemoglobin in the sample liquid to be tested is low when the concentration of hemoglobin is within the range less than the first concentration threshold, and selecting the second calibration curve as the target calibration curve, the concentration obtained based on the second calibration curve can be made lower than the concentration obtained based on the first calibration curve. It can be understood that the concentration obtained based on the second calibration curve is closer to the actual concentration or equal to the actual concentration, thereby obtaining a more accurate detection result.

[0115] Optionally, the second calibration curve is obtained by compensating the first calibration curve.

[0116] For example, see Figure 5 , the first calibration curve can be called the original calibration curve of glycated hemoglobin, for example, it is expressed as c=k×(R-R0), wherein R represents the reactivity determined according to the detection data of the sample solution to be tested, c represents the concentration of glycated hemoglobin corresponding to the reactivity, k and R0 are preset values ​​or can be determined by the reactivity obtained by detecting a standard solution with a known glycated hemoglobin concentration, the standard solution includes a standard solution with a glycated hemoglobin concentration greater than or equal to a second concentration threshold, wherein when the glycated hemoglobin concentration is greater than or equal to the second concentration threshold, the corresponding hemoglobin concentration is usually greater than or equal to the first concentration threshold. For example, the detection component 120 is also used to detect a standard solution with a known glycated hemoglobin concentration to obtain detection data; the controller 130 is also used to determine the reactivity of the standard solution according to the detection data of the standard solution, and determine the first calibration curve according to the glycated hemoglobin concentration and reactivity of the standard solution, such as determining k and R0 in the first calibration curve.

[0117] For example, the first calibration curve can be compensated by the compensation amounts Δk and ΔR0 to obtain a second calibration curve, and the compensated second calibration curve can be expressed as: c = (k + Δk) × [R-(R0 + ΔR0)]; the compensation amounts Δk and ΔR0 are preset values ​​or can be established through experiments. For example, a standard solution with a known glycosylated hemoglobin concentration is detected and the corresponding reactivity is determined. The standard solution can also include a standard solution with a glycosylated hemoglobin concentration less than the second concentration threshold. According to the glycosylated hemoglobin concentration less than the second concentration threshold and the corresponding reactivity, the first calibration curve is compensated so that the glycosylated hemoglobin concentration less than the second concentration threshold and the corresponding reactivity are on the compensated second calibration curve.

[0118] In some embodiments, when the controller 130 obtains the test result of the sample based on the test data and the target calibration curve, it is used to: obtain the concentration of glycated hemoglobin in the sample liquid to be tested based on the test data and the target calibration curve; obtain the test result of the sample based on the concentration of hemoglobin and the concentration of glycated hemoglobin in the sample liquid to be tested, and the concentration of glycated hemoglobin in the sample includes the concentration of glycated hemoglobin in the sample in the hemoglobin of the sample.

[0119] In the sample analysis system provided in the embodiment of the present application, the preparation component 110 is used to prepare a pretreatment test solution using a sample of a subject and a pretreatment reagent, and to prepare a sample solution to be tested using a detection reagent and the pretreatment test solution; the detection component 120 is used to detect the sample solution to be tested to obtain detection data; the controller 130 is used to detect the pretreatment test solution to obtain intermediate detection information; select a target calibration curve from at least two calibration curves based on the intermediate detection information; and obtain the detection result of the sample based on the detection data and the target calibration curve. By adaptively selecting the corresponding calibration curve as the target calibration curve based on the intermediate detection information of the pretreatment test solution, a more accurate detection result can be obtained based on the target calibration curve.

[0120] Please refer to the above examples. Figure 1 In other embodiments of the present application, the preparation component 110 in the sample analysis system is used to prepare a sample liquid to be tested using a sample from a subject and reagents; the detection component 120 is used to detect the sample liquid to be tested to obtain detection data; the controller 130 is used to select a target calibration curve from at least two calibration curves based on the detection information of the target substance in the sample from the subject; and obtain the detection result of the sample based on the detection data and the target calibration curve.

[0121] It is understandable that the detection information of the target substance in the sample of the subject in the embodiment of the present application is not limited to the intermediate detection information obtained by detecting the pre-treated test solution as described above. By adaptively selecting the corresponding calibration curve as the target calibration curve according to the detection information of the target substance in the sample, a more accurate detection result can also be obtained based on the target calibration curve.

[0122] Exemplarily, the test result of the sample includes the test result of the first target substance, the target substance may be the second target substance, the second target substance is a substance that has a deterministic relationship with the first target substance, and the test information can characterize the relevant information of the second target substance. For example, the first target substance may be glycated hemoglobin, the second target substance may be hemoglobin, and the test information may include the test value of the hemoglobin concentration or the hematocrit.

[0123] In some embodiments, the controller 130 obtains the detection information of the target substance in the sample of the subject in at least one of the following ways: obtaining detection information of preset detection items, where the preset detection items are different from the detection items corresponding to the detection results of the sample liquid to be tested, for example, the detection items at least include the detection of hemoglobin concentration; obtaining the detection information of the target substance in the sample of the subject from another sample analysis system, which can be applied to the scenario where the detection information of multiple sample analysis systems is summarized and managed; obtaining the detection information of the target substance in the sample of the subject determined based on the detection data of another detection component 120 in the sample analysis system, which can be applied to the scenario where the sample analysis system includes multiple sample analyzers; obtaining the detection information of the target substance in the sample of the subject input by the user, for example, by Figure 2 The input module in obtains the detection information; obtains the historical detection record of the subject, and obtains the detection information according to the historical detection record, for example, obtains the detection information in the historical detection record within three months.

[0124] In some embodiments, the target substance includes hemoglobin, the detection information of the target substance includes the concentration of hemoglobin, and the detection result of the sample includes the concentration of glycated hemoglobin in the sample.

[0125] Exemplarily, the at least two calibration curves include at least a first calibration curve and a second calibration curve, wherein the first calibration curve overlaps with the second calibration curve in a range where the hemoglobin concentration is greater than or equal to a first concentration threshold, and does not overlap in a range where the hemoglobin concentration is less than the first concentration threshold.

[0126] Exemplarily, the calibration curve is used to characterize the corresponding relationship between the concentration of glycated hemoglobin in the sample liquid to be tested and the reactivity of the sample liquid to be tested. When the processor obtains the test result of the sample based on the test data and the target calibration curve, it is used to: determine the reactivity of the sample liquid to be tested based on the test data, and obtain the test result of the sample based on the reactivity and the target calibration curve.

[0127] Exemplarily, when the processor selects a target calibration curve from at least two calibration curves based on the intermediate detection information, it is used to: when the concentration of the hemoglobin is greater than or equal to a first concentration threshold, select the first calibration curve as the target calibration curve; when the concentration of the hemoglobin is less than the first concentration threshold, select the second calibration curve as the target calibration curve; the second calibration curve does not at least partially overlap with the first calibration curve.

[0128] Preferably, within the range where the hemoglobin concentration is less than the first concentration threshold, the ratio of the glycated hemoglobin concentration to the corresponding reactivity in the second calibration curve is greater than the ratio of the glycated hemoglobin concentration to the corresponding reactivity in the first calibration curve.

[0129] Preferably, within the range where the hemoglobin concentration is less than the first concentration threshold, the concentration of glycated hemoglobin corresponding to at least one reactivity in the second calibration curve is less than the concentration of glycated hemoglobin corresponding to the same reactivity in the first calibration curve.

[0130] Exemplarily, the second calibration curve is obtained by compensating the first calibration curve.

[0131] Please refer to the above examples. Figure 6 In some other embodiments of the present application, the sample analysis system may further include a mode selection module 140. The preparation component 110 in the sample analysis system is used to prepare the sample solution to be tested using the sample of the subject and the reagent; the detection component 120 is used to detect the sample solution to be tested to obtain detection data; the mode selection module 140 is used to select a target detection mode from at least two detection modes; the controller 130 is used to obtain the concentration of glycated hemoglobin in the sample according to the target detection mode and the detection data, and the calibration curves corresponding to at least two of the detection modes are different and the concentrations of hemoglobin in the sample solution to be tested detected by at least two detection modes are different.

[0132] Exemplarily, the at least two detection modes include a first detection mode and a second detection mode, wherein in the first detection mode the controller 130 selects the first calibration curve as the target calibration curve, and in the second detection mode the controller 130 selects the second calibration curve as the target calibration curve.

[0133] By using the target detection mode selected by the mode selection module 140 , a relatively accurate detection result can also be obtained based on a calibration curve corresponding to the target detection mode.

[0134] In some embodiments, the mode selection module 140 selects a target detection mode from at least two detection modes according to the intermediate detection information of the pretreatment test solution prepared from the sample of the subject and the pretreatment reagent. For example, the mode selection module 140 may obtain the intermediate detection information obtained by detecting the pretreatment test solution, or the mode selection module 140 may perform detection on the pretreatment test solution to obtain the intermediate detection information.

[0135] Exemplarily, the pretreatment reagent includes a hemolytic agent for lysing red blood cells in the sample to release hemoglobin, and the intermediate detection information includes a detection value related to the hemoglobin concentration of the pretreatment test solution.

[0136] Exemplarily, the pretreatment reagent includes a diluent for diluting the blood sample to be tested to detect the hematocrit, and the intermediate detection information includes a detection value related to the hematocrit of the pretreatment test solution.

[0137] In some embodiments, the mode selection module 140 can obtain the detection information of the target substance in the sample of the subject in at least one of the following ways, and select the target detection mode from at least two detection modes according to the detection information: obtaining detection information of preset detection items, wherein the preset detection items are different from the detection items corresponding to the detection results of the sample liquid to be tested, for example, the detection items at least include the detection of hemoglobin concentration; obtaining the detection information of the target substance in the sample of the subject from another sample analysis system, which can be applied to the scenario where the detection information of multiple sample analysis systems is summarized and managed; obtaining the detection information of the target substance in the sample of the subject determined according to the detection data of another detection component 120 in the sample analysis system, which can be applied to the scenario where the sample analysis system includes multiple sample analyzers; obtaining the detection information of the target substance in the sample of the subject input by the user, for example, by Figure 2 The input module in obtains the detection information; obtains the historical detection record of the subject, and obtains the detection information according to the historical detection record, for example, obtains the detection information in the historical detection record within three months.

[0138] In some embodiments, the mode selection module 140 can select the target detection mode from at least two detection modes according to user operation. For example, the user can set the second detection mode as the target detection mode when it is determined that the concentration of hemoglobin in a certain sample is less than the first concentration threshold; or the user can set the second detection mode as the target detection mode when it is determined that the concentration of glycated hemoglobin in the sample solution to be tested corresponding to a certain sample is less than or equal to the second concentration threshold; or the user can set the second detection mode as the target detection mode when it is determined that the concentration of hemoglobin in a certain sample is greater than the third concentration threshold.

[0139] Please refer to the above examples. Figure 7 , Figure 7 It is a flow chart of a sample analysis method provided in one embodiment of the present application.

[0140] like Figure 7 As shown, the sample analysis method includes the following steps S110 to S150.

[0141] Step S110, using the subject's sample and the pretreatment reagent to prepare a pretreatment test solution, and using the detection reagent and the pretreatment test solution to prepare a sample solution to be tested;

[0142] Step S120, testing the sample liquid to obtain test data;

[0143] Step S130, testing the pre-treated test solution to obtain intermediate test information;

[0144] Step S140, selecting a target calibration curve from at least two calibration curves according to the intermediate detection information;

[0145] Step S150: obtaining a test result of the sample according to the test data and the target calibration curve.

[0146] In some embodiments, the intermediate detection information includes the concentration of hemoglobin, and the detection result of the sample includes the concentration of glycated hemoglobin in the sample.

[0147] In some embodiments, the concentration of glycated hemoglobin in the sample liquid to be tested is obtained based on the test data and the target calibration curve; the test result of the sample is obtained based on the concentration of hemoglobin and the concentration of glycated hemoglobin in the sample liquid to be tested, and the concentration of glycated hemoglobin in the sample includes the concentration of glycated hemoglobin in the sample in the hemoglobin of the sample.

[0148] In some embodiments, the calibration curve is used to characterize the corresponding relationship between the concentration of glycated hemoglobin in the sample solution to be tested and the reactivity of the sample solution to be tested. The reactivity of the sample solution to be tested can be determined based on the test data, and the test result of the sample can be obtained based on the reactivity and the target calibration curve.

[0149] In some embodiments, when the concentration of hemoglobin is greater than or equal to a first concentration threshold, the first calibration curve is selected as the target calibration curve; when the concentration of hemoglobin is less than the first concentration threshold, the second calibration curve is selected as the target calibration curve; the second calibration curve at least partially does not overlap with the first calibration curve.

[0150] Preferably, within the range where the hemoglobin concentration is less than the first concentration threshold, the ratio of the glycated hemoglobin concentration to the corresponding reactivity in the second calibration curve is greater than the ratio of the glycated hemoglobin concentration to the corresponding reactivity in the first calibration curve.

[0151] Preferably, within the range where the hemoglobin concentration is less than the first concentration threshold, the concentration of glycated hemoglobin corresponding to at least one reactivity in the second calibration curve is less than the concentration of glycated hemoglobin corresponding to the same reactivity in the first calibration curve.

[0152] Preferably, the second calibration curve is obtained by compensating the first calibration curve.

[0153] Preferably, the first calibration curve and the second calibration curve overlap in a range where the hemoglobin concentration is greater than or equal to a first concentration threshold, and do not overlap in a range where the hemoglobin concentration is less than the first concentration threshold.

[0154] The specific principles and implementation methods of the sample analysis method provided in the embodiment of the present application are similar to those of the sample analysis system in the aforementioned embodiment, and will not be described in detail here.

[0155] Please refer to the above examples. Figure 8 , Figure 8 It is a flow chart of a sample analysis method provided in one embodiment of the present application.

[0156] like Figure 8 As shown, the sample analysis method includes the following steps S210 to S240.

[0157] Step S210, using the subject's sample and reagents to prepare a sample solution to be tested;

[0158] Step S220, testing the sample liquid to obtain test data;

[0159] Step S230, selecting a target calibration curve from at least two calibration curves according to the detection information of the target substance in the sample of the subject;

[0160] Step S240: obtaining a test result of the sample according to the test data and the target calibration curve.

[0161] In some embodiments, the target substance includes hemoglobin, the detection information of the target substance includes the concentration of hemoglobin, and the detection result of the sample includes the concentration of glycated hemoglobin in the sample.

[0162] In some embodiments, the at least two calibration curves include at least a first calibration curve and a second calibration curve, wherein the first calibration curve overlaps with the second calibration curve in a range where the hemoglobin concentration is greater than or equal to a first concentration threshold, and does not overlap with the second calibration curve in a range where the hemoglobin concentration is less than the first concentration threshold.

[0163] In some embodiments, the controller obtains the detection information of the target substance in the sample of the subject by at least one of the following methods:

[0164] Acquiring detection information of a preset detection item, wherein the preset detection item is different from the detection item corresponding to the detection result of the sample liquid to be tested;

[0165] Acquiring detection information of a target substance in the sample of the subject from another sample analysis system;

[0166] Acquiring detection information of a target substance in the sample of the subject determined based on detection data of another detection component in the sample analysis system;

[0167] Acquiring detection information of a target substance in a sample of the subject input by a user;

[0168] Obtain the historical test records of the subject, and obtain the test information according to the historical test records.

[0169] The specific principles and implementation methods of the sample analysis method provided in the embodiment of the present application are similar to those of the sample analysis system in the aforementioned embodiment, and will not be described in detail here.

[0170] Please refer to the above examples. Fig. 9 , Fig. 9 It is a flow chart of a sample analysis method provided in one embodiment of the present application.

[0171] like Fig. 9 As shown, the sample analysis method includes the following steps S310 to S340.

[0172] Step S310, using the subject's sample and reagents to prepare a sample solution to be tested;

[0173] Step S320, testing the sample liquid to obtain test data;

[0174] Step S330, selecting a target detection mode from at least two detection modes;

[0175] Step S340, obtaining the concentration of glycated hemoglobin in the sample according to the target detection mode and the detection data, wherein the calibration curves corresponding to at least two of the detection modes are different and the concentrations of hemoglobin in the sample liquid to be tested detected by at least two detection modes are different.

[0176] In some embodiments, the mode selection module selects a target detection mode from at least two detection modes based on intermediate detection information of a pretreatment test solution prepared from the subject's sample and a pretreatment reagent.

[0177] In some embodiments, the pretreatment reagent includes a hemolytic agent for lysing red blood cells in the sample to release hemoglobin, and the intermediate detection information includes a detection value related to the hemoglobin concentration of the pretreatment test solution.

[0178] In some embodiments, the pretreatment reagent includes a diluent for diluting the blood sample to be tested to detect the hematocrit, and the intermediate detection information includes a detection value related to the hematocrit of the pretreatment test solution.

[0179] The specific principles and implementation methods of the sample analysis method provided in the embodiment of the present application are similar to those of the sample analysis system in the aforementioned embodiment, and will not be described in detail here.

[0180] It should be understood that the terminology used in this application is for the purpose of describing particular embodiments only and is not intended to be limiting of the application.

[0181] It will also be understood that the term "and / or" as used in this application and the appended claims refers to and includes any and all possible combinations of one or more of the associated listed items.

[0182] The above is only a specific implementation of the present application, but the protection scope of the present application is not limited thereto. Any technician familiar with the technical field can easily think of various equivalent modifications or replacements within the technical scope disclosed in the present application, and these modifications or replacements should be included in the protection scope of the present application. Therefore, the protection scope of the present application shall be based on the protection scope of the claims.

Claims

1. A sample analysis system, characterized in that: include: A preparation component, wherein the preparation component is used to prepare a pretreatment test solution using a sample of a subject and a pretreatment reagent, and to prepare a sample solution to be tested using a detection reagent and the pretreatment test solution; A detection component, the detection component is used to detect the sample liquid to be tested to obtain detection data; A controller, the controller being configured to: Testing the pre-treated test solution to obtain intermediate test information; selecting a target calibration curve from at least two calibration curves according to the intermediate detection information; And obtaining the detection result of the sample according to the detection data and the target calibration curve.

2. The sample analysis system according to claim 1, characterized in that: The intermediate detection information includes the concentration of hemoglobin, and the detection result of the sample includes the concentration of glycated hemoglobin in the sample.

3. The sample analysis system according to claim 2, characterized in that: When the controller obtains the detection result of the sample according to the detection data and the target calibration curve, it is used to: Obtaining the concentration of glycated hemoglobin in the sample solution to be tested according to the test data and the target calibration curve; The test result of the sample is obtained according to the concentration of the hemoglobin and the concentration of the glycated hemoglobin in the sample solution to be tested. The concentration of the glycated hemoglobin in the sample includes the concentration of the glycated hemoglobin in the sample in the hemoglobin of the sample.

4. The sample analysis system according to claim 2, characterized in that: The calibration curve is used to characterize the corresponding relationship between the concentration of glycated hemoglobin in the sample solution to be tested and the reactivity of the sample solution to be tested. When the processor obtains the test result of the sample according to the test data and the target calibration curve, it is used to: determine the reactivity of the sample solution to be tested according to the test data, and obtain the test result of the sample according to the reactivity and the target calibration curve; When the processor selects a target calibration curve from at least two calibration curves according to the intermediate detection information, it is configured to: When the concentration of the hemoglobin is greater than or equal to a first concentration threshold, selecting the first calibration curve as the target calibration curve; When the concentration of the hemoglobin is less than the first concentration threshold, selecting the second calibration curve as the target calibration curve; The second calibration curve at least partially does not overlap with the first calibration curve; Preferably, within the range where the hemoglobin concentration is less than the first concentration threshold, the ratio of the glycated hemoglobin concentration to the corresponding reactivity in the second calibration curve is greater than the ratio of the glycated hemoglobin concentration to the corresponding reactivity in the first calibration curve; and / or In the range where the hemoglobin concentration is less than the first concentration threshold, the concentration of glycated hemoglobin corresponding to at least one reactivity in the second calibration curve is less than the concentration of glycated hemoglobin corresponding to the same reactivity in the first calibration curve.

5. The sample analysis system according to claim 4, characterized in that: The second calibration curve is obtained by compensating the first calibration curve.

6. The sample analysis system according to claim 4, characterized in that: The first calibration curve overlaps with the second calibration curve in a range where the hemoglobin concentration is greater than or equal to a first concentration threshold, and does not overlap with the second calibration curve in a range where the hemoglobin concentration is less than the first concentration threshold.

7. A sample analysis system, characterized in that: include: A preparation component, the preparation component is used to prepare a sample solution to be tested using a sample from a subject and a reagent; A detection component, the detection component is used to detect the sample liquid to be tested to obtain detection data; A controller, the controller being configured to: selecting a target calibration curve from at least two calibration curves according to detection information of the target substance in the sample of the subject; And obtaining the detection result of the sample according to the detection data and the target calibration curve.

8. The sample analysis system according to claim 7, characterized in that: The target substance includes hemoglobin, the detection information of the target substance includes the concentration of hemoglobin, and the detection result of the sample includes the concentration of glycated hemoglobin in the sample.

9. The sample analysis system according to claim 8, characterized in that: The at least two calibration curves include at least a first calibration curve and a second calibration curve, wherein the first calibration curve overlaps with the second calibration curve in a range where the hemoglobin concentration is greater than or equal to a first concentration threshold, and does not overlap with the second calibration curve in a range where the hemoglobin concentration is less than the first concentration threshold.

10. The sample analysis system according to any one of claims 7 to 9, characterized in that: The controller obtains the detection information of the target substance in the sample of the subject by at least one of the following methods: Acquiring detection information of a preset detection item, wherein the preset detection item is different from the detection item corresponding to the detection result of the sample liquid to be tested; Acquiring detection information of a target substance in the sample of the subject from another sample analysis system; Acquiring detection information of a target substance in the sample of the subject determined based on detection data of another detection component in the sample analysis system; Acquiring detection information of a target substance in a sample of the subject input by a user; Obtain the historical test records of the subject, and obtain the test information according to the historical test records.

11. A sample analysis system, characterized in that: include: A preparation component, the preparation component is used to prepare a sample solution to be tested using a sample from a subject and a reagent; A detection component, the detection component is used to detect the sample liquid to be tested to obtain detection data; A mode selection module, configured to select a target detection mode from at least two detection modes; A controller is used to obtain the concentration of glycated hemoglobin in the sample according to the target detection mode and the detection data, wherein the calibration curves corresponding to at least two of the detection modes are different and the concentrations of hemoglobin in the sample liquid to be tested detected by at least two detection modes are different.

12. The sample analysis system according to claim 11, characterized in that: The mode selection module selects a target detection mode from at least two detection modes according to intermediate detection information of a pretreatment test solution prepared from the sample of the subject and a pretreatment reagent.

13. The sample analysis system according to claim 12, wherein: The pretreatment reagent includes a hemolytic agent for lysing red blood cells in the sample to release hemoglobin, and the intermediate detection information includes a detection value related to the hemoglobin concentration of the pretreatment test solution.

14. The sample analysis system according to claim 12, wherein: The pretreatment reagent includes a diluent for diluting the blood sample to be tested to detect the hematocrit, and the intermediate detection information includes a detection value related to the hematocrit of the pretreatment test solution.

15. A sample analysis method, characterized in that: include: A pretreatment test solution is prepared using a sample of a subject and a pretreatment reagent, and a sample solution to be tested is prepared using a detection reagent and the pretreatment test solution; Testing the sample liquid to be tested to obtain test data; Testing the pre-treated test solution to obtain intermediate test information; selecting a target calibration curve from at least two calibration curves according to the intermediate detection information; And obtaining the detection result of the sample according to the detection data and the target calibration curve.

16. A sample analysis method, characterized in that: include: Using the subject's sample and reagents to prepare a sample solution to be tested; Testing the sample liquid to be tested to obtain test data; selecting a target calibration curve from at least two calibration curves according to detection information of the target substance in the sample of the subject; And obtaining the detection result of the sample according to the detection data and the target calibration curve.

17. A sample analysis method, characterized in that: include: Using the subject's sample and reagents to prepare a sample solution to be tested; Testing the sample liquid to be tested to obtain test data; selecting a target detection mode among at least two detection modes; The concentration of glycated hemoglobin in the sample is obtained according to the target detection mode and the detection data, the calibration curves corresponding to at least two of the detection modes are different, and the concentrations of hemoglobin in the sample liquid to be tested detected by at least two detection modes are different.