Sample analysis system and sample analysis method

Abstract

The embodiment of the invention provides a sample analysis system and a sample analysis method. A preparation device of the sample analysis system is used for preparing a pretreatment 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 solution; the first detection device is used for detecting the pretreatment liquid to obtain intermediate detection information; the second detection device is used for detecting the to-be-detected sample liquid to obtain detection data; the controller is used for acquiring a range in which an intermediate detection value corresponding to the intermediate detection information is located; when the intermediate detection value is in the first range, obtaining a detection result for the target detection item according to the detection data; and when the intermediate detection value is in the second range, correcting the detection data, and obtaining a detection result for the target detection item by adopting the corrected detection data. And when the intermediate detection value is in the second range, the detection data is corrected, so that a more accurate detection result for the target detection item can be obtained.

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. Taking glycated hemoglobin testing as an example, clinically, the average blood sugar level of a person in the last 2 to 3 months can be evaluated through the test results of hemoglobin (Hb) and glycated hemoglobin (HbA1c). When the current relevant technology detects the concentration of glycated hemoglobin, for some samples with a low concentration of glycated hemoglobin, the test results are not accurate enough. For example, the test results of samples with a low concentration of glycated hemoglobin deviate greatly from the true value, which will affect the analysis of the average blood sugar level of the human body. 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 device, the preparation device is used to prepare a pretreatment liquid using a sample of a subject and a pretreatment reagent, and to prepare a sample liquid to be tested using a detection reagent and the pretreatment liquid;

[0006] A first detection device, used to detect the pretreatment liquid to obtain intermediate detection information;

[0007] A second detection device, used to detect the sample liquid to be tested to obtain detection data;

[0008] A controller, the controller being configured to:

[0009] Obtaining a range of intermediate detection values ​​corresponding to the intermediate detection information;

[0010] When the intermediate detection value is within a first range, obtaining a detection result for a target detection item according to the detection data;

[0011] When the intermediate detection value is within the second range, the detection data is corrected, and the detection result for the target detection item is obtained using the corrected detection data, and the first range and the second range do not overlap.

[0012] In a second aspect, an embodiment of the present application provides a sample analysis system, including:

[0013] A preparation device, the preparation device is used to prepare a sample solution to be tested using a sample from a subject and a detection reagent;

[0014] A second detection device, used to detect the sample liquid to be tested to obtain detection data;

[0015] A controller, the controller being configured to:

[0016] Obtaining a range of detection values ​​of a target substance in a sample of the subject;

[0017] When the detection value of the target substance is within a first range, obtaining a detection result for the target detection item according to the detection data;

[0018] When the detection value of the target substance is within the second range, the detection data is corrected, and the detection result for the target detection item is obtained using the corrected detection data, and the first range and the second range do not overlap.

[0019] In a third aspect, an embodiment of the present application provides a sample analysis system, including:

[0020] A preparation device, the preparation device is used to prepare a sample solution to be tested using a sample from a subject and a detection reagent;

[0021] A second detection device, used to detect the sample liquid to be tested to obtain detection data;

[0022] A mode selection module, configured to select a target detection mode from at least two detection modes;

[0023] A controller is used to obtain a detection result for a target detection item based on the target detection mode and the detection data, wherein at least one of the detection modes corrects the detection data, and uses the corrected detection data to obtain a detection result for the target detection item.

[0024] In a fourth aspect, an embodiment of the present application provides a sample analysis method, including:

[0025] A pretreatment 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 solution;

[0026] Testing the pretreatment liquid to obtain intermediate test information;

[0027] Testing the sample liquid to be tested to obtain test data;

[0028] Obtaining a range of intermediate detection values ​​corresponding to the intermediate detection information;

[0029] When the intermediate detection value is within a first range, obtaining a detection result for a target detection item according to the detection data;

[0030] When the intermediate detection value is within the second range, the detection data is corrected, and the detection result for the target detection item is obtained using the corrected detection data, and the first range and the second range do not overlap.

[0031] In a fifth aspect, an embodiment of the present application provides a sample analysis method, including:

[0032] Using the subject's sample and the detection reagent to prepare the sample solution to be tested;

[0033] Testing the sample liquid to be tested to obtain test data;

[0034] Obtaining a range of detection values ​​of a target substance in a sample of the subject;

[0035] When the detection value of the target substance is within a first range, obtaining a detection result for the target detection item according to the detection data;

[0036] When the detection value of the target substance is within the second range, the detection data is corrected, and the detection result for the target detection item is obtained using the corrected detection data, and the first range and the second range do not overlap.

[0037] In a sixth aspect, an embodiment of the present application provides a sample analysis method, comprising:

[0038] Using the subject's sample and the detection reagent to prepare the sample solution to be tested;

[0039] Testing the sample liquid to be tested to obtain test data;

[0040] selecting a target detection mode among at least two detection modes;

[0041] A detection result for a target detection item is obtained according to the target detection mode and the detection data, wherein at least one of the detection modes corrects the detection data, and the detection result for the target detection item is obtained using the corrected detection data.

[0042] The sample analysis system and sample analysis method provided by the embodiment of the present application, the sample analysis system preparation device is used to prepare the pretreatment liquid using the sample of the subject and the pretreatment reagent, and to prepare the sample liquid to be tested using the detection reagent and the pretreatment liquid; the first detection device is used to detect the pretreatment liquid to obtain the intermediate detection information; the second detection device is used to detect the sample liquid to be tested to obtain the detection data; the controller is used to: obtain the range of the intermediate detection value corresponding to the intermediate detection information; when the intermediate detection value is in the first range, obtain the detection result for the target detection item according to the detection data; when the intermediate detection value is in the second range, correct the detection data, and use the corrected detection data to obtain the detection result for the target detection item, and the first range and the second range do not overlap. By determining whether to correct the detection data of the sample liquid to be tested according to the intermediate detection information of the pretreatment liquid, when the intermediate detection value is in the second range, correcting the detection data can obtain a more accurate detection result for the target detection item.

[0043] 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

[0044] 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.

[0045] Figure 1 is a structural schematic diagram of a sample analysis system provided in an embodiment of the present application;

[0046] Figure 2 is a schematic block diagram of a sample analysis system in one embodiment of the present application;

[0047] Figure 3 is a schematic block diagram of a sample analysis system in another embodiment of the present application;

[0048] Figure 4 It is a schematic diagram of the linear relationship between the theoretical value and the actual test value of the hemoglobin detection item in one embodiment of the present application;

[0049] Figure 5 It is a schematic diagram of the relationship between the detected concentration and the actual concentration of glycated hemoglobin in the related art;

[0050] Figure 6 is a schematic diagram showing a linear relationship between the corrected glycated hemoglobin concentration and the reactivity in one embodiment of the present application;

[0051] Figure 7 is a schematic diagram of a preset correction curve in one embodiment of the present application;

[0052] Figure 8 It is a schematic diagram of determining a preset corresponding relationship in an implementation manner of the present application;

[0053] Fig. 9 is a structural schematic diagram of a sample analysis system provided by another embodiment of the present application;

[0054] Fig.10 It is a flow chart of a sample analysis method provided in one embodiment of the present application;

[0055] Fig.11 is a flow chart of a sample analysis method provided by another embodiment of the present application;

[0056] Fig.12 It is a flow chart of a sample analysis method provided in yet another embodiment of the present application.

[0057] Description of reference numerals:

[0058] 110, preparation device; 120, first detection device; 130, second detection device; 140, controller; 150, mode selection module;

[0059] 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

[0060] 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.

[0061] 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.

[0062] 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.

[0063] 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.

[0064] like Figure 1 As shown, the sample analysis system of the embodiment of the present application includes: a preparation device 110 , a first detection device 120 , a second detection device 130 , and a controller 140 .

[0065] 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 and obtain the test results of the samples for the target test items. After obtaining the test results of the target test items for each sample, the corresponding test results can be stored and / or output.

[0066] 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.

[0067] 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.

[0068] Before describing the present invention in detail, the structure of a sample analyzer in some embodiments is described first.

[0069] Please refer to Figure 2 , the sample analyzer includes at least one functional module 10 (or one or more functional modules 10).

[0070] 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.

[0071] 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.

[0072] 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.

[0073] 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.

[0074] 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.

[0075] 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.

[0076] 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.

[0077] 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.

[0078] 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.

[0079] Exemplarily, the preparation device 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.

[0080] 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).

[0081] Exemplarily, at least one of the first detection device 120 and the second detection device 130 in the sample analysis system may include Figure 3 The detection device 17 shown. In some embodiments, the first detection device 120 and the second detection device 130 can be different detection devices, and in other embodiments, the first detection device 120 and the second detection device 130 can be the same detection device. Optionally, the first detection device 120 and the second detection device 130 correspond to different detection wavelengths, or the same detection device can use different wavelengths for detection, respectively realizing the functions of the first detection device 120 and the second detection device 130.

[0082] 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 140 includes at least the processor 50 .

[0083] 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.

[0084] 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.

[0085] 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.

[0086] 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.

[0087] 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.

[0088] 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.

[0089] 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.

[0090] See also Figure 1 The preparation device 110 in the sample analysis system is used to prepare a pretreatment 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 solution.

[0091] 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.

[0092] For example, the pretreatment reagent includes a hemolytic agent for lysing red blood cells in the sample 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.

[0093] 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 device 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 device includes a detection device based on the ion exchange chromatography method.

[0094] See also Figure 1 The first detection device 120 in the sample analysis system is used to detect the pretreatment liquid to obtain intermediate detection information, the second detection device 130 is used to detect the sample liquid to be tested to obtain detection data, and the controller 140 is at least used to obtain the detection result of the sample for the target detection item based on the detection data, and can also determine whether to correct the detection data based on the intermediate detection information to ensure the accuracy of the detection result.

[0095] For example, at least one of the first detection device 120 and the second detection device 130 includes a light measurement component, but it 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 embodiments of the present application are mainly described by taking a light measurement detection device as an example. For example, the light measurement detection component of the second detection device 130 can detect the light measurement results of the sample liquid to be tested, such as obtaining absorbance at multiple different times.

[0096] In some embodiments, the pretreatment liquid detected by the first detection device 120, i.e., the pretreatment liquid used to detect the intermediate detection information, can be the same as the pretreatment liquid used to prepare the sample liquid to be tested, i.e., after detecting the intermediate detection information of the pretreatment liquid, the pretreatment liquid can be used to prepare the sample liquid 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.

[0097] In other embodiments, the pretreatment liquid detected by the first detection device 120 is a pretreatment liquid used to detect the intermediate detection information, and the pretreatment liquid used to prepare the sample liquid to be tested can also be a different pretreatment liquid; for example, the preparation device 110 can prepare the first pretreatment liquid and the second pretreatment liquid respectively, the first pretreatment liquid is used to detect the intermediate detection information, and the second pretreatment liquid is used to prepare the sample liquid to be tested. Exemplarily, the first pretreatment liquid and the second pretreatment liquid can be prepared and detected by different sample analyzers in the sample analysis system.

[0098] Specifically, the controller 140 is used to: obtain the range of the intermediate detection value corresponding to the intermediate detection information; when the intermediate detection value is in the first range, obtain the detection result for the target detection item according to the detection data; when the intermediate detection value is in the second range, correct the detection data, and use the corrected detection data to obtain the detection result for the target detection item, and the first range and the second range do not overlap. By using the corrected detection data to obtain the detection result for the target detection item when the intermediate detection value is in the second range, the accuracy of the detection result can be improved.

[0099] In some embodiments, the detection results of the sample for the target detection item include the detection results of the first target substance, and the intermediate detection information can characterize the relevant information of the second target substance in the sample, wherein the second target substance is a substance that has a deterministic relationship with the first target substance; for example, the detection value of the second target substance, such as the concentration of the second target substance, usually has a linear relationship with the concentration of the first target substance.

[0100] For example, glycated hemoglobin is the product of a continuous and irreversible non-enzymatic protein glycosylation reaction between hemoglobin and glucose in red blood cells. When the hemoglobin concentration in a sample is extremely low, regardless of whether the person corresponding to the sample suffers from diabetes (or severe diabetes), the corresponding glycated hemoglobin concentration is within the range corresponding to the hemoglobin concentration, for example, the glycated hemoglobin concentration is proportional to the hemoglobin concentration, wherein the first target substance may be glycated hemoglobin, and the second target substance may be hemoglobin.

[0101] Exemplarily, when the concentration of the first target substance of the target detection item is different, the accuracy of the test result obtained according to the test data is also different. For example, when the concentration of the first target substance of the target detection item is small, the accuracy of the test result obtained according to the test data is low, and sometimes retesting is required, which may even affect clinical diagnosis. The second target substance is a substance that has a deterministic relationship with the first target substance. The embodiment of the present application can determine whether the test data needs to be corrected according to the intermediate detection value of the second target substance corresponding to the first target substance. For example, when the intermediate detection value is in the second range, the corrected test data is used to obtain the test result for the target detection item, which can improve the accuracy of the test result.

[0102] In some embodiments, the intermediate detection information includes the concentration of hemoglobin, the detection data includes the concentration of glycated hemoglobin; the detection result for the target detection item includes the relative concentration of glycated hemoglobin in hemoglobin in the sample of the subject. For example, the unit of the test result can be the ratio or percentage of glycated hemoglobin to hemoglobin, such as IFCC (mmol / mol), US NGSP (%), Japanese JDS / JSCC (%) and Swedish MonoS (%) units.

[0103] Exemplarily, when the controller 140 determines the test result of the sample for the target test item, it is used to: obtain the concentration of glycated hemoglobin in the sample solution to be tested according to the test data or the corrected test data; obtain the relative concentration of glycated hemoglobin in 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 concentration of glycated hemoglobin in the sample can be determined according to the concentration of glycated hemoglobin in the sample solution to be tested, and the relative concentration of glycated hemoglobin in the sample according to the concentration of glycated hemoglobin in the sample and the concentration of hemoglobin in the sample can be obtained. Optionally, the concentration of glycated hemoglobin in the sample solution to be tested, and the dilution ratio of the pretreatment reagent to prepare the pretreatment solution and the pretreatment solution to prepare the sample solution to be tested, the concentration of glycated hemoglobin in the sample is determined.

[0104] The accuracy of the relative concentration of glycated hemoglobin in hemoglobin in a sample is related to the accuracy of the concentration of hemoglobin and the accuracy of the concentration of glycated hemoglobin.

[0105] For example, the first detection device 120 detects the light signal generated by the subject's blood sample after being irradiated with light during the reaction between the subject's blood sample and the hemolytic agent, and obtains the hemoglobin concentration of the pretreatment solution based on the light signal. Of course, it is not limited to this. For example, the first detection device 120 uses a camera to capture an image of the pretreatment solution, and obtains the hemoglobin concentration of the pretreatment solution based on the image.

[0106] For example, the second detection device 130 can obtain the reactivity of the sample liquid according to the optical detection result of the sample liquid, and determine the detection data, such as the concentration of glycated hemoglobin, according to the reactivity based on the calibration curve.

[0107] like Figure 4 As shown, the theoretical value of the hemoglobin test item has a good linear relationship with the actual test value. For anemia patients with low hemoglobin concentration, accurate results can usually be measured.

[0108] At present, the relevant technology has good accuracy for samples with higher glycated hemoglobin concentrations, but the test results are not accurate enough for samples with some glycated hemoglobin concentrations. For example, samples with lower glycated hemoglobin concentrations are greatly affected by impurities and the test results are not accurate enough, which may 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. For example, please refer to Figure 5 In the glycated hemoglobin test, when the glycated hemoglobin concentration in the sample liquid is not very low, the change of the glycated hemoglobin concentration is linear, and the precision and accuracy of the test results can meet the requirements; however, for samples with low glycated hemoglobin concentrations, such as samples from anemic patients, the glycated hemoglobin concentration obtained is too high; especially for low-value samples with an actual glycated hemoglobin concentration of less than 2μmol / L, the glycated hemoglobin concentration obtained can even reach 6μmol / L, which is greatly deviated from the actual glycated hemoglobin concentration and has poor accuracy. In severe cases, it will affect the clinical diagnosis of diabetes.

[0109] According to the relevant information of the second target substance represented by the intermediate detection information, the detection data of the first target substance, such as the range of the concentration of glycated hemoglobin, can be estimated. For example, it can be determined whether the concentration of glycated hemoglobin in the sample liquid to be tested is too low or too high; and when the concentration of glycated hemoglobin is too low or too high, the concentration of glycated hemoglobin is corrected to accurately determine the relative concentration of glycated hemoglobin in hemoglobin according to the corrected concentration of glycated hemoglobin, so as to obtain a more accurate detection result.

[0110] In some embodiments, the embodiments of the present application can estimate the range of the glycated hemoglobin concentration in the sample liquid to be tested based on intermediate detection information such as the detection value related to the hemoglobin concentration of the pretreatment liquid and the detection value related to the hematocrit; at least when the glycated hemoglobin concentration in the sample liquid to be tested is estimated to be too low, the glycated hemoglobin concentration is corrected to solve the problem of the glycated hemoglobin concentration being too high.

[0111] 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 liquid, such as the hemoglobin concentration of the pretreatment liquid. 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. Whether to correct the detection data can be determined based on the detection value related to the hemoglobin concentration of the pretreatment liquid.

[0112] For example, when the hemoglobin concentration corresponding to the sample is within the first range, it can be determined that the actual glycated hemoglobin concentration is within the third range, and the second detection device 130 detects the sample liquid to be tested and obtains detection data with high accuracy; when the hemoglobin concentration corresponding to the sample is within the second range, it can be determined that the actual glycated hemoglobin concentration is within the fourth range, and the second detection device 130 detects the sample liquid to be tested and obtains detection data with low accuracy, and the detection data can be corrected to obtain a detection result with high accuracy.

[0113] 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 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), it is also possible to determine whether to correct the detection data based on the detection value related to the hematocrit.

[0114] For example, the controller 140 obtains a pulse measurement signal when a detection device such as a resistance measurement device passes through the pretreatment liquid, and obtains a detection value related to the 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 pretreatment liquid.

[0115] In some embodiments, the concentration of hemoglobin in the second range is lower than the concentration of hemoglobin in the first range, and the sample whose hemoglobin concentration is within the second range may be referred to as a low-value sample.

[0116] For ease of explanation, the embodiments of the present application are mainly explained by taking the hemoglobin concentration in the second range including the hemoglobin concentration being less than or equal to the preset first concentration threshold as an example; in some other embodiments, when the hemoglobin concentration of the sample is greater than or equal to the second concentration threshold, the concentration of glycated hemoglobin in the sample can also be corrected to improve the accuracy of the test results. It should be noted that the hemoglobin concentration of the intermediate detection information can be the hemoglobin concentration in the pretreatment solution or the hemoglobin concentration 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 solution.

[0117] Exemplarily, the detecting of the sample liquid to be tested to obtain the detection data includes: obtaining the optical measurement result of the sample liquid to be tested, obtaining the reactivity of the sample liquid to be tested according to the optical measurement result, and obtaining the concentration of the glycated hemoglobin according to the reactivity. For example, the concentration of the glycated hemoglobin can be determined according to the reactivity of the sample liquid to be tested based on a calibration curve; the calibration curve is used, for example, to characterize the corresponding relationship between the concentration of the glycated hemoglobin in the sample liquid to be tested and the reactivity of the sample liquid to be tested.

[0118] The corrected glycated hemoglobin concentration is linearly related to the reactivity.

[0119] See also Figure 6 When the glycated hemoglobin concentration is low, the glycated hemoglobin concentration corresponding to the reactivity obtained based on the calibration curve is raised, that is, the low value part is tilted. When the glycated hemoglobin concentration is low, the ratio of the corrected glycated hemoglobin concentration to the reactivity is equal to or approximately equal to the ratio of the glycated hemoglobin concentration to the reactivity when the glycated hemoglobin concentration is high. For example, the glycated hemoglobin concentration can be corrected according to the ratio of the glycated hemoglobin concentration to the reactivity within the third range in the calibration curve, so that the ratio of the corrected glycated hemoglobin concentration to the reactivity is equal to the ratio of the glycated hemoglobin concentration to the reactivity within the third range in the calibration curve. When the glycated hemoglobin concentration is low, the influence of the impurity background on the glycated hemoglobin concentration can be deducted to achieve an expansion of the linear range of the glycated hemoglobin concentration, so that accurate results can be obtained under a wide linear range in one test, 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.

[0120] Exemplarily, the concentration of hemoglobin within the second range is less than the concentration of hemoglobin within the first range; the detection data is corrected and the detection result for the target detection item is obtained using the corrected detection data, including: obtaining the theoretical concentration of glycated hemoglobin corresponding to the concentration of the glycated hemoglobin obtained by the detection according to a preset corresponding relationship, and obtaining the detection result for the target detection item according to the theoretical concentration.

[0121] For example, a correspondence between the actual test concentration and the theoretical concentration of glycosylated hemoglobin of a low-value sample is pre-established, and when the test data is corrected, the theoretical concentration corresponding to the actual test concentration can be determined based on the correspondence.

[0122] For example, the preset corresponding relationship is represented by a preset correction function, or represented by a preset correction curve, but it is certainly not limited thereto. For example, the corresponding relationship can also be represented in the form of a table. Figure 7 The figure shows a schematic diagram of a preset correction curve in one embodiment. For low-value samples, the theoretical concentration corresponding to the determined detection concentration is lower than the detection concentration. When the glycated hemoglobin concentration is low, the effect of the impurity background on the glycated hemoglobin concentration can be deducted, and the obtained theoretical concentration is more accurate.

[0123] Optionally, the controller 140 is also used to: perform the detection of the target detection item on standard samples of each preset concentration and obtain the concentration of the glycated hemoglobin; obtain the preset corresponding relationship based on the concentration of the glycated hemoglobin obtained by detecting the standard samples of each concentration and the actual glycated hemoglobin concentration of the standard sample, and the actual glycated hemoglobin concentration of the standard sample is the theoretical concentration of the glycated hemoglobin.

[0124] The actual glycated hemoglobin concentration of the standard sample is at least within the third range and the fourth range, wherein the standard sample whose actual glycated hemoglobin concentration is within the third range corresponds to a hemoglobin concentration within the first range, and the standard sample whose actual glycated hemoglobin concentration is within the fourth range corresponds to a hemoglobin concentration within the second range.

[0125] For example, the third range includes a range greater than a preset concentration threshold, such as 2 μmol / L, the fourth range includes a range less than or equal to the preset concentration threshold, and the glycated hemoglobin concentration of the sample whose hemoglobin concentration is within the second range is usually also within the fourth range.

[0126] For example, the preparation component is also used to dilute the standard sample of preset concentration to obtain the standard samples of various concentrations. The theoretical concentration of glycated hemoglobin of each standard sample can be determined according to the dilution ratio, for example.

[0127] In some embodiments, when obtaining the preset corresponding relationship, the standard sample with the preset concentration can be diluted first to obtain multiple standard samples with an actual glycosylated hemoglobin concentration greater than 2 μmol / L, and multiple standard samples with an actual glycosylated hemoglobin concentration less than 2 μmol / L; then the concentration of the glycosylated hemoglobin of each standard sample is detected and obtained, which can be called the actual test value, and the glycated hemoglobin concentration obtained by fitting according to the actual test value. Figure 8 Curve 1 shown; curve 2 is obtained by fitting according to the actual test value of the standard sample with an actual glycosylated hemoglobin concentration greater than 2μmol / L and the theoretical concentration of the standard sample with an actual glycosylated hemoglobin concentration less than 2μmol / L; then the corresponding relationship can be determined according to curve 1 and curve 2. For example, taking 2μmol / L as the dividing point, a preset correction function or preset correction curve between the actual test value and the theoretical concentration of the glycosylated hemoglobin concentration between curve 1 and curve 2 is established. By adopting a dilution process, standard samples of various preset concentrations can be obtained, and multi-point calibration can be completed according to the actual test values ​​and theoretical concentrations of each standard sample. In some other embodiments, the preset corresponding relationship can also be obtained in advance through experiments, or the preset corresponding relationship can be derived based on experience.

[0128] In some embodiments, the controller 140 is further configured to: when the intermediate detection value is within the second range, output an uncorrected detection result for the target detection item obtained based on the detection data, and output prompt information corresponding to the uncorrected detection result. For example, when the intermediate detection value is within the second range, a prompt information may be output to prompt the user that the uncorrected detection result has low accuracy and needs special attention, and a detection result of a detection result seat recommendation for the target detection item obtained using the corrected detection data may also be output.

[0129] The sample analysis system provided in the embodiment of the present application comprises a preparation device 110 for preparing a pretreatment liquid using a sample of a subject and a pretreatment reagent, and a detection reagent and a pretreatment liquid for preparing a sample liquid to be tested; a first detection device 120 for detecting the pretreatment liquid to obtain intermediate detection information; a second detection device 130 for detecting the sample liquid to be tested to obtain detection data; a controller 140 for: obtaining a range where an intermediate detection value corresponding to the intermediate detection information is located; when the intermediate detection value is within a first range, obtaining a detection result for a target detection item according to the detection data; when the intermediate detection value is within a second range, correcting the detection data, and obtaining a detection result for a target detection item using the corrected detection data, and the first range and the second range do not overlap. By determining whether to correct the detection data of the sample liquid to be tested according to the intermediate detection information of the pretreatment liquid, when the intermediate detection value is within the second range, correcting the detection data can obtain a more accurate detection result for the target detection item.

[0130] The embodiment of the present application can expand the linear range of glycated hemoglobin detection by correcting the detection data when the intermediate detection value is in the second range, and can especially make the measurement results of low-value samples more accurate. As shown in Table 1, a comparison table of the NGSP obtained by the method of the embodiment of the present application in one embodiment and the detection results of the relative concentration of glycated hemoglobin when the detection data is not corrected can determine that the embodiment of the present application expands the linear range of glycated hemoglobin detection and can obtain a more accurate relative concentration.

[0131] Table 1 NGSP of the embodiment of the present application and NGSP without modification

[0132] Sample level NGSP without modification The NGSP obtained in the present embodiment 0 -98.79 -24.02 0.5 12.30 6.57 1 6.99 5.25 1.5 5.35 4.98 2 4.89 4.82 3 4.57 4.57 4 4.33 4.46 5 4.41 4.39 6 4.37 4.33 7 4.33 4.29 8 4.23 4.27

[0133] In other embodiments of the present application, the sample analysis system may not include Figure 1 The first detection device 120 in the sample analysis system. Specifically, the preparation device 110 in the sample analysis system is used to prepare the sample liquid to be tested using the sample of the subject and the reagent; the second detection device 130 is used to detect the sample liquid to be tested to obtain detection data; the controller 140 is used to obtain the range of the detection value of the target substance in the sample of the subject; when the detection value of the target substance is in the first range, the detection result for the target detection item is obtained according to the detection data; when the detection value of the target substance is in the second range, the detection data is corrected, and the detection result for the target detection item is obtained using the corrected detection data, and the first range and the second range do not overlap.

[0134] It is understandable that the detection value 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 the detection of the pretreatment liquid. By correcting the detection data when the detection value of the target substance is in the second range, using the corrected detection data to obtain the detection result for the target detection item, a more accurate detection result can also be obtained.

[0135] Exemplarily, the test result of the sample for the target test item 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 value of the second target substance can characterize the relevant information of the first target substance. For example, the first target substance may be glycated hemoglobin, the second target substance may be hemoglobin, and the test value of the second target substance may include the test value of the concentration of hemoglobin or the hematocrit.

[0136] In some embodiments, the controller 140 obtains the detection value of the target substance in the sample of the subject in at least one of the following ways: obtaining the detection value of a preset detection item, the preset detection item is different from the target detection item, for example, the detection item at least includes the detection of hemoglobin concentration; obtaining the detection value 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 value of the target substance in the sample of the subject determined based on the detection data of another detection device in the sample analysis system, which can be applied to the scenario where the sample analysis system includes multiple sample analyzers; obtaining the detection value 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 value; obtains the detection value of the target substance in the historical detection information record of the subject, for example, obtains the detection value in the historical detection record within three months.

[0137] In some embodiments, the target substance includes hemoglobin, the detection value of the target substance includes the concentration of hemoglobin, and the detection result data includes the concentration of glycated hemoglobin; the detection result of the sample for the target detection item includes the relative concentration of glycated hemoglobin in hemoglobin in the sample of the subject.

[0138] The concentration of the hemoglobin in the second range is less than the concentration of the hemoglobin in the first range;

[0139] The detecting the sample liquid to be detected to obtain the detection data includes: obtaining the optical detection result of the sample liquid to be detected, obtaining the reactivity of the sample liquid to be detected according to the optical detection result, and obtaining the concentration of the glycated hemoglobin according to the reactivity;

[0140] The corrected glycated hemoglobin concentration is linearly related to the reactivity.

[0141] Exemplarily, the concentration of hemoglobin within the second range is less than the concentration of hemoglobin within the first range; the detection data is corrected and the detection result for the target detection item is obtained using the corrected detection data, including: obtaining the theoretical concentration of glycated hemoglobin corresponding to the concentration of the glycated hemoglobin obtained by the detection according to a preset corresponding relationship, and obtaining the detection result for the target detection item according to the theoretical concentration.

[0142] Exemplarily, the controller 140 is also used to: perform detection of the target detection item on standard samples of preset concentrations and obtain the concentration of glycated hemoglobin, the actual glycated hemoglobin concentration of the standard sample being at least within the third range and the fourth range; wherein the hemoglobin concentration corresponding to the standard sample whose actual glycated hemoglobin concentration is within the third range is within the first range, and the hemoglobin concentration corresponding to the standard sample whose actual glycated hemoglobin concentration is within the fourth range is within the second range; the preset corresponding relationship is obtained based on the glycated hemoglobin concentrations obtained by detecting the standard samples of various concentrations and the actual glycated hemoglobin concentrations of the standard samples, and the actual glycated hemoglobin concentrations of the standard samples are the theoretical concentrations of glycated hemoglobin.

[0143] For example, the preset corresponding relationship is represented by a preset correction function, or by a preset correction curve.

[0144] For example, the preparation component is also used to dilute the standard sample of preset concentration to obtain the standard sample of various concentrations.

[0145] Optionally, the controller 140 is further configured to:

[0146] When the intermediate detection value is within the second range, an uncorrected detection result for the target detection item obtained according to the detection data is output, and prompt information corresponding to the uncorrected detection result is output.

[0147] Please refer to the above examples. Fig. 9 In some other embodiments of the present application, the sample analysis system includes a preparation device 110 , a second detection device 130 , a mode selection module 150 and a controller 140 .

[0148] Specifically, the preparation device 110 in the sample analysis system is used to prepare the sample liquid to be tested using the sample of the subject and the reagent; the second detection device 130 is used to detect the sample liquid to be tested to obtain detection data; the mode selection module 150 is used to select a target detection mode from at least two detection modes; the controller 140 is used to obtain a detection result for a target detection item based on the target detection mode and the detection data, wherein at least one of the detection modes corrects the detection data, and uses the corrected detection data to obtain a detection result for the target detection item.

[0149] 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 140 obtains a detection result for the target detection item based on the detection data; in the second detection mode, the controller 140 corrects the detection data and uses the corrected detection data to obtain a detection result for the target detection item.

[0150] By using the target detection mode selected by the mode selection module 150 , the detection data can be corrected based on the target detection mode, and a more accurate detection result for the target detection item can be obtained by using the corrected detection data.

[0151] In some embodiments, the mode selection module 150 is used to select a target detection mode from at least two of the detection modes according to the intermediate detection value of the pretreatment solution prepared by the sample of the subject and the pretreatment reagent. For example, the mode selection module 150 can obtain the intermediate detection information obtained by detecting the pretreatment solution, or the mode selection module 150 can obtain the detection value of the target substance in the sample of the subject in at least one of the following ways: obtaining the detection value of a preset detection item, the preset detection item is different from the target detection item; obtaining the detection value of the target substance in the sample of the subject from another sample analysis system; obtaining the detection value of the target substance obtained by detecting the sample of the subject by another detection device in the sample analysis system; obtaining the detection value of the target substance in the sample of the subject input by the user; obtaining the detection value of the target substance in the historical detection information record of the subject.

[0152] Exemplarily, the pretreatment reagent includes a hemolytic agent for lysing red blood cells in the sample to release hemoglobin, and the intermediate detection value includes a detection value related to the hemoglobin concentration of the pretreatment solution.

[0153] Exemplarily, the pretreatment reagent includes a diluent for diluting the blood sample to be tested to detect the hematocrit, and the intermediate detection value includes a detection value related to the hematocrit of the pretreatment solution.

[0154] In some embodiments, the mode selection module 150 can obtain the detection value of the target substance in the sample of the subject in at least one of the following ways: obtaining the detection value of a preset detection item, the preset detection item is different from the target detection item, for example, the detection item at least includes the detection of hemoglobin concentration; obtaining the detection value 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 value of the target substance in the sample of the subject determined based on the detection data of another detection device in the sample analysis system, which can be applied to the scenario where the sample analysis system includes multiple sample analyzers; obtaining the detection value 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 value; obtains the detection value of the target substance in the historical detection information record of the subject, for example, obtains the detection value in the historical detection record within three months.

[0155] In some embodiments, the mode selection module 150 can select the target detection mode from at least two detection modes according to user operation. For example, when the user determines that the hemoglobin concentration of a certain sample is within the second range, the user can set the second detection mode as the target detection mode; or when the user determines that the glycated hemoglobin concentration of the sample solution to be tested corresponding to a certain sample is within the fourth range, the user can set the second detection mode as the target detection mode.

[0156] Please refer to the above examples. Fig.10 , Fig.10 It is a flow chart of a sample analysis method provided in one embodiment of the present application.

[0157] like Fig.10 As shown, the sample analysis method includes the following steps S110 to S160.

[0158] Step S110, using the subject's sample and the pretreatment reagent to prepare a pretreatment solution, and using the detection reagent and the pretreatment solution to prepare a sample solution to be tested;

[0159] Step S120, testing the pretreatment liquid to obtain intermediate testing information;

[0160] Step S130, testing the sample liquid to obtain test data;

[0161] Step S140, obtaining a range of intermediate detection values ​​corresponding to the intermediate detection information;

[0162] Step S150, when the intermediate detection value is within the first range, obtaining a detection result for a target detection item according to the detection data;

[0163] Step S160: When the intermediate detection value is within the second range, the detection data is corrected, and the detection result for the target detection item is obtained using the corrected detection data, and the first range and the second range do not overlap.

[0164] In some embodiments, the intermediate detection information includes the concentration of hemoglobin, the detection data includes the concentration of glycated hemoglobin; and the detection result for the target detection item includes the relative concentration of glycated hemoglobin in hemoglobin in the sample of the subject.

[0165] Optionally, the concentration of hemoglobin in the second range is less than the concentration of hemoglobin in the first range; the detecting the sample liquid to be tested to obtain the detection data includes: obtaining the optical measurement result of the sample liquid to be tested, obtaining the reactivity of the sample liquid to be tested according to the optical measurement result, and obtaining the concentration of glycated hemoglobin according to the reactivity; wherein the corrected glycated hemoglobin concentration is linearly related to the reactivity.

[0166] Optionally, the concentration of hemoglobin in the second range is less than the concentration of hemoglobin in the first range; the detection data is corrected and the detection result for the target detection item is obtained using the corrected detection data, including: obtaining the theoretical concentration of glycated hemoglobin corresponding to the concentration of the glycated hemoglobin obtained by the detection according to a preset corresponding relationship, and obtaining the detection result for the target detection item according to the theoretical concentration.

[0167] Optionally, the target detection item can be detected for standard samples of preset concentrations and the concentration of glycated hemoglobin can be obtained, and the actual glycated hemoglobin concentration of the standard sample is at least within the third range and the fourth range; wherein the hemoglobin concentration corresponding to the standard sample whose actual glycated hemoglobin concentration is within the third range is within the first range, and the hemoglobin concentration corresponding to the standard sample whose actual glycated hemoglobin concentration is within the fourth range is within the second range; and the preset corresponding relationship is obtained based on the glycated hemoglobin concentrations obtained by detecting the standard samples of various concentrations and the actual glycated hemoglobin concentrations of the standard samples, and the actual glycated hemoglobin concentrations of the standard samples are the theoretical concentrations of glycated hemoglobin.

[0168] Optionally, the preset corresponding relationship is represented by a preset correction function, or by a preset correction curve.

[0169] In some embodiments, a standard sample of a preset concentration may be diluted to obtain the standard samples of various concentrations.

[0170] Optionally, the controller is further used to: when the intermediate detection value is within the second range, output an uncorrected detection result for the target detection item obtained based on the detection data, and output prompt information corresponding to the uncorrected detection result.

[0171] 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.

[0172] Please refer to the above examples. Fig.11 , Fig.11 It is a flow chart of a sample analysis method provided in one embodiment of the present application.

[0173] like Fig.11 As shown, the sample analysis method includes the following steps S210 to S250.

[0174] Step S210, using the subject's sample and the detection reagent to prepare a sample solution to be tested;

[0175] Step S220, testing the sample liquid to obtain test data;

[0176] Step S230, obtaining the range of the detection value of the target substance in the sample of the subject;

[0177] Step S240, when the detection value of the target substance is within the first range, obtaining a detection result for the target detection item according to the detection data;

[0178] Step S250: When the detection value of the target substance is within the second range, the detection data is corrected, and the detection result for the target detection item is obtained using the corrected detection data, and the first range and the second range do not overlap.

[0179] In some embodiments, the detection value of the target substance includes the concentration of hemoglobin, and the detection result data includes the concentration of glycated hemoglobin; the detection result for the target detection item includes the relative concentration of glycated hemoglobin in hemoglobin in the sample of the subject.

[0180] In some embodiments, the detection value of the target substance in the sample of the subject can be obtained by at least one of the following methods:

[0181] Acquire detection information of a preset detection item, where the preset detection item is different from the target detection item;

[0182] Obtaining a detection value of the target substance in the sample of the subject from another sample analysis system;

[0183] Acquiring a detection value of the target substance obtained by detecting the sample of the subject using another detection device in the sample analysis system;

[0184] Obtaining a detection value of the target substance in the sample of the subject input by a user;

[0185] The detection value of the target substance in the historical detection information record of the subject is obtained.

[0186] 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.

[0187] Please refer to the above examples. Fig.12 , Fig.12 It is a flow chart of a sample analysis method provided in one embodiment of the present application.

[0188] like Fig.12 As shown, the sample analysis method includes the following steps S310 to S340.

[0189] Step S310, using the subject's sample and the detection reagent to prepare a sample solution to be tested;

[0190] Step S320, testing the sample liquid to obtain test data;

[0191] Step S330, selecting a target detection mode from at least two detection modes;

[0192] Step S340, obtaining a detection result for the target detection item according to the target detection mode and the detection data, wherein at least one of the detection modes corrects the detection data, and the detection result for the target detection item is obtained using the corrected detection data.

[0193] In some embodiments, a target detection mode may be selected from at least two of the detection modes based on an intermediate detection value of the sample of the subject and a pretreatment solution prepared from a pretreatment reagent.

[0194] 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 value includes a detection value related to the hemoglobin concentration of the pretreatment solution.

[0195] In other embodiments, the pretreatment reagent includes a diluent for diluting the blood sample to be tested to detect the hematocrit, and the intermediate detection value includes the detection value of the hematocrit of the pretreatment solution.

[0196] 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.

[0197] 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.

[0198] 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.

[0199] 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 device, the preparation device is used to prepare a pretreatment liquid using a sample of a subject and a pretreatment reagent, and to prepare a sample liquid to be tested using a detection reagent and the pretreatment liquid; A first detection device, used to detect the pretreatment liquid to obtain intermediate detection information; A second detection device, used to detect the sample liquid to be tested to obtain detection data; A controller, the controller being configured to: Obtaining a range of intermediate detection values ​​corresponding to the intermediate detection information; When the intermediate detection value is within a first range, obtaining a detection result for a target detection item according to the detection data; When the intermediate detection value is within the second range, the detection data is corrected, and the detection result for the target detection item is obtained using the corrected detection data, and the first range and the second range do not overlap.

2. The sample analysis system according to claim 1, characterized in that: The intermediate detection information includes the concentration of hemoglobin, and the detection data includes the concentration of glycosylated hemoglobin; The test result for the target test item includes the relative concentration of glycated hemoglobin in hemoglobin in the sample of the subject.

3. The sample analysis system according to claim 2, characterized in that: The concentration of the hemoglobin in the second range is less than the concentration of the hemoglobin in the first range; The detecting the sample liquid to be detected to obtain the detection data includes: obtaining the optical detection result of the sample liquid to be detected, obtaining the reactivity of the sample liquid to be detected according to the optical detection result, and obtaining the concentration of the glycated hemoglobin according to the reactivity; The corrected glycated hemoglobin concentration is linearly related to the reactivity.

4. The sample analysis system according to claim 2, characterized in that: The concentration of the hemoglobin in the second range is less than the concentration of the hemoglobin in the first range; The test data is corrected and the test result for the target test item is obtained using the corrected test data, including: obtaining the theoretical concentration of glycated hemoglobin corresponding to the concentration of the glycated hemoglobin obtained by the test according to a preset corresponding relationship, and obtaining the test result for the target test item according to the theoretical concentration.

5. The sample analysis system according to claim 4, characterized in that: The controller is also used for: The target detection item is detected for the standard samples of various preset concentrations to obtain the concentration of the glycated hemoglobin, wherein the actual glycated hemoglobin concentration of the standard sample is at least within a third range and a fourth range; wherein the standard sample whose actual glycated hemoglobin concentration is within the third range corresponds to a hemoglobin concentration within the first range, and the standard sample whose actual glycated hemoglobin concentration is within the fourth range corresponds to a hemoglobin concentration within the second range; The preset corresponding relationship is obtained according to the concentration of the glycated hemoglobin obtained by detecting the standard samples of various concentrations and the actual glycated hemoglobin concentration of the standard samples, and the actual glycated hemoglobin concentration of the standard samples is the theoretical concentration of the glycated hemoglobin.

6. The sample analysis system according to claim 4 or 5, characterized in that: The preset corresponding relationship is represented by a preset correction function, or by a preset correction curve.

7. The sample analysis system according to claim 5, characterized in that: The preparation component is also used to dilute the standard sample of preset concentration to obtain the standard sample of various concentrations.

8. The sample analysis system according to any one of claims 1 to 5, characterized in that: The controller is also used for: When the intermediate detection value is within the second range, an uncorrected detection result for the target detection item obtained according to the detection data is output, and prompt information corresponding to the uncorrected detection result is output.

9. A sample analysis system, characterized in that: include: A preparation device, the preparation device is used to prepare a sample solution to be tested using a sample from a subject and a detection reagent; A second detection device, used to detect the sample liquid to be tested to obtain detection data; A controller, the controller being configured to: Obtaining a range of detection values ​​of a target substance in a sample of the subject; When the detection value of the target substance is within a first range, obtaining a detection result for the target detection item according to the detection data; When the detection value of the target substance is within the second range, the detection data is corrected, and the detection result for the target detection item is obtained using the corrected detection data, and the first range and the second range do not overlap.

10. The sample analysis system according to claim 9, characterized in that: The detection value of the target substance includes the concentration of hemoglobin, and the detection result data includes the concentration of glycated hemoglobin; The test result for the target test item includes the relative concentration of glycated hemoglobin in hemoglobin in the sample of the subject.

11. The sample analysis system according to claim 9, characterized in that: The controller obtains the detection value of the target substance in the sample of the subject by at least one of the following methods: Acquire a detection value of a preset detection item, where the preset detection item is different from the target detection item; Obtaining a detection value of the target substance in the sample of the subject from another sample analysis system; Acquiring a detection value of the target substance obtained by detecting the sample of the subject using another detection device in the sample analysis system; Obtaining a detection value of the target substance in the sample of the subject input by a user; The detection value of the target substance in the historical detection information record of the subject is obtained.

12. A sample analysis system, characterized in that: include: A preparation device, the preparation device is used to prepare a sample solution to be tested using a sample from a subject and a detection reagent; A second detection device, 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 a detection result for a target detection item based on the target detection mode and the detection data, wherein at least one of the detection modes corrects the detection data, and uses the corrected detection data to obtain a detection result for the target detection item.

13. The sample analysis system according to claim 12, wherein: The mode selection module is used to select a target detection mode from at least two detection modes according to an intermediate detection value of the sample of the subject and a pretreatment solution prepared by a pretreatment reagent.

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

15. A sample analysis method, characterized in that: include: A pretreatment 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 solution; Testing the pretreatment liquid to obtain intermediate test information; Testing the sample liquid to be tested to obtain test data; Obtaining a range of intermediate detection values ​​corresponding to the intermediate detection information; When the intermediate detection value is within a first range, obtaining a detection result for a target detection item according to the detection data; When the intermediate detection value is within the second range, the detection data is corrected, and the detection result for the target detection item is obtained using the corrected detection data, and the first range and the second range do not overlap.

16. A sample analysis method, characterized in that: include: Using the subject's sample and the detection reagent to prepare the sample solution to be tested; Testing the sample liquid to be tested to obtain test data; Obtaining a range of detection values ​​of a target substance in a sample of the subject; When the detection value of the target substance is within a first range, obtaining a detection result for the target detection item according to the detection data; When the detection value of the target substance is within the second range, the detection data is corrected, and the detection result for the target detection item is obtained using the corrected detection data, and the first range and the second range do not overlap.

17. A sample analysis method, characterized in that: include: Using the subject's sample and the detection reagent to prepare the 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; A detection result for a target detection item is obtained according to the target detection mode and the detection data, wherein at least one of the detection modes corrects the detection data, and the detection result for the target detection item is obtained using the corrected detection data.

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