A sample analysis method, apparatus, and computer readable storage medium

Abstract

The application discloses a sample analysis method, device and computer readable storage medium, wherein the sample analysis method comprises the following steps: acquiring real concentration values of a plurality of high-concentration sample solutions; wherein the concentration values of the high-concentration sample solutions are greater than a preset concentration value; determining estimated concentration values of the plurality of high-concentration sample solutions according to characteristic parameters of reaction curves of the plurality of high-concentration sample solutions and a calibration curve; establishing a hook effect curve according to the real concentration values and the estimated concentration values of the plurality of high-concentration sample solutions; and detecting the concentration of a sample solution to be detected by using the calibration curve and the hook effect curve. In the foregoing manner, the detection cost can be reduced, and the detection efficiency can be improved.

Description

Technical Field

[0001] The present application relates to the field of sample detection technology, and in particular to a sample analysis method, device, and computer-readable storage medium. Background Art

[0002] The basic principle of traditional immunoserological testing for antigens and antibodies (agglutination, precipitation, etc.) is that antigen-antibody molecules move freely and collide with each other in a liquid environment to complete their specific binding reaction. The amount of the conjugate formed is related to the concentration of the reactant, and the concentration of the reactant is then further calculated by detecting the conjugate. Whether adding different amounts of antigen to a certain amount of antibody or adding different amounts of antibody to a certain amount of antigen, it is found that the strongest antigen-antibody reaction only occurs when the molecular ratio of the two is appropriate.

[0003] The hook effect, also known as high-dose-hook or HD-hook, typically occurs when, in immunoassays, excessive levels of the antigen in the specimen cause the excess antigen to bind to both the solid-phase antibody and the enzyme-labeled antibody, preventing the formation of a sandwich complex. This can affect test results and result in high concentrations being erroneously reported as low. This phenomenon, known as the "hook effect," is also known as high-dose-hook or HD-hook. Avoiding the impact of the hook effect on test results has become a key issue. Summary of the Invention

[0004] To solve the above problems, the present application provides a sample analysis method, device and computer-readable storage medium, which can reduce detection costs and improve detection efficiency.

[0005] A technical solution adopted in the present application is to provide a sample analysis method, the method comprising: obtaining true concentration values ​​of multiple high-concentration sample solutions; wherein the concentration value of the high-concentration sample solution is greater than a preset concentration value; determining estimated concentration values ​​of the multiple high-concentration sample solutions based on characteristic parameters of reaction curves of the multiple high-concentration sample solutions and a calibration curve; wherein the calibration curve represents a correspondence between the characteristic parameters and the estimated concentration values; establishing a hook effect curve based on the true concentration values ​​and the estimated concentration values ​​of the multiple high-concentration sample solutions; and detecting the concentration of the sample solution to be detected using the calibration curve and the hook effect curve.

[0006] The method further includes: obtaining concentration values ​​of multiple calibration sample solutions; obtaining characteristic parameters of reaction curves corresponding to the mixing of the multiple calibration sample solutions with the reagent solution; and establishing a calibration curve based on the multiple calibration concentration values ​​and the corresponding characteristic parameters.

[0007] The method further includes: obtaining a target reaction curve corresponding to a target sample solution with the largest concentration value among multiple calibration sample solutions; determining the absorbance value corresponding to a first moment and a second moment in the target reaction curve; wherein the second moment is greater than the first moment.

[0008] The concentration of the sample solution to be detected is detected using a calibration curve and a hook effect curve, including: obtaining a reaction curve to be detected of a mixed solution; wherein the mixed solution is formed by mixing the sample solution to be detected and a reagent solution, the mixed solution and the reagent solution react to form a mixture, and the reaction curve represents the corresponding relationship between the absorbance value of the mixture and time; based on the characteristic parameters of the reaction curve to be detected, determining the estimated concentration value of the sample solution to be detected in the calibration curve; based on the estimated concentration value, determining the corresponding true concentration value in the hook effect curve; and determining the serum concentration of the sample solution to be detected according to the true concentration value.

[0009] The hook effect curve is divided into multiple concentration intervals based on the true concentration value; based on the estimated concentration value, the corresponding true concentration value is determined in the hook effect model, including: determining the concentration interval corresponding to the test response curve; and determining the true concentration value corresponding to the estimated concentration value within the concentration interval corresponding to the test response curve.

[0010] The hook effect curve is divided into at least a first concentration interval, a second concentration interval, and a third concentration interval based on the true concentration value. The dividing point between the first concentration interval and the second concentration interval is the true concentration value corresponding to the sample solution corresponding to the preset concentration value. The second concentration interval and the third concentration interval are the true concentration values ​​corresponding to the reaction curves of multiple high-concentration sample solutions with the largest characteristic parameters. The estimated concentration value and the true concentration value corresponding to the first concentration interval are equal.

[0011] Among them, determining the concentration range corresponding to the reaction curve to be measured includes: when ADt < thres_dbMax_AD and R < thres_dbMax_R, determining that the reaction curve corresponds to the first concentration range; or when ADt ≥ thres_dbMax_AD and Saturation ≥ thres_S_Saturation, determining that the reaction curve corresponds to the second concentration range; or when ADt ≥ thres_S_AD and Saturation < thres_S_Saturation, determining that the reaction curve corresponds to the third concentration range; where ADt is the absorbance value at the first moment of the reaction curve to be measured, thres_dbMax_AD is the absorbance value at the first moment of the target reaction curve, R is the characteristic parameter corresponding to the reaction curve to be measured, thres_dbMax_R is the characteristic parameter corresponding to the target reaction curve, Saturation is the time when the absorbance value of the reaction curve to be measured reaches the absorbance value corresponding to the second moment in the target reaction curve, thres_S_Saturation is the time when the absorbance value of the reaction curve corresponding to the peak in the hook effect curve reaches the absorbance value corresponding to the second moment in the target reaction curve, and thres_S_AD is the absorbance value at the first moment of the reaction curve corresponding to the peak in the hook effect curve.

[0012] Among them, determining the serum concentration of the sample solution to be detected according to the true concentration value includes: calculating the serum concentration according to the following formula: where C , ,

[0012] , 全血 , ,

[0015] , ,

[0014] , ,

[0013] is the true concentration value, and HCT is the hematocrit.

[0013] Another technical solution adopted by this application is: to provide a sample analysis device, which includes a processor and a memory. The memory is used to store program data, and the processor is used to execute the program data to implement the method as described above.

[0014] Another technical solution adopted by this application is: to provide a computer-readable storage medium, in which program data is stored. When the program data is executed by a processor, it is used to implement the method as described above.

[0015] The sample analysis method provided by the present application includes: obtaining the true concentration values ​​of multiple high-concentration sample solutions; wherein the concentration value of the high-concentration sample solution is greater than a preset concentration value; determining the estimated concentration values ​​of the multiple high-concentration sample solutions based on the characteristic parameters of the reaction curves of the multiple high-concentration sample solutions and a calibration curve; wherein the calibration curve represents the correspondence between the characteristic parameters and the estimated concentration values; establishing a hook effect curve based on the true concentration values ​​and the estimated concentration values ​​of the multiple high-concentration sample solutions; and detecting the concentration of the sample solution to be detected using the calibration curve and the hook effect curve. In the above manner, the concentration value is detected using the pre-established calibration curve and the hook effect curve, thereby avoiding the problem of waste of reagents and reduced detection efficiency when the dilution method is used in the prior art for detecting the hook effect in high-concentration sample solutions, thereby reducing detection costs and improving detection efficiency. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] In order to more clearly illustrate the technical solutions in the embodiments of the present application, the following briefly introduces the drawings required for describing the embodiments. Obviously, the drawings described below are only some embodiments of the present application. For those skilled in the art, other drawings can be obtained based on these drawings without inventive efforts. Among them:

[0017] Figure 1 It is a graph showing the absorbance and antigen increase in the existing sample test;

[0018] Figure 2 It is a corresponding diagram of the relationship between the existing measured concentration and the actual concentration;

[0019] Figure 3 This is a flow chart of the first embodiment of the sample analysis method provided by this application;

[0020] Figure 4 is a schematic diagram of the calibration curve of this application;

[0021] Figure 5 is a schematic diagram of the target reaction curve of the target sample solution of the present application;

[0022] Figure 6 is a schematic diagram of the hook effect curve provided in this application;

[0023] Figure 7 This is a flow chart of the second embodiment of the sample analysis method provided by this application;

[0024] Figure 8 This is a schematic structural diagram of an embodiment of a sample analysis device provided by the present application;

[0025] Figure 9 It is a structural diagram of an embodiment of a computer-readable storage medium provided by this application. DETAILED DESCRIPTION

[0026] The technical solutions in the embodiments of the present application will be clearly and completely described below in conjunction with the drawings in the embodiments of the present application. It will be understood that the specific embodiments described herein are only used to explain the present application, rather than to limit the present application. It should also be noted that, for ease of description, only some, rather than all, structures related to the present application are shown in the drawings. Based on the embodiments in the present application, all other embodiments obtained by ordinary technicians in this field without making creative work are within the scope of protection of this application.

[0027] The terms "first," "second," and the like in this application are used to distinguish between different objects, not to describe a particular order. Furthermore, the terms "including," "having," and any variations thereof, are intended to cover non-exclusive inclusions. For example, a process, method, system, product, or apparatus comprising a series of steps or elements is not limited to the listed steps or elements, but may optionally include steps or elements not listed, or may optionally include other steps or elements inherent to the process, method, product, or apparatus.

[0028] References herein to "embodiments" mean that a particular feature, structure, or characteristic described in connection with the embodiments may be included in at least one embodiment of the present application. The appearance of this phrase in various places in the specification does not necessarily refer to the same embodiment, nor does it constitute an independent or alternative embodiment that is mutually exclusive of other embodiments. It is understood, both explicitly and implicitly, by those skilled in the art that the embodiments described herein may be combined with other embodiments.

[0029] In the field of sample testing, conventional methods for detecting immunoturbidimetry include scattering immunoturbidimetry and transmission immunoturbidimetry. The main principle is to use a light source to irradiate the reaction solution of antigen and antibody (such as a mixed solution formed by adding reagents to the sample to be tested), and use a receiver at the other end of the reaction cup to collect the transmitted light or scattered light and convert it into a signal value. Then, based on the curve obtained by varying the signal value with the reaction time, the concentration of the antigen solution can be calculated.

[0030] However, in the actual detection process, it is limited by the ratio of antigen-antibody concentration. When different concentrations of antigen are added to a constant dose of antibody solution, the amount of immune complex formed will increase with the increase of antigen concentration. After reaching the peak, the amount of immune complex will decrease with the increase of antigen concentration, as shown in the following figure. Figure 1 The bell-shaped curve shown is what the famous Heidelberg curve expresses.

[0031] See Figure 1As can be seen from the figure, the peak part of the curve is the range of the appropriate antigen-antibody ratio, which is called the equivalence zone of the antigen-antibody reaction, also known as the equilibrium zone. Within this range, the antigen and antibody are fully combined, and the immune complex formed is the largest, that is, the precipitate is the largest, and the ratio of antigen and antibody is the most appropriate, which is called the optimal ratio. Before and after the equivalence zone are the antibody excess zone and the antigen excess zone, respectively. Both ranges will affect the formation of precipitates. This phenomenon is called the zone phenomenon. When the antibody is in excess, it is called the prezone, and when the antigen is in excess, it is called the postzone. Whether in the prezone or the postzone, false negative results will occur, resulting in the actual antigen concentration measured being Figure 2 Therefore, in order to minimize false negative results, the measured Figure 2 The ideal concentration of the solid curve usually requires the integration of antigen excess detection function into the immunoturbidimetric detection method. Conventional methods include pre-reaction before detection, adding antigens consistent with the substance to be tested at the end of the reaction, or using different identification methods for different projects, etc. However, these methods all have the disadvantages of long reaction time and high reagent consumption.

[0032] See Figure 3 , Figure 3 : is a flow chart of a first embodiment of a sample analysis method provided by the present application, the method comprising:

[0033] Step 31: Acquire actual concentration values ​​of a plurality of high-concentration sample solutions; wherein the concentration value of the high-concentration sample solution is greater than a preset concentration value.

[0034] Understandably, it has been found through experiments that high-concentration samples to be tested are more likely to experience a hook effect during the reaction. Therefore, in this embodiment, by modeling the actual concentration value of the high-concentration sample to form a hook effect curve, the high-concentration sample to be tested can be better accurately detected.

[0035] Specifically, several high-concentration sample points b1, b2…bm, S, c1, c2…cn are selected, where S is a cutoff point. In one embodiment, the cutoff point is the point with the highest reactivity. Reactivity is a characteristic parameter used to measure reaction efficiency and can be determined from a reaction curve. In some embodiments, reactivity can be a reaction rate.

[0036] Step 32: Determine estimated concentration values ​​of the multiple high-concentration sample solutions based on the characteristic parameters of the reaction curves of the multiple high-concentration sample solutions and the calibration curve; wherein the calibration curve represents the corresponding relationship between the characteristic parameters and the estimated concentration values.

[0037] The reaction curve is a graph plotting absorbance versus time. The absorbance is obtained by mixing a sample solution (antibody solution) with a reagent solution (antigen solution), illuminating the reaction cell with a light source, and receiving the scattered / transmitted signals with a receiver for further processing. The absorbance reflects the amount of conjugate in the mixed solution and can be used to calculate the concentration of the original sample solution.

[0038] The characteristic parameter is a parameter used to represent the characteristics of the reaction curve. Specifically, the characteristic parameter mainly represents the reaction efficiency corresponding to the reaction curve, such as the reaction rate.

[0039] The calibration curve is a curve used to represent the corresponding relationship between characteristic parameters and estimated concentration values. Optionally, in one embodiment, the calibration curve can be obtained in the following manner:

[0040] Acquire concentration values ​​of multiple calibration sample solutions; and acquire characteristic parameters of reaction curves corresponding to the mixing of the multiple calibration sample solutions with the reagent solution; and establish a calibration curve based on the multiple calibration concentration values ​​and the corresponding characteristic parameters.

[0041] like Figure 4 As shown, Figure 4 It is a schematic diagram of the calibration curve of this application, the horizontal axis of the calibration curve is the estimated concentration value, and the vertical axis is the characteristic parameter.

[0042] Specifically, k calibration sample solutions with different concentration points (a1, a2…ak) are set, and the k calibration sample solutions are mixed with the reagent solution to obtain k reaction curves. Then, k reactivity degrees are determined from the k reaction curves, and then a mapping relationship between the reactivity degree and the estimated concentration is constructed, namely the calibration curve.

[0043] It is understandable that, in one embodiment, the k concentration points may be selected to be smaller than the preset concentration value in step 31. That is, a1, a2...ak and b1, b2...bm, S, c1, c2...cn constitute three intervals.

[0044] Optionally, in this step, some important parameters can be further obtained based on the reaction curve of the calibration sample solution with the highest concentration value, so as to be used in subsequent sample testing. Specifically:

[0045] A target reaction curve corresponding to a target sample solution with the largest concentration value is obtained from a plurality of calibration sample solutions; and an absorbance value corresponding to a first moment and an absorbance value corresponding to a second moment in the target reaction curve are determined; wherein the second moment is greater than the first moment.

[0046] Specific as Figure 5 As shown, Figure 5It is a schematic diagram of the target reaction curve of the target sample solution of the present application, wherein the horizontal axis represents time and the vertical axis represents absorbance value. Specifically, the absorbance value thres_dbMax_AD corresponding to time t and the absorbance value thres_dbMax_Saturation at time T (T>t) are determined.

[0047] Furthermore, the plurality of high-concentration sample solutions are mixed with the reagent solution to react respectively, thereby obtaining corresponding reaction curves, and further obtaining characteristic parameters (reactivity) corresponding to each high-concentration sample solution.

[0048] Since the above calibration curve represents the mapping relationship between the characteristic parameters and the estimated concentration, the estimated concentration value of each high-concentration sample solution can be obtained according to the characteristic parameters of each high-concentration sample solution.

[0049] Step 33: Establish a hook effect curve based on the actual concentration values ​​and the estimated concentration values ​​of the multiple high-concentration sample solutions.

[0050] It can be understood that, by combining the above steps 31 and 32, the true concentration values ​​and estimated concentration values ​​corresponding to the multiple high-concentration sample solutions are obtained respectively, and the corresponding relationship between the true concentration values ​​and the estimated concentration values ​​can be established.

[0051] Optionally, in a further embodiment, the hook effect curve may be divided into a plurality of intervals, so that when performing concentration detection on the sample solution to be detected, different intervals may be used for detection according to the difference of the sample solution to be detected.

[0052] like Figure 6 As shown, Figure 6 This is a schematic diagram of the hook effect curve provided by this application. In this embodiment, three intervals are taken as an example:

[0053] First interval: a1, a2…ak;

[0054] Second interval: b1, b2…bm;

[0055] The third interval: c1, c2…cn;

[0056] The dividing point between the second interval and the third interval is S, and S is the point corresponding to the sample with the highest reactivity among the multiple high-concentration sample solutions.

[0057] It can be understood that the above three intervals are only one embodiment. In other embodiments, more intervals may be divided according to the reaction characteristics, which is not limited here.

[0058] Step 34: Detect the concentration of the sample solution to be detected using the calibration curve and the hook effect curve.

[0059] Different from the prior art, the sample analysis method provided by the present application includes: obtaining the true concentration values ​​of multiple high-concentration sample solutions; wherein the concentration value of the high-concentration sample solution is greater than a preset concentration value; determining the estimated concentration values ​​of the multiple high-concentration sample solutions based on the characteristic parameters of the reaction curves of the multiple high-concentration sample solutions and a calibration curve; wherein the calibration curve represents the correspondence between the characteristic parameters and the estimated concentration values; establishing a hook effect curve based on the true concentration values ​​and the estimated concentration values ​​of the multiple high-concentration sample solutions; and detecting the concentration of the sample solution to be detected using the calibration curve and the hook effect curve. In the above manner, the concentration value is detected using the pre-established calibration curve and hook effect curve, thereby avoiding the problem of waste of reagents and reduced detection efficiency when the dilution method is used in the prior art for detecting the hook effect in high-concentration sample solutions, thereby reducing detection costs and improving detection efficiency.

[0060] The above embodiment mainly introduces the process of establishing the hook effect curve. The following describes how to use the hook effect interval to detect the concentration of a sample solution.

[0061] See Figure 7 , Figure 7 : is a flow chart of a second embodiment of the sample analysis method provided by this application, the method comprising:

[0062] Step 71: Obtain a reaction curve to be tested of the mixed solution.

[0063] The mixed solution is formed by mixing the sample solution to be detected and the reagent solution. The mixed solution and the reagent solution react to form a mixture. The reaction curve represents the corresponding relationship between the absorbance value of the mixture and time.

[0064] Optionally, in one embodiment, the sample solution to be detected is an antibody solution, and the reagent solution is an antigen solution. The antibody solution and the antigen solution are mixed and reacted to generate an immune conjugate. The mixed solution is irradiated with a light source and the reflected / transmitted light is collected to detect the absorbance, and the concentration of the antibody solution is further detected.

[0065] Step 72: Based on the characteristic parameters of the reaction curve to be tested, determine the estimated concentration value of the sample solution to be tested in a pre-established calibration curve.

[0066] The calibration curve represents the corresponding relationship between the characteristic parameters and the estimated concentration values, and the calibration curve can be established using the method in the above embodiment.

[0067] Step 73: Based on the estimated concentration value, determine the corresponding true concentration value in the pre-established hook effect curve.

[0068] Among them, the hook effect curve represents the corresponding relationship between the estimated concentration value and the true concentration value.

[0069] Optionally, in one embodiment, since the hook effect curve is divided into multiple different intervals, the reference interval can be determined according to the characteristics of the reaction curve as follows:

[0070] When ADt < thres_dbMax_AD and R < thres_dbMax_R, it is determined that the reaction curve corresponds to the first concentration interval; or

[0071] When ADt ≥ thres_dbMax_AD and Saturation ≥ thres_S_Saturation, it is determined that the reaction curve corresponds to the second concentration interval; or

[0072] When ADt ≥ thres_S_AD and Saturation < thres_S_Saturation, it is determined that the reaction curve corresponds to the third concentration interval;

[0073] Among them, ADt is the absorbance value at the first moment of the reaction curve to be measured, thres_dbMax_AD is the absorbance value at the first moment of the target reaction curve, R is the characteristic parameter corresponding to the reaction curve to be measured, thres_dbMax_R is the characteristic parameter corresponding to the target reaction curve, Saturation is the time corresponding to when the absorbance value of the reaction curve to be measured reaches the absorbance value corresponding to the second moment in the target reaction curve, thres_S_Saturation is the time corresponding to when the absorbance value of the reaction curve corresponding to the peak in the hook effect curve reaches the absorbance value corresponding to the second moment in the target reaction curve, and thres_S_AD is the absorbance value at the first moment of the reaction curve corresponding to the peak in the hook effect curve.

[0074] Furthermore, when determining that the sample solution to be detected corresponds to the first interval, its estimated concentration value is directly used as the true concentration value. When determining that the sample solution to be detected corresponds to the second interval or the third interval, the mapping relationship on the hook effect curve is used to determine the true concentration value corresponding to its estimated concentration value.

[0075] Step 74: Determine the serum concentration of the sample solution to be detected according to the true concentration value.

[0076] It can be understood that the true concentration value determined in the above embodiment is the whole blood concentration. In practical applications, the serum concentration value is often required and can be calculated using the following formula:

[0077]

[0078] Among them, C 全血is the true concentration value (ie, the whole blood concentration value), and HCT is the hematocrit.

[0079] It can be understood that in the above embodiments, generally for the same type of instruments, samples, and reagents, the establishment of the calibration curve and the hook effect curve can be one-time. If there is a sample replacement or a reagent replacement, it is necessary to repeat the process of the above first embodiment and re-establish the calibration curve and the hook effect curve.

[0080] Different from the prior art, the sample analysis method provided in this application includes: obtaining a reaction curve to be tested for a mixed solution; determining an estimated concentration value of the sample solution to be tested in a pre-established calibration curve based on characteristic parameters of the reaction curve to be tested; determining the corresponding true concentration value in a pre-established hook effect curve based on the estimated concentration value; and determining the serum concentration of the sample solution to be tested based on the true concentration value. By utilizing the pre-established calibration curve and hook effect curve to detect concentration values ​​in this manner, the problem of reagent waste and reduced detection efficiency when using the dilution method in the prior art for detecting the hook effect in high-concentration sample solutions is avoided, thereby reducing detection costs and improving detection efficiency.

[0081] See Figure 8 , Figure 8 8 is a schematic diagram of the structure of an embodiment of a sample analysis device provided by the present application. The sample analysis device includes a processor 81 and a memory 82. The memory 82 is used to store program data, and the processor 81 is used to execute the program data to implement the following method:

[0082] Obtaining the true concentration values ​​of multiple high-concentration sample solutions; wherein the concentration value of the high-concentration sample solution is greater than a preset concentration value; determining the estimated concentration values ​​of the multiple high-concentration sample solutions based on the characteristic parameters of the reaction curves of the multiple high-concentration sample solutions and the calibration curve; wherein the calibration curve represents the correspondence between the characteristic parameters and the estimated concentration values; establishing a hook effect curve based on the true concentration values ​​and the estimated concentration values ​​of the multiple high-concentration sample solutions; and detecting the concentration of the sample solution to be detected using the calibration curve and the hook effect curve. Or

[0083] Obtain a reaction curve of a mixed solution to be tested; wherein the mixed solution is formed by mixing a sample solution to be tested and a reagent solution, the mixed solution and the reagent solution react to form a mixture, and the reaction curve represents the corresponding relationship between the absorbance value of the mixture and time; based on the characteristic parameters of the reaction curve to be tested, determine an estimated concentration value of the sample solution to be tested in a pre-established calibration curve; wherein the calibration curve represents the corresponding relationship between the characteristic parameters and the estimated concentration value; based on the estimated concentration value, determine the corresponding true concentration value in a pre-established hook effect curve; wherein the hook effect curve represents the corresponding relationship between the estimated concentration value and the true concentration value; and determine the serum concentration of the sample solution to be tested according to the true concentration value.

[0084] See Figure 9 , Figure 9 1 is a schematic diagram of the structure of an embodiment of a computer-readable storage medium provided by the present application. The computer-readable storage medium 90 stores program data 91. When the program data 91 is executed by a processor, it is used to implement the following method:

[0085] Obtaining the true concentration values ​​of multiple high-concentration sample solutions; wherein the concentration value of the high-concentration sample solution is greater than a preset concentration value; determining the estimated concentration values ​​of the multiple high-concentration sample solutions based on the characteristic parameters of the reaction curves of the multiple high-concentration sample solutions and the calibration curve; wherein the calibration curve represents the correspondence between the characteristic parameters and the estimated concentration values; establishing a hook effect curve based on the true concentration values ​​and the estimated concentration values ​​of the multiple high-concentration sample solutions; and detecting the concentration of the sample solution to be detected using the calibration curve and the hook effect curve. Or

[0086] Obtain a reaction curve of a mixed solution to be tested; wherein the mixed solution is formed by mixing a sample solution to be tested and a reagent solution, the mixed solution and the reagent solution react to form a mixture, and the reaction curve represents the corresponding relationship between the absorbance value of the mixture and time; based on the characteristic parameters of the reaction curve to be tested, determine an estimated concentration value of the sample solution to be tested in a pre-established calibration curve; wherein the calibration curve represents the corresponding relationship between the characteristic parameters and the estimated concentration value; based on the estimated concentration value, determine the corresponding true concentration value in a pre-established hook effect curve; wherein the hook effect curve represents the corresponding relationship between the estimated concentration value and the true concentration value; and determine the serum concentration of the sample solution to be tested according to the true concentration value.

[0087] In the several embodiments provided in this application, it should be understood that the disclosed methods and devices can be implemented in other ways. For example, the device embodiments described above are merely illustrative. For example, the division of the modules or units is merely a logical functional division. In actual implementation, other division methods may be used, such as combining or integrating multiple units or components into another system, or ignoring or not implementing certain features.

[0088] The units described as separate components may or may not be physically separate, and the components shown as units may or may not be physical units, that is, they may be located in one place or distributed across multiple network units. Some or all of the units may be selected according to actual needs to achieve the purpose of this embodiment.

[0089] In addition, each functional unit in each embodiment of the present application may be integrated into a processing unit, each unit may exist physically separately, or two or more units may be integrated into a single unit. The above-mentioned integrated units may be implemented in the form of hardware or software functional units.

[0090] The above description is only an implementation method of the present application and does not limit the patent scope of the present application. Any equivalent structure or equivalent process transformation made according to the contents of the description and drawings of this application, or directly or indirectly applied in other related technical fields, are also included in the patent protection scope of the present application.

Claims

1. A sample analysis method, characterized in that: The method comprises: Acquiring actual concentration values ​​of a plurality of high-concentration sample solutions; wherein the concentration value of the high-concentration sample solution is greater than a preset concentration value; Determining estimated concentration values ​​of the plurality of high-concentration sample solutions based on characteristic parameters of the reaction curves of the plurality of high-concentration sample solutions and a calibration curve; wherein the calibration curve represents a correspondence between the characteristic parameters and the estimated concentration values; establishing a hook effect curve according to the actual concentration values ​​and the estimated concentration values ​​of the plurality of high-concentration sample solutions; Detecting the concentration of the sample solution to be detected using the calibration curve and the hook effect curve; The method of detecting the concentration of the sample solution to be detected by using the calibration curve and the hook effect curve includes: Obtaining a reaction curve of a mixed solution to be tested; wherein the mixed solution is formed by mixing the sample solution to be tested and a reagent solution, the mixed solution and the reagent solution react to form a mixture, and the reaction curve represents a corresponding relationship between the absorbance value of the mixture and time; determining an estimated concentration value of the sample solution to be tested in the calibration curve based on characteristic parameters of the reaction curve to be tested; Based on the estimated concentration value, determining a corresponding true concentration value in the hook effect curve; The serum concentration of the sample solution to be tested is determined according to the true concentration value.

2. The method according to claim 1, characterized in that The method further comprises: obtaining concentration values ​​of a plurality of calibration sample solutions; and Obtaining characteristic parameters of reaction curves corresponding to the mixing of the plurality of calibration sample solutions with the reagent solution; The calibration curve is established according to the concentration values ​​of the plurality of calibration sample solutions and the corresponding characteristic parameters.

3. The method according to claim 2, characterized in that The method further comprises: Obtaining a target reaction curve corresponding to a target sample solution having the largest concentration value among the multiple calibration sample solutions; Determine the absorbance value corresponding to the first moment and the absorbance value corresponding to the second moment in the target reaction curve; wherein the second moment is greater than the first moment.

4. The method according to claim 1, wherein The hook effect curve is divided into a plurality of concentration intervals based on the true concentration value; Determining a corresponding true concentration value in the hook effect curve based on the estimated concentration value includes: Determining the concentration interval corresponding to the reaction curve to be tested; In the concentration interval corresponding to the reaction curve to be measured, a true concentration value corresponding to the estimated concentration value is determined.

5. The method according to claim 4, characterized in that The hook effect curve is divided into at least a first concentration interval, a second concentration interval, and a third concentration interval based on the true concentration value, wherein the boundary point between the first concentration interval and the second concentration interval is the true concentration value corresponding to the sample solution corresponding to the preset concentration value, and the second concentration interval and the third concentration interval are the true concentration values ​​corresponding to the sample solution with the largest characteristic parameter in the reaction curves of the multiple high-concentration sample solutions; The estimated concentration value and the actual concentration value corresponding to the first concentration interval are equal.

6. The method according to claim 5, wherein: The determination of the concentration range corresponding to the reaction curve to be measured includes: When ADt < thres_dbMax_AD and R < thres_dbMax_R, determining that the reaction curve corresponds to the first concentration range; or When ADt ≥ thres_dbMax_AD and Saturation ≥ thres_S_Saturation, determining that the reaction curve corresponds to the second concentration range; or When ADt ≥ thres_S_AD and Saturation < thres_S_Saturation, determining that the reaction curve corresponds to the third concentration range; wherein, ADt is the absorbance value at the first moment of the reaction curve to be measured, thres_dbMax_AD is the absorbance value at the first moment of the target reaction curve, R is the characteristic parameter corresponding to the reaction curve to be measured, thres_dbMax_R is the characteristic parameter corresponding to the target reaction curve, Saturation is the time corresponding to when the absorbance value of the reaction curve to be measured reaches the absorbance value corresponding to the second moment in the target reaction curve, thres_S_Saturation is the time corresponding to when the absorbance value of the reaction curve corresponding to the peak in the hook effect curve reaches the absorbance value corresponding to the second moment in the target reaction curve, and thres_S_AD is the absorbance value at the first moment of the reaction curve corresponding to the peak in the hook effect curve.

7. The method according to claim 1, wherein: The determination of the serum concentration of the sample solution to be detected according to the true concentration value includes: Calculating the serum concentration according to the following formula: Among them, C 全血 is the actual concentration value, and HCT is the hematocrit.

8. A sample analysis device, characterized in that: The sample analysis device includes a processor and a memory, the memory is used to store program data, and the processor is used to execute the program data to implement the method according to any one of claims 1-7.

9. A computer-readable storage medium, characterized in that The program data is stored in the computer-readable storage medium, and when the program data is executed by the processor, it is used to implement the method according to any one of claims 1-7.

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