Method for testing HbA1c value by correcting latex turbidimetry and device for testing HbA1c value by correcting latex turbidimetry

Abstract

The invention discloses a method for testing an HbA1c value by correcting latex turbidimetry and a device for testing the HbA1c value by correcting latex turbidimetry, and relates to the technical field of detection methods.The method for testing the HbA1c value by correcting latex turbidimetry comprises the steps that Hb information of a to-be-detected sample, the HbA1c value of the to-be-detected sample and the scattered light intensity value M of the to-be-detected sample are obtained; comparing the preset Hb information with the Hb information of the to-be-tested sample; when the Hb information of the to-be-tested sample is greater than preset Hb information, displaying an HbA1c value of the to-be-tested sample; when the Hb information of the to-be-tested sample is smaller than or equal to preset Hb information, the HbA1c value of the to-be-tested sample is corrected, and the corrected HbA1c value of the to-be-tested sample is obtained; wherein the Hb information comprises an Hb value and an HCT value. The corrected HbA1c value is closer to the true value, the accuracy of the HbA1c value result is improved, the detection range and the use range of the latex turbidimetry are expanded, and the Hb range tolerated by the corrected latex turbidimetry is 30-200g / L; and the detection result of the HbA1c value of the to-be-detected sample is directly corrected, so that the detection time and the detection cost are saved.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of detection methods, in particular to a method for testing HbA1c value by modified latex turbidimetry and a device for testing HbA1c value by modified latex turbidimetry. BACKGROUND

[0002] Diabetes is an endocrine metabolic disease. In recent years, the incidence of diabetes has been rising, and it has become the third largest non-communicable disease after cardiovascular and cerebrovascular diseases and tumors, and has become one of the important causes of disability and death. Traditional diabetes diagnosis and treatment monitoring uses fasting blood glucose, postprandial blood glucose and oral glucose tolerance test methods, but blood glucose parameters only represent the instantaneous blood glucose level at the time of blood sampling, and the measurement is not accurate.

[0003] In the human body, glycosylated hemoglobin HbA1c is generated by the combination of blood glucose and hemoglobin (Hemoglobin, Hb), which is an irreversible reaction. HbA1c is proportional to blood glucose concentration, and can be maintained for about 120 days. Therefore, HbA1c is the most important and stable glycosylated hemoglobin form, so observing the HbA1c concentration between 120 days can more accurately reflect the blood glucose concentration of the human body.

[0004] Currently, the methods for detecting HbA1c concentration mainly include high performance liquid chromatography (HPLC) and latex immunoturbidimetry. Among them, HPLC has high cost, so latex immunoturbidimetry is more suitable for primary detection.

[0005] The prerequisite for detecting HbA1c concentration by latex immunoturbidimetry is to achieve saturated adsorption of latex microspheres. Due to individual differences, the hemoglobin Hb content of most people in clinical practice is different. The hemoglobin Hb concentration of normal people is in the range of 110-160g / L, and the hemoglobin Hb concentration of anemic patients can be as low as 30g / L. At this time, the hemoglobin Hb concentration is too low to saturate the adsorption of latex microspheres, and the test value of HbA1c will be lower than the true value, which may lead to misjudgment by doctors and delay the disease. SUMMARY

[0006] The main purpose of the present application is to provide a method for testing HbA1c value by modified latex turbidimetry and a device for testing HbA1c value by modified latex turbidimetry, which aims to solve the problem that low Hb samples will lead to inaccurate test results when testing HbA1c content by latex immunoturbidimetry in the prior art.

[0007] To achieve the above-mentioned purpose, the present application provides a method for testing HbA1c value by modified latex turbidimetry, comprising the following steps:

[0008] S10, obtaining Hb information of a to-be-tested sample, HbA1c value of the to-be-tested sample, and scattering light intensity value M of the to-be-tested sample;

[0009] S20, comparing the preset Hb information with the Hb information of the sample to be tested;

[0010] S30, when the Hb information of the sample to be tested is greater than the preset Hb information, displaying the HbA1c value of the sample to be tested;

[0011] S40, when the Hb information of the sample to be tested is less than or equal to the preset Hb information, correcting the HbA1c value of the sample to be tested to obtain the corrected HbA1c value of the sample to be tested;

[0012] The Hb information includes Hb value and HCT value.

[0013] In an embodiment, in step S40, the correction method comprises:

[0014] S410, calculating the corrected scattered light intensity value of the sample to be tested according to the correction formula E=k*D+b, wherein E is the corrected scattered light intensity value of the sample to be tested, k is the correction slope, D is the converted scattered light intensity value of the scattered light intensity M of the sample to be tested, and b is the correction intercept;

[0015] S420, calculating the corrected HbA1c value of the sample to be tested according to the corrected scattered light intensity value E of the sample to be tested and the standard curve between the scattered light intensity value and the HbA1c value of the hemoglobin standard.

[0016] In an embodiment, before step S410, further comprising obtaining a correction formula, and the step of obtaining the correction formula comprises:

[0017] S401, obtaining a hemoglobin group of HbA1c determined by latex turbidimetry, wherein the hemoglobin group contains an HbA1c value under a first Hb information and an HbA1c value under a second Hb information, the first Hb information>the preset Hb information>the second Hb information, and the scattered light intensity value B1 corresponding to the first Hb information and the scattered light intensity value B2 corresponding to the second Hb information determined by latex turbidimetry are obtained;

[0018] S402, obtaining the HbA1c value corresponding to the first Hb information and the HbA1c value corresponding to the second Hb information in the hemoglobin group determined by HPLC method;

[0019] S403, calculating the scattered light intensity coefficient C corresponding to the second Hb information in the hemoglobin group by the scattered light intensity value B2 corresponding to the second Hb information determined by latex turbidimetry and the second Hb information, wherein C=B2 / second Hb information;

[0020] S404, calculating a converted scattering light intensity value D of the second Hb information according to the scattering light intensity coefficient C corresponding to the second Hb information and the first Hb information, wherein D=C*the first Hb information;

[0021] S405, obtaining a first linear regression equation y1=a1*x1+b1 according to the HbA1c value corresponding to the first Hb information measured by the HPLC method and the scattering light intensity value B1 corresponding to the first Hb information measured by the latex turbidimetry, wherein y1 is the HbA1c value corresponding to the first Hb information measured by the HPLC method, x1 is the scattering light intensity value B1 corresponding to the first Hb information measured by the latex turbidimetry, a1 is the slope of the first linear regression equation, and b1 is the intercept of the first linear regression equation;

[0022] S406, obtaining a second linear regression equation y2=a2*x2+b2 according to the converted scattering light intensity value D of the second Hb information and the HbA1c value corresponding to the second Hb information measured by the HPLC method, wherein y2 is the HbA1c value corresponding to the second Hb information measured by the HPLC method, x2 is the converted scattering light intensity value D of the second Hb information, a1 is the slope of the second linear regression equation, and b2 is the intercept of the second linear regression equation;

[0023] S407, calculating a correction formula according to the first linear regression equation and the second linear regression equation;

[0024] The first Hb information includes a first Hb value, and the second Hb information includes a second Hb value.

[0025] The first Hb information includes a first HCT value, and the second Hb information includes a second HCT value.

[0026] In an embodiment, the number of the groups of hemoglobins is multiple.

[0027] In an embodiment, the step S407 comprises:

[0028] S4071, obtaining a correction slope k=a2 / a1 according to the slope a1 of the first linear regression equation and the slope a2 of the second linear regression equation;

[0029] S4072, obtaining a correction intercept b=(b2-b1) / a1 according to the intercept b1 of the first linear regression equation and the intercept b2 of the second linear regression equation;

[0030] S4073, obtaining a correction formula E=k*D+b according to the converted scattering light intensity value D of the scattering light intensity value M of the sample to be measured measured by the latex turbidimetry, the correction slope k, and the correction intercept b, wherein E is a corrected scattering light intensity value.

[0031] In an embodiment, the first Hb information comprises a first Hb value, and the first Hb value ranges from 120 g / L to 160 g / L; or,

[0032] The first Hb information comprises a first HCT value, and the first HCT value ranges from 37% to 50%.

[0033] In an embodiment, before step S20, the method comprises calculating preset Hb information, and the step of calculating the preset Hb information comprises:

[0034] S21, calculating a corrected scattered light intensity value E corresponding to the second Hb information in the plurality of hemoglobin groups by a correction formula E=k*D+b;

[0035] S22, calculating a corrected Hb information Z of the second Hb information in the plurality of hemoglobin groups by a plurality of corrected scattered light intensity values E and a plurality of scattered light intensity coefficients C corresponding to the second Hb information in the plurality of hemoglobin groups, wherein Z=E / C;

[0036] S23, calculating an average value X of the corrected Hb information Z of the second Hb information in the plurality of hemoglobin groups by the corrected Hb information Z of the second Hb information in the plurality of hemoglobin groups;

[0037] S24, calculating a standard deviation value SD of the corrected Hb information Z of the second Hb information in the plurality of hemoglobin groups by the corrected Hb information Z of the second Hb information in the plurality of hemoglobin groups;

[0038] S25, calculating the preset Hb information by the average value X of the corrected Hb information Z of the second Hb information in the plurality of hemoglobin groups and the standard deviation value SD of the corrected Hb information Z of the second Hb information in the plurality of hemoglobin groups.

[0039] In an embodiment, in step S25, the relationship between the preset Hb information and the average value X of the corrected Hb information Z of the second Hb information in the plurality of hemoglobin groups and the standard deviation value SD of the corrected Hb information Z of the second Hb information in the plurality of hemoglobin groups is: preset Hb information=X+2*SD.

[0040] The application also provides a device for correcting the HbA1c value tested by the latex turbidimetry method, which is used to realize the steps of the method for correcting the HbA1c value tested by the latex turbidimetry method, and comprises:

[0041] An acquisition module is configured to acquire Hb information of a sample to be tested, an HbA1c value of the sample to be tested, and a scattered light intensity value M of the sample to be tested.

[0042] A comparison module is configured to compare the preset Hb information with the Hb information of the sample to be tested.

[0043] a correction module configured to correct the HbA1c value of the sample to be tested when the Hb information of the sample to be tested is less than or equal to the preset Hb information, and obtain a corrected HbA1c value of the sample to be tested; and

[0044] a display module configured to display the Hb information of the sample to be tested and the corrected HbA1c value of the sample to be tested.

[0045] In an embodiment, the device for correcting the HbA1c value tested by the latex turbidimetry method further comprises a calculation module configured to calculate the corrected HbA1c value of the sample to be tested.

[0046] The present application provides a method for correcting the HbA1c value tested by the latex turbidimetry method. First, the preset Hb information is compared with the Hb information of the sample to be tested, so that it can be quickly determined whether the HbA1c value of the sample to be tested needs to be corrected. When the Hb information of the sample to be tested is greater than the preset Hb information, the HbA1c value tested by the latex turbidimetry method is close to the true value, and the HbA1c value of the sample to be tested does not need to be corrected, thereby saving the correction time. When the Hb information of the sample to be tested is less than or equal to the preset Hb information, the HbA1c value tested by the latex turbidimetry method is smaller than the true value, and the HbA1c value of the sample to be tested needs to be corrected. The corrected HbA1c value is closer to the true value, thereby improving the accuracy of the latex turbidimetry method for testing the HbA1c value, expanding the detection range and use range of the latex turbidimetry method, and satisfying the demand for the Hb content range in clinical application. The detection result of the HbA1c value of the sample to be tested is directly corrected, and the detection does not need to be performed again, thereby saving the detection time and cost. BRIEF DESCRIPTION OF DRAWINGS

[0047] In order to more clearly illustrate the technical solutions of the embodiments of the present application or the prior art, the following will briefly introduce the drawings needed to be used in the embodiments or the prior art description. Obviously, the drawings in the following description are only some embodiments of the present application, and other drawings can also be obtained according to the structures shown in the drawings without creative labor for those skilled in the art.

[0048] Figure 1 A brief flowchart of the method for correcting the HbA1c value tested by the latex turbidimetry method is provided.

[0049] Figure 2 A correlation analysis diagram of the HbA1c value before correction by the latex turbidimetry method and the HbA1c value tested by the HPLC method in Example 1 provided by the present application is provided.

[0050] Figure 3A correlation analysis chart of the HbA1c value corrected by the latex turbidimetry method and the HbA1c value tested by the HPLC method in Example 1 provided by the present application;

[0051] Figure 4 A correlation analysis chart of the HbA1c value corrected by the latex turbidimetry method and the HbA1c value tested by the HPLC method in Example 2 provided by the present application;

[0052] Figure 5 A correlation analysis chart of the HbA1c value corrected by the latex turbidimetry method and the HbA1c value tested by the HPLC method in Example 2 provided by the present application.

[0053] The purposes, functional features and advantages of the present application will be further described with reference to the embodiments and the accompanying drawings. DETAILED DESCRIPTION

[0054] In order to make the purposes, technical solutions and advantages of the embodiments of the present application more clear, the technical solutions in the embodiments of the present application will be clearly and completely described below. The specific conditions not mentioned in the embodiments are carried out according to the conventional conditions or the conditions suggested by the manufacturers. The reagents or instruments not mentioned by the manufacturers are all conventional products which can be purchased in the market. In addition, the meaning of "and / or" appearing in the whole text includes three parallel solutions. Taking "A and / or B" as an example, it includes the solution of A, or the solution of B, or the solution of A and B. In addition, the technical solutions of each embodiment can be combined with each other, but it must be based on the fact that the technical solutions can be realized by the ordinary skilled in the art. When the combination of the technical solutions appears contradictory or unachievable, it should be considered that the combination of the technical solutions does not exist and is not within the protection scope of the present application. Based on the embodiments in the present application, all other embodiments obtained by the ordinary skilled in the art without making creative efforts are within the protection scope of the present application.

[0055] Diabetes is an endocrine metabolic disease. In recent years, the incidence of diabetes has been rising, and it has become the third largest non-communicable disease after cardiovascular and cerebrovascular diseases and tumors, and has become one of the important reasons for disability and death. Traditional diabetes diagnosis and treatment monitoring adopts fasting blood glucose, postprandial blood glucose and oral glucose tolerance test methods, but the blood glucose parameter only represents the instantaneous blood glucose level at the time of blood sampling, and the measurement is not accurate.

[0056] Total hemoglobin (Hb) can be divided into three components: Hemoglobin A (HbA), Hemoglobin A2 (HbA2) and Hemoglobin F (HbF). Among them, HbF mainly exists in the fetal period, HbF is formed by two alpha chains and two gamma chains; HbA accounts for 97% of Hb in adult blood, HbA is composed of two alpha chains and two beta chains; HbA2 accounts for a small proportion in hemoglobin, which is formed by two alpha chains and two delta chains. HbA is divided into HbA0 and HbA1, HbA0 is not glycosylated, HbA1 is glycosylated, and HbA1 accounts for about 6% of HbA. HbA1 is divided into HbA1a, HbA1a2, HbA1b and HbA1c, HbA1c is the most stable glycosylated hemoglobin form, the average HbA1c level of normal people is about 5% of HbA1, and HbA1a and HbA1b account for less than 1% of the total proportion of HbA1. The combination of blood sugar and hemoglobin to generate glycosylated hemoglobin HbA1c is an irreversible reaction, which is proportional to the blood sugar concentration, and can be maintained for about 120 days, so the HbA1c concentration between 120 days can be observed to reflect the blood sugar concentration, and thus the blood sugar control of the patient in the past 8-12 weeks. The World Health Organization also recommends using HbA1c as a diagnostic indicator to diagnose diabetes.

[0057] The method for determining HbA1c can be divided into three categories according to the detection principle: the first category is based on the difference in charge, including electrophoresis and high performance liquid chromatography (HPLC) and the like; the second category is based on the difference in chemical structure, including affinity chromatography and immunological method and the like; the third category is based on the characteristics of participating in special biochemical reactions, including enzyme method and the like. Among them, HPLC and latex immunoturbidimetry are the most common, although HPLC is the most reliable method for detecting HbA1c, but its cost is high, compared with latex immunoturbidimetry, which is more suitable for popularization and use in the grassroots.

[0058] The basic principle of testing the HbA1c content by latex immunoturbidimetry is as follows: the latex microspheres can simultaneously adsorb non-glycated hemoglobin HbA0 and glycated hemoglobin HbA1, the load of the latex microspheres in the reaction system is less than the total content of the two substances, and therefore the latex microspheres are in a saturated adsorption state, at this time, the amount of the glycated hemoglobin HbA1c adsorbed on the surface of the latex microspheres is positively correlated with the percentage concentration of HbA1c in the sample. Since the size of the complex formed after the combination of the latex microspheres and the glycated hemoglobin HbA1c is increased, the scattering light is significantly enhanced, and therefore the change of the scattering light intensity can be determined by a photoelectric detector. By establishing the correlation curve of the percentage concentration of HbA1c and the scattering light intensity, the percentage content of the glycated hemoglobin HbA1c in the total hemoglobin Hb in the sample can be obtained. However, due to individual differences, the hemoglobin Hb content of most people is different in the clinic, the hemoglobin Hb concentration of normal people is in the range of 110-160 g / L, and the hemoglobin Hb concentration of anemic patients can be as low as 30 g / L, at this time, the hemoglobin Hb concentration is too low to saturate the adsorption of the latex microspheres, so that the percentage of HbA1c directly read is not accurate enough and is lower than the true value, which may lead to misjudgment of the doctor and delay the disease.

[0059] In view of the problem that the HbA1c measurement value in the sample with low hemoglobin concentration is low, there are mainly two methods: 1) increasing the binding capacity of the latex microspheres to Hb and HbA1c, 2) increasing the sample content. However, the former is suitable for eliminating the influence of low Hb concentration on the HbA1c measurement result in the range of 50-160 g / L of Hb concentration, and cannot completely meet the detection needs of severe anemia samples; the latter needs to analyze the result, and the low Hb sample needs to be processed and then repeatedly tested, which is relatively cumbersome.

[0060] In view of this, the present application provides a method for correcting the HbA1c value tested by latex turbidimetry, comprising the following steps:

[0061] S10, obtaining the Hb information of the sample to be tested, the HbA1c value of the sample to be tested, and the scattering light intensity value M of the sample to be tested;

[0062] S20, comparing the preset Hb information with the Hb information of the sample to be tested;

[0063] S30, when the Hb information of the sample to be tested is greater than the preset Hb information, displaying the HbA1c value of the sample to be tested;

[0064] S40, when the Hb information of the sample to be tested is less than or equal to the preset Hb information, correcting the HbA1c value of the sample to be tested to obtain the corrected HbA1c value of the sample to be tested;

[0065] The Hb information includes the Hb value and the HCT value.

[0066] A simplified flowchart of the above correction method is shown in Figure 1

[0067] In step S10, the preset Hb information can be HGB value and HCT value. The HGB value represents hemoglobin Hb, i.e. Hb value. The HCT is hematocrit, i.e. the percentage of total blood volume occupied by red blood cells in blood, which is used to measure the proportion of red blood cells in blood relative to the total volume of blood. Hematocrit HCT and hemoglobin concentration Hb are correlated, so both HGB value and HCT value can confirm whether the HbA1c of the sample to be measured is in the range that needs to be corrected.

[0068] The corrected HbA1c value of the present application is the HbA1c concentration in the sample, i.e. the percentage content of glycated hemoglobin HbA1c in total hemoglobin Hb in the sample detected by latex turbidimetry. When the amount of latex microspheres is fixed and the latex microspheres are saturated adsorption, the absolute content of HbA1c on the latex microspheres is only related to the HbA1c concentration of the sample itself, i.e. the percentage content of glycated hemoglobin HbA1c in total hemoglobin Hb in the blood sample. The monoclonal antibody specific to HbA1c is fixed on the surface of the latex microspheres. When the sample containing HbA1c is added, the HbA1c in the sample will bind to the antibody on the latex microspheres to form a latex-antibody-HbA1c complex. Since multiple latex-antibody-HbA1c complexes gather together, it will significantly increase the turbidity of the reaction system. The higher the HbA1c concentration of the sample itself, the greater the turbidity. Therefore, the turbidity and the HbA1c percentage concentration are positively correlated. By establishing the turbidity and HbA1c percentage concentration curve, the HbA1c percentage concentration of the sample can be obtained. Turbidity is a measure of the transparency of a liquid, mainly representing the scattering and absorption effect of suspended particles in the solution on light passing through. The solution with high turbidity has more and larger suspended particles in the interior, which will cause the scattering light intensity to increase. Therefore, the change of turbidity corresponds to the change of scattering light intensity.

[0069] ​Taking the Hb information as the Hb value as an example, for the high Hb concentration sample with the same HbA1c concentration, the high Hb concentration sample, i.e. the sample with the Hb value greater than the preset Hb value, in the saturated adsorption state of the latex microspheres, even if the Hb concentration is higher, the absolute content of HbA1c on the latex microspheres will not change, and therefore the measured HbA1c concentration will remain unchanged, so it is not necessary to correct the HbA1c concentration of the high Hb concentration sample; when the Hb concentration in the sample is too low, i.e. lower than the preset Hb value, the latex microspheres are not saturated adsorption, at this time the absolute content of HbA1c on the latex microspheres is lower than that in the saturated state, in the case of still using the standard curve of the scattering light intensity and the percentage concentration of HbA1c when the latex microspheres are saturated, the measured percentage of HbA1c will be lower than the true value, and it is necessary to correct it; the Hb concentration in the low Hb sample is less than the preset Hb value, when the Hb value of the low Hb sample increases in the range lower than the preset Hb value, the latex microspheres will continue to adsorb the hemoglobin Hb and glycated hemoglobin HbA1c in the sample, the absolute content of HbA1c on the latex microspheres increases, and the measured HbA1c concentration will also increase accordingly, at this time the HbA1c concentration and the Hb concentration are positively correlated.

[0070] In the technical scheme of the present application, first, the preset Hb information and the Hb information of the sample to be measured are compared, so that it can be quickly judged whether the HbA1c value of the sample to be measured needs to be corrected; when the Hb information of the sample to be measured is greater than the preset Hb information, the HbA1c value obtained by the latex turbidimetry is close to the true value, and it is not necessary to correct the HbA1c value, thereby saving the correction time; when the Hb information of the sample to be measured is less than or equal to the preset Hb information, the HbA1c value obtained by the latex turbidimetry is smaller than the true value of HbA1c, and it is necessary to correct the HbA1c value of the sample to be measured, the corrected HbA1c value is closer to the true value, the accuracy of the HbA1c value tested by the latex turbidimetry is improved, the detection range and the use range of the latex turbidimetry are expanded, the Hb value range of the Hb sample used after correction of the latex turbidimetry is 30-200 g / L, which meets the demand of the Hb content range in the clinic; and the detection result of the HbA1c value of the sample to be measured is directly corrected, without the need to re-detect, thereby saving the detection time and the detection cost.

[0071] In any embodiment of the present application, in step S40, the correction method comprises:

[0072] S410, calculate the corrected scattering light intensity value of the sample to be measured according to the correction formula E=k*D+b, wherein E is the corrected scattering light intensity value of the sample to be measured, k is the correction slope, D is the converted scattering light intensity value of the scattering light intensity M of the sample to be measured, and b is the correction intercept;

[0073] S420, according to the modified to be measured sample scattering light intensity value E, and the standard curve between the scattering light intensity value of hemoglobin standard and HbA1c value, calculate the modified HbA1c value of the to-be-measured sample.

[0074] In step S410, the calculation formula of the conversion scattering light intensity value D of the scattering light intensity M of the to-be-measured sample is: D=M / Hb information of to-be-measured sample*first Hb information, wherein M is the scattering light intensity value of the to-be-measured sample, and the first Hb information is the same as the first Hb information in step S404.

[0075] Before step S420, it also includes the step of obtaining the standard curve between the scattering light intensity value of hemoglobin standard and HbA1c value.

[0076] A, preparing a plurality of hemoglobin standards with different HbA1c concentrations, the hemoglobin standards containing different concentrations of glycated hemoglobin HbA1c;

[0077] B, adding latex microspheres to the plurality of hemoglobin standards with different HbA1c concentrations to obtain a plurality of mixed liquids; the latex microspheres have antibodies that can specifically bind to glycated hemoglobin HbA1c;

[0078] C, detecting the plurality of mixed liquids by spectrophotometry to obtain the scattering light intensity values of the plurality of mixed liquids;

[0079] D, establishing a standard curve of scattering light intensity value and HbA1c concentration by the scattering light intensity values of the plurality of mixed liquids and the concentrations of HbA1c in the corresponding hemoglobin standards of the plurality of mixed liquids.

[0080] In the above steps, the HbA1c concentration refers to the percentage of HbA1c content in Hb content in the hemoglobin standard.

[0081] For example, when the Hb information is Hb value, because the intensity of the scattered light in the sample reflects the absolute content of HbA1c adsorbed on the latex microspheres during the latex turbidimetry detection, the absolute content of HbA1c on the latex microspheres when the latex microspheres are saturated adsorption is different from the absolute content of HbA1c on the latex microspheres when the latex microspheres are unsaturated adsorption, and thus the intensity of the scattered light when the latex microspheres are saturated adsorption is different from the intensity of the scattered light when the latex microspheres are unsaturated adsorption. The intensity of the scattered light of the sample is corrected by the correction parameter, that is, the absolute content of HbA1c in the sample is corrected to the intensity of the scattered light and the absolute content of HbA1c in the theoretical saturated adsorption state of the latex microspheres. Because the intensity of the scattered light in the sample is positively correlated with the percentage of HbA1c in the total hemoglobin in the sample, that is, the percentage of the corrected HbA1c in the total hemoglobin corresponding to the corrected intensity of the scattered light can be calculated through the standard curve of the intensity of the scattered light and the concentration of HbA1c. Therefore, when the Hb value of the sample to be detected is less than the preset Hb value, the intensity of the scattered light detected by the latex turbidimetry is corrected by a specific correction parameter or algorithm to obtain the scattered light close to the true value, and then the result close to the true HbA1c concentration is obtained through the standard curve of the intensity of the scattered light and the concentration of HbA1c, so that the latex turbidimetry can better reflect the true percentage of HbA1c in the total hemoglobin in the sample to be detected, and the percentage of HbA1c in the total hemoglobin in the sample to be detected can be more accurately obtained.

[0082] In any embodiment of the present application, before step S410, the method further comprises obtaining a correction formula, and the step of obtaining the correction formula comprises:

[0083] S401, obtaining a hemoglobin group of HbA1c determined by the latex turbidimetry, wherein the hemoglobin group contains an HbA1c value under a first Hb information and an HbA1c value under a second Hb information, the first Hb information > a preset Hb information > the second Hb information, and a scattered light intensity value B1 corresponding to the first Hb information and a scattered light intensity value B2 corresponding to the second Hb information are obtained by the latex turbidimetry;

[0084] S402, obtaining the HbA1c value corresponding to the first Hb information and the HbA1c value corresponding to the second Hb information in the hemoglobin group by the HPLC method;

[0085] S403, calculating a scattered light intensity coefficient C corresponding to the second Hb information in the hemoglobin group by the scattered light intensity value B2 corresponding to the second Hb information and the second Hb information determined by the latex turbidimetry, wherein C = B2 / second Hb information;

[0086] S404, calculating a converted scattering light intensity value D of the second Hb information according to the scattering light intensity coefficient C corresponding to the second Hb information and the first Hb information, wherein D=C*the first Hb information;

[0087] S405, obtaining a first linear regression equation y1=a1*x1+b1 according to the HbA1c value corresponding to the first Hb information measured by the HPLC method and the scattering light intensity value B1 corresponding to the first Hb information measured by the latex turbidimetry, wherein y1 is the HbA1c value corresponding to the first Hb information measured by the HPLC method, x1 is the scattering light intensity value B1 corresponding to the first Hb information measured by the latex turbidimetry, a1 is the slope of the first linear regression equation, and b1 is the intercept of the first linear regression equation;

[0088] S406, obtaining a second linear regression equation y2=a2*x2+b2 according to the converted scattering light intensity value D of the second Hb information and the HbA1c value corresponding to the second Hb information measured by the HPLC method, wherein y2 is the HbA1c value corresponding to the second Hb information measured by the HPLC method, x2 is the converted scattering light intensity value D of the second Hb information, a1 is the slope of the second linear regression equation, and b2 is the intercept of the second linear regression equation;

[0089] S407, calculating a correction formula according to the first linear regression equation and the second linear regression equation.

[0090] Preferably, the first Hb information comprises a first Hb value, and the second Hb information comprises a second Hb value; or, the first Hb information comprises a first HCT value, and the second Hb information comprises a second HCT value.

[0091] Preferably, the step S401 comprises: obtaining a hemoglobin group of HbA1c measured by the latex turbidimetry, wherein the hemoglobin group comprises an HbA1c value under a first Hb information and an HbA1c value under a second Hb information, the HbA1c value under the first Hb information is the same as the HbA1c value under the second Hb information, the first Hb information>the preset Hb information>the second Hb information, and obtaining a scattering light intensity value B1 corresponding to the first Hb information and a scattering light intensity value B2 corresponding to the second Hb information measured by the latex turbidimetry.

[0092] It should be noted that the HbA1c value under the first Hb information of the hemoglobin group and the HbA1c value under the second Hb information can not be the same, which is convenient for selecting samples to establish a linear equation. Preferably, the HbA1c value under the first Hb information of the hemoglobin group and the HbA1c value under the second Hb information can be the same, which has a more stringent requirement for sample screening and can obtain a more accurate linear equation.

[0093] For example, when the Hb information is the Hb value, the HbA1c value of the first Hb value measured by the latex turbidimetry in the hemoglobin group is the same as the HbA1c value of the second Hb value, the first Hb value is greater than the second Hb value, the second Hb value is less than the preset Hb value, and the first Hb value is greater than the preset Hb value. Since the HbA1c value is a relative content, its value is affected by the mass concentration of Hb and the absolute content of HbA1c in the sample. When the mass concentration of Hb and the absolute content of HbA1c in the sample change, the mass concentration of Hb and the absolute content of HbA1c in the two hemoglobin standards are different, but the HbA1c values are the same. The HbA1c value measured by the latex turbidimetry for the sample with Hb value higher than the preset Hb is close to the true value, and no correction is needed. Therefore, the first linear regression equation between the scattered light intensity value measured by the latex turbidimetry and the HbA1c value measured by the HPLC method of the first hemoglobin standard can be used as a correction standard to obtain the correction parameter for correcting the scattered light intensity value measured by the latex turbidimetry of the second hemoglobin standard. Before correction, the scattered light intensity value of the second hemoglobin group needs to be processed: first, obtain the scattered light intensity value per unit Hb in the second hemoglobin group, that is, the scattered light intensity coefficient C; then calculate the product of the first Hb value in the first hemoglobin group and the scattered light coefficient C of the second hemoglobin group to obtain the converted scattered light intensity value D of the second Hb value. The reason for obtaining the scattered light intensity D corresponding to the second Hb value is to predict the Δ scattered light intensity of the low Hb sample when Hb and HbA1c are increased at the same rate to the normal concentration of Hb. The calculation of the scattered light intensity C per unit Hb is to eliminate the influence of Hb concentration on the scattered light intensity B2. On the basis of eliminating the influence of Hb, multiplying by the normal Hb value can predict the Δ scattered light intensity D of the latex saturated adsorption under the HbA1c concentration; the second linear regression equation is established by the scattered light intensity value D of the second Hb value and the HbA1c value corresponding to the second Hb value in the hemoglobin group measured by the HPLC method. The linear regression equation is obtained to determine whether the predicted low Hb value scattered light intensity D is correct. If it is correct, it does not need to be corrected, and the "D" value is the correct Δ scattered light intensity corresponding to the low Hb value. If it is not correct, the "D" needs to be corrected.

[0094] In step S407, the method for calculating the correction parameter in the correction formula by the first linear regression equation and the second linear regression equation includes y1=y2.

[0095] In any embodiment of the present application, the number of hemoglobin groups is multiple. When the number of hemoglobin groups is greater than 5, more accurate first linear regression equation and second linear regression equation can be obtained. When the number of hemoglobin groups is greater, more data for fitting the first linear regression equation and the second linear regression equation are obtained, and the first linear regression equation and the second linear regression equation are more accurate and more reliable, so that the correction parameter obtained by the first linear regression equation and the second linear regression equation is more accurate, and thus the real HbA1c concentration can be more accurately obtained by the correction parameter.

[0096] When the HbA1c value under the first Hb information of the hemoglobin group is different from the HbA1c value under the second Hb information, a batch of samples with the same Hb value but different HbA1c and scattering light intensity can be selected from the multiple hemoglobin groups as the first hemoglobin sample.

[0097] In any embodiment of the present application, step S407 comprises:

[0098] S4071, obtaining a correction slope k = a2 / a1 by the slope a1 of the first linear regression equation and the slope a2 of the second linear regression equation;

[0099] S4072, obtaining a correction intercept b = (b2-b1) / a1 by the intercept b1 of the first linear regression equation and the intercept b2 of the second linear regression equation;

[0100] S4073, obtaining a correction formula E = k*D+b by the conversion scattering light intensity value D of the scattering light intensity value M of the sample to be measured determined by the latex turbidimetry, the correction slope k and the correction intercept b, wherein E is the corrected scattering light intensity value.

[0101] The correction parameters include a correction slope and a correction intercept. By the above calculation method, the correction slope k and the correction intercept b are calculated in the case of y1=y2. The reason for obtaining the correction slope k and the correction intercept b by y1=y2 is that they are used to correct the predicted low Hb value Δ scattered light intensity "D". The test has errors, and the HbA1c results of two samples tested by the HPLC method are the same, which may be due to the reserved decimal places or errors and other reasons, and the true values of HbA1c are not necessarily the same. Similarly, the latex turbidimetry method also has the same situation. Therefore, the "D" value and the regression equation of HPLC will certainly have differences with the Δ scattered light intensity of the normal Hb concentration sample and the HPLC regression equation. The correction parameters directly act on "D" and can correct this part of the difference. By correcting the conversion scattered light intensity value D of the latex turbidimetry method measured sample scattered light intensity value M by the correction slope k and the correction intercept b, the correctness of the corrected Δ scattered light intensity D can be ensured. The "D" value is the predicted Δ scattered light intensity of the HbA1c concentration under the normal Hb concentration, but this value certainly has errors and needs to be corrected.

[0102] In some embodiments of the present application, the first Hb information includes a first Hb value, and the value range of the first Hb value is 120-160 g / L. The first Hb value can be 120 g / L, 140 g / L or 160 g / L, and the value range of the first Hb value is 120-160 g / L, which is to ensure that the HbA1c value corresponding to the first Hb value detected by the latex turbidimetry method is close to the true value and does not need to be corrected. In this way, the accuracy of the corrected HbA1c value corresponding to the second Hb value can be ensured. It should be noted that the value range of the first Hb value is not limited to this, and any Hb range that can make the HbA1c test value normal and not need to be corrected is also available.

[0103] In some embodiments of the present application, the first Hb information includes a first HCT value, and the value range of the first HCT value is 37-50%. The first HCT value can be 37%, 45% or 50%, and the value range of the first HCT value is 37-50%, which is to ensure that the HbA1c value corresponding to the first HCT value detected by the latex turbidimetry method is close to the true value. It should be noted that the value range of the first HCT value is not limited to this, and any HCT range that can make the HbA1c test value normal and not need to be corrected is also available. The low HCT sample can be selected from samples with a HCT value of <15%.

[0104] In the latex turbidimetry, due to the following differences in different detection reagents: 1) the size, surface modification, concentration, etc. of the latex microspheres used are different; 2) the types of antibodies used are different, including primary antibodies and secondary antibodies; 3) the concentrations of the antibodies used are different; 4) the types and concentrations of buffer substances, salt ions, protective agents, preservatives, blocking agents, etc. in the reagent system used are different; 5) the hemolysis method, the type of hemolysis agent, the dilution multiple, the volume of the hemolyzed sample, the concentration of the physically adsorbed latex used, the concentration of the monoclonal antibody-antibody complex used, the reaction time, the reaction temperature, etc. in the reaction system are different, the above factors cause differences in the critical information of the corrected Hb determined by different detection systems, i.e. the preset Hb information. The method for confirming the critical Hb / HCT value that needs to be corrected by each detection system includes comparing the detection HbA1c value with the result of the gold standard HPLC, if the correlation coefficient R 2 >0.95, and the relative deviation with the HPLC result is <7% (the accuracy requirement of the national industry standard for glycosylated hemoglobin), it is confirmed that the Hb information is the preset Hb information. In any embodiment of the present application, before step S20, the preset Hb information is calculated, and the step of calculating the preset Hb information includes:

[0105] S21, calculating the corrected scattered light intensity value E corresponding to the second Hb information in the plurality of hemoglobin groups by the correction formula E=k*D+b;

[0106] S22, calculating the corrected Hb information Z of the second Hb information in the plurality of hemoglobin groups by the plurality of corrected scattered light intensity values E and the scattered light intensity coefficient C corresponding to the second Hb information in the plurality of hemoglobin groups, wherein Z=E / C;

[0107] S23, calculating the average value X of the corrected Hb information Z of the second Hb information in the plurality of hemoglobin groups by the corrected Hb information Z of the second Hb information in the plurality of hemoglobin groups;

[0108] S24, calculating the standard deviation value SD of the corrected Hb information Z of the second Hb information in the plurality of hemoglobin groups by the corrected Hb information Z of the second Hb information in the plurality of hemoglobin groups;

[0109] S25, calculating the preset Hb information by the average value X of the corrected Hb information Z of the second Hb information in the plurality of hemoglobin groups and the standard deviation value SD of the corrected Hb information Z of the second Hb information in the plurality of hemoglobin groups.

[0110] In step S22, the corrected Hb value Z of the second Hb value in the hemoglobin group is calculated by correcting the scattering light intensity value E with the scattering light intensity coefficient C corresponding to the second Hb information in the hemoglobin group, because both C and E change with the HbA1c concentration, and the ratio of the two eliminates the influence of the HbA1c concentration, and the ratio is only affected by the Hb concentration. E is the corrected scattering light intensity, and the scattering light intensity of the same sample is the same when the Hb / HCT is equal to or higher than the critical value, that is, “E”, so the critical Hb concentration or HCT value to be corrected can be obtained by E / C. The corrected Hb information Z of the second Hb information calculated by Z=E / C is the critical Hb information of one hemoglobin group, and the statistical processing of the multiple critical Hb information calculated from multiple hemoglobin groups, that is, taking the average value X and the standard deviation SD of the multiple critical Hb information, the preset Hb information is calculated according to X and SD. The calculation of the preset Hb information from multiple hemoglobin groups can ensure that the error caused by the test is eliminated, so as to ensure that the preset Hb information is suitable for samples with a wider range of HbA1c and Hb concentrations.

[0111] In any embodiment of the present application, in step S25, the relationship between the preset Hb information and the average value X of the corrected Hb information Z of the second Hb information in the multiple hemoglobin groups and the standard deviation value SD of the corrected Hb information Z of the second Hb information in the multiple hemoglobin groups is: preset Hb information=X+2*SD.

[0112] The calculation formula of the preset Hb information includes preset Hb information=X+2*SD, and the calculation of the preset Hb information by the formula can ensure that the critical Hb information of the sample is also corrected.

[0113] The present application also provides a device for correcting the HbA1c value tested by the latex turbidimetry method, which is used to realize the steps of the method for correcting the HbA1c value tested by the latex turbidimetry method, and the device for correcting the HbA1c value tested by the latex turbidimetry method comprises:

[0114] The acquisition module is used to acquire the Hb information of the sample to be tested, the HbA1c value of the sample to be tested, and the scattering light intensity value M of the sample to be tested.

[0115] The comparison module is used to compare the preset Hb information with the Hb information of the sample to be tested.

[0116] The correction module is used to correct the HbA1c value of the sample to be tested when the Hb information of the sample to be tested is less than or equal to the preset Hb information, so as to obtain the corrected HbA1c value of the sample to be tested; and

[0117] The display module is used to display the Hb information of the sample to be tested and the corrected HbA1c value of the sample to be tested.

[0118] In any embodiment of the present application, the device for testing HbA1c value by modified latex turbidimetry further comprises a calculation module for calculating the modified HbA1c value of the sample to be tested.

[0119] The acquisition module of the device for testing HbA1c value by modified latex turbidimetry comprises an Hb information acquisition module of the sample to be tested and an HbA1c value and scattered light intensity value M acquisition module of the sample to be tested, and the detection method of the HbA1c value and scattered light intensity value M acquisition module is latex turbidimetry. Therefore, the device for testing HbA1c value by modified latex turbidimetry can simultaneously detect the Hb information, HbA1c value and scattered light intensity value of the sample to be tested; according to the Hb information of the sample to be tested, the system automatically corrects the result of the HbA1c value and corrects the judgment, and the correction is performed simultaneously with the HbA1c test, and the result is directly displayed after correction, without the need for retesting.

[0120] The device for testing HbA1c value by modified latex turbidimetry has all the technical solutions of the method for testing HbA1c value by modified latex turbidimetry, and therefore also has all the beneficial effects brought by the above technical solutions, which will not be repeated here. The device for testing HbA1c value by modified latex turbidimetry can be applied to special application scenarios including but not limited to laboratories.

[0121] The technical solutions of the present application will be further described in detail below in combination with specific embodiments and drawings, and it should be understood that the following embodiments are only used to explain the present application and not to limit the present application.

[0122] Embodiment 1

[0123] A method for testing HbA1c value by modified latex turbidimetry, the latex turbidimetry is detected by using a glycosylated hemoglobin detection kit (immunoturbidimetry) (Zhongyuanhuiji, Lot: H231104), and the reagent includes R0, R1 and R2, wherein R0 is a hemolytic agent, R1 is a physically adsorbed latex, and R2 is a monoclonal antibody-antibody complex, and the detection steps are as follows: the full-automatic glycosylated hemoglobin instrument inhales the sample, uses the R0 hemolytic agent to hemolyze for 30s, reacts the hemolyzed sample with R1 at 37℃ for 3min, then adds R2 to react for 1min, and then measures the absorbance value (i.e. scattered light intensity value) at 600nm. The correction method comprises the following steps:

[0124] S10, acquiring the Hb value of the sample to be tested, and the HbA1c value of the sample to be tested, and the scattered light intensity value M of the sample to be tested; the sample information is shown in Table 1, and the sample to be tested is 145 cases;

[0125] Table 1 Sample information

[0126]

[0127]

[0128]

[0129]

[0130] S20, obtaining a preset Hb value, the preset Hb value is 51.48908059; comparing the size between the preset Hb value and the Hb value of the sample to be measured;

[0131] S30, when the Hb value of the sample to be measured is greater than the preset Hb value, the HbA1c value of the sample to be measured is displayed; the sample to be measured with the Hb value greater than the preset Hb value is sample No. 55-145, and the HbA1c thereof is shown in Table 1;

[0132] S40, when the Hb value of the sample to be measured is less than the preset Hb value, the HbA1c value of the sample to be measured is corrected to obtain the corrected HbA1c value of the sample to be measured; the sample to be measured with the Hb value less than the preset Hb value is sample No. 1-54, and the corrected HbA1c value thereof is shown in Table 1;

[0133] S401-S404, obtaining the hemoglobin group information of HbA1c determined by latex turbidimetry, as shown in Table 2;

[0134] Table 2 Hemoglobin group information

[0135]

[0136]

[0137] S405-S406, obtaining the first linear regression equation y1=0.0024x1+2.2939 through the HbA1c value of the first hemoglobin standard determined by HPLC method and the scattering light intensity value of the first hemoglobin standard determined by latex turbidimetry in Table 2; obtaining the second linear regression equation y2=0.0011x2+1.9711 through the scattering light intensity value D of the second hemoglobin standard in Table 2 and the HbA1c value of the second hemoglobin standard determined by HPLC method;

[0138] S4071, correcting the slope k=a2 / a1=0.455398813;

[0139] S4072, correcting the intercept b=(b2-b1) / a1=-135.6166042;

[0140] S4073, the correction formula is E=k*D+b;

[0141] S410, calculating the corrected scattering light intensity value of the sample to be tested according to the correction formula E=k*D+b, wherein E is the correction parameter of the scattering light intensity value, k is the correction slope, D is the converted scattering light intensity value of the scattering light intensity of the sample to be tested, and b is the correction intercept;

[0142] S420, calculating the corrected HbA1c value of the sample to be tested according to the standard curve between the corrected scattering light intensity value E of the sample to be tested and the scattering light intensity value and HbA1c value of the hemoglobin standard, wherein the standard curve between the scattering light intensity value and HbA1c value of the hemoglobin standard is y=(A-D) / [1+(x / C)^B]+D, A=7110.56964, B=-2.09311, C=10.87478, D=-50.39333, y is the scattering light intensity value of the hemoglobin standard, and x is the HbA1c value of the hemoglobin standard;

[0143] The hemoglobin group information for calculating the preset Hb value is shown in Table 3.

[0144] Table 3 Hemoglobin group information for calculating the preset Hb value

[0145]

[0146]

[0147] The average value X of the corrected Hb value Z is 49.88708485, the standard deviation value SD of the corrected Hb value Z is 0.80099787, and the preset Hb value is X+2*SD=51.48908059.

[0148] Example 2

[0149] A method for correcting the HbA1c value tested by the latex turbidimetry, wherein the latex turbidimetry is detected by the method of Example 1, and the correction method comprises the following steps:

[0150] S10, obtaining the HCT value of the sample to be tested, the HbA1c value of the sample to be tested, and the scattering light intensity value M of the sample to be tested, wherein the sample to be tested information is shown in Table 4, and the sample to be tested is 145 cases.

[0151] Table 4 Sample to be tested information

[0152]

[0153]

[0154]

[0155]

[0156] S20, obtaining a preset HCT value, the preset HCT value being 20.6347301; comparing the size between the preset HCT value and the HCT value of the sample to be tested;

[0157] S30, when the HCT value of the sample to be tested is greater than the preset HCT value, displaying the HbA1c value of the sample to be tested; the sample to be tested with the HCT value greater than the preset HCT value is sample No. 56-130, and the HbA1c thereof is shown in Table 4;

[0158] S40, when the HCT value of the sample to be tested is less than the preset HCT value, correcting the HbA1c value of the sample to be tested to obtain the corrected HbA1c value of the sample to be tested; the sample to be tested with the HCT value less than the preset HCT value is sample No. 1-55, and the corrected HbA1c value thereof is shown in Table 4;

[0159] S401-S404, obtaining the hemoglobin group information of HbA1c determined by the latex turbidimetry, as shown in Table 5;

[0160] Table 5 Hemoglobin group information

[0161]

[0162]

[0163] S405-S406, obtaining the first linear regression equation y1=0.0021x1+2.7973 by the HbA1c value of the first hemoglobin standard determined by the HPLC method and the scattering light intensity value of the first hemoglobin standard determined by the latex turbidimetry in Table 5; obtaining the second linear regression equation y2=0.0012x2+2.3382 by the scattering light intensity value D of the second hemoglobin standard in Table 5 and the HbA1c value of the second hemoglobin standard determined by the HPLC method;

[0164] S4071, correcting the slope k=a2 / a1=0.565560722;

[0165] S4072, correcting the intercept b=(b2-b1) / a1=-220.8464131;

[0166] S4073, the calculation formula of the corrected scattering light intensity value E is E=k*D+b;

[0167] S410, calculating the corrected scattering light intensity value of the sample to be tested according to the correction formula E=k*D+b, wherein E is the correction parameter of the scattering light intensity value, k is the correction slope, D is the converted scattering light intensity value of the scattering light intensity of the sample to be tested, and b is the correction intercept;

[0168] S420、According to the corrected scattering light intensity value E of the sample to be tested, and the standard curve between the scattering light intensity value and the HbA1c value of the hemoglobin standard, the corrected HbA1c value of the sample to be tested is calculated; the standard curve between the scattering light intensity value and the HbA1c value of the hemoglobin standard is: y=(A-D) / [1+(x / C)^B]+D, wherein A=7110.56964, B=-2.09311, C=10.87478, D=-50.39333, y is the scattering light intensity value of the hemoglobin standard, and x is the HbA1c value of the hemoglobin standard;

[0169] The hemoglobin group information used to calculate the preset HCT value is shown in Table 6;

[0170] Table 6 Hemoglobin group information used to calculate the preset HCT value

[0171] Number Corrected scattered light intensity value E Scattered light intensity coefficient C Corrected HCT value Z (%) 1 1946 95.79 20.31688941 2 1505 76.31 19.72838556 3 1076 57.31 18.76921199 4 1277 66.19 19.28611276 5 1535 77.61 19.7770082 6 956 52.03 18.37803689 7 1576 79.41 19.84139998 8 1328 68.46 19.3962877 9 1817 90.09 20.17094844 10 1528 77.31 19.76582855 11 1082 57.60 18.78850981 12 1053 56.30 18.6999329 13 1298 67.14 19.33322699 14 1475 74.96 19.67623875 15 1727 86.08 20.05693329 16 1366 70.16 19.47445239 17 1672 83.65 19.98232945 18 1768 87.92 20.11052701 19 994 53.72 18.51143505 20 1104 58.55 18.85039649 21 1361 69.92 19.46403586 22 1768 87.91 20.11015488 23 1435 73.19 19.60492344 24 1186 62.17 19.07000627 25 1268 65.83 19.26749431 26 1801 89.37 20.15117667 27 1666 83.41 19.97457441 28 1434 73.17 19.60397742 29 1097 58.26 18.83140175 30 1101 58.41 18.84149823 31 1901 93.79 20.2678164 32 1738 86.60 20.07223936

[0172] The average value X of the corrected HCT value Z is 19.50541846; the standard deviation value SD of the corrected HCT value Z is 0.56465582; and the preset HCT value is X+2*SD=20.6347301.

[0173] Comparative Example 1

[0174] In Comparative Example 1, a method for testing the HbA1c value of an anemic patient by using a latex turbidimetry method is used, in which a latex microsphere coupled with an antibody capable of simultaneously binding hemoglobin and glycated hemoglobin is used to solidify hemoglobin and glycated hemoglobin.

[0175] Since the method also tests the HbA1c value in the sample by quantifying the content of the latex microsphere in the reaction system, there is also the problem that when the Hb content in the sample cannot allow the latex microsphere to be saturatedly connected, the HbA1c test value is low, and the detection accuracy is relatively low.

[0176] Performance Test

[0177] The accuracy of the method for testing the HbA1c value by the modified latex turbidimetry method in Example 1, Example 2 and Comparative Example 1 is studied.

[0178] The samples to be tested in Table 1 of Example 1 are corrected using Hb information, and the corrected HbA1c value detected by the latex turbidimetry method and the HbA1c value detected by the HPLC gold standard method are respectively analyzed for correlation, and the corrected HbA1c value detected by the latex turbidimetry method and the HbA1c value detected by the HPLC gold standard method are analyzed for correlation, two correlation coefficients are obtained, and the accuracy of the correction method is determined by the size of the correlation coefficient. The results are shown in Table 7,Figure 2 and Figure 3 as shown.

[0179] Table 7 HbA1c values of the test samples before and after correction by latex turbidimetry

[0180]

[0181]

[0182] As shown in Table 7, for the 54 samples with Hb within 60 g / L, sample numbers 1-54, the Hb information was used for correction, and the maximum relative deviation of the corrected HbA1c values from the HPLC HbA1c values changed from 33% to 4%, and the accuracy was obviously improved; for the 145 samples with Hb content in the range of 26-207 g / L, Figure 2 and Figure 3 As can be seen from the comparison, the correlation coefficient R 2 of the HbA1c values before and after correction by latex turbidimetry and the HbA1c values detected by HPLC increased from 0.8694 to 0.9925>0.95, and the correlation was obviously improved.

[0183] The test samples in Table 4 of Example 2 were corrected using HCT information, and the HbA1c values detected by latex turbidimetry before correction and the HbA1c values detected by the HPLC gold standard method were subjected to correlation analysis, and the HbA1c values detected by latex turbidimetry before correction and the HbA1c values detected by the HPLC gold standard method were subjected to correlation analysis, and two correlation coefficients were obtained, and the accuracy of the correction method was determined by the size of the correlation coefficients. The results are shown in Table 8, Figure 4 and Figure 5 as shown.

[0184] Table 8 HbA1c values of the test samples before and after correction by latex turbidimetry

[0185]

[0186]

[0187] As shown in Table 8, for the 55 samples with Hb within 60 g / L, sample numbers 1-55, the HCT was used to correct the results, and the maximum relative deviation of the corrected HbA1c values from the HPLC HbA1c values changed from 33% to 5%, and the accuracy was obviously improved; for the 145 samples with Hb content in the range of 26-207 g / L, Figure 4 and Figure 5 As can be seen from the comparison, the correlation coefficient R 2The correlation is obviously improved from 0.8694 to 0.991>0.95.

[0188] The samples with Hb<110g / L or HCT<40% were tested by the method of Comparative Example 1, and the results are shown in Table 9.

[0189] Table 9: Test of samples to be tested by modified latex turbidimetry of Comparative Example 1, Example 1 and Example 2

[0190]

[0191]

[0192]

[0193] As shown in Table 9, when the method of Comparative Example 1 is used to determine samples with Hb>80g / L, the deviation from the HPLC results is within 7%, and the determination results are relatively accurate. When the sample Hb is less than 80g / L, the determination results deviate from the HPLC by more than 7%, and the lower the Hb, the greater the deviation of the determination results from the HPLC. When the Hb is as low as 30g / L, the deviation from the HPLC results is more than 10%, and the influence of low Hb samples on the HbA1c measurement value cannot be completely eliminated. After the results are corrected using the method in the present application, even if the sample Hb is as low as 30g / L, the deviation from the HPLC is less than 5%, which is closer to the true value than when the method of Comparative Example 1 is used to determine low Hb samples.

[0194] In summary, the method for testing HbA1c values by modified latex turbidimetry of the present application has a wide range of Hb samples, from 30g / L to 200g / L, which meets the needs of clinical Hb content range. The test results are corrected based on Hb values or HCT values, which can eliminate the influence of individual Hb or HCT content differences on HbA1c results, and meet the testing needs of different degrees of anemia and normal people for HbA1c. The detection results of the HbA1c values of the samples to be tested are directly corrected, without the need for re-detection, which saves detection time and detection cost.

[0195] The above is only a preferred embodiment of the present application, and does not limit the patent scope of the present application. For those skilled in the art, the present application can have various modifications and changes. Any modification, equivalent replacement, improvement, etc. made within the spirit and principles of the present application shall be included in the patent protection scope of the present application.

Claims

1. A method of correcting the HbAlc value measured by the latex turbidimetry method, characterized by, The method comprises the following steps: S10, obtaining Hb information of a sample to be measured, HbA1c value of the sample to be measured, and scattering light intensity value M of the sample to be measured; S20, comparing preset Hb information with the Hb information of the sample to be measured; S30, when the Hb information of the sample to be measured is greater than the preset Hb information, displaying the HbA1c value of the sample to be measured; S40, when the Hb information of the sample to be measured is less than or equal to the preset Hb information, correcting the HbA1c value of the sample to be measured to obtain a corrected HbA1c value of the sample to be measured; The Hb information comprises Hb value and HCT value.

2. The method of claim 1, wherein the HbAlc value is measured by a modified latex turbidity assay. In step S40, the correction method comprises: S410, calculating the corrected scattering light intensity value of the sample to be measured according to a correction formula E=k*D+b, wherein E is the corrected scattering light intensity value of the sample to be measured, k is a correction slope, D is the converted scattering light intensity value of the scattering light intensity M of the sample to be measured, and b is a correction intercept; S420, calculating the corrected HbA1c value of the sample to be measured according to the corrected scattering light intensity value E of the sample to be measured and a standard curve between the scattering light intensity value and the HbA1c value of the hemoglobin standard.

3. The method for testing HbAlc value by modified latex turbidity method according to claim 2, characterized in that, Before step S410, the method further comprises obtaining a correction formula, and the step of obtaining the correction formula comprises: S401, obtaining a hemoglobin group of HbA1c measured by latex turbidimetry, wherein the hemoglobin group comprises an HbA1c value under a first Hb information and an HbA1c value under a second Hb information, the first Hb information>the preset Hb information>the second Hb information, and a scattering light intensity value B1 corresponding to the first Hb information and a scattering light intensity value B2 corresponding to the second Hb information measured by latex turbidimetry are obtained; S402, obtaining the HbA1c value corresponding to the first Hb information and the HbA1c value corresponding to the second Hb information in the hemoglobin group measured by HPLC method; S403, calculating a scattering light intensity coefficient C corresponding to the second Hb information in the hemoglobin group by the scattering light intensity value B2 corresponding to the second Hb information measured by latex turbidimetry and the second Hb information, wherein C=B2 / second Hb information; S404, calculating a converted scattering light intensity value D of the second Hb information by the scattering light intensity coefficient C corresponding to the second Hb information and the first Hb information in the hemoglobin group, wherein D=C*first Hb information; S405, obtaining a first linear regression equation y1=a1*x1+b1 by the HbA1c value corresponding to the first Hb information in the hemoglobin group measured by HPLC method and the scattering light intensity value B1 corresponding to the first Hb information measured by latex turbidimetry, wherein y1 is the HbA1c value corresponding to the first Hb information in the hemoglobin group measured by HPLC method, x1 is the scattering light intensity value B1 corresponding to the first Hb information measured by latex turbidimetry, a1 is a slope of the first linear regression equation, and b1 is an intercept of the first linear regression equation; S406, obtain a second linear regression equation y2=a2*x2+b2 by the second Hb information corresponding to the HbA1c value of the second Hb information in the hemoglobin group determined by the HPLC method and the converted scattering light intensity value D of the second Hb information, wherein y2 is the HbA1c value of the second Hb information in the hemoglobin group determined by the HPLC method, x2 is the converted scattering light intensity value D of the second Hb information, a1 is the slope of the second linear regression equation, and b2 is the intercept of the second linear regression equation; S407, calculate a correction formula by the first linear regression equation and the second linear regression equation; The first Hb information includes a first Hb value, and the second Hb information includes a second Hb value; or The first Hb information includes a first HCT value, and the second Hb information includes a second HCT value.

4. The method for testing HbAlc value by modified latex turbidity method according to claim 3, characterized in that, The number of the hemoglobin groups is multiple.

5. The method for testing HbAlc value by modified latex turbidity method according to claim 3, characterized in that, Step S407 includes: S4071, obtain a correction slope k=a2 / a1 by the slope a1 of the first linear regression equation and the slope a2 of the second linear regression equation; S4072, obtain a correction intercept b=(b2-b1) / a1 by the intercept b1 of the first linear regression equation and the intercept b2 of the second linear regression equation; S4073, obtain a correction formula E=k*D+b by the converted scattering light intensity value D of the scattering light intensity value M of the sample to be measured determined by the latex turbidimetry, the correction slope k, and the correction intercept b, wherein E is the corrected scattering light intensity value.

6. The method for testing HbAlc value by modified latex turbidity method according to claim 3, wherein, The first Hb information includes a first Hb value, and the value range of the first Hb value is 120-160 g / L; or The first Hb information includes a first HCT value, and the value range of the first HCT value is 37-50%.

7. The method for testing HbAlc value by modified latex turbidity method according to claim 4, wherein, Before step S20, the method includes calculating a preset Hb information, and the step of calculating the preset Hb information includes: S21, calculate a corrected scattering light intensity value E corresponding to the second Hb information in the multiple hemoglobin groups by the correction formula E=k*D+b; S22, calculate a corrected Hb information Z of the second Hb information in the multiple hemoglobin groups by the multiple corrected scattering light intensity values E and a scattering light intensity coefficient C corresponding to the second Hb information in the multiple hemoglobin groups, wherein Z=E / C; S23, calculate an average value X of the corrected Hb information Z of the second Hb information in the multiple hemoglobin groups by the corrected Hb information Z of the second Hb information in the multiple hemoglobin groups; S24, calculate a standard deviation value SD of the corrected Hb information Z of the second Hb information in the multiple hemoglobin groups by the corrected Hb information Z of the second Hb information in the multiple hemoglobin groups; S25, calculate the preset Hb information by the average value X of the corrected Hb information Z of the second Hb information in the multiple hemoglobin groups and the standard deviation value SD of the corrected Hb information Z of the second Hb information in the multiple hemoglobin groups.

8. The method of claim 7, wherein the HbAlc value is measured by a modified latex turbidity assay. In step S25, the relationship between the preset Hb information and the average value X of the corrected Hb information Z of the second Hb information in the plurality of hemoglobin groups and the standard deviation value SD of the corrected Hb information Z of the second Hb information in the plurality of hemoglobin groups is: preset Hb information = X + 2*SD.

9. A device for correcting HbAlc values tested by latex turbidity method, characterized by, Comprise: An acquisition module is configured to acquire Hb information of a to-be-tested sample, HbA1c value of the to-be-tested sample, and scattered light intensity value M of the to-be-tested sample; A comparison module is configured to compare the preset Hb information with the Hb information of the to-be-tested sample; A correction module is configured to correct the HbA1c value of the to-be-tested sample when the Hb information of the to-be-tested sample is less than or equal to the preset Hb information, to obtain a corrected HbA1c value of the to-be-tested sample; and A display module is configured to display the Hb information of the to-be-tested sample and the corrected HbA1c value of the to-be-tested sample.

10. The apparatus for testing HbA1 c value by modified latex turbidimetry according to claim 9, wherein, The device for correcting the HbA1c value tested by the latex turbidimetry method further comprises a calculation module configured to calculate the corrected HbA1c value of the to-be-tested sample.

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