Sample treating fluid for glycosylated hemoglobin detection, detection kit and detection method thereof

Abstract

The invention belongs to the technical field of in-vitro diagnosis, and particularly relates to a sample treating fluid for glycosylated hemoglobin detection, a detection kit and a detection method thereof. The sample treatment liquid comprises a first buffer solution, a surfactant and a preservative; the surfactant is selected from any one or a combination of more of triton, Tween-20, Tween-80 or lauryl sodium sulfate. A sample treated by the sample treatment liquid is used for detection, high accuracy and specificity are achieved, the correlation between the measured value of the glycosylated hemoglobin content in a whole blood sample and the sample value is analyzed, and the R value can reach 0.9996; and the deviation with a sample value is small.

Description

Technical Field

[0001] The present invention belongs to the technical field of in vitro diagnosis, and in particular relates to a sample processing liquid, a detection kit and a detection method thereof for detecting glycosylated hemoglobin. Background Art

[0002] Diabetes is a global epidemic in the 21st century. Glycated hemoglobin (HbA1c) is not only the target of blood sugar control for diabetic patients, but also an effective indicator for evaluating blood sugar management treatment plans. In addition, HbA1c is the preferred diagnostic indicator for diabetes recommended by the World Health Organization (WHO) and many national diabetes associations. Compared with the traditional diabetes diagnostic indicator - blood sugar, HbA1c has the characteristics of small biological variability, not easily affected by blood sugar fluctuations, no need to fast or draw blood at a specific time, and small instability before analysis. It is an indicator that has been gradually promoted and applied internationally since the mid-1990s.

[0003] There are many HbA1c determination methods commonly used in clinical laboratories, which can be divided into two categories according to the principle: one is based on the different charges carried by glycated and non-glycated hemoglobin, such as ion exchange chromatography and electrophoresis; the other is based on the different structures of glycated and non-glycated hemoglobin, such as immunoassay, affinity chromatography and enzyme method.

[0004] Among them, the immunoassay is a more commonly used method. When conducting the test, the whole blood sample is used for testing. The degree of red blood cell lysis will affect the sensitivity and accuracy of the test. Summary of the invention

[0005] The present invention develops a sample processing liquid for glycated hemoglobin detection. The sample processing liquid is used to treat a whole blood sample, and the red blood cells in the whole blood sample are fully lysed. The subsequent detection is performed using quantum dot fluorescence immunoassay, which has strong specificity and accuracy. The correlation with the glycated hemoglobin content in the whole blood sample is analyzed, and the R value can reach 0.9996.

[0006] In order to achieve the above object, the present invention can adopt the following technical solutions:

[0007] On one hand, the present invention provides a sample processing solution for glycated hemoglobin detection, comprising a first buffer system, a surfactant and a preservative; the surfactant is selected from any one or more combinations of Triton, Tween-20, Tween-80 or sodium dodecyl sulfate.

[0008] Preferably, the first buffer system is selected from any one or more combinations of MES, HEPPES, Tris-HCl, PBS or boric acid; and / or the preservative is selected from Proclin-300.

[0009] Preferably, the concentration of the first buffer system is 0.01M-0.1M; and / or the concentration of the surfactant is 0.01mg / mL-10mg / mL; and / or the volume concentration V / V of the preservative is 0.01%-1%.

[0010] Preferably, the sample processing liquid can be selected from any one of the following:

[0011] (a) Sample treatment solutions include Tris-HCl, Triton, Tween-80 and Proclin-300;

[0012] (b) Sample treatment solution includes boric acid, Tween-20, sodium dodecyl sulfate and Proclin-300.

[0013] Another aspect of the present invention provides a detection kit for detecting glycated hemoglobin, comprising the sample processing solution and the reagent card of the present invention.

[0014] Preferably, the reagent card comprises a labeling pad; the preparation method of the labeling pad comprises: spraying a labeling liquid on a blank release pad and drying to obtain the labeling pad; the labeling liquid comprises quantum dot-biotin labeled glycated hemoglobin antibody and quantum dot-biotin labeled hemoglobin antibody.

[0015] Preferably, the preparation method of the above-mentioned marking liquid comprises: (1) mixing biotin and glycated hemoglobin monoclonal antibody, and mixing with a protein protective agent after dialysis to obtain biotin-labeled glycated hemoglobin monoclonal antibody; mixing biotin and hemoglobin monoclonal antibody, and mixing with a protein protective agent after dialysis to obtain biotin-labeled hemoglobin monoclonal antibody; the protein protective agent is selected from one or more of BSA, casein or skim milk; (2) mixing quantum dots with biotin-labeled glycated hemoglobin monoclonal antibody and biotin-labeled hemoglobin monoclonal antibody respectively to react to obtain quantum dot-biotin-labeled glycated hemoglobin antibody and quantum dot-biotin-labeled hemoglobin antibody; (3) mixing quantum dot-biotin-labeled glycated hemoglobin antibody and quantum dot-biotin-labeled hemoglobin antibody to obtain marking liquid.

[0016] Preferably, the quantum dots are diluted with a diluent before being mixed with the biotin-labeled glycated hemoglobin monoclonal antibody and the biotin-labeled hemoglobin monoclonal antibody, respectively; the diluent comprises a second buffer system, a stabilizer and a preservative; the diluent satisfies one or more combinations of the following conditions: (a) the second buffer system is selected from any one or more combinations of MES, HEPES, Tris-Hcl, PBS, and boric acid; (b) the stabilizer is selected from any one or more combinations of fructose, sucrose, trehalose or glucose; (c) the concentration of the second buffer system is 0.01M-0.1M; (d) the mass concentration M / V of the stabilizer is 0.01%-10%; (e) the volume concentration V / V of the preservative is 0.01%-10%.

[0017] Preferably, the volume ratio of the quantum dots diluted with diluent is (1:1)-(1:20); and / or the volume ratio of the quantum dots and the biotin-labeled glycated hemoglobin monoclonal antibody is (1:0.01)-(1:1); and / or the volume ratio of the quantum dots and the biotin-labeled hemoglobin monoclonal antibody is (1:0.01)-(1:1).

[0018] In another aspect, the present invention provides a method for detecting the glycated hemoglobin content, which is detected using the detection kit of the present invention, comprising: (1) first using a sample processing solution to treat a whole blood sample to obtain a liquid to be detected; (2) using a reagent card to detect the liquid to be detected; (3) reading the fluorescence signal value and calculating the glycated hemoglobin content in the whole blood sample according to a standard curve.

[0019] The beneficial effects of the present invention include at least: the sample treated with the sample processing solution for glycated hemoglobin detection provided by the present invention is tested with high accuracy and specificity, and the correlation between the actual measured value of the present invention and the sample value of the glycated hemoglobin content in the whole blood sample is analyzed, and the R value can reach 0.9996; and the deviation from the sample value is small. DETAILED DESCRIPTION

[0020] The examples are provided to better illustrate the present invention, but the present invention is not limited to the examples. Therefore, those skilled in the art may make non-essential improvements and adjustments to the implementation scheme according to the above invention content, which still fall within the protection scope of the present invention.

[0021] The terms used herein are only used to describe specific embodiments and are not intended to limit the present disclosure. Unless the context has a significantly different meaning, expressions in the singular include expressions in the plural. As used herein, it should be understood that terms such as "include", "have", "include" are intended to indicate the presence of features, numbers, operations, components, parts, elements, materials or combinations. The terms of the present invention are disclosed in the specification, and are not intended to exclude the possibility that one or more other features, numbers, operations, components, parts, elements, materials or combinations thereof may exist or may be added. As used herein, " / " may be interpreted as "and" or "or", depending on the circumstances.

[0022] The working solutions such as the sample processing solution and the diluent used in the present invention are all solutions with water as the medium.

[0023] An embodiment of the present invention provides a sample processing solution for glycated hemoglobin detection, comprising a first buffer system, a surfactant and a preservative; the surfactant is selected from any one or more combinations of Triton, Tween-20, Tween-80 or sodium dodecyl sulfate.

[0024] It should be noted that in the present invention, a sample processing liquid for glycated hemoglobin detection can be obtained by adjusting the buffer system, surfactant and preservative. After the sample is treated with the sample processing liquid, the specificity and accuracy of glycated hemoglobin detection using a detection kit (quantum dot immunofluorescence method) are high. The correlation between the actual measured value of the present invention and the sample value of the glycated hemoglobin content in the whole blood sample is analyzed, and the R value can reach 0.9996; and the deviation from the sample value is small.

[0025] In some specific examples, the first buffer system is selected from any one or more combinations of MES (4-morpholineethanesulfonic acid), HEPES, Tris-HCl (trishydroxymethylaminomethane hydrochloride), PBS (phosphate) or boric acid; and / or the preservative is selected from Proclin-300.

[0026] In some specific examples, the concentration of the first buffer system is 0.01M-0.1M, such as 0.03M, 0.05M or 0.07M; and / or the concentration of the surfactant is 0.01mg / mL-10mg / mL, such as 1mg / mL, 5mg / mL or 8mg / mL, etc.; and / or the volume concentration of the preservative is 0.01%-1% (V / V), such as 0.03%, 0.05% or 0.07%, etc.

[0027] In some specific examples, the sample processing liquid can be selected from any one of the following:

[0028] (a) The sample processing solution includes Tris-Hcl, Triton, Tween-80 and Proclin-300; specifically, the sample processing solution in the present invention can preferably be the above combination. In some specific examples, the above combination has high accuracy and specificity when used to process whole blood samples for detection, and the correlation with the glycated hemoglobin content in the whole blood samples is analyzed, and the R value can reach 0.9996; in some specific examples, the concentration of Tris-Hcl can be 0.01M, the concentration of Triton can be 0.5mg / mL, the concentration of Tween-80 can be 0.2mg / mL, and the volume concentration of Proclin-300 can be 0.1% (V / V);

[0029] (b) The sample processing liquid includes boric acid, Tween-20, sodium dodecyl sulfate and Proclin-300; specifically, the sample processing liquid in the present invention can preferably be the above combination. In some specific examples, the above combination has high accuracy and specificity when used to process whole blood samples for detection, and the correlation with the glycated hemoglobin content in the whole blood samples is analyzed, and the R value can reach 0.9895; in some specific examples, the concentration of boric acid can be 0.01M, the concentration of Tween-20 can be 0.5mg / mL, the concentration of sodium dodecyl sulfate can be 0.1mg / mL, and the volume concentration of Proclin-300 can be 0.1% (V / V).

[0030] The embodiment of the present invention further provides a detection kit for detecting glycated hemoglobin, comprising the sample processing solution and the reagent card of the present invention.

[0031] It should be noted that the sample processing liquid and reagent card for glycated hemoglobin detection in the present invention can be assembled into a kit form, which is more convenient for transportation and storage; it should be understood that the form of the kit is a form well known in the art, for example, in addition to the above-mentioned sample processing liquid and reagent card for glycated hemoglobin detection, it can also include a plastic card shell or an aluminum foil bag, etc. The reagent card is assembled on the plastic card shell, and finally packaged into an aluminum foil bag together with a desiccant to prepare a glycated hemoglobin (HbA1c) detection kit (quantum dot immunofluorescence method).

[0032] In some specific examples, the above-mentioned reagent card includes a marking pad; the preparation method of the marking pad includes: spraying a marking liquid on a blank release pad and drying to obtain a marking pad; the marking liquid includes quantum dot-biotin labeled glycated hemoglobin antibody and quantum dot-biotin labeled hemoglobin antibody.

[0033] It should be noted that the reagent card of the present invention includes, in addition to the marking pad, a sample pad, a nitrocellulose membrane, a blotting paper, a bottom plate and other commonly used structures, and the sample pad, the marking pad, the nitrocellulose membrane and the blotting paper are arranged on the bottom plate in sequence; the nitrocellulose membrane is coated with a detection line (another glycosylated hemoglobin monoclonal antibody and another hemoglobin monoclonal antibody) and a quality control line (sheep anti-mouse IgG); in addition, the sample pad, nitrocellulose membrane, blotting paper and bottom plate in the above reagent card are all well known in the art; in addition, the material of the bottom plate is preferably PVC material. In addition, the quantum dots, biotin-labeled glycosylated hemoglobin antibodies and biotin-labeled hemoglobin antibodies in the present invention are all well known in the art and can be selected according to specific needs.

[0034] In some specific examples, the preparation method of the above-mentioned marking liquid includes: (1) mixing biotin and glycated hemoglobin monoclonal antibody, and mixing with a protein protective agent after dialysis to obtain biotin-labeled glycated hemoglobin monoclonal antibody; mixing biotin and hemoglobin monoclonal antibody, and mixing with a protein protective agent after dialysis to obtain biotin-labeled hemoglobin monoclonal antibody; the protein protective agent is selected from one or more of BSA, casein or skim milk; (2) mixing quantum dots with biotin-labeled glycated hemoglobin monoclonal antibody and biotin-labeled hemoglobin monoclonal antibody respectively to react to obtain quantum dot-biotin-labeled glycated hemoglobin antibody and quantum dot-biotin-labeled hemoglobin antibody; (3) mixing quantum dot-biotin-labeled glycated hemoglobin antibody and quantum dot-biotin-labeled hemoglobin antibody to obtain marking liquid.

[0035] It should be noted that the volume of the mixture of quantum dot-biotin labeled glycated hemoglobin antibody and quantum dot-biotin labeled hemoglobin antibody can be preferably 1:1.

[0036] In some specific examples, the quantum dots are diluted with a diluent before being mixed with the biotin-labeled glycated hemoglobin monoclonal antibody and the biotin-labeled hemoglobin monoclonal antibody; the diluent includes a second buffer system, a stabilizer, and a preservative; and the diluent satisfies one or more combinations of the following conditions:

[0037] (a) the second buffer system is selected from any one or more combinations of MES, HEPES, Tris-HCl, PBS, and boric acid;

[0038] (b) a stabilizer selected from any one or more combinations of fructose, sucrose, trehalose or glucose;

[0039] (c) the concentration of the second buffer system is 0.01M-0.1M, such as 0.02M, 0.05M, 0.07M or 0.09M;

[0040] (d) The mass concentration M / V of the stabilizer is 0.01%-10%, such as 1%, 3%, 7% or 9%;

[0041] (e) The volume concentration V / V of the preservative is 0.01%-10%, such as 1%, 4%, 6%, 8% or 9%.

[0042] It should be noted that the diluent in the present invention can be selected from one of the above conditions (a) to (e), preferably two of the above conditions are selected at the same time; more preferably, all of the above conditions are selected at the same time.

[0043] In some specific examples, the volume ratio of the quantum dots diluted with diluent is (1:1)-(1:20), such as 1:5, 1:10 or 1:15, etc.; and / or the volume ratio of quantum dots and biotin-labeled glycated hemoglobin monoclonal antibodies is (1:0.01)-0(1:1), such as 1:0.1, 1:0.3, 1:0.7 or 1:0.9, etc.; and / or the volume ratio of quantum dots and biotin-labeled hemoglobin monoclonal antibodies is (1:0.01)-(1:1), such as 1:0.03, 1:0.05, 1:0.07 or 1:0.09, etc.

[0044] The embodiment of the present invention also provides a method for detecting the glycated hemoglobin content, which is detected using the detection kit of the present invention. The detection method comprises: (1) first using a sample processing solution to process a whole blood sample to obtain a liquid to be detected; (2) using a reagent card to detect the liquid to be detected; (3) reading the fluorescence signal value and calculating the glycated hemoglobin content in the whole blood sample according to a standard curve.

[0045] It should be noted that the detection kit in the present invention is a kit based on quantum dot fluorescence immunoassay. When a sample to be tested containing glycated hemoglobin and hemoglobin is added to the sample pad, the sample flows through the labeling pad and the nitrocellulose membrane to form a solid phase antibody-antigen-labeled antibody complex, and then the signal value is read by the analyzer. The content of glycated hemoglobin in the sample and its percentage of hemoglobin can be calculated based on the standard curve.

[0046] In order to better understand the present invention, the content of the present invention is further explained below in conjunction with specific examples, but the content of the present invention is not limited to the following examples.

[0047] In the following example, the preparation method of the marking liquid is carried out according to the following steps:

[0048] (1) adding 50 mmol / L biotin to the glycosylated hemoglobin monoclonal antibody and the hemoglobin monoclonal antibody diluted with PBS buffer, respectively, and mixing at room temperature for 3 hours to obtain different biotin-labeled antibodies; dialyzing with PBS buffer for 3 times, collecting the antibodies into a centrifuge tube, and measuring the volume;

[0049] (2) adding 10% (M / V) BSA to different dialyzed biotin-labeled antibodies, with the added volume being 10% of the total volume, to prepare different biotin-labeled antibody solutions;

[0050] (3) diluting the quantum dots (CdSe-ZnS modified with streptavidin, with a luminescence value of 628 nm) with a diluent (0.1 M MES solution (pH = 6-9) containing 10% fructose by mass and 10% Proclin-300 by volume) at a volume ratio of 1:10;

[0051] (4) The diluted quantum dots were mixed evenly with different biotin-labeled antibody solutions in a volume ratio of 1:1, and reacted for 3 hours to prepare different quantum dot-biotin-labeled antibodies (quantum dot-biotin-labeled glycated hemoglobin antibody and quantum dot-biotin-labeled hemoglobin antibody), and then the quantum dot-biotin-labeled glycated hemoglobin antibody and the quantum dot-biotin-labeled hemoglobin antibody were mixed evenly in equal volumes to prepare a labeling solution.

[0052] In the following example, the preparation of the glycated hemoglobin (HbA1c) detection kit (quantum dot immunofluorescence method) is carried out according to the following steps:

[0053] (1) Marking pad preparation: Use an XYZ three-dimensional line gold spraying instrument to spray the marking liquid onto a blank release pad, place it at 25°C, and dry it for 3 hours to make a marking pad;

[0054] (2) using an XYZ three-dimensional streaking gold spraying instrument, streaking glycosylated hemoglobin monoclonal antibody, hemoglobin monoclonal antibody and goat anti-mouse IgG on a nitrocellulose membrane, respectively, placing it at 60°C and drying it for 10 hours to form a test line 1 (glycosylated hemoglobin monoclonal antibody), a test line 2 (hemoglobin monoclonal antibody) and a quality control line (goat anti-mouse IgG);

[0055] (3) Starting from the sample application end, the sample pad, the marking pad, the nitrocellulose membrane and the absorbent paper are assembled on the PVC base plate in order, cut into strips by a chopper, and the reagent card is assembled on the plastic card shell. Finally, it is packaged into an aluminum foil bag together with a desiccant to prepare a glycated hemoglobin (HbA1c) detection kit (quantum dot immunofluorescence method).

[0056] Example 1

[0057] Different whole blood samples were divided into two parts, one of which was tested using the Glycated Hemoglobin A1c Test Kit (HPLC method) of Bio-Rad Laboratories Ltd. to obtain the Glycated Hemoglobin content (sample value);

[0058] A sample to be tested is mixed with a sample treatment solution, and the sample to be tested is detected using the above-prepared glycated hemoglobin (HbA1c) detection kit (quantum dot immunofluorescence method) to obtain the content of glycated hemoglobin (standard value measured in Example 1); wherein the sample treatment solution includes Tris-Hcl, Triton, Tween-80 and Proclin-300, the concentration of Tris-Hcl is 0.01M, the concentration of Triton is 0.5mg / mL, the concentration of Tween-80 is 0.2mg / mL, and the concentration of Proclin-300 is 0.1% (V / V);

[0059] The sample values ​​obtained by the glycosylated hemoglobin A1c detection kit (HPLC method) and the measured values ​​obtained by the test in Example 1 are shown in Table 1 below.

[0060] Table 1 Measurement results and sample values ​​of Example 1

[0061]

[0062] Note: In the table, 4%-6% indicates normal blood sugar, and above 6% indicates high blood sugar.

[0063] It can be seen from Table 1 above that the measurement results of Example 1 have a small deviation from the sample value regardless of whether it is a high content or a low content, indicating that it has excellent accuracy regardless of whether it is a low concentration value or a high concentration value. In addition, the correlation and the mean deviation of the two are analyzed, and the R value reaches 0.9996, and the mean deviation is 0.45%.

[0064] Example 2

[0065] The difference between Example 2 and Example 1 is that the sample processing solution of Example 2 is different from that of Example 1. The sample processing solution of Example 2 includes boric acid, Tween-20, sodium dodecyl sulfate and Proclin-300. The concentration of boric acid is 0.01M, the concentration of Tween-20 is 0.5mg / mL, the concentration of sodium dodecyl sulfate is 0.1mg / mL, and the concentration of Proclin-300 is 0.1% (V / V). The other steps are the same as those of Example 1. The measurement results and sample values ​​of Example 2 are shown in Table 2 below.

[0066] Table 2 Measurement results and sample values ​​of Example 2

[0067]

[0068]

[0069] Note: In the table, 4%-6% indicates normal blood sugar, and above 6% indicates high blood sugar.

[0070] It can be seen from Table 2 above that the measured value of Example 2 has a small deviation from the sample value, especially for high-concentration whole blood samples, the deviation is smaller than that of low-concentration samples, but the overall deviation is small, but greater than Example 1; in addition, the correlation between the two is analyzed, the R value can reach 0.9895, and the mean deviation is 4.9%, which also has high accuracy and specificity, weaker than Example 1.

[0071] Comparative Example 1

[0072] The difference between Comparative Example 1 and Example 1 is that the sample processing solution of Comparative Example 1 is different from that of Example 1, and the sample processing solution of Comparative Example 1 includes Tris-HCl and Proclin-300, the concentration of Tris-HCl is 0.01M, and the volume concentration of Proclin-300 is 0.1% (V / V); the other steps are the same as Example 1; the measurement results and sample values ​​of Comparative Example 1 are shown in Table 3 below.

[0073] Table 3 Measurement results and sample values ​​of comparative example 1

[0074]

[0075]

[0076] Note: In the table, 4%-6% indicates normal blood sugar, and above 6% indicates high blood sugar.

[0077] It can be seen from Table 3 above that although the correlation R value between the measured value and the sample value of Comparative Example 1 is 0.9433, which is much smaller than that of Example 1; and the deviation between the measured value and the sample value is large, with an average value of -38.15%, which is much larger than that of Examples 1 and 2. Therefore, it is shown that not adding a surfactant to the sample treatment liquid will affect the accuracy of the measured value.

[0078] Comparative Example 2

[0079] The difference between Comparative Example 2 and Example 1 is that the sample processing solution of Comparative Example 2 is different from that of Example 1. The sample processing solution of Comparative Example 2 includes Tris-HCl, Triton and Proclin-300, the concentration of Tris-HCl is 0.01M, the concentration of Triton is 0.7mg / mL, the concentration of Proclin-300 is 0.1% (V / V), and the other steps are the same as Example 1; the measurement results and sample values ​​of Comparative Example 2 are shown in Table 4 below.

[0080] Table 4: Measurement results and sample values ​​of Example 2

[0081]

[0082]

[0083] Note: In the table, 4%-6% indicates normal blood sugar, and >6% indicates high blood sugar.

[0084] It can be seen from Table 4 above that the deviation between the measured value and the sample value of Comparative Example 2 is greater than that of Example 1 and Example 2, the mean deviation is -17.73%, and 3 samples with high blood sugar were detected to have normal blood sugar; in addition, the correlation between the two was analyzed, and the R value was 0.9862, which is also much smaller than that of Example 1 and Example 2.

[0085] Comparative Example 3

[0086] The difference between Comparative Example 3 and Example 1 is that the sample processing solution of Comparative Example 3 is different from that of Example 1. The sample processing solution of Comparative Example 3 includes Tris-HCl, Tween-80 and Proclin-300, the concentration of Tris-HCl is 0.01M, the concentration of Tween-80 is 0.7mg / mL, the concentration of Proclin-300 is 0.1% (V / V), and the other steps are the same as Example 1; the measurement results and sample values ​​of Comparative Example 3 are shown in Table 5 below.

[0087] Table 5: Measurement results of comparative example 3 and standard values

[0088]

[0089]

[0090] Note: In the table, 4%-6% indicates normal blood sugar, and above 6% indicates high blood sugar.

[0091] It can be seen from Table 5 above that the deviation between the measured value and the sample value of Comparative Example 3 is much greater than that of Example 1 and Example 2, the mean deviation is -29.76%, and 7 samples with high blood sugar were detected to have normal blood sugar; in addition, the correlation between the two was analyzed, and the R value was 0.9773, which is also much smaller than that of Example 1 and Example 2.

[0092] Finally, it should be noted that the above embodiments are only used to illustrate the technical solution of the present invention rather than to limit it. Although the present invention has been described in detail with reference to the preferred embodiments, those skilled in the art should understand that the technical solution of the present invention can be modified or replaced by equivalents without departing from the purpose and scope of the technical solution of the present invention, which should be covered by the scope of the claims of the present invention.

Claims

1. A sample processing solution for glycated hemoglobin detection, characterized in that: The invention comprises a first buffer system, a surfactant and a preservative; the surfactant is selected from any one or more combinations of Triton, Tween-20, Tween-80 or sodium dodecyl sulfate.

2. The sample processing solution for glycated hemoglobin detection according to claim 1, characterized in that: The first buffer system is selected from any one or more combinations of MES, HEPES, Tris-HCl or PBS or boric acid; and / or the preservative is selected from Proclin-300.

3. The sample processing solution for glycated hemoglobin detection according to claim 1 or 2, characterized in that: The concentration of the first buffer system is 0.01M-0.1M; and / or the concentration of the surfactant is 0.01mg / mL-10mg / mL; and / or the volume concentration V / V of the preservative is 0.01%-1%.

4. The sample processing solution for glycated hemoglobin detection according to claim 3, characterized in that: Select any of the following: (a) Sample treatment solutions include Tris-HCl, Triton, Tween-80 and Proclin-300; (b) Sample treatment solution includes boric acid, Tween-20, sodium dodecyl sulfate and Proclin-300.

5. A test kit for detecting glycated hemoglobin, characterized in that: The invention comprises the sample processing liquid and the reagent card as claimed in any one of claims 1 to 4.

6. The detection kit according to claim 5, characterized in that The reagent card comprises a marking pad; the preparation method of the marking pad comprises: spraying a marking liquid on a blank release pad and drying to obtain the marking pad; the marking liquid comprises a quantum dot-biotin labeled glycosylated hemoglobin antibody and a quantum dot-biotin labeled hemoglobin antibody.

7. The detection kit according to claim 6, characterized in that The preparation method of the marking liquid comprises: (1) mixing biotin and glycosylated hemoglobin monoclonal antibody, and then dialyzing and mixing with a protein protective agent to obtain a biotin-labeled glycosylated hemoglobin monoclonal antibody; mixing biotin and hemoglobin monoclonal antibody, and then dialyzing and mixing with a protein protective agent to obtain a biotin-labeled hemoglobin monoclonal antibody; the protein protective agent is selected from any one or more combinations of BSA, casein or skim milk; (2) mixing the quantum dots with biotin-labeled glycated hemoglobin monoclonal antibody and biotin-labeled hemoglobin monoclonal antibody respectively to obtain quantum dots-biotin-labeled glycated hemoglobin antibody and quantum dots-biotin-labeled hemoglobin antibody; (3) Mixing the quantum dot-biotin labeled glycated hemoglobin antibody and the quantum dot-biotin labeled hemoglobin antibody to obtain a labeling solution.

8. The detection kit according to claim 7, characterized in that Before the quantum dots are mixed with the biotin-labeled glycated hemoglobin monoclonal antibody and the biotin-labeled hemoglobin monoclonal antibody, they are diluted with a diluent; the diluent includes a second buffer system, a stabilizer and a preservative; and the diluent satisfies one or more combinations of the following conditions: (a) the second buffer system is selected from any one or more combinations of MES, HEPPES, Tris-HCl, PBS or boric acid; (b) a stabilizer selected from one or more combinations of fructose, sucrose, trehalose or glucose; (c) the concentration of the second buffer system is 0.01M-0.1M; (d) the mass concentration M / V of the stabilizer is 0.01%-10%; (e) The volume concentration V / V of the preservative is 0.01%-10%.

9. The detection kit according to claim 7 or 8, characterized in that: The volume ratio of quantum dots diluted with diluent is (1:1)-(1:20); and / or the volume ratio of quantum dots and biotin-labeled glycated hemoglobin monoclonal antibody is (1:0.01)-(1:1); and / or the volume ratio of quantum dots and biotin-labeled hemoglobin monoclonal antibody is (1:0.01)-(1:1).

10. A method for detecting the content of glycosylated hemoglobin, using a detection kit for detection, characterized in that: The detection kit is the detection kit according to any one of claims 5 to 9, and the detection method comprises: (1) firstly use a sample processing solution to process a whole blood sample to obtain a test solution; (2) Testing the liquid to be tested using a reagent card; (3) Read the fluorescence signal value and calculate the content of glycated hemoglobin in the whole blood sample based on the standard curve.

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