Quality control product for detecting anti-mullerian hormone and preparation method of quality control product

Abstract

The invention relates to a quality control product for anti-mullerian hormone detection and a preparation method thereof, the quality control product comprises natural human anti-mullerian hormone and a diluent, and the diluent comprises a phosphate buffer, sodium chloride, bovine serum albumin and a preservative. The chemiluminescence detection probe is suitable for various chemiluminescence detection platforms and is stable in performance.

Description

Technical Field

[0001] The present application relates to the technical field of immunoassay detection, and in particular to a quality control product for anti-Mullerian hormone detection and a preparation method thereof. Background Art

[0002] Anti-Mullerian hormone (AMH) is a member of the transforming growth factor β (TGF-β) superfamily. It is a protein secreted by granulosa cells of preantral follicles and small antral follicles of the ovary and immature Sertoli cells of the testis. In adult women, AMH inhibits the recruitment of primordial follicles and the development of antral follicles, preventing premature follicle exhaustion. Compared with other traditional biological indicators, AMH has many obvious advantages in assessing ovarian reserve. AMH reflects the trend of ovarian reserve decline with age earlier than FSH, estradiol (E2), inhibin B (inhB) and antral follicle count (AFC), and its level is not affected by the menstrual cycle, hormonal contraceptives and pregnancy. AMH is currently the most accurate, stable and convenient biomarker of ovarian aging. In adult women, the higher the AMH value, the more eggs are stored; the lower the value, the worse the ovarian function.

[0003] Common immunoassay methods for anti-Mullerian hormone include enzyme-linked immunosorbent assay, colloidal gold method, immunofluorescence method, chemiluminescence method, etc. At present, common anti-Mullerian hormone quality control products on the market are only compatible with one or two detection platforms, not compatible with other platforms, and are easily affected by reagent manufacturers. Summary of the invention

[0004] Based on this, it is necessary for the present application to provide an anti-Mullerian hormone quality control product that is compatible with multiple types of chemiluminescence detection platforms and has stable performance.

[0005] The technical solutions include the following:

[0006] The anti-Mullerian hormone quality control product comprises natural human anti-Mullerian hormone and a diluent, wherein the diluent comprises a phosphate buffer, sodium chloride, bovine serum albumin and a preservative.

[0007] In one embodiment, the diluent includes 0.04M-0.06M phosphate buffer, 5g / L-10g / L sodium chloride, 20g / L-40g / L bovine serum albumin and 0.2g / L-1.5g / L preservative.

[0008] In one embodiment, the diluent does not contain mannitol. Optionally, the diluent further comprises trehalose.

[0009] In one embodiment, the phosphate buffer includes disodium hydrogen phosphate and sodium dihydrogen phosphate.

[0010] In one embodiment, the preservative includes one or more of ProClin 300, mercuric chloride, sodium azide and bronopol.

[0011] In one embodiment, the preservatives include ProClin 300 and mercuric chloride.

[0012] In one embodiment, the concentration of ProClin300 in the quality control product is 0.1 g / L to 0.5 g / L, and the concentration of mercuric chloride is 0.1 g / L to 1 g / L.

[0013] In one embodiment, the concentration of the natural human anti-Mullerian hormone is 1.25 ng / mL to 16.5 ng / mL.

[0014] In one embodiment, the concentration of the natural human anti-Mullerian hormone is (1.5±15%) ng / mL.

[0015] In one embodiment, the concentration of the natural human anti-Mullerian hormone is (7±10%) ng / mL.

[0016] In one embodiment, the concentration of the natural human anti-Mullerian hormone is (15±10%) ng / mL.

[0017] In one embodiment, the quality control product is a set product, which includes multiple quality control products, and the concentrations of natural human anti-Mullerian hormone in the multiple quality control products are different.

[0018] The method for preparing the quality control product comprises mixing the natural human anti-Mullerian hormone and the diluent to prepare the quality control product.

[0019] A quality control method for an anti-Mullerian hormone assay platform or product comprises measuring the quality control product by using the anti-Mullerian hormone assay platform or product, and making a quality control judgment according to the measurement result.

[0020] In one embodiment, the anti-Mullerian hormone assay platform comprises a chemiluminescent assay platform.

[0021] An anti-Mullerian hormone detection kit comprises the quality control product.

[0022] Compared with the traditional technology, this application has the following beneficial effects:

[0023] The preparation method of the anti-Mullerian hormone quality control product of the present application is simple, using natural human anti-Mullerian hormone raw materials. Human serum raw materials avoid matrix effect problems, have good interchangeability, and good stability, do not need to be freeze-dried for storage, and are not affected by factors such as temperature. It has high consistency with clinical sample reactions and can be adapted to most manufacturers' anti-Mullerian hormone detection reagents.

[0024] The present invention can be used on multiple testing platforms, and is of great significance for the development of anti-Mullerian hormone test kits, product quality control, and industry standardization. It is also beneficial for different testing institutions to communicate and discuss with each other during the quality control process using essential control products, further improve the accuracy and comparability of test results, and promote the mutual recognition and integration of test results from multiple laboratories. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] In order to more clearly illustrate the technical solutions in the embodiments of the present application and to more completely understand the present application and its beneficial effects, the following is a brief introduction to the drawings required for the description of the embodiments. Obviously, the drawings described below are only some embodiments of the present application, and those skilled in the art can obtain other drawings based on these drawings without creative work.

[0026] Figure 1 It is used for monitoring the daily difference of level 1 quality control products;

[0027] Figure 2 For monitoring the daily difference of level 2 quality control products;

[0028] Figure 3 For monitoring the inter-day difference of level 3 quality control products. DETAILED DESCRIPTION

[0029] In order to make the above-mentioned purposes, features and advantages of the present application more obvious and easy to understand, the specific implementation methods of the present application are described in detail below. In the following description, many specific details are set forth to facilitate a full understanding of the present application. However, the present application can be implemented in many other ways different from those described herein, and those skilled in the art can make similar improvements without violating the connotation of the present application, so the present application is not limited by the specific embodiments disclosed below.

[0030] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as those commonly understood by those skilled in the art to which this application belongs. The terms used herein in the specification of this application are only for the purpose of describing specific embodiments and are not intended to limit this application.

[0031] As used herein, the term "and / or" includes any and all combinations of one or more of the associated listed items.

[0032] Currently, the common anti-Mullerian hormone quality control products on the market are only compatible with one or two platforms and are easily affected by reagent manufacturers. As a third-party quality control product, the essential control product is not affected by the reagent manufacturers.

[0033] This essential control product is compatible with a variety of chemiluminescence detection platforms (such as acridinium ester chemiluminescence, pyridine ruthenium electrochemiluminescence, alkaline phosphatase chemiluminescence, isoluminol chemiluminescence, horseradish peroxidase chemiluminescence, etc.), which is of great significance for the research and development of anti-Mullerian hormone detection kits, product quality control and industrial standardization; it also makes the test results between different laboratories comparable, providing clinicians and scientific researchers with a more consistent and reliable data basis, helping them to analyze and compare results more accurately.

[0034] An embodiment of the present application provides an anti-Mullerian hormone quality control product, comprising natural human anti-Mullerian hormone and a diluent, wherein the diluent comprises a phosphate buffer, sodium chloride, bovine serum albumin and a preservative.

[0035] In one specific example, the phosphate buffer includes disodium hydrogen phosphate and sodium dihydrogen phosphate.

[0036] In one specific example, the diluent does not contain mannitol.

[0037] In one specific example, the diluent further includes trehalose.

[0038] In a specific example, the concentration of trehalose in the diluent is 15 g / L to 25 g / L, and can be selected from 15 g / L, 18 g / L, 20 g / L, 22 g / L, 24 g / L or 25 g / L.

[0039] In a specific example, the quality control product is a liquid quality control product.

[0040] At present, the common anti-Mullerian hormone quality control products on the market are mainly in the form of lyophilized powder, which requires diluent when used, and improper reconstitution process will lead to differences between bottles. The above risks will affect the stability and precision of the test. The intrinsic control product is in liquid state, easy to use, stable performance, simple preparation process, less time-consuming and energy-saving than lyophilized powder. In addition, compared with competing products that use non-natural recombinant anti-Mullerian hormone as raw materials, the intrinsic control product uses natural human anti-Mullerian hormone raw materials, which has high consistency with clinical sample reactions and can be adapted to most manufacturers' anti-Mullerian hormone detection reagents.

[0041] In a specific example, the diluent includes 0.04M to 0.06M phosphate buffer, 5g / L to 10g / L sodium chloride, 20g / L to 40g / L bovine serum albumin, and 0.2g / L to 1.5g / L preservative.

[0042] In a specific example, the concentration of the phosphate buffer in the diluent may be, but is not limited to, 0.04 M, 0.05 M, 0.06 M, or a range between any two of the above values.

[0043] In a specific example, the concentration of sodium chloride in the diluent may be, but is not limited to, 5 g / L, 6 g / L, 7 g / L, 8 g / L, 9 g / L, 10 g / L, or a range between any two of the above values.

[0044] In a specific example, the concentration of bovine serum albumin in the diluent may be, but is not limited to, 20 g / L, 25 g / L, 30 g / L, 35 g / L, 40 g / L or a range between any two of the above values.

[0045] In a specific example, the concentration of the preservative included in the diluent may be, but is not limited to, 0.2 g / L, 0.3 g / L, 0.4 g / L, 0.5 g / L, 0.6 g / L, 0.7 g / L, 0.8 g / L, 0.9 g / L, 1.0 g / L, 1.1 g / L, 1.2 g / L, 1.3 g / L, 1.4 g / L, 1.5 g / L, or a range between any two of the above values.

[0046] In a specific example, the preservative includes one or more of ProClin 300, mercuric chloride, sodium azide, and bronopol.

[0047] In one specific example, the preservative includes ProClin 300 and mercuric chloride.

[0048] In a specific example, the concentration of ProClin300 in the quality control product is 0.1 g / L to 0.5 g / L, and the concentration of mercuric chloride is 0.1 g / L to 1 g / L.

[0049] In a specific example, the concentration of natural human anti-Mullerian hormone is 1.25 ng / mL to 16.5 ng / mL. Optionally, the concentration of natural human anti-Mullerian hormone is (1.5±15%) ng / mL. Optionally, the concentration of natural human anti-Mullerian hormone is (7±10%) ng / mL. Optionally, the concentration of natural human anti-Mullerian hormone is (15±10%) ng / mL.

[0050] The natural human anti-Mullerian hormone was diluted into a low-concentration quality control product, a medium-concentration quality control product or a high-concentration quality control product using a diluent. The concentration range of the natural human anti-Mullerian hormone in the low-concentration quality control product was controlled at (1.5±15%) ng / mL; the concentration range of the natural human anti-Mullerian hormone in the medium-concentration quality control product was controlled at (7±10%) ng / mL; the concentration range of the natural human anti-Mullerian hormone in the high-concentration quality control product was controlled at (15±10%) ng / mL.

[0051] In a specific example, the quality control product is a set product, which includes multiple quality control products, and the concentrations of natural human anti-Mullerian hormone in the multiple quality control products are different.

[0052] One embodiment of the present application also provides a method for preparing the quality control product, comprising mixing the natural human anti-Mullerian hormone and the diluent to prepare the quality control product.

[0053] One embodiment of the present application also provides a quality control method for an anti-Mullerian hormone assay platform or product, comprising assaying the above-mentioned quality control product through the anti-Mullerian hormone assay platform or product, and performing quality control determination according to the assay result;

[0054] In one specific example, the AMH assay platform includes a chemiluminescent testing platform.

[0055] In a specific example, the chemiluminescent testing platform includes, but is not limited to, one or more of acridinium ester chemiluminescence, ruthenium pyridine electrochemiluminescence, alkaline phosphatase chemiluminescence, isoluminol chemiluminescence, and horseradish peroxidase chemiluminescence.

[0056] One embodiment of the present application also provides an anti-Mullerian hormone detection kit, including the quality control product.

[0057] The embodiments of the present application will be described in detail below in conjunction with examples. It should be understood that these examples are only used to illustrate the present application and are not intended to limit the scope of the present application. The experimental methods for which specific conditions are not specified in the following examples are preferably referred to the guidance provided in the present application, and can also be based on the experimental manual or normal conditions in this area, can also be based on the conditions recommended by the manufacturer, or refer to experimental methods known in the art.

[0058] In the following specific embodiments, the measured parameters of raw material components may have slight deviations within the range of weighing accuracy unless otherwise specified. For temperature and time parameters, acceptable deviations caused by instrument test accuracy or operation accuracy are allowed.

[0059] Example 1

[0060] A method for preparing an anti-Mullerian hormone quality control product comprises the following steps:

[0061] S1. Preparation of anti-Mullerian hormone positive materials:

[0062] Human serum with anti-Mullerian hormone concentration ≥ 100ng / mL was selected to measure hepatitis B surface antigen, hepatitis C antibody, syphilis antibody, and HIV antibody in the serum. The serum with negative results for all four items was mixed, added to ProClin300, and then centrifuged (10000rpm, 10min) and filtered (0.22μm pore size), and the concentration of anti-Mullerian hormone positive material was measured.

[0063] S2. Preparation of quality control diluent: 0.04M phosphate buffer, containing 20g / L bovine serum albumin, 5g / L sodium chloride, 0.1g / L ProClin300, and 0.1g / L mercuric chloride.

[0064] S3. Preparation of quality control products: Add anti-Mullerian hormone-positive materials to the quality control product diluent in proportion to prepare three levels of quality control products with concentrations of (1.5±15%) ng / mL (level 1), (7±10%) ng / mL (level 2) and (15±10%) ng / mL (level 3).

[0065] S4. Assignment of quality control products: Prepare 5 chemiluminescence analyzers, and use the anti-Mullerian hormone assay kit calibrated by the product on each instrument to repeat the quality control product for a total of 5 days, testing 4 times a day. After the 5-day test is completed, 20 test data are obtained for each quality control product concentration on each instrument. The test results are eliminated according to the Grubbs criterion. The number of eliminated outliers shall not exceed 2.5%. When the outliers exceed 2.5%, it should be suspected whether it is caused by unstable method or unfamiliar operator. At this time, the data of this test cannot be used. After checking and solving the problem, restart a new evaluation experiment. After eliminating the outliers from the test results, calculate the mean X and standard deviation SD of the remaining data to determine the target value range of the quality control product (X±3SD).

[0066] Example 2

[0067] The content of Example 2 is substantially the same as that of Example 1, except for the preparation of the quality control dilution solution in step S2.

[0068] The details are as follows:

[0069] S2. Preparation of quality control diluent: 0.05M phosphate buffer, containing 40g / L bovine serum albumin, 9g / L sodium chloride, 0.5g / L ProClin300, and 0.2g / L mercuric chloride.

[0070] Example 3

[0071] The content of Example 3 is substantially the same as that of Example 1, except for the preparation of the quality control dilution solution in step S2.

[0072] The details are as follows:

[0073] S2. Preparation of quality control diluent: 0.06M phosphate buffer, containing 30g / L bovine serum albumin, 10g / L sodium chloride, 0.5g / L ProClin300, and 1g / L mercuric chloride.

[0074] Example 4

[0075] The contents of Example 4 are substantially the same as those of Example 2, except that in the preparation of the quality control diluent in step S2, the diluent also includes 20 g / L trehalose.

[0076] The details are as follows:

[0077] S2. Preparation of quality control diluent: 0.05M phosphate buffer, containing 40g / L bovine serum albumin, 9g / L sodium chloride, 0.5g / L ProClin300, 0.2g / L mercuric chloride, and 20g / L trehalose.

[0078] Comparative Example 1

[0079] Comparative Example 1 is substantially the same as Example 2, except that in the preparation of the control dilution in step S2, 0.05 M phosphate buffer is replaced by 0.05 M MOPS buffer.

[0080] The details are as follows:

[0081] S2. Preparation of quality control diluent: 0.05M MOPS buffer, containing 40g / L bovine serum albumin, 9g / L sodium chloride, 0.5g / L ProClin300, and 0.2g / L mercuric chloride.

[0082] Comparative Example 2

[0083] Comparative Example 2 is substantially the same as Example 2, except that in the preparation of the control dilution in step S2, 0.05 M phosphate buffer is replaced with 0.05 M Tris buffer.

[0084] The details are as follows:

[0085] S2. Preparation of quality control diluent: 0.05M Tris buffer, containing 40g / L bovine serum albumin, 9g / L sodium chloride, 0.5g / L ProClin300, and 0.2g / L mercuric chloride.

[0086] Comparative Example 3

[0087] Comparative Example 3 is substantially the same as Example 2, except that in the preparation of the quality control dilution in step S2, the dilution further includes mannitol at a concentration of 80 g / L.

[0088] The details are as follows:

[0089] S2. Preparation of quality control diluent: 0.05M phosphate buffer, containing 40g / L bovine serum albumin, 9g / L sodium chloride, 0.5g / L ProClin300, 0.2g / L mercuric chloride, and 80g / L mannitol.

[0090] Comparative Example 4

[0091] Comparative Example 4 is substantially the same as Example 2, except that in the preparation of the control dilution solution in step S2, 0.05 M phosphate buffer is replaced by 0.03 M phosphate buffer.

[0092] The details are as follows:

[0093] S2. Preparation of quality control diluent: 0.03M phosphate buffer, containing 40g / L bovine serum albumin, 9g / L sodium chloride, 0.5g / L ProClin300, and 0.2g / L mercuric chloride.

[0094] Experimental Example 1

[0095] Accelerated stability verification of the anti-Mullerian hormone quality control product of Example 1-3

[0096] In order to verify the performance of the anti-Mullerian hormone quality control product prepared in Examples 1-3 in a high temperature environment, the product was heat treated at 37°C for 10 days, and the product stored at 2-8°C was used as a control. The anti-Mullerian hormone assay kit produced by Yahuilong was selected, and the luminescence value and concentration value of the anti-Mullerian hormone quality control product under various conditions were measured on a chemiluminescence platform. Compared with Comparative Example 4, Examples 1-3 had good stability, and the relative deviations were all within ±10%. The results are shown in Table 1.

[0097] Table 1

[0098]

[0099] Experimental Example 2

[0100] Stability verification and multi-platform application of the anti-Mullerian hormone quality control product of Example 2:

[0101] 1. Stability verification of anti-Mullerian hormone quality control products:

[0102] In order to verify the performance of the anti-Mullerian hormone quality control product prepared in Example 2 in extreme environments such as high temperature, the product was heat treated at 37°C for 10 days, and the product stored at 2-8°C was used as a control; at the same time, in order to determine the stability of the anti-Mullerian hormone quality control product under different storage conditions after opening, the product was stored at 20-25°C, 2-8°C and -20°C for 3 days, 30 days and 90 days after opening, and the unopened product was stored at 2-8°C as a control. The anti-Mullerian hormone assay kit produced by Yahuilong was selected, and the luminescence value and concentration value of the anti-Mullerian hormone quality control product under various conditions were measured on the chemiluminescence platform. The stability was good, and the relative deviation was within ±10%. The results are shown in Tables 2 and 3.

[0103] Table 2

[0104]

[0105] Table 3

[0106]

[0107] 2. Application of anti-Mullerian hormone quality control products in multiple chemiluminescence testing platforms:

[0108] In order to verify the application of the anti-Mullerian hormone quality control product produced in Example 2 in multiple chemiluminescent test platforms, the anti-Mullerian hormone assay kits of domestic and foreign manufacturers with different detection methods were selected for testing: manufacturer 1 (acridinium ester chemiluminescence), manufacturer 2 (isoluminol chemiluminescence), manufacturer 3 (acridinium ester chemiluminescence), manufacturer 4 (horseradish peroxidase chemiluminescence), manufacturer 5 (alkaline phosphatase chemiluminescence), manufacturer 6 (pyridine ruthenium electrochemiluminescence), manufacturer 7 (alkaline phosphatase chemiluminescence). The test results are shown in Table 4, and the three levels of the anti-Mullerian hormone quality control product are within the test range of the seven platforms.

[0109] Manufacturers 1, 3, and 6 were selected to conduct inter-day difference detection on the anti-Mullerian hormone quality control products: the three levels of quality control products were tested once a day on the three platforms for 20 consecutive days, and the data of the three levels for 20 days were plotted separately ( Figure 1 , Figure 2 , Figure 3 ), and the corresponding mean, standard deviation (SD) and coefficient of variation (CV%) were calculated and shown in Table 5. Figure 1 , 2 As shown in Tables 3 and 5, the coefficient of variation of quality control is small, between 2% and 4%, and the daily measured values ​​are relatively stable, which meets the quality control requirements of the testing agency during the testing process.

[0110] Table 4 Measured values ​​of 7 platforms of quality control products

[0111]

[0112] Table 5 Mean (ng / mL), standard deviation and coefficient of variation of the daily difference of quality control products for 20 days

[0113]

[0114] Experimental Example 3

[0115] 1. Accelerated stability test of the anti-Mullerian hormone quality control product of Example 2 and Comparative Example 1-2:

[0116] Take 2 bottles of quality control products from level 1, level 2, and level 3, of which 1 bottle is placed at 2-8°C as a control sample, and the other bottle is placed at 37°C as an experimental sample. After 10 days of storage, take out 2 samples and test them on a calibrated chemiluminescence analyzer. Repeat the test for each sample 3 times, calculate the average of the test results of each sample, and calculate the relative deviation between the average of each experimental sample and the average of the control sample. The results are shown in Table 6. The anti-Mullerian hormone assay kit produced by Yahuilong was selected.

[0117] Table 6

[0118]

[0119] II. Unsealing Test of Anti-Mullerian Hormone Quality Control Products in Example 2 and Comparative Example 1-2

[0120] There are 4 bottles of quality control products in each of Level 1, Level 2 and Level 3, of which 1 bottle is opened on the 7th day and placed at 2-8℃ as experimental sample 1, 1 bottle is opened on the 0th day and placed at ≤-20℃ as experimental sample 2, and 1 unopened bottle of quality control product is placed at 2-8℃ as a control sample.

[0121] On the 10th day, the experimental sample 1, the experimental sample 2 and the control sample were unsealed and tested; each sample was tested 3 times, and the average value of the test results of each sample was calculated. At the same time, the relative deviation between the average values ​​of each experimental sample and the control sample was calculated, as shown in Table 7 (Table 7-1, Table 7-2 and Table 7-3).

[0122] Table 7-1

[0123]

[0124] Table 7-2

[0125]

[0126] Table 7-3

[0127]

[0128] It can be seen from the results in Tables 6-7 that among the anti-Mullerian hormone quality control products containing PBS, Tris, and MOPS buffers, only the quality control product containing PBS buffer has qualified acceleration performance.

[0129] Experimental Example 3

[0130] 1. Accelerated stability test of anti-Mullerian hormone quality control products of Example 2, Example 4 and Comparative Example 3

[0131] Take 2 bottles of quality control products from level 1, level 2, and level 3, of which 1 bottle is placed at 2-8°C as a control sample, and the other bottle is placed at 37°C as an experimental sample. After 10 days of storage, take out 2 samples and test them on a calibrated chemiluminescence analyzer. Repeat the test for each sample 3 times, calculate the average of the test results of each sample, and calculate the relative deviation between the average of each experimental sample and the average of the control sample as shown in Table 8. The anti-Mullerian hormone assay kit produced by Yahuilong was selected.

[0132] Table 8

[0133]

[0134] II. Unsealing Test of Anti-Mullerian Hormone Quality Control Products in Example 2, Example 4 and Comparative Example 3

[0135] There are 4 bottles of quality control products in each of Level 1, Level 2 and Level 3, of which 1 bottle is opened on the 7th day and placed at 2-8℃ as experimental sample 1, 1 bottle is opened on the 0th day and placed at ≤-20℃ as experimental sample 2, and 1 unopened bottle of quality control product is placed at 2-8℃ as a control sample.

[0136] On the 10th day, the experimental sample 1, the experimental sample 2 and the control sample were unsealed and tested; each sample was tested 3 times, and the average value of the test results of each sample was calculated. At the same time, the relative deviation between the average value of each experimental sample and the control sample was calculated, as shown in Table 9 (Table 9-1, Table 9-2 and Table 9-3).

[0137] Table 9-1

[0138]

[0139] Table 9-2

[0140]

[0141] Table 9-3

[0142]

[0143] As can be seen from Tables 8-9, in the quality control product, adding mannitol to the phosphate solution formula will reduce the -20℃ stability of AMH, while adding trehalose has no obvious difference from the original solution.

[0144] The technical features of the above-described embodiments may be arbitrarily combined. To make the description concise, not all possible combinations of the technical features in the above-described embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0145] The above-mentioned embodiments only express several implementation methods of the present application, and the descriptions thereof are relatively specific and detailed, but they cannot be understood as limiting the scope of the invention patent. It should be pointed out that, for a person of ordinary skill in the art, several variations and improvements can be made without departing from the concept of the present application, and these all belong to the protection scope of the present application. Therefore, the protection scope of the patent of the present application shall be subject to the attached claims, and the description may be used to interpret the content of the claims.

Claims

1. Anti-Mullerian hormone quality control product, characterized in that: The invention comprises natural human anti-Mullerian hormone and a diluent, wherein the diluent comprises a phosphate buffer, sodium chloride, bovine serum albumin and a preservative.

2. The quality control product according to claim 1, characterized in that: The diluent comprises 0.04M-0.06M phosphate buffer, 5g / L-10g / L sodium chloride, 20g / L-40g / L bovine serum albumin and 0.2g / L-1.5g / L preservative.

3. The quality control product according to claim 1, characterized in that: The diluent does not contain mannitol. Optionally, the diluent further comprises trehalose.

4. The quality control product according to any one of claims 1 to 3, characterized in that: The phosphate buffer includes disodium hydrogen phosphate and sodium dihydrogen phosphate.

5. The quality control product according to any one of claims 1 to 3, characterized in that: The preservative includes one or more of ProClin300, mercuric chloride, sodium azide and bronopol; Optionally, the preservatives include ProClin300 and mercuric chloride; Optionally, the concentration of ProClin300 in the quality control product is 0.1 g / L to 0.5 g / L, and the concentration of mercuric chloride is 0.1 g / L to 1 g / L.

6. The quality control product according to any one of claims 1 to 3, characterized in that: The concentration of the natural human anti-Mullerian hormone is 1.25 ng / mL to 16.5 ng / mL; Optionally, the concentration of the natural human anti-Mullerian hormone is (1.5±15%) ng / mL; Optionally, the concentration of the natural human anti-Mullerian hormone is (7±10%) ng / mL; Optionally, the concentration of the natural human anti-Mullerian hormone is (15±10%) ng / mL.

7. The quality control product according to claim 6, characterized in that: The quality control product is a set product, which includes multiple quality control products, and the concentrations of natural human anti-Mullerian hormone in the multiple quality control products are different.

8. The method for preparing the quality control product according to any one of claims 1 to 7, characterized in that: The method comprises mixing the natural human anti-Mullerian hormone and the diluent to prepare the quality control product.

9. A quality control method for an anti-Mullerian hormone assay platform or product, characterized in that: The method comprises measuring the quality control product according to any one of claims 1 to 7 by using an anti-Mullerian hormone measurement platform or product, and making a quality control determination according to the measurement result; Optionally, the anti-Mullerian hormone assay platform comprises a chemiluminescence test platform.

10. An anti-Mullerian hormone detection kit, characterized in that: Including the quality control product described in any one of claims 1 to 7.

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