Quality control for anti-mullerian hormone assay and method of preparation thereof

Abstract

The application relates to a quality control product for anti-Mullerian hormone detection and a preparation method thereof. The quality control product is natural human anti-Mullerian hormone and a diluent. The diluent comprises a phosphate buffer, sodium chloride, bovine serum albumin and a preservative. The quality control product is suitable for multiple types of chemiluminescence detection platforms and has stable performance.

Description

Technical Field

[0001] This application relates to the field of immunoassay technology, specifically to a quality control material for the detection of anti-Müllerian hormones and its preparation method. Background Technology

[0002] Anti-Mullerian hormone (AMH) belongs to the transforming growth factor β (TGF-β) superfamily and is a protein secreted by granulosa cells of preantral and small antral follicles in the ovary and immature Sertoli cells in the testes. In adult women, AMH inhibits the recruitment of primordial follicles and the development of antral follicles, preventing premature follicle depletion. Compared to other traditional biological indicators, AMH has many significant advantages in assessing ovarian reserve. AMH reflects the age-related decline in ovarian reserve earlier than FSH, estradiol (E2), inhibin B (inhB), and antral follicle count (AFC), and its levels are not affected by the menstrual cycle, hormonal contraceptives, or pregnancy. AMH is currently the most accurate, stable, and convenient biomarker for ovarian aging. In adult women, higher AMH levels indicate a greater reserve of eggs; lower levels indicate poorer ovarian function.

[0003] Commonly used immunoassay methods for anti-Müllerian hormone (AMH) include enzyme-linked immunosorbent assay (ELISA), colloidal gold assay, immunofluorescence assay, and chemiluminescence assay. Currently, commercially available AMH quality control products are only compatible with one or two testing platforms and lack compatibility with other platforms, and are easily affected by reagent manufacturers. Summary of the Invention

[0004] Therefore, this application needs to provide an anti-Müllerian hormone quality control product that is compatible with various chemiluminescence detection platforms and has stable performance.

[0005] The technical solutions include the following:

[0006] Quality control products for anti-Müllerian hormones include natural human anti-Müllerian hormones and a diluent, wherein the diluent includes phosphate buffer, sodium chloride, bovine serum albumin, and preservatives.

[0007] In one embodiment, the diluent comprises 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.

[0008] In one embodiment, the diluent does not contain mannitol, and optionally, the diluent also includes trehalose.

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

[0010] In one embodiment, the preservative includes one or more of ProClin300, mercuric chloride, sodium azide, and bromonitrobenzyl glycol.

[0011] In one embodiment, the preservative includes ProClin300 and mercuric chloride.

[0012] In one embodiment, the concentration of ProClin300 in the quality control sample 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-Müllerian hormone is 1.25 ng / mL to 16.5 ng / mL.

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

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

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

[0017] In one embodiment, the quality control product is a kit product, which includes multiple quality control products, each containing a different concentration of natural human anti-Müllerian hormone.

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

[0019] A quality control method for an anti-Müllerian hormone assay platform or product includes measuring the quality control material using the anti-Müllerian hormone assay platform or product, and making a quality control judgment based on the measurement results.

[0020] In one embodiment, the anti-Müllerian hormone assay platform includes a chemiluminescence assay platform.

[0021] An anti-Müllerian hormone assay kit, including the aforementioned quality control material.

[0022] Compared with traditional technologies, this application has the following advantages:

[0023] The method for preparing the anti-Müllerian hormone (AMH) quality control material in this application is simple, using natural human AMH raw materials. Human serum raw materials avoid matrix effects, exhibit good interchangeability, and demonstrate excellent stability. It requires no lyophilization and is unaffected by temperature or other factors. It shows high consistency with clinical samples and is compatible with AMH detection reagents from most manufacturers.

[0024] This invention can be used on multiple testing platforms and is of great significance for the research and development, product quality control, and industrial standardization of anti-Müllerian hormone test kits. It also facilitates communication and discussion among different testing institutions during quality control processes using the control samples, further improving the accuracy and comparability of test results and promoting mutual recognition and integration of test results across multiple laboratories. Attached Figure Description

[0025] To more clearly illustrate the technical solutions in the embodiments of this application and to more completely understand this application and its beneficial effects, the drawings used in the description of the embodiments will be briefly introduced below. Obviously, the drawings described below are only some embodiments of this application. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0026] Figure 1 For monitoring the daytime variation of Level 1 quality control products;

[0027] Figure 2 For monitoring the daytime variation of Level 2 quality control products;

[0028] Figure 3 For monitoring the inter-day variation of Level 3 quality control products. Detailed Implementation

[0029] To make the above-mentioned objectives, features, and advantages of this application more apparent and understandable, a detailed description of specific embodiments of this application is provided below. Many specific details are set forth in the following description to provide a thorough understanding of this application. However, this application can be implemented in many other ways different from those described herein, and those skilled in the art can make similar modifications without departing from the spirit of this application. Therefore, this application is not limited to the specific embodiments disclosed below.

[0030] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the application.

[0031] The term “and / or” as used herein includes any and all combinations of one or more of the related listed items.

[0032] Currently, most commercially available anti-Müllerian hormone quality control products are only compatible with one or two platforms and are easily affected by reagent manufacturers. In contrast, quality control products, as third-party quality control products, are not affected by reagent manufacturers.

[0033] The compatibility of this product with various chemiluminescence detection platforms (such as acridinium ester chemiluminescence, pyridine ruthenium electrochemiluminescence, alkaline phosphatase chemiluminescence, isoluminol chemiluminescence, horseradish peroxidase chemiluminescence, etc.) is of great significance for the research and development, product quality control, and industrial standardization of anti-Müllerian hormone test kits. It also enables the comparability of test results between different laboratories, providing clinicians and researchers with a more consistent and reliable data foundation, which helps them to analyze and compare results more accurately.

[0034] One embodiment of this application provides an anti-Müllerian hormone quality control product, comprising natural human anti-Müllerian hormone and a diluent, wherein the diluent comprises phosphate buffer, sodium chloride, bovine serum albumin and 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 also 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 as 15 g / L, 18 g / L, 20 g / L, 22 g / L, 24 g / L or 25 g / L.

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

[0040] Currently, most commercially available anti-Müllerian hormone (AMH) quality control products are in lyophilized powder form, requiring dilution buffer for use. Improper reconstitution can lead to inconsistencies between vials, impacting detection stability and precision. In contrast, intrinsic control products are liquid, offering greater ease of use, stable performance, and a simpler preparation process that is less time-consuming and energy-efficient than lyophilized powder products. Furthermore, compared to competing products using non-natural recombinant AMH as raw materials, intrinsic control products use natural human AMH, exhibiting high consistency with clinical samples and compatibility with most manufacturers' AMH detection reagents.

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

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

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

[0045] In a specific example, the concentration of the preservative 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 one specific example, the preservative includes one or more of ProClin300, mercuric chloride, sodium azide, and bromonitrobenzyl glycol.

[0047] In one specific example, the preservatives include ProClin300 and mercuric chloride.

[0048] In a specific example, the concentration of ProClin300 in the quality control sample 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 one specific example, the concentration of naturally derived human anti-Müllerian hormone is 1.25 ng / mL to 16.5 ng / mL. Optionally, the concentration of naturally derived human anti-Müllerian hormone is (1.5 ± 15%) ng / mL. Optionally, the concentration of naturally derived human anti-Müllerian hormone is (7 ± 10%) ng / mL. Optionally, the concentration of naturally derived human anti-Müllerian hormone is (15 ± 10%) ng / mL.

[0050] Natural human anti-Müllerian hormone was diluted with a diluent to produce low-concentration, medium-concentration, or high-concentration quality control products. The concentration range of natural human anti-Müllerian hormone in the low-concentration quality control products was controlled within (1.5±15%) ng / mL; the concentration range of natural human anti-Müllerian hormone in the medium-concentration quality control products was controlled within (7±10%) ng / mL; and the concentration range of natural human anti-Müllerian hormone in the high-concentration quality control products was controlled within (15±10%) ng / mL.

[0051] In a specific example, the quality control product is a kit product, which includes multiple quality control products with different concentrations of natural human anti-Müllerian hormone.

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

[0053] An embodiment of this application also provides a quality control method for an anti-Müllerian hormone assay platform or product, comprising measuring the above-mentioned quality control material using the anti-Müllerian hormone assay platform or product, and making a quality control judgment based on the measurement results.

[0054] In one specific example, the anti-Müllerian hormone assay platform includes a chemiluminescence assay platform.

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

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

[0057] The embodiments of this application will be described in detail below with reference to examples. It should be understood that these embodiments are for illustrative purposes only and are not intended to limit the scope of this application. For experimental methods in the following embodiments where specific conditions are not specified, please refer to the guidelines given in this application, or follow experimental manuals or conventional conditions in the art, or follow the conditions recommended by the manufacturer, or refer to experimental methods known in the art.

[0058] In the specific embodiments described below, the measurement parameters involving raw material components may have slight deviations within the weighing accuracy range unless otherwise specified. Temperature and time parameters are subject to acceptable deviations due to instrument testing accuracy or operational precision.

[0059] Example 1

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

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

[0062] Serum samples from individuals with anti-Müllerian hormone concentrations ≥100 ng / mL were selected, and the levels of hepatitis B surface antigen, hepatitis C antibody, syphilis antibody, and HIV antibody in the serum were measured. Serum samples that were negative for all four items were mixed, ProClin 300 was added, and the mixture was centrifuged (10000 rpm, 10 min), filtered (0.22 μm pore size), and the concentration of anti-Müllerian hormone positive samples was then 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 materials: Add anti-Müllerian hormone positive material to the quality control material diluent in proportion to prepare three-level concentration quality control materials 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. Quality Control Assignment: Prepare 5 chemiluminescence analyzers. On each instrument, use a product-calibrated anti-Müllerian hormone assay kit to repeatedly test the quality control sample for 5 days, 4 times per day. After 5 days of testing, obtain 20 test data points for each quality control sample concentration on each instrument. Remove outliers according to Grubbs' criteria. The number of outliers removed should not exceed 2.5%. If outliers exceed 2.5%, it should be suspected that the method is unstable or the operator is unfamiliar with it. In this case, the data from this experiment should not be used; check and resolve the problem, and then start a new evaluation experiment. After removing outliers, calculate the mean X and standard deviation SD of the remaining data to determine the target value range for the quality control sample (X ± 3SD).

[0066] Example 2

[0067] Example 2 is largely the same as Example 1, except for the preparation of the quality control diluent in step S2.

[0068] Specifically 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] Example 3 is largely the same as Example 1, except for the preparation of the quality control diluent in step S2.

[0072] Specifically 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] Example 4 is largely the same as Example 2, except that in step S2, the quality control diluent is prepared and the diluent also contains 20 g / L trehalose.

[0076] Specifically 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 largely the same as Example 2, except that in step S2, the 0.05M phosphate buffer is replaced with 0.05M MOPS buffer in the preparation of the quality control diluent.

[0080] Specifically 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 largely the same as Example 2, except that in step S2, the 0.05M phosphate buffer is replaced with 0.05M Tris buffer in the preparation of the quality control diluent.

[0084] Specifically 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 largely the same as Example 2, except that in step S2, the quality control diluent is prepared and the diluent also contains mannitol at a concentration of 80 g / L.

[0088] Specifically 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 largely the same as Example 2, except that in step S2, the 0.05M phosphate buffer is replaced with 0.03M phosphate buffer in the preparation of the quality control diluent.

[0092] Specifically 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 anti-Müllerian hormone quality control products in Examples 1-3

[0096] To verify the performance of the anti-Müllerian hormone quality control products prepared in Examples 1-3 under high-temperature conditions, the products were heat-treated at 37°C for 10 days, while products stored at 2–8°C served as controls. The anti-Müllerian hormone assay kit manufactured by YHLO was used to measure the luminescence and concentration values ​​of the anti-Müllerian hormone quality control products under various conditions using a chemiluminescence platform. Compared with Comparative Example 4, Examples 1-3 showed better stability, with relative deviations all within ±10%. The results are shown in Table 1.

[0097] Table 1

[0098]

[0099] Experiment Example 2

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

[0101] I. Stability verification of anti-Müllerian hormone quality control products:

[0102] To verify the performance of the anti-Müllerian hormone quality control product prepared in Example 2 under 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 served as a control. Simultaneously, to determine the stability of the anti-Müllerian 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, respectively, and the unopened product stored at 2–8°C served as a control. The anti-Müllerian hormone assay kit produced by YHLO was used to measure the luminescence value and concentration value of the anti-Müllerian hormone quality control product under various conditions using a chemiluminescence platform. The stability was good, with relative deviations all within ±10%. The results are shown in Tables 2 and 3.

[0103] Table 2

[0104]

[0105] Table 3

[0106]

[0107] II. Application of anti-Müllerian hormone quality control products on multiple chemiluminescence testing platforms:

[0108] To verify the application of the anti-Müllerian hormone quality control product obtained in Example 2 on multiple chemiluminescence testing platforms, anti-Müllerian hormone assay kits from domestic and international manufacturers using 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 (ruthenium pyridine electrochemiluminescence), and Manufacturer 7 (alkaline phosphatase chemiluminescence). The test results are shown in Table 4. All three levels of the anti-Müllerian hormone quality control product were within the test range of the seven platforms.

[0109] Daily variation testing was performed on anti-Müllerian duct hormone quality control samples from manufacturers 1, 3, and 6: the three levels of quality control samples were tested once daily on three different platforms for 20 consecutive days, and the data from the three levels over 20 days were plotted. Figure 1 , Figure 2 , Figure 3 Furthermore, the corresponding mean, standard deviation (SD), and coefficient of variation (CV%) were calculated and are shown in Table 5. The results are as follows: Figure 1 , 2 As shown in Tables 3 and 5, the coefficient of variation of the quality control is relatively small, between 2% and 4%, and the daily measurements are relatively stable, meeting the quality control requirements of the testing organization during the testing process.

[0110] Table 4. Measurement values ​​of quality control products on 7 platforms.

[0111]

[0112] Table 5. Mean (ng / mL), standard deviation, and coefficient of variation of quality control samples over 20 days.

[0113]

[0114] Experimental Example 3

[0115] I. Accelerated stability test of anti-Müllerian hormone quality control products of Comparative Examples 1-2: Example 2

[0116] Two bottles each of Level 1, Level 2, and Level 3 quality control samples were taken. One bottle was placed at 2–8℃ as a control sample, and the other bottle was placed at 37℃ as an experimental sample. After 10 days of storage, two samples were taken and tested on a calibrated chemiluminescence analyzer. Each sample was tested three times. The average value of the test results for each sample was calculated, and the relative deviation between the average value of each experimental sample and the average value of the control sample was also calculated. The results are shown in Table 6. The anti-Müllerian hormone assay kit manufactured by YHLO was used.

[0117] Table 6

[0118]

[0119] II. Example 2: Opening test of anti-Müllerian hormone quality control samples from Comparative Examples 1-2

[0120] Four quality control samples were used for each of Level 1, Level 2, and Level 3. One sample was opened on day 7 and placed at 2–8°C as Experimental Sample 1. Another sample was opened on day 0 and placed at ≤-20°C as Experimental Sample 2. The unopened sample was placed at 2–8°C as Control Sample.

[0121] On day 10, experimental sample 1, experimental sample 2 and control sample were opened 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 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] As can be seen from the results in Table 6-7, among the anti-Müllerian hormone quality control products containing PBS, Tris, and MOPS buffers, only the quality control product containing PBS buffer passed the acceleration performance test.

[0129] Experimental Example 3

[0130] I. Accelerated stability test of anti-Müllerian hormone quality control products in Examples 2, 4 and Comparative Example 3

[0131] Two bottles each of Level 1, Level 2, and Level 3 quality control samples were taken. One bottle was placed at 2–8℃ as a control sample, and the other bottle was placed at 37℃ as an experimental sample. After 10 days of storage, two samples were taken and tested on a calibrated chemiluminescence analyzer. Each sample was tested three times. The average value of the test results for each sample was calculated, and the relative deviation between the average value of each experimental sample and the average value of the control sample was calculated, as shown in Table 8. The anti-Müllerian hormone assay kit manufactured by YHLO was used.

[0132] Table 8

[0133]

[0134] II. Opening Tests of Anti-Müllerian Hormone Quality Controls in Examples 2, 4, and 3

[0135] Four quality control samples were used for each of Level 1, Level 2, and Level 3. One sample was opened on day 7 and placed at 2–8°C as Experimental Sample 1. Another sample was opened on day 0 and placed at ≤-20°C as Experimental Sample 2. The unopened sample was placed at 2–8°C as Control Sample.

[0136] On day 10, experimental sample 1, experimental sample 2 and control sample were opened 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 Table 8-9, in the quality control products, the addition of mannitol to the phosphate solution formula reduces the stability of AMH at -20℃, while the addition of trehalose shows no significant difference from the original solution.

[0144] The technical features of the above embodiments can be combined in any way. For the sake of brevity, not all possible combinations of the technical features in the above 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 embodiments described above are merely illustrative of several implementation methods of this application, and while the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the invention patent. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of this application, and these all fall within the protection scope of this application. Therefore, the protection scope of this patent application should be determined by the appended claims, and the specification can be used to interpret the content of the claims.

Claims

1. A quality control product for anti-Müllerian hormones, characterized in that, It includes a natural human anti-Müllerian hormone and a diluent, which consists of 0.04 M to 0.06 M phosphate buffer, 5 g / L to 10 g / L sodium chloride, 20 g / L to 40 g / L bovine serum albumin, 0.1 g / L to 0.5 g / L ProClin300 and 0.1 g / L to 1 g / L mercuric chloride.

2. A quality control product for anti-Müllerian hormones, characterized in that, It includes a natural human anti-Müllerian hormone and a diluent, the diluent consisting of 0.04 M to 0.06 M phosphate buffer, 5 g / L to 10 g / L sodium chloride, 20 g / L to 40 g / L bovine serum albumin, 0.1 g / L to 0.5 g / L ProClin300, 0.1 g / L to 1 g / L mercuric chloride and 20 g / L trehalose.

3. The quality control product according to claim 1 or 2, characterized in that, The phosphate buffer includes disodium hydrogen phosphate and sodium dihydrogen phosphate.

4. The quality control product according to claim 1 or 2, characterized in that, The concentration of the natural human anti-Müllerian hormone is 1.25 ng / mL to 16.5 ng / mL.

5. The quality control product according to claim 4, characterized in that, The concentration of the natural human anti-Müllerian hormone was (1.5±15%) ng / mL.

6. The quality control product according to claim 4, characterized in that, The concentration of the natural human anti-Müllerian hormone was (7±10%) ng / mL.

7. The quality control product according to claim 4, characterized in that, The concentration of the natural human anti-Müllerian hormone was (15±10%) ng / mL.

8. The quality control product according to claim 4, characterized in that, The quality control products are a packaged product, which includes multiple quality control products with different concentrations of natural human anti-Müllerian hormone in each product.

9. A method for preparing the quality control product according to any one of claims 1 to 8, characterized in that, The method includes mixing the natural human anti-Müllerian hormone with the diluent to prepare the quality control product.

10. A quality control method for an anti-Müllerian duct hormone assay platform or product, characterized in that, This includes testing the quality control product as described in any one of claims 1 to 8 using an anti-Müllerian hormone assay platform or product, and making quality control judgments based on the assay results.

11. The quality control method according to claim 10, characterized in that, The anti-Müllerian hormone assay platform includes a chemiluminescence assay platform.

12. An anti-Müllerian duct hormone detection kit, characterized in that, Includes the quality control products as described in any one of claims 1 to 8.

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