Anti-mullerian hormone quality control product as well as preparation method and application thereof
By simplifying the ingredients of anti-Muler's hormone quality control products, the quality control product matrix liquid of buffer, bovine serum albumin, surfactant S9, polyoxyethylene alkyl ether, bisegpeptide and preservatives is solved, and the stability, uniformity and detection accuracy of the existing quality control products are achieved.
Patent Information
- Application Number
- CN202411519659.8
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2024-10-29
- Publication Date
- 2025-02-25
AI Technical Summary
There are many additives for anti-Muller's hormone quality control products, which can easily produce matrix effects, affect the accuracy of the analysis results, and at the same time, the shelf life is short, making it difficult to meet the needs of clinical applications.
The quality control product consisting of anti-Muler's hormone antigen and a quality control product matrix solution, which includes buffer solution, bovine serum albumin, surfactant S9, polyoxyethylene alkyl ether, bisegrene peptide and preservative. By simplifying ingredients and optimizing formula, the matrix effect is reduced and the shelf life is extended.
It achieves the stability and uniformity of anti-Muller's hormone quality control products, extends the shelf life, reduces matrix effects, and improves the accuracy of the test results. It is suitable for the preparation of detection kits and direct testing.
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Abstract
Description
Technical Field
[0001] The invention belongs to the technical field of anti-Mullerian hormone detection, and in particular relates to an anti-Mullerian hormone quality control product and a preparation method and application thereof. Background Art
[0002] Anti-Mullerian hormone (AMH) is a dimeric glycoprotein belonging to the transforming growth factor (TGF-β) family. It is secreted by female follicular granulosa cells and male testicular supporting cells. It can inhibit the recruitment and growth of female follicles and regulate the function of male testicular interstitial cells. In women, AMH plays an important role in the development of ovarian follicles. The serum level of AMH is almost undetectable at birth, reaches the highest level after puberty, and then gradually decreases with age, and cannot be detected after menopause. AMH is not affected by pituitary gonadotropin, and its value does not change much throughout the menstrual cycle. Compared with the traditional methods commonly used to predict ovarian reserve and ovarian responsiveness, serum AMH can evaluate ovarian reserve function earlier and more accurately, and can indirectly reflect the number of follicles in the ovaries. It can more accurately diagnose premature ovarian insufficiency and is used to predict the response to controlled ovarian induction. AMH has a high clinical value in polycystic ovary syndrome.
[0003] At present, there are many AMH detection reagents on the market, and the quality of products from different manufacturers varies. How to improve the effectiveness of the test results has become an urgent requirement for clinical applications. The purpose of indoor quality control is to detect and control the precision of routine work in the laboratory and detect changes in its accuracy, so as to improve the consistency of specimen testing in routine work in the laboratory, thereby ensuring the accurate issuance of test reports. Therefore, the quality of indoor quality control products is the foundation and key link of laboratory quality management.
[0004] At present, the manufacturers of AMH quality control products registered by CFDA include Roche, Beckman, Micropoint and Mindray, but most of these manufacturers' quality control products are used in conjunction with the manufacturer's reagents and instruments. In addition, the AMH quality control products commonly used currently have many additives, which are prone to matrix effects, affecting the accuracy of the analysis results, and also have a short shelf life. Therefore, it is very necessary to develop a stable and reliable AMH quality control product. Summary of the invention
[0005] In view of this, the present invention aims to provide an anti-Mullerian hormone quality control product, which has the advantages of less additives, simple ingredients, long shelf life, good stability and uniformity.
[0006] In order to achieve the above object, the present invention specifically adopts the following technical solutions: An anti-Mullerian hormone quality control product consists of an anti-Mullerian hormone antigen and a quality control product matrix liquid, wherein the quality control product matrix liquid comprises a buffer, bovine serum albumin, a surfactant S9, a polyoxyethylene alkyl ether, a diglycopeptide and a preservative.
[0007] Preferably, in the above-mentioned anti-Mullerian hormone quality control product, the preservative is any one or two of ProClin300, gentamicin sulfate, sodium azide and thimerosal, among which it is more preferable when the preservative is sodium azide and / or ProClin300.
[0008] Preferably, in the above-mentioned anti-Mullerian hormone quality control product, the quality control product matrix liquid includes 10-60 mM MMOPS buffer, 0.5-6.0% w / v bovine serum albumin, 0.1-2.0% w / v surfactant S9, 0.5-3.0% w / v polyoxyethylene alkyl ether, 0.5-3.0% w / v diglycosidic peptide and 0.1-0.4% w / v preservative.
[0009] More preferably, in the above-mentioned anti-Mullerian hormone quality control product, the pH of the quality control product matrix liquid is 7.0-8.0, and the quality control product matrix liquid is composed of 10-60 mM MOPS buffer, 0.5-6.0% w / v bovine serum albumin, 0.1-2.0% w / v surfactant S9, 0.5-3.0% w / v polyoxyethylene alkyl ether, 0.5-3.0% w / v diglycosidic peptide, and 0.1-0.4% w / v preservative; wherein the preservative is composed of sodium azide and ProClin300.
[0010] Preferably, in the above-mentioned anti-Mullerian hormone quality control product, the anti-Mullerian hormone antigen content is 4.8-11.2 ng / mL or 0.3-0.7 ng / mL. It can be understood that when the anti-Mullerian hormone antigen content is 4.8-11.2 ng / mL, the obtained quality control product is a high (concentration) level quality control product, and when the anti-Mullerian hormone antigen content is 0.3-0.7 ng / mL, the obtained quality control product is a low (concentration) level quality control product.
[0011] The present invention also provides a method for preparing the above-mentioned anti-Mullerian hormone quality control product, which specifically comprises: adding bovine serum albumin, surfactant S9, polyoxyethylene alkyl ether, diglycosidic peptide and preservative into a buffer solution, adjusting the pH after mixing evenly, and filtering to obtain a quality control product matrix liquid; then dissolving the anti-Mullerian hormone antigen into the quality control product matrix liquid, and packaging after quantification to obtain the anti-Mullerian hormone quality control product.
[0012] Preferably, in the above preparation method, filtration is performed using a 0.22 μm filter membrane.
[0013] The anti-Mullerian hormone quality control product provided by the present invention can be specifically stored at 2~8°C in the dark; for example, in some embodiments of the present invention, the quality control product matrix solution has a pH of 7.5, and is specifically composed of 50 mM MOPS buffer, 1.0% w / v bovine serum albumin, 0.5% w / v surfactant S9, 1.0% w / v polyoxyethylene alkyl ether, 1.0% w / v diglycosidic peptide, 0.09% w / v sodium azide and 0.05% w / v ProClin300. The obtained quality control product has excellent stability and can be stored at 2~8°C in the dark for 1 year.
[0014] The anti-Mullerian hormone quality control product provided by the present invention can be used to prepare an anti-Mullerian hormone detection kit, and can also be directly used for anti-Mullerian hormone detection. Moreover, the quality control product provided by the present invention is a liquid quality control product, which can be directly used without re-dissolving, which is conducive to simplifying the operation and shortening the detection process.
[0015] Compared with the prior art, the beneficial effects of the present invention are: (1) Since proteins always tend to interact with surfaces, highly diluted protein samples are easily adsorbed and denatured and inactivated. Therefore, adding some isolation proteins can reduce the adsorption of the target protein to the container. However, compared with other protective proteins, the use of serum albumin as a protective protein in the quality control product of the present invention is more conducive to maintaining the stability of the anti-Mullerian hormone antigen. In addition, serum albumin is the main component of blood. By cooperating with buffer and other components, it can adjust the osmotic pressure and stability of the system, simulate human blood samples, and reduce the matrix effect.
[0016] (2) The quality control product of the present invention contains surfactant S9, which is a copolymer of propylene oxide-ethylene oxide-vinyl diamine, a typical zwitterionic surfactant, and has good interfacial activity. Whether it is adsorbed on a positively charged or negatively charged interface, it will not form a hydrophobic interface. It has the advantages of both anionic and cationic surfactants, has no cloud point phenomenon, is not easily affected by inorganic electrolytes, and has good emulsification ability, dispersibility and antistatic ability. As a zwitterionic molecule, S9 can well solve the problem of hydrophobic precipitation polymerization inactivation caused by the externalization of more hydrophobic amino acids on the surface of the anti-Mullerian hormone protein after recombinant, thereby effectively protecting the anti-Mullerian hormone antigen.
[0017] (3) The quality control product of the present invention contains polyoxyethylene alkyl ether, which, when used in combination with the surfactant S9, can more effectively maintain the stability of the quality control product.
[0018] (4) The quality control product of the invention also contains an antioxidant, diglycosidic peptide, which can effectively remove metal ions and prevent oxidation. Experimental data show that compared with other antioxidants such as sodium thiosulfate, diglycosidic peptide is obviously more suitable for the system of the invention.
[0019] (5) Quality control products can be prepared by simply adding materials, dissolving and packaging, which is convenient for large-scale production; the obtained quality control products are ready-to-use liquid reagents, which are more convenient to use and have good stability and uniformity.
[0020] (6) The anti-Mullerian hormone quality control product provided by the present invention has good stability after opening the bottle, which helps to reduce waste and cost. It also has good stability and is not affected by factors such as transportation and temperature, and has stable performance. DETAILED DESCRIPTION
[0021] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by those skilled in the art to which the present invention belongs. The term "comprises" and any variations thereof in the specification and claims of the present invention are intended to cover non-exclusive inclusions.
[0022] In view of the problems that existing anti-Mullerian hormone quality control products have many additives and a short shelf life, the present invention provides an anti-Mullerian hormone quality control product with simple ingredients and stable and reliable characteristics. In addition to anti-Mullerian hormone antigen and buffer, the anti-Mullerian hormone quality control product only contains bovine serum albumin, surfactant S9, polyoxyethylene alkyl ether, diglycopeptide and preservative, thereby minimizing the matrix effect while ensuring stability.
[0023] In a preferred embodiment, the anti-Mullerian hormone quality control product is composed of an anti-Mullerian hormone antigen and a quality control product matrix liquid, wherein the pH of the quality control product matrix liquid is 7.0-8.0, and is specifically composed of 10-60 mM MOPS buffer, 0.5-6.0% w / v bovine serum albumin, 0.1-2.0% w / v surfactant S9, 0.5-3.0% w / v polyoxyethylene alkyl ether, 0.5-3.0% w / v diglycosidic peptide, and 0.1-0.4% w / v preservative.
[0024] The technical solution of the present invention will be described clearly and completely below in conjunction with specific embodiments. It should be understood that the embodiments described herein are only used to illustrate and explain the present invention and are not used to limit the present invention.
[0025] If no specific techniques or conditions are specified in the following examples, all of them are carried out according to the techniques or conditions described in the literature in the field or according to the product instructions; if the manufacturer of the reagents or instruments is not specified, they are all conventional products that can be obtained commercially.
[0026] Example 1 This example provides an anti-Mullerian hormone quality control product, which is specifically composed of an anti-Mullerian hormone antigen and a quality control product matrix solution, wherein the quality control product matrix solution has a pH of 7.5 and is composed of 50 mM MOPS buffer, 1.0% w / v bovine serum albumin, 0.5% w / v surfactant S9, 1.0% w / v polyoxyethylene alkyl ether, 1.0% w / v diglycosidic peptide, 0.09% w / v sodium azide and 0.05% w / v ProClin300.
[0027] The preparation method of anti-Mullerian hormone quality control is as follows: ①Prepare 50 mM MOPS buffer; ② Add sodium azide, ProClin300, bovine serum albumin, surfactant S9, polyoxyethylene alkyl ether and diglycosidic peptide to 50 mM MOPS buffer in proportion, stir to dissolve, adjust the pH to 7.5, and filter with a 0.22 μm filter membrane; ③ Add anti-Mullerian hormone antigen to the filtrate obtained in step ②, stir and dissolve, and prepare high and low level quality control products respectively; wherein, in the low level (level 1) quality control product, the content of anti-Mullerian hormone antigen is set to 0.5 ng / mL, and in the high level (level 2) quality control product, the content of anti-Mullerian hormone antigen is set to 8.0 ng / mL; ④ Detect the anti-Mullerian hormone antigen content in the above quality control products, divide them into glass bottles, assign values, obtain liquid quality control products, and store them in a sealed state at 2-8°C.
[0028] The detection method of the quality control product content is shown in Table 1, where the target value is the target value when the quality control product is prepared, and the reference range refers to the standard value range used for internal laboratory quality control. If it exceeds this range, the quality control product is judged to be out of control.
[0029] Table 1 Content detection of quality control products
[0030] Example 2 This example provides an anti-Mullerian hormone quality control product, which is specifically composed of an anti-Mullerian hormone antigen and a quality control product matrix solution, wherein the quality control product matrix solution has a pH of 7.0 and is composed of 10 mM MOPS buffer, 0.5% w / v bovine serum albumin, 0.1% w / v surfactant S9, 0.5% w / v polyoxyethylene alkyl ether, 0.5% w / v diglycosidic peptide, 0.05% w / v sodium azide and 0.05% w / v ProClin300.
[0031] The preparation method of anti-Mullerian hormone quality control is as follows: ①Prepare 10 mM MOPS buffer; ② Add sodium azide, ProClin300, bovine serum albumin, surfactant S9, polyoxyethylene alkyl ether and diglycosidic peptide to 10 mM MOPS buffer in proportion, stir to dissolve, adjust the pH to 7.0, and filter with a 0.22 μm filter membrane; ③ Add anti-Mullerian hormone antigen to the filtrate obtained in step ②, stir and dissolve, and prepare high and low level quality control products respectively; wherein, in the low level (level 1) quality control product, the content of anti-Mullerian hormone antigen is set to 0.5 ng / mL, and in the high level (level 2) quality control product, the content of anti-Mullerian hormone antigen is set to 8.0 ng / mL; ④ Detect the anti-Mullerian hormone antigen content in the above quality control products, divide them into glass bottles, assign values, prepare liquid quality control products, and store them in a sealed state at 2-8°C.
[0032] Example 3 This example provides an anti-Mullerian hormone quality control product, which is specifically composed of an anti-Mullerian hormone antigen and a quality control product matrix solution, wherein the quality control product matrix solution has a pH of 8.0 and is composed of 60 mM MOPS buffer, 6.0% w / v bovine serum albumin, 2.0% w / v surfactant S9, 3.0% w / v polyoxyethylene alkyl ether, 3.0% w / v diglycosidic peptide, 0.2% w / v sodium azide and 0.2% w / v ProClin300.
[0033] The preparation method of anti-Mullerian hormone quality control is as follows: ①Prepare 60 mM MOPS buffer; ② Add sodium azide, ProClin300, bovine serum albumin, surfactant S9, polyoxyethylene alkyl ether and diglycosidic peptide to 60 mM MOPS buffer in proportion, stir to dissolve, adjust the pH to 8.0, and filter with a 0.22 μm filter membrane; ③ Add anti-Mullerian hormone antigen to the filtrate obtained in step ②, stir and dissolve, and prepare high and low level quality control products respectively; wherein, in the low level (level 1) quality control product, the content of anti-Mullerian hormone antigen is set to 0.5 ng / mL, and in the high level (level 2) quality control product, the content of anti-Mullerian hormone antigen is set to 8.0 ng / mL; ④ Detect the anti-Mullerian hormone antigen content in the above quality control products, divide them into glass bottles, assign values, prepare liquid quality control products, and store them in a sealed state at 2-8°C.
[0034] Example 4 This example provides an anti-Mullerian hormone quality control product, which is specifically composed of an anti-Mullerian hormone antigen and a quality control product matrix solution, wherein the quality control product matrix solution has a pH of 7.5 and is composed of 40 mM MOPS buffer, 2.0% w / v bovine serum albumin, 1.5% w / v surfactant S9, 2.0% w / v polyoxyethylene alkyl ether, 2.0% w / v diglycosidic peptide, 0.09% w / v sodium azide and 0.05% w / v ProClin300.
[0035] The preparation method of anti-Mullerian hormone quality control is as follows: ①Prepare 40 mM MOPS buffer; ② Add sodium azide, ProClin300, bovine serum albumin, surfactant S9, polyoxyethylene alkyl ether and diglycosidic peptide to 460 mM MOPS buffer in proportion, stir to dissolve, adjust the pH to 7.5, and filter with a 0.22 μm filter membrane; ③ Add anti-Mullerian hormone antigen to the filtrate obtained in step ②, stir and dissolve, and prepare high and low level quality control products respectively; wherein, in the low level (level 1) quality control product, the content of anti-Mullerian hormone antigen is set to 0.5 ng / mL, and in the high level (level 2) quality control product, the content of anti-Mullerian hormone antigen is set to 8.0 ng / mL; ④ Detect the anti-Mullerian hormone antigen content in the above quality control products, divide them into glass bottles, assign values, prepare liquid quality control products, and store them in a sealed state at 2-8°C.
[0036] The quality control products prepared in the above examples were tested as follows: (1) Uniformity test.
[0037] Take 10 bottles of quality control products of each level, randomly number them 1 to 10, and test them on the Mindex CP800 fully automatic chemiluminescence immunoassay analyzer with good precision (the detection method is magnetic particle chemiluminescence method). Repeat the measurement of each item at each concentration level 3 times. The 3 tests are performed in different orders, such as 1, 3, 5, 7, 9, 2, 4, 6, 8, 10, 10, 9, 8, 7, 6, 5, 4, 3, 2, 1, 2, 4, 6, 8, 10, 1, 3, 5, 7, 9. Record the test results. When the test results have numerical values, calculate them according to formulas 1 to 11. F , S bb , Sr and CV 瓶间 ; Formula 1: ; Formula 2: ; Formula 3: ; Formula 4: ; Formula 5: ; Formula 6: ; Formula 7: ; Formula 8: ; Formula 9: ; Formula 10: ; Formula 11: ; Where: SS -variance; x i —Specify the i-th measurement value or calculation result of the parameter; — overall mean value; n i —Number of repeated measurements of sample i; x ij —the jth result of sample i; MS — mean square; v — degrees of freedom; F — F Test value; n 0—valid measurement times; a — the number of samples drawn; N —Total number of tests; S bb —Standard deviation between bottles; S r —Intra-bottle standard deviation (repeatability standard deviation).
[0038] when F ≤1, S r Instead of S bb calculate CV 瓶间 , the result should be CV 瓶间 ≤10.0%; when F ≤ When the test results show that there is no significant difference in uniformity between bottles, the results should be CV 瓶间 ≤10.0%; when F > , S bb ≤0.3 δ , it is considered that the uniformity between bottles is good, and the result should be CV 瓶间 ≤10.0%; when F > , Sbb >0.3 δ , it is believed that the uniformity between bottles is poor and does not meet the requirements.
[0039] Among them, the uniformity results of high and low level quality control solutions in Example 1 are shown in Table 2.
[0040] Table 2 Homogeneity results of quality control solution in Example 1
[0041] As can be seen from Table 2, both levels of the anti-Mullerian hormone quality control product in Example 1 meet the uniformity requirements. The results of Examples 2-4 are also "no significant difference in uniformity between bottles" at both levels.
[0042] (2) Accelerated stability test.
[0043] Take 6 bottles of each level of quality control, 3 of which are placed in a 2-8℃ refrigerator away from light, and the other 3 bottles are placed in a 37℃ constant temperature box. Then test one bottle of sample on the 1st, 4th, and 7th day, and take one bottle of refrigerated quality control at each node as the control sample for each node for testing. During the test, the two level samples were measured 3 times and the average value was calculated. Calculate the relative deviation of the mean value of the quality control product at each time node and the mean value of the refrigerated control quality control product at each node. The relative deviation should not exceed ±10%.
[0044] Among them, the test data of the quality control product of Example 1 is shown in Table 3.
[0045] Table 3 Test results of quality control products in Example 1
[0046] As can be seen from Table 3, the 7-day deviation of the accelerated stability of the two levels of quality control products in Example 1 was less than 10%. The test results of Examples 2-4 also showed that the relative deviation was less than 10%.
[0047] (3) Opening stability test.
[0048] Take 6 bottles of quality control products of each level, of which 1 bottle is placed in a 2-8℃ refrigerator away from light after opening, and the other 5 bottles are placed in a 2-8℃ away from light as an unopened control group. Take the opened sample for testing on the 5th, 10th, 15th, 24th, and 28th days, and take 1 bottle of unopened control sample for testing at each node. During the test, the 2 level samples were measured 3 times and the average value was calculated. Calculate the relative deviation between the mean value of the quality control product at the end of the opening period and the mean value of each unopened quality control product. The relative deviation should not exceed ±10%.
[0049] Among them, the detection data of Example 1 is shown in Table 4.
[0050] Table 4 Opening stability test results of the quality control product of Example 1
[0051] Table 4 shows that the 28-day deviation of the two levels of the quality control prepared in Example 1 was less than 10%. The test results of Examples 2-4 were consistent with those of Example 1, indicating that the quality control diluent provided by the present invention can well maintain the stability of the anti-Mullerian hormone antigen.
[0052] Comparative Example 1 The only difference from Example 4 is that in the anti-Mullerian hormone quality control product provided in this example, gelatin is used to replace bovine serum albumin.
[0053] Comparative Example 2 The only difference from Example 4 is that in the anti-Mullerian hormone quality control product provided in this example, casein is used to replace bovine serum albumin.
[0054] Comparative Example 3 The only difference from Example 4 is that in the anti-Mullerian hormone quality control product provided in this example, polyethylene glycol 400 is used to replace the surfactant S9.
[0055] Comparative Example 4 The only difference from Example 4 is that in the anti-Mullerian hormone quality control product provided in this example, calcium chloride dihydrate is used to replace polyoxyethylene alkyl ether.
[0056] Comparative Example 5 The only difference from Example 4 is that in the anti-Mullerian hormone quality control product provided in this example, EDTA-disodium is used to replace polyoxyethylene alkyl ether.
[0057] Comparative Example 6 The only difference from Example 4 is that in the anti-Mullerian hormone quality control product provided in this example, sodium thiosulfate is used to replace the diglycopeptide.
[0058] Comparative Example 7 The only difference from Example 4 is that in the anti-Mullerian hormone quality control product provided in this example, the MOPS buffer is replaced by borate buffer.
[0059] The following tests were performed on the quality control products prepared in Example 4 and Comparative Examples 1-2: 2 replicates were set for each quality control product, and the product was stored at 4°C for 1d, 2d, 3d, 4d, 5d, 6d, and 7d after opening the bottle, and the concentration value changes were continuously monitored. The specific monitoring data are shown in Table 5.
[0060] Table 5 Stability monitoring results of different protective proteins
[0061] It can be seen from Table 5 that, compared with gelatin and casein, bovine serum albumin is more conducive to maintaining the stability of the quality control system of the present invention.
[0062] The following tests were performed on the quality control products prepared in Example 4 and Comparative Example 3: 2 replicates were set for each quality control product, and the samples were stored at 4°C for 1d, 2d, 3d, 4d, 5d, 6d, and 7d, and the concentration value changes were continuously monitored. The specific monitoring data are shown in Table 6.
[0063] Table 6 Stability monitoring results of different surfactants
[0064] It can be seen from Table 6 that although polyethylene glycol 400 is also a surfactant, it has no positive effect on the stability of the quality control product, while S9 can effectively maintain the stability of the quality control product.
[0065] The following tests were performed on the quality control products prepared in Example 4 and Comparative Examples 4-5: 2 replicates were set for each quality control product, and the samples were stored at 4°C for 1d, 2d, 3d, 4d, 5d, 6d, and 7d, and the concentration value changes were continuously monitored. The specific monitoring data are shown in Table 7.
[0066] Table 7 Stability monitoring results under different stabilizers
[0067] It can be seen from Table 7 that, relative to calcium chloride dihydrate and EDTA-disodium, the presence of polyoxyethylene alkyl ether is more conducive to maintaining the stability of the quality control product of the present invention.
[0068] The following tests were performed on the quality control products prepared in Example 4 and Comparative Example 6: 2 replicates were set for each quality control product, and the samples were stored at 4°C for 1d, 2d, 3d, 4d, 5d, 6d, and 7d, and the concentration value changes were continuously monitored. The specific monitoring data are shown in Table 8.
[0069] Table 8 Stability monitoring results under different antioxidants
[0070] As can be seen from Table 8, the quality control product of the present invention uses diglycosidic peptide as an antioxidant, which can effectively maintain the stability of the quality control product.
[0071] The following tests were performed on the quality control products prepared in Example 4 and Comparative Example 7: 2 replicates were set for each quality control product, and the samples were stored at 4°C for 1d, 2d, 3d, 4d, 5d, 6d, and 7d, and the concentration changes were continuously monitored. The specific monitoring data are shown in Table 9.
[0072] Table 9 Stability monitoring results of different buffers
[0073] As can be seen from Table 9, compared with boric acid buffer, the use of MOPS buffer combined with the various additive components of the present invention can more effectively maintain the stability of the quality control product.
[0074] In summary, the anti-Mullerian hormone quality control product provided by the present invention has the advantages of few specific additives, simple ingredients and low cost. In addition, the quality control product provided by the present invention has good uniformity and stability, which effectively extends the shelf life of the quality control product and is conducive to transportation and storage.
[0075] It should be noted that the above embodiments are only part of the embodiments of the present invention rather than all the embodiments, and are only used to illustrate the technical solution of the present invention rather than to limit it. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative work are within the scope of protection of the present invention.
Claims
1. An anti-Mullerian hormone quality control product, characterized in that: The quality control product consists of anti-Mullerian hormone antigen and quality control product matrix liquid, wherein the quality control product matrix liquid includes buffer, bovine serum albumin, surfactant S9, polyoxyethylene alkyl ether, biglycoside peptide and preservative.
2. The anti-Mullerian hormone quality control product according to claim 1, characterized in that: The quality control matrix solution includes 10-60 mM MOPS buffer, 0.5-6.0% w / v bovine serum albumin, 0.1-2.0% w / v surfactant S9, 0.5-3.0% w / v polyoxyethylene alkyl ether, 0.5-3.0% w / v diglycosidic peptide and 0.1-0.4% w / v preservative.
3. The anti-Mullerian hormone quality control product according to claim 2, characterized in that: The quality control matrix solution also includes a preservative, which is any one or any two of ProClin300, gentamicin sulfate, sodium azide and thimerosal.
4. The anti-Mullerian hormone quality control product according to claim 3, characterized in that: The preservative is composed of sodium azide and / or ProClin300.
5. The anti-Mullerian hormone quality control product according to claim 2, characterized in that: The pH of the quality control matrix solution is 7.0-8.
0.
6. The anti-Mullerian hormone quality control product according to claim 2, characterized in that: The content of the anti-Mullerian hormone antigen is 4.8-11.2 ng / mL or 0.3-0.7 ng / mL.
7. A method for preparing the anti-Mullerian hormone quality control product according to any one of claims 1 to 6, characterized in that: Add bovine serum albumin, surfactant S9, polyoxyethylene alkyl ether, diglycosidic peptide and preservative to the buffer solution, adjust the pH after mixing evenly, and filter to obtain a quality control matrix liquid; then dissolve the anti-Mullerian hormone antigen in the quality control matrix liquid to obtain the anti-Mullerian hormone quality control product.
8. The method according to claim 7, characterized in that The filtration was performed using a 0.22 μm filter membrane.
9. Use of the anti-Mullerian hormone quality control product according to any one of claims 1 to 6 in the preparation of an anti-Mullerian hormone detection kit.
10. Use of the anti-Mullerian hormone quality control product according to any one of claims 1 to 6 in the detection of anti-Mullerian hormone.