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AMH Chemiluminescence Immunoassay Test Double Antibody Sandwich Method

Basic Information
Place of Origin: China
Brand Name: Unveil
Certification: CE
Model Number: CI-AMH
Minimum Order Quantity: N/A
Price: negotiation
Packaging Details: 40T
Delivery Time: 2-4 Weeks
Supply Ability: 10 M tests/month
Product Name: Anti-mullerian Hormone (AMH) Test Kit (CLIA),Chemiluminescence Immunoassay Test,Double Antibody Sandwich Method Cat No.: CI-AMH
Principle: Double Antibody Sandwich Method Specimen: S/P
Pack: 40T Shelf Life: 2 Years
Format: Strip Certificate: CE
Storage Temperature: 2-8℃ Cut-Off: 0.02-23 Ng/mL
High Light:

Chemiluminescence Immunoassay Test

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AMH Chemiluminescence Immunoassay Test

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Anti Mullerian Hormone CLIA Test

Anti-mullerian Hormone (AMH) Test Kit (CLIA),Chemiluminescence Immunoassay Test,Double Antibody Sandwich Method
 
Product Name: Anti-mullerian Hormone (AMH) Test Kit (CLIA),Chemiluminescence Immunoassay Test,Double Antibody Sandwich Method
Principle: Double Antibody Sandwich Method
Pack: 40T
Format: Strip
Storage Temperature: 2-8℃
Cat No.: CI-AMH
Specimen: S/P
Shelf Life: 2 Years
Certificate: CE
Cut-Off: 0.02-23 Ng/mL

 

 

A CLIA test kit for the quantitative determination of Anti-mullerian Hormone (AMH) in human serum or plasma with the use of Automatic Chemiluminescence Immunoassay Analyzer.
 
【INTENDED USE】
 
The Anti-mullerian Hormone (AMH) Test Kit (CLIA) is intended for quantitative determination of Anti-mullerian Hormone (AMH) in human serum and plasma, used to evaluate ovarian function with other clinical and experimental results. For professional in vitro diagnostic use only.
 
【SUMMARY】
 
Anti-Mullerian Hormone (AMH) is a member of the transforming growth factor beta superfamily, a protein secreted by the granular cells of small ovarian follicles. The main physiological role is to regulate the development of germ cells and gonadal tissues and inhibits the growth and development of the Mullerian duct; in males, AMH is secreted by the supporting cells of the testis, and in male embryonic development, the secretion of AMH from the supporting cells of the testis is responsible for the production of the Mullerian duct. Sertoli AMH secretion begins during embryogenesis and continues for life. AMH continues to be produced from the testes until puberty, and then slowly decreases to the postpubertal level.
 
In women, AMH plays an important role in the development of ovarian follicles:
1. AMH inhibits the transition of follicles from the initial stage to the mature stage, and then plays an important role in regulating the number of remaining follicles in the initial follicle pool;
 
2. AMH can inhibit follicles The sensitivity of FSH therefore plays a role in the follicle selection process .
When a woman is born, the serum AMH content is extremely low. After puberty, the AMH concentration reaches a peak and maintains a high level throughout the reproductive age. After that, as age and various factors are gradually consumed, the concentration will decrease until it cannot be measured after menopause.
 
3 Value of AMH presents different average levels in different age groups, the higher the AMH index, the greater the inventory of eggs and the stronger fertility; when AMH decreases, it means that the ovaries are aging, so AMH can be used to evaluate the ovaries the reserve function. Studies have shown that compared with healthy ovulating women, the concentration of AMH in the follicular fluid in patients with polycystic ovary syndrome is 5 times higher than the normal value, and AMH is recommended to diagnose polycystic ovary syndrome.4 A further clinical application of AMH is to diagnose sexual developmental diseases in children.
 
【PRINCIPLE】
 
This product uses the double antibody sandwich method. In the first step, the sample, the AMH antibody labeled with alkaline phosphatase, and the magnetic particles coated with the AMH antibody are mixed. After incubation, the AMH in the sample forms an immune complex with the corresponding antibody.
 
In the second step, magnetic separation and cleaning are performed to remove free enzyme-labeled antibodies. The third step is to add the chemiluminescent substrate solution to the immune complex. Luminescence signal generated by the enzyme reaction is detected by Automatic Chemiluminescence Immunoassay Analyzer and the detected luminescence intensity is related to the concentration of AMH in the sample. Automatic Chemiluminescence Immunoassay Analyzer can calculate the concentration of AMH in the sample.
 
【REAGENTS】
 
The reagent strip includes AMH antibody coated with magnetic particles, alkaline phosphatase labeled AMH antibody, wash buffer and substrate solution.
 
【PRECAUTIONS】
 
1. For professional in vitro diagnostic use only.
 
2. Read the entire package insert carefully prior to testing.
 
3. Do not use after the expiration date indicated on the package.
 
4. The single reagent strip has been assembled into a ready-to-use unit that cannot be separated.
 
5. Do not interchange or mix reagents from different batches.
 
6. Used test materials should be disposed of in accordance with local regulations.
 
7. Test kits and samples need to be equilibrated to room temperature before testing.
 
8. It is recommended to use fresh blood. Samples with high-fat chylo, jaundice, and high rheumatoid factor are not recommended and hemolyzed samples are also not recommended.
 
9. Handle all specimens as if they contain infectious agents. Observe established precautions against microbiological hazards throughout all procedures and follow the standard procedures for proper disposal of specimens. Wear protective clothing such as laboratory coats, disposable gloves and eye protection when specimens are assayed.
 
10. The test results of this kit are for clinical reference only, clinical diagnosis and treatment of patients should be comprehensively considered in conjunction with their symptoms/signs, medical history, other laboratory tests and treatment responses.
 
11. Due to methodological or antibody specificity and other reasons, test the same sample with reagent strips from different manufacturers may result in different test results. The results obtained from testing with different reagent strips should not be directly compared with each other, which may cause erroneous medical interpretations.
 
12. Store and test reasonably in strict accordance with the instructions of the package insert. Keep the reagents away from light, do not turn it over.
 
13. The Anti-mullerian Hormone (AMH) Test Kit (CLIA) should only be used with the Automatic Chemiluminescence Immunoassay Analyzer by professionals.
 
【STORAGE AND STABILITY】
 
1. Unopened test kits should be stored at 2-8 °C. When stored and handled as required, all unopened reagents are stable through the expiration date printed on the label.
 
2. Do not freeze. Do not turn the reagent strips over.
 
3. Store the test kit upright. Do not expose reagents to strong light during storage. Care should be taken to protect the components of the test from contamination.
 
4. Remaining reagents in the kit should be stored at 2-8°C immediately.
 
5. Do not use if there is evidence of microbial contamination or precipitation. Biological contamination of dispensing equipment,
containers or reagents may lead to false results. 
 
6. Calibrator and Control Materials:
Unopened:
Stable until the expiration date when stored at 2-8 °C.
Opened: Stable for 1 week at 2-8 °C

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