CE approval Human use Anti-Mullerian Hormone (AMH) Elisa test Kit blood or serum test 96T

Intended use

The AMH assay is an enzyme-linked immunosorbent assay (ELISA) for the in vitro quantitative determination of Anti-Mullerian Hormone (AMH) in human serum. For professional use only.

Summary

Anti-Müllerian hormone (AMH) is a glycoprotein hormone structurally related to inhibin and activin from the transforming growth factor beta superfamily, whose key roles are in growth differentiation and folliculogenesis.1

In fetal males, AMH is produced by the Sertoli cells and induces regression of the Müllerian duct and therefore promotes development of the male reproductive tract.2 Infant males have very high levels of AMH (>30 ng/ml) that slowly decreases until post-pubescence where it remains at a low level (<10 ng/ml).3,4

In females, AMH begins to be produced near the time of birth with levels increasing until puberty. After puberty, blood AMH levels decrease until menopause where it becomes nearly undetectable (<0.1 ng/ml). AMH concentration in female blood has repeatedly been linked to ovarian reserve, thereby giving an indication to patients’ remaining reproductive lifespans. Additionaly, high levels of AMH (>4.7 ng/ml, 80% CI) in females are an indication of polycystic ovarian syndrome (PCOS).5

When AMH levels drop below 1.0 ng/ml in females, they are considered to have low ovarian reserves. Patients in these ranges are advised to not delay family planning or to undergo infertility treatments such as in vitro fertilization.5,6

The AMH ELISA kit can be used to monitor the progress of patients’ infertility treatments and approximate the onset of menopause.

Summary

• Anti-Müllerian hormone (AMH) is a glycoprotein hormone structurally related to inhibin and activin from the transforming growth factor beta superfamily, whose key roles are in growth differentiation and folliculogenesis.1 In fetal males, AMH is produced by the Sertoli cells and induces regression of the Müllerian duct and therefore promotes development of the male reproductive tract.2 Infant males have very high levels of AMH (>30 ng/ml) that slowly decreases until post-pubescence where it remains at a low level (<10 ng/ml).3,4 In females, AMH begins to be produced near the time of birth with levels increasing until puberty. After puberty, blood AMH levels decrease until menopause where it becomes nearly undetectable (<0.1 ng/ml). AMH concentration in female blood has repeatedly been linked to ovarian reserve, thereby giving an indication to patients’ remaining reproductive lifespans. Additionaly, high levels of AMH (>4.7 ng/ml, 80% CI) in females are an indication of polycystic ovarian syndrome (PCOS).5 When AMH levels drop below 1.0 ng/ml in females, they are considered to have low ovarian reserves. Patients in these ranges are advised to not delay family planning or to undergo infertility treatments such as in vitro fertilization.5,6 The AMH ELISA kit can be used to monitor the progress of patients’ infertility treatments and approximate the onset of menopause.

Technical Parameters:

Test principle

Test principle Sandwich principle. Total duration of assay: 80 minutes.

• Sample, Anti-AMH coated microwells and enzyme labeled Anti-AMH are combined.

• During the incubation, AMH presents in the sample is allowed to react simultaneously with the two antibodies, resulting in the AMH molecules being sandwiched between the solid phase and enzyme-linked antibodies.

• After washing, a complex is generated between the solid phase, the AMH within the sample and enzyme-linked antibodies by immunological reactions.

• Substrate solution is then added and catalyzed by this complex, resulting in a chromogenic reaction. The resulting chromogenic reaction is measured as absorbance.

• The absorbance is proportional to the amount of AMH in the sample.

Precautions and warnings

• Precautions and warnings

• For in vitro diagnostic use only.

• Exercise the normal precautions required for handling all laboratory reagents.

• Disposal of all waste material should be in accordance with local guidelines.

• Do not use reagents beyond the labeled expiry date.

• Do not mix or use components from kits with different batch codes.

• All the specimen and reaction wastes should be considered potentially biohazard. The handling of specimens and reaction wastes should be in accordance with the local regulations and guidelines.

• The Stop Solution contains sulfuric acid, which can cause severe burns. In the event of contact with eyes, rinse immediately with plenty of water and seek medical advice.

• Neutralized acids and other liquid waste should be decontaminated by adding a sufficient volume of sodium hypochlorite to obtain a final concentration of at least 1.0%. Exposure to 1.0% sodium hypochlorite for 30 minutes may be necessary to ensure effective decontamination.

• Some reagents contain 0.05% or 0.1% ProClin 300 which may cause sensitization by skin contact, which must therefore be avoided. Reagents and their containers must be disposed of safely. If swallowed, seek medical advice immediately and show this container or label.

• Substrate has an irritant effect on skin and mucosa. In case of possible contact, wash eyes with an abundant volume of water and skin with soap and abundant water. Wash contaminated objects before reusing them. If inhaled, take the person to open air.

• For information on hazardous substances included in the kit please refer to the Materials Safety Data Sheet (MSDS), which is available on request. • Do not smoke, drink, eat or apply cosmetics in the work area.

• Do not pipette by mouth. Wear protective clothing, disposable gloves and eye/face protection when handling samples and reagents. Wash hands after use.

• If any of the reagents comes into contact with the skin or eyes, wash the area extensively with water.

Support and Services:

The Elisa Test Kit product technical support and services include:

• Assistance with product installation and initial setup
• Guidance on product usage and troubleshooting
• Product training and education
• Documentation and manuals for reference
• Regular software updates and maintenance
• Remote technical support and assistance
• On-site technical support and repair services

Packing and Shipping:

Shipping:

Our company provides fast and reliable shipping for the Elisa Test Kit product. We use reputable carriers to ensure that your order arrives in a timely and secure manner. Shipping times may vary depending on your location, but we strive to deliver your order as quickly as possible.

Storage and stability

• Store at 2-8℃.

• Seal and return unused reagents to 2-8℃, under which conditions the stability will be retained for 2 months, or until the labeled expiry date, whichever is earlier.