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Clinically Validated, FDA Cleared

 

MenoCheck®, a double monoclonal antibody ELISA immunoassay, is a unique assay specifically designed to detect ultra-low levels of Anti-Mullerian Hormone (AMH) in serum. It is manufactured by Ansh Labs LLC and is FDA Cleared for measuring AMH in the determination of menopausal status.

MenoCheck is the only commercially available AMH immunoassay that has the sensitivity to detect ultra-low levels of AMH in menopausal women. The data supporting the use of the MenoCheck test was acquired from over 1500 women participating in a 20-year study, involving careful clinical observations and hormone measurements annually, as they underwent the menopausal transition and 12 months of amenorrhea to allow an accurate FMP date.

Results Interpretation: AMH Values and Time to Final Menstrual Period

 

The FMP for each woman in the SWAN Study were assigned retrospectively after 12 months of amenorrhea (the clinical definition of natural menopause). Menopausal categories for assigning status were based on the approximate time to the FMP. Three menopausal categories were defined based on the time to final menstrual period (TTFMP).

Category Menopausal Category MenoCheck (pg/mL)
High > 5 years from FMP ≥100 pg/mL
Medium < 5 years from FMP 10-99.9 pg/mL
Low at FMP or later ≤10 pg/mL

 

NOTE: AMH values are not commutable between brands. And, AMH results should always be assessed in conjunction with the patient’s medical history, clinical examination and other findings when being interpreted for diagnostic purposes.

Technical Support, Esoteric Laboratory Services

 

Ansh Labs provides technical expertise and sophisticated troubleshooting support for interpreting the laboratory values reported by any laboratory using MenoCheck. Laboratories can also send their samples to Ansh Labs to be run in our CLIA-certified (45D2081313) reference laboratory.

Request MenoCheck’s Instructions for Use (IFU)

 

The regulatory clearances and labeling differ from country to country so please complete the form and send it to us. We will respond with the correct IFU.