Ansh Labs has two main assays for human AMH, the original Ultra-Sensitive (US) AMH kit and an assay designed with even more sensitivity for measuring the very low AMH levels in peri-menopausal women, the picoAMH kit. The US AMH assay can be used to measure AMH levels between 0.06 and 23 ng/mL without dilution. The picoAMH assay is designed to measure AMH levels between 0.006 and 1.0 ng/mL without dilution, but specimens with AMH levels between 1.0 ng/mL and >200 ng/mL (e.g., women < 40 years of age, women with PCOS, children) must be diluted before testing.

Recently, the picoAMH has been FDA cleared as an aid in the determination of menopausal status in women. This assay is now offered as the MenoCheck picoAMH ELISA AL-124. To learn more about this test, please visit www.MenoCheck.com or download the product flyer by clicking here. The IFU can be downloaded by clicking here.

Because the original picoAMH ELISAs is so versatile for assessment of menopausal status as well as research into areas such as oncofertility, primary ovarian insufficiency, and related fields, we have maintained a ‘Research Use Only’ version of the picoAMH ELISA to ensure that laboratories and researchers avoid any potential conflicts with off-label uses.

Summary:

If you are in the United States and you want to measure….	Then you should order….	Regulatory Status within U.S.
Women with normal range AMH up to PCOS samples	US AMH ELISA, AL-105	Research Use Only
Women for menopausal status	MenoCheck picoAMH ELISA, AL-124	FDA Cleared
Women undergoing chemotherapy, have secondary amenorrhea (e.g., premature ovarian failure, hypothalamic amenorrhea, etc), or with pre-testing dilution women with normal to high levels of AMH (e.g., healthy young women, women with PCOS, children)	picoAMH ELISA, AL-124-r	Research Use Only

 

Ansh Labs recently received FDA clearance for the picoAMH ELISA kit to be used as an aid in the determination of menopausal status in women thus the kit has now been rebranded as MenoCheck ELISA, AL-124. To learn more about this test, please visit www.MenoCheck.com or download the product flyer by clicking here. The IFU can be downloaded by clicking here.

Because the original picoAMH ELISA is so versatile for clinical assessment of menopausal status as well as clinical research into areas such as oncofertility, primary ovarian insufficiency, and related fields, we have maintained a ‘Research Use Only’ version of the picoAMH ELISA to ensure that laboratories and researchers avoid any potential conflicts with off-label uses.

Summary:

If you are in the United States and you want to measure….	Then you should order….	Regulatory Status within U.S.
Women with normal range AMH up to PCOS samples	US AMH ELISA, AL-105	Research Use Only
Women for menopausal status	MenoCheck picoAMH ELISA, AL-124	FDA Cleared
Women undergoing chemotherapy, have secondary amenorrhea (e.g., premature ovarian failure, hypothalamic amenorrhea, etc), or with pre-testing dilution women with normal to high levels of AMH (e.g., healthy young women, women with PCOS, children)	picoAMH ELISA, AL-124-r	Research Use Only

Ansh Labs has two main assays for human AMH, the original Ultra-Sensitive (U.S.) AMH kit and an assay designed with even more sensitivity for measuring the very low AMH levels in peri-menopausal women, the picoAMH ELISA, AL-124-i. The U.S. AMH assay can be used to measure AMH levels between 0.06 and 23 ng/mL without dilution. The picoAMH assay is designed to measure AMH levels between 0.006 and 1.0 ng/mL without dilution, but specimens with AMH levels between 1.0 ng/mL and >200 ng/mL (e.g., women < 40 years of age, women with PCOS, children) must be diluted before testing.

Recently, the picoAMH has been cleared by the U.S. FDA for the clinical assessment of menopausal status. Within the U.S., the item will be referenced as MenoCheck picoAMH ELISA AL-124 (note that there is no -i at the end). For the international markets, especially Europe with the CE mark, the catalog number is and will continue to be AL-124-i. We are adding the MenoCheck data to the existing IFU to complement the existing IFU data. The IFU can be accessed by clicking here.

We know that several countries will require an RUO version because the product may not be registered with the Ministry of Health.  Also, because the picoAMH ELISA is so versatile for clinical assessment of menopausal status as well as clinical research into areas such as oncofertility, primary ovarian insufficiency, and related fields, we have maintained a ‘research use only’ version of the picoAMH ELISA to ensure that laboratories and researchers avoid any potential conflicts with off-label uses. The IFU for the RUO version can be accessed by clicking here.

Summary:

If you are outside the U.S. and you want to measure….	Then you should order….	Regulatory Status
Women with normal range AMH up to PCOS samples	U.S. AMH ELISA, AL-105-i	CE Mark
Women for the clinical measurement of AMH for any condition where the concentration is very low, to include Menopause. The labeling references multiple applications.	picoAMH (MenoCheck) ELISA, AL-124-i	CE Mark
This is the Research Use Only version of the original picoAMH ELISA assay. The intended use is a generic “for the measurement of AMH in serum”. Some countries need an RUO label in case the assay is not registered. This also allows labs to use it for off-label uses.	picoAMH ELISA, AL-124-r	Research Use Only