The MenoCheck® picoAMH ELISA is FDA cleared for in vitro diagnostic use as an aid in the determination of menopausal status in women between 42 and 62 years of age. This is the only AMH test with the sensitivity to quantify declining AMH concentrations in women who are entering their menopausal transition.
For more information about the utility, please reference the IFU in the documents section and the press release titled, “Ansh Labs Earns De Novo FDA Clearance for the MenoCheck® picoAMH ELISA”
| Regulatory Status | For in vitro diagnostic use. |
|---|---|
| Packaging | 96 well microtiter |
| Detection | HRP-based ELISA, colorimetric detection by dual wavelength absorbance at 450 nm and 630 nm as reference filter |
| Dynamic Range | 7, 3.8-1091 pg/mL |
| Limit of Detection | 2 pg/mL |
| Sample Size | 10 to 50 µL |
| Sample Type | Plasma, Serum |
| Assay Time | 4.5 hours |
| Species Reactivity | Human, Non-Human Primate |
| Shelf Life | 24 months |
| Availability | United States |
Anti-Müllerian hormone (AMH), a member of the TGFβ superfamily, is a homodimeric glycoprotein composed of two 55 kDa N-terminal and two 12.5 kDa C-terminal homodimers, non-covalently linked by disulfide bridges.1
Recent studies have shown that the AMH C-terminal homodimer is much less active than the noncovalent complex, but almost all activity can be restored by associating with the N-terminal pro-region, which reforms a complex with the mature C-terminal homodimer. This finding raises the possibility that the AMH noncovalent complex is the active form of protein. It was reported that the cleaved AMH noncovalent complex binds to AMHRII and stimulates intracellular signaling, whereas full-length AMH shows only minimal activity.2
AMH is secreted by the Sertoli cells in males. During embryonic development, AMH is responsible for Müllerian duct regression. AMH continues to be produced by the testes until puberty and then decreases slowly to residual post-puberty values. In females, AMH is produced by the granulosa cells of small growing follicles from the 36th week of gestation onwards until menopause when levels become undetectable. Potential clinical applications of low end anti-müllerian hormone (AMH) have been published in premature ovarian insufficiency, ovarian tumors, menopause and many more.
References:
1. Pepinski, R.B., et al. (1988) J. Biol. Chem., 263, 18961-18964.
2. di Clemente et al. Mol Endocrinol, November 2010, 24 (11): 2193-2206.
3. HHS Publication, 5th ed., 2007. Biosafety in Microbiological and Biomedical Laboratories. Available http://www.cdc.gov/biosafety/publications/bmbl5/BMBL5
4. DHHS (NIOSH) Publication No. 78–127, August 1976. Current Intelligence Bulletin 13 – Explosive Azide Hazard. Available http:// www.cdc.gov/niosh
5. Approved Guideline – Procedures for the Handling and Processing of Blood Specimens, H18-A3. 2004. Clinical and Laboratory Standards Institute.
6. Kricka L. Interferences in immunoassays – still a threat. Clin Chem 2000; 46: 1037–1038.
AMH (pico) ELISA AL-124
Barad D, Kushnir V, Khanna P, Gleicher N. Clinical in Vitro Fertilization (IVF) Outcomes Based on Comparative Anti-Müllerian Hormone (AMH) Testing with a Standard and New Highly Sensitive Assay. Poster session presented at: Endocrine Society’s 96th Annual Meeting; 2014; June 21-24; Chicago, IL.
All Products Cited picoAMH ELISA AL-124
Broer SL, Broekmans FJM, Laven JSE, Fauser, BCJM. Anti-Müllerian hormone: ovarian reserve testing and its potential clinical implications. Hum. Reprod. Update. 2014 May 12. PMID 24821925
All Products Cited picoAMH ELISA AL-124
Buckbinder J, Mucowski S, Burks H, Stanczyk F, Hodis H, Mack W, Bendikson K, Shoupe D. The Detection and Clinical Utilization of Anti-Mullerian Hormone (AMH) in Postmenopausal Women Using the New Highly Sensitive ELISA. Poster session at American Society for Reproductive Medicine; 2015 Oct 17-21; Baltimore, Maryland
All Products Cited picoAMH ELISA AL-124
Burks H, Ross L, Opper N, Stancyzk F. Can Ultrasensitive Anti-Mullerian Hormone Testing Predict Failed Response to Ovarian Stimulation? PCRS Abstracts Vol. 101, No. 2, Supplement, February 2014 PMID 26158904
All Products Cited picoAMH ELISA AL-124
Burks HR, Ross L, Opper N, Paulson E, Stanczyk F, Chung K. Can highly sensitive antimullerian hormone testing predict failed response to ovarian stimulation? Fertility and Sterility. 2015 Sep; 104(3):643-648. PMID 26158904
All Products Cited AMH ELISA AL-105; picoAMH ELISA AL-124
Chai J, Cameron D, Howie F, Anderson A. A Highly-Sensitive AMH Assay Improves Analysis of Ovarian Function Following Chemotherapy for Early Breast Cancer. European Journal of Cancer 2014 Sep; 50(14):2367-74. PMID 25027307
All Products Cited picoAMH ELISA AL-124
Chai J, Howie F, Cameron DA, Anderson, RA. Analysis of ovarian function following chemotherapy for early breast cancer using an ultra-sensitive assay. Poster session presented at: European Society for Human Reproduction and Embryology; 2014, Jun 29 – July 2 Munich, Germany.
All Products Cited picoAMH ELISA AL-124
Crawford S, Finkelstein J, Gold E, Greendale G, Harlow S, Joffe H, Kalra B, Kumar A, Martin D, Merillat S, Morrison A, Sluss P, Thurston R, Avis N. Predicting Onset of Menopausal Vasomotor Symptoms with Anti-Mullerian Hormone in the Study of Women’s Health Across the Nation (SWAN) Presented at 98th Annual Endocrine Society Meeting; 2016 Apr 1-3; Boston, MA
All Products Cited picoAMH ELISA AL-124
Cui L, Qin Y, Gao X, Lu J, Geng L, Ding L, Qu Z, Zhang X, Chen Z. Anti-Mullerian Hormone: correlation with age and androgenic and metabolic factors in women from birth to postmenopause. Reproductive Endocrinology. 2016 Feb, 105(2):481-5. PMID 26549157
All Products Cited AMH ELISA AL-105; picoAMH ELISA AL-124
de Kat AC, van der Schouw YT, Eijkemans MJ, Herber-Gast GC, Visser JA, Verschuren WM, Broekmans FJ. Back to the basics of ovarian aging: a population-based study on longitudinal anti-Müllerian hormone decline. BMC Med. 2016 Oct 3;14(1):151. PMC504697
All Products Cited picoAMH ELISA AL-124
De Kat AC, van der Schouw YT, Eijkemans MJC, Herber-Gast GC, Visser JA, Verschuren WMM, Broekmans FJM. Back to the basics of ovarian aging: a population-based study on longitudinal anti-Müllerian hormone decline. BMC Medicine. 2016;14:151. PMC504697
All Products Cited picoAMH ELISA AL-124
Dean A, van den Driesche S, Wang Y, McKinnell C, Macpherson S, Eddie S, Kinnell H, Hurtado-Gonzalez P, Chambers T, Stevenson K, Wolfinger E, Hrabalkova L, Calarrao A, Bayne R, Hagen C, Mitchell R, Anderson R, Sharpe R. Analgesic exposure in pregnant rats affects fetal germ cell development with inter-generational reproductive consequences. Sci. Rep. 6, 19789, 2016 Jan 27
PMID 26813099
All Products Cited picoAMH ELISA AL-124
Decanter C, Peigne M, Mailliez A, Morschhauser F, Dassonneville A, Dewailly D, Pigny P. Toward a better follow-up of ovarian recovery in young women after chemotherapy with a hypersensitive antimüllerian hormone assay. Fertility and Sterility. 2014 Aug; 102(2):483-7. PMID 24951363
All Products Cited picoAMH ELISA AL-124
El Khoudary SR, Wang L, Brooks MM, Matthews KA, Thurston RC, Crawford S, Derby C, Jackson EA, Lee JS, Un-Yong Chae C, McConnell DS, Finkelstein J. Associations of Anti-Mullerian Hormone Premenopausal Levels and Their Changes over the Menopausal Transition with Lipids: The Study of Women′s Health Across the Nation(SWAN). Presented at 98th Annual Endocrine Society Meeting; 2016 Apr 1-3; Boston, MA
All Products Cited picoAMH ELISA AL-124
Finkelstein JS, Lee H, Burnett-Bowie SAM, Santoro N, Yu EW, Joffe H, Morrison A, Kumar A, Greendale GA, Gold E, Harlow S, Lasley BL, Derby C, Randolph JF, Matthews KA, Kravitz HM, McConnell DS, Brooks MM, Martin D, Darakananda K, Hirsch SC, Sluss PM. Utility of Anti-Mullerian Hormone (AMH) for Predicting the Time to the Final Menstrual Period: The Study of Women’s Health Across the Nation (SWAN). Presented at 98th Annual Endocrine Society Meeting; 2016 Apr 1-3; Boston, MA
All Products Cited picoAMH ELISA AL-124
Huddleston H, Santoro N, Eisenberg E, Haisenleder DJ, Diamond MP, Cedars M. Can We Expect to Improve Age at Menopause Predictions with Repeated AMH Measurements. Poster session at American Society for Reproductive Medicine; 2016 Oct 17-21; Salt Lake City, Utah.
All Products Cited picoAMH ELISA AL-124
Iliodromiti S, Anderson RA, Nelson SM. Technical and performance characteristics of anti-Müllerian hormone and antral follicle count as biomarkers of ovarian response. Hum Reprod Update. 2015 Nov-Dec;21(6):698-710. PMID 25489055
All Products Cited AMH ELISA AL-105; picoAMH ELISA AL-124
Iwase A, Nakamura T, Nakahara T, Goto M, Kikkawa F. Anti-Mullerian Hormone and Assessment of Ovarian Reserve After Ovarian Toxic Treatment, a Systematic Narrative Review. Reproductive Sciences. 2015 May, 22(5):519-26. PMID 25228631
All Products Cited AMH ELISA AL-105; picoAMH ELISA AL-124
Iwase A, Nakamura T, Osuka S, Takikawa S, Goto M, Kikkawa F. Anti-Müllerian hormone as a marker of ovarian reserve: What have we learned, and what should we know? Reprod Med Biol (2016) 15:127–136
All Products Cited AMH ELISA AL-105; picoAMH ELISA AL-124
Iwase A, Osuka S, Nakamura T, Kato N, Takikawa S, Goto M, Kikkawa. Usefulness of the Ultrasensitive Anti-Mullerian Hormone Assay for Predicting True Ovarian Reserve. Reproductive Sciences, 2015, 1-5. PMID 26614267
All Products Cited picoAMH ELISA AL-124
Joffe H, Crawford S, Bromberger JT, Kalra B, Kumar A, Morrison A, Finkelstein J, Kravitz JM. Vasomotor Symptoms Mediate the Association Between Anti-Mullerian Hormone Levels and New-Onset Sleep Disturbance in Women during the Menopause Transition: Study of Women’s Health Across the Nation (SWAN). Presented at 98th Annual Endocrine Society Meeting; 2016 Apr 1-3; Boston, MA
All Products Cited AMH (pico) ELISA AL-124
Johnson L, Sammel MD, Domchek S, Schanne A, Prewitt M, Gracia C. Antimüllerian hormone levels are lower in BRCA2 mutation carriers. Fertil Steril. 2017 May;107(5):1256-1265.e6. PMID 28476184
All Products Cited picoAMH ELISA AL-124
Jung S, Allen N, Arslan AA, Baglietto L, Barricarte A, Brinton LA, Egleston BL, Falk RT, Fortner RT, Helzlsouer KJ, Gao Y, Idahl A, Kaaks R, Krogh V, Merritt MA, Lundin E, Onland-Moret NC, Rinaldi S, Schock H, Shu XO, Sluss PM, Staats PN, Sacerdote C, Travis RC, Tjønneland A, Trichopoulou A, Tworoger SS, Visvanathan K, Weiderpass E, Zeleniuch-Jacquotte A, Dorgan JF. Anti-Müllerian Hormone and risk of ovarian cancer in nine cohorts. Int J Cancer. 2017 Sep 18. PMID 28921520
All Products Cited picoAMH ELISA AL-124
Jung S, Allen N, Arslan AA, Baglietto L, Brinton LA, Egleston BL, Falk R, Fortner RT, Helzlsouer KJ, Idahl A, Kaaks R, Lundin E, Merritt M, Onland-Moret C, Rinaldi S, Sánchez MJ, Sieri S, Schock H, Shu XO, Sluss PM, Staats PN, Travis RC, Tjønneland A, Trichopoulou A, Tworoger S, Visvanathan K, Krogh V, Weiderpass E, Zeleniuch-Jacquotte A, Zheng W, Dorgan JF. Demographic, lifestyle, and other factors in relation to antimüllerian hormone levels in mostly late premenopausal women. Fertil Steril. 2017 Apr;107(4):1012-1022.e2. PMC542622
All Products Cited AMH (pico) ELISA AL-124
Karlamangla AS, Shieh A, Burnett-Bowie SA, Yu EW, Greendale GA, Sluss PM, Martin D, Finkelstein JS. Anti-Mullerian Hormone and Prediction of Trans-Menopausal Bone Loss. Presented at 98th Annual Endocrine Society Meeting; 2016 Apr 1-3; Boston, MA
All Products Cited picoAMH ELISA AL-124
Karlamangla AS. Anti-Mullerian hormone may estimate magnitude of menopausal bone loss. 2016 April 1. Retrieved from http://www.healio.com/endocrinology/bone-mineral-metabolism/news/online/%7B4f8e49d7-e1e8-4567-bdca-dd7d018f7fea%7D/anti-mullerian-hormone-may-estimate-magnitude-of-menopausal-boneloss
All Products Cited picoAMH ELISA AL-124
Kumar A, Kalra B, Patel A, Shah S, Savjani G, Themmen A, Visser J, Pruysers, Robertson D. Development of Stable picoAnti-Müllerian Hormone ELISA: Sensitive, Reliable and Reproducible Results. Poster session presented at the 96th Annual Endocrine Society Meeting; 2014 Jun 21-24; Chicago, IL.
All Products Cited picoAMH ELISA AL-124
Lambert-Messerlian G. “The New Egg Timer – Anti-Mullerian Hormone Levels for Assessing Ovarian Reserve”. Clinical Laboratory News. Jan 2015:14-18.
All Products Cited AMH ELISA AL-105; picoAMH ELISA AL-124
Lu J, Holt C, Choi M, Kalp K, Straseski J. Quantitation of Anti-Müllerian Hormone by the AnshLabs picoAMH ELISA Assay. Poster session presented at American Association for Clinical Chemistry; 2014 Jul 27-31; Chicago, IL.
All Products Cited picoAMH ELISA AL-124
Lukaszuk K, Plociennik L,, Lukaszuk A, Dialobrzeska D. The Heterogenity of Anti-Mullerian Hormone Depletion in Models Across Assays in 12917 Women. Poster session at American Society for Reproductive Medicine; 2015 Oct 17-21; Baltimore, Maryland
All Products Cited picoAMH ELISA AL-124
Mamsen LS, Munthe-Fog L, Petersen TS, Jeppesen JV, Møllgård K, Grøndahl ML, Larsen A, Ernst E, Oxvig C, Kumar A, Kalra B, Andersen CY. Reply: Methodological considerations in measuring different AMH splice forms using ELISA: validity of proAMH ELISA. Mol Hum Reprod. 2016 May;22(5):374-5. PMID 26965311
All Products Cited picoAMH ELISA AL-124
Marsh EE, Bernardi LA, Steinberg ML, de Chavez PJ, Visser JA, Carnethon MR, Baird DD. Novel correlates between antimullerian hormone and menstrual cycle characteristics in African-American women (23–35 years-old). Fertil Steril. 2016 Apr 23. pii: S0015-0282(16)61100-7. Epub ahead of print. PMID 27114331
All Products Cited AMH ELISA AL-105; picoAMH ELISA AL-124
Meczekalski B, Czyzyk A, Kunicki M, Podfigurna-Stopa A, Plociennik L, Jakiel G, Maciejewska-Jeske M, Lukaszuk K. Fertility in women of late reproductive age: the role of serum anti-Müllerian hormone (AMH) levels in its assessment. J Endocrinol Invest. 2016 Nov;39(11):1259-1265. PMC506931
All Products Cited AMH ELISA AL-105; picoAMH ELISA AL-124
Morse, H. Anti-Müllerian hormone as a marker of ovarian reserve in girls before, during and after treatment for childhood cancer. [Dissertation, 2017]. Lund (Sweden): Lund University.
All Products Cited AMH ELISA AL-105; picoAMH ELISA AL-124
Nichols H, Baird D, Stanczyk F. Anti-Müllerian Hormone Concentrations in Premenopausal Women and Breast Cancer Risk. Cancer Prevention Research. 2015 April 14 epub ahead of print. PMID 25873369
All Products Cited AMH ELISA AL-105; picoAMH ELISA AL-124
Pankhurst MW, Leathart BL, Batchelor NJ, McLennan IS. The Anti-Müllerian Hormone Precursor (proAMH) Is Not Converted to the Receptor-Competent Form (AMHN,C) in the Circulating Blood of Mice. Endocrinology. 2016 Apr;157(4):1622-9. Epub 2016 Feb 1. PMID 26828745
All Products Cited picoAMH ELISA AL-124
Robertson DM, Kumar A, Kalra B, Shah S, Pruysers E, Vanden Brink H, Chizen D, Visser JA, Themmen AP, Baerwald A. Detection of serum antimüllerian hormone in women approaching menopause using sensitive antimüllerian hormone enzyme-linked immunosorbent assays. Menopause. 2014 Dec; 21(12):1277-86. PMID 24781853
All Products Cited AMH ELISA AL-105; picoAMH ELISA AL-124
Rodriguez-Purata J, Luna M, Cervantes E, Lee J, Whitehouse M, Copperman A, Bandler B. Very Low Levels of Anti-Mullerian Hormone (AMH) in a Large Cohort of ART Patients. Poster session at American Society for Reproductive Medicine; 2015 Oct 17-21; Baltimore, Maryland
All Products Cited AMH (pico) ELISA AL-124
Straseski J, Lu J, Holt C, Choi M, Kalp K. Analytical Evaluation of the Ansh Labs picoAMH ELISA assay for Anti-Mullerian Hormone. Poster session presented at the 96th Annual Endocrine Society Meeting; 2014 Jun 21-24; Chicago, IL.
All Products Cited picoAMH ELISA AL-124
Su HI, Sammel MD, Homer MV, Bui K, Haunschild C, Stanczyk FZ. Comparability of antimüllerian hormone levels among commercially available immunoassays. Fertility and Sterility. 2014 Jun; 101(6):1766-72.e1. PMID 24726216
All Products Cited AMH ELISA AL-105; picoAMH ELISA AL-124
Welsh P, Smith K, Nelson SM. A single-centre evaluation of two new Anti-Mullerian Hormone assays and comparison with the current clinical standard assay. Human Reproduction. 2014 May; 29(5):1035-41. PMID 24578473
All Products Cited AMH ELISA AL-105; picoAMH ELISA AL-124
White A, Sandler D, D’Aloisio A, Stanczyk F, Whitworth K, Baird D, Nichols H. Anti-Mullerian hormone (AMH) in relation to tobacco and marijuana use and sources of indoor heating/cooking. Fertility and Sterility. First published online May 27, 2016. PMID 27240193
All Products Cited AMH ELISA AL-105; picoAMH ELISA AL-124