Elecsys® AMH (Anti-Mullerian Hormone)

Elecsys AMH

The new Elecsys® AMH test, which received CE-mark in July 2014 is now available to all customers.

Infertility and ovarian reserve

  • Infertility is a disease of the reproductive system defined by the failure to achieve a clinical pregnancy after 12 months or more of regular unprotected sexual intercourse1. Male and female factors contribute equally to infertility.3
  • Mean female age at first birth has increased steadily over the past few decades in many developed countries. This postponement leads to couples attempting to have children during a period where female fertility is already in decline.4
  • The number of ART (Assisted Reproductive Technology) cycles performed rises every year with ~ 1.5 million ART cycles performed each year worldwide, with an estimated 350,000 babies born.5
  • The ovary contains a finite number of primordial (non-growing) follicles6,7. The ovarian follicular pool declines with age and depletion of these follicles marks the menopause.8,9

Anti-Mullerian Hormone (AMH)

  • Anti-Mullerian hormone (AMH) is a direct serum marker of functional ovarian reserve (the number of growing follicles that can be recruited by exogenous FSH to grow to a preovulatory stage).10
  • AMH is secreted primarily by the granulosa cells of preantral and small antral follicles11 and serum levels correlate with the number of primordial follicles in an ovary.12,13
  • Serum AMH levels have been shown to remain relatively stable during the menstrual cycle14,15 and therefore may be measured on any day of the cycle.
  • The Elecsys® AMH immunoassay is a reliable automated laboratory test to be used for the assessment of ovarian reserve in conjunction with other clinical and laboratory findings.
  • A simple blood test can now deliver clear, reliable results of AMH levels in lab, hospital, or IVF clinic setting.
References

1. Zegers-Hochschild F et al. Fertil Steril 2009;92:1520–1524.
2. ASRM. Quick facts about infertility. Available at: http://www.asrm.org/detail.aspx?id=2322 (Last accessed June 2014).
3. CDC. National Survey of Family Growth (2006–2010). Available at: http://www.cdc.gov/nchs/data/nhsr/nhsr051.pdf (Last accessed June 2014).
4. Mills M et al. Hum Reprod Update 2011;17:848–860
5. European Society of Human Reproduction and Embryology. ART fact sheet, version of June 2014.
6. Iliodromiti S, Nelson SM. Biomark Med 2013;7:147–158.
7. Dewailly D et al. Hum Reprod Update 2014;20:370–385
8. Nelson SM et al. Fertil Steril 2011;95:736–741.
9. Kelsey TW et al. PLoS One 2011;6:e22024.
10. Anderson RA et al. Mauritas 2012;71:28–33;
11. Iliodromiti S, Nelson SM. Biomark Med 2013;7:147–158;
12. Hansen KR et al.Fertil Steril 2011;95:170–175;
13. Dewailly D et al. Hum Reprod Update 2014;20:370–385;
14. van Disseldorp J et al. Hum Reprod 2010;25:221–227;
15. Tsepelidis S et al. Hum Reprod 2007;22:1837–1840;

Assay time 18 min
Sample material Serum and Li-heparin plasma
Sample volume 50 µL
Detection Limit 0.010 ng/mL, (0.071 pmol/L)
Measuring range 0.01 - 23 ng/mL (0.071 - 164.2 pmol/L)
Traceability Standardized against BCI AMH Gen II ELISA
Imprecision <5%
Age Specific reference ranges Provided in package insert
Agreement with AFC* Provided in package insert

*AFC (Antral-Follicle Count): The number of antral follicles present in the ovary on Day 3 using vaginal ultrasound scanning

Clinical performance of the Elecsys® AMH assay

  • High precision for precise discrimination of low, normal and high values related to ovarian reserve
  • High agreement with AFC providing reassurance when concordant results confirms expected level of ovarian reserve
  • Age specific reference ranges and PCOS** information for improved interpretation of circulating AMH and counselling of infertile patients

**PCOS (Polycystic Ovary Syndrome): One of the most common female endocrine disorders.

Fertility / IVF assays on cobas e analyzers (Elecsys)

Fertility AMH, DHEA-S, Progesterone, Prolactin, SHBG, Testosterone, HCG +B, HCG STAT, Adrostenedione*, 17 OH progesterone*
Thyroid Function FT4, TSH, FT3, Anti TPO, Anti TSHR
Infectious Disease CMV, Toxo, Hep B, Hep C, HIV, Rubella, Syphilis
Ovarian Markers CA 125, HE4
Bone Health Vitamin D
Pregnancy care PAPP-A, free Beta HCG, sFlt-1, PlGF

*Under development

Full automation

Avoids the between-user/inter-laboratory variation associated with manual AMH assays

High precision and sensitivity

Confidence that results are reliable, consistent and reproducible, and that the assay provides a robust assessment of ovarian reserve

Broad measuring range / low limit of detection

Allows measurement at extrems of detection scale for assessment of ovarian reserve

Rapid results

Potential to provide results on the day of consultation, reduce time to starting optimal management, optimize lab resources

Age-specific reference ranges

Improved interpretation of circulating AMH and counselling of infertile patients

Single platform for multiple assays

The AMH assay can easily be added to the menu of the Elecsys® / cobas® platform:

Available for use on cobas e 411, MODULAR ANALYTICS E170, cobas e 601 and cobas e 602 systems

Agreement with AFC

Providing reassurance when concordant results confirm expected level of ovarian reserve