New Fertility Test Assesses Ovarian Reserve for Pregnancy

By LabMedica International staff writers
Posted on 17 Oct 2014

A new anti-Müllerian Hormone (AMH) fertility test increases the accuracy of ovarian reserve assessment compared to conventional methods as AMH is an important fertility marker used by healthcare professionals to assess ovarian reserve levels.

The AMH blood test can be measured during any day of the menstrual cycle and is a superior indicator of ovarian reserve as compared to the follicle-stimulating hormone (FSH) and estradiol. In addition, the AMH blood test produces standardized results for assessing ovarian reserve as compared with the use of ultrasound, in which the result is often dependent on the operator or clinic.

Image: The Elecsys cobas e 411 electrochemiluminescence immunoassay platform (Photo courtesy of Roche Diagnostics).

The Elecsys Anti-Müllerian Hormone (AMH) blood test (Roche Diagnostics; Basel, Switzerland) is the first fully-automated AMH test for assessing a woman’s ovarian reserve. Elecsys AMH is a monoclonal two-site assay used to measure AMH in 50 µL of serum or lithium heparin plasma in about 18 minutes. Its measuring range is from 0.01 to 23 ng/mL. The assay detects primarily 140 kDa total AMH (proAMH and AMHN, C). Limit of detection (LoD) was 0.01 ng/mL equivalent to a limit of quantitation (LoQ) of (0.03 ng/mL. Percent recovery in dilution studies was less than 10% and after mixing of high and low AMH pools 94% to 103%. The highly sensitive, fast and fully automated AMH assay was developed for use on the Elecsys cobas e electrochemiluminescence immunoassay platform.

In the future, the Elecsys AMH assay is also intended to be used in combination with the new human recombinant follicle-stimulating hormone (human rFSH) treatment, currently in phase III development at Ferring Pharmaceuticals (Saint Prex, Switzerland). This combination, which will make possible individualized dosing of human rFSH based on a woman’s specific AMH level, may provide an improved option for couples seeking to conceive through in vitro fertilization.

Roland Diggelmann, chief operating officer of Roche Diagnostics, said, “The introduction of our Elecsys AMH test will enable healthcare professionals to incorporate AMH testing into routine clinical practice while getting more reliable results faster than conventional protocols and manual AMH assays. It is an important example of our focus on improving diagnostics in the area of women’s health.”

Roche Diagnostics
Ferring Pharmaceutical

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