A single-centre evaluation of two new anti-Mullerian hormone assays and comparison with the current clinical standard assay

Welsh, P. , Smith, K. and Nelson, S. M. (2014) A single-centre evaluation of two new anti-Mullerian hormone assays and comparison with the current clinical standard assay. Human Reproduction, 29(5), pp. 1035-1041. (doi:10.1093/humrep/deu036) (PMID:24578473)

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Abstract

STUDY QUESTION

Are the new Ansh Labs Ultra-Sensitive anti-Müllerian hormone (AMH) and picoAMH ELISA assays suitable for clinical use and is the Ultra-Sensitive assay comparable to the Beckman Coulter AMH Gen II assay?

SUMMARY ANSWER

The Ultra-Sensitive assay appears to have different calibration to the Gen II assay, but has performance characteristics generally suitable for clinical use.

WHAT IS KNOWN ALREADY

The Gen II assay is the most commonly used AMH assay in routine biochemistry at present, but persistent calibration/interference problems have been reported.

STUDY DESIGN, SIZE, DURATION

Serum from patients referred for AMH measurement was assayed (in duplicate) using the Gen II assay in Glasgow Royal Infirmary between January and February 2013. We randomly selected 193 stored serum samples to re-run (in duplicate) using the Ultra-Sensitive AMH Ansh Labs assay, blinded to the original result. Samples that returned low results were run on the picoAMH Ansh Labs assay. Performance characteristics and linearity of the new assays were also assessed.

PARTICIPANTS/MATERIALS, SETTING, METHODS

All serum samples from patients referred for AMH at Glasgow Royal Infirmary between January and February 2013 were eligible for inclusion. Investigators were blinded to any identifiable information regarding the patients, including sex, age and reason for AMH measurement.

MAIN RESULTS AND THE ROLE OF CHANCE

Intra-assay and inter-assay coefficients of variation of the Ultra-Sensitive and picoAMH assays were ≤6.0 and ≤10.7%, respectively, over a range of concentrations. The assays had mean linearity of 98 and 97% over the dilution range of 1:2–1:16 and 1:2–1:8, respectively. The limit of detection of the ultrasensitive assay was calculated to be 0.34 pmol/l. For 166 samples which provided a quantitative result on the Gen II and Ultra-Sensitive Ansh Labs assays, the median (interquartile range) was 12.2 (3.4–29.3) pmol/l and 20.0 (6.6–36.8) pmol/l, respectively (P<0.0001). The Passing–Bablok regression equation (in pmol/l) was y (Ultra-Sensitive) = 1.7 + 1.4 × Gen II. More samples were below the clinical cut-off of 5.4 pmol/l using the Gen II assay (a difference between paired proportions of 15.0%, P < 0.001). Fifteen of the 22 undetectable samples yielded a measurable concentration result on the picoAMH assay.

LIMITATIONS, REASONS FOR CAUTION

The present study is a pragmatic assessment of the new assay under ideal conditions. Lot-to-lot variation could not be assessed. Demographics and outcomes of patients referred for AMH measurement were not known.

WIDER IMPLICATIONS OF THE FINDINGS

The Ansh Labs Ultra-Sensitive assay performance characteristics are similar to the Gen II assay and may be suitable for clinical and epidemiological use. Enhanced sensitivity of the Ansh Labs picoAMH assay enables measurement of low AMH concentrations. These results re-emphasize the need for an AMH international standard.

Item Type:Articles
Status:Published
Refereed:Yes
Glasgow Author(s) Enlighten ID:Welsh, Dr Paul and Nelson, Professor Scott and Smith, Ms Karen
Authors: Welsh, P., Smith, K., and Nelson, S. M.
College/School:College of Medical Veterinary and Life Sciences > Institute of Cardiovascular and Medical Sciences
College of Medical Veterinary and Life Sciences > School of Medicine, Dentistry & Nursing
Journal Name:Human Reproduction
Publisher:Oxford University Press
ISSN:0268-1161
ISSN (Online):1460-2350

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Project CodeAward NoProject NamePrincipal InvestigatorFunder's NameFunder RefLead Dept
612031Cardiac biomarkers and CVD risk screening: a cost-effective public health measure?Paul WelshBritish Heart Foundation (BHF)FS/12/62/29889RI CARDIOVASCULAR & MEDICAL SCIENCES