Two new automated, compared with two enzyme-linked immunosorbent, antimüllerian hormone assays

Nelson, S. M. , Pastuszek, E., Kloss, G., Malinowska, I., Liss, J., Lukaszuk, A., Plociennik, L. and Lukaszuk, K. (2015) Two new automated, compared with two enzyme-linked immunosorbent, antimüllerian hormone assays. Fertility and Sterility, 104(4), 1016-1021.e6. (doi:10.1016/j.fertnstert.2015.06.024) (PMID:26183313)

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Abstract

Objective: To compare new automated antimüllerian hormone (AMH) assay performance characteristics from the new automated Elecsys AMH (Roche; Elecsys) and Access AMH (Beckman Coulter; Access) assays with the existing AMH Gen II ELISA (enzyme-linked immunosorbent assay; Gen II; Beckman Coulter) and AMH ELISA (Ansh Labs) assays. Design: Prospective assay evaluation. Setting: University-affiliated clinical chemistry laboratory. Patient(s): Patients referred for serum AMH measurement (n = 83) before start of in vitro fertilization cycle between September 2014 and October 2014. Intervention(s): None. Main Outcome Measure(s): Serum AMH concentration.: Result(s): Intra-assay coefficients of variation were low; Ansh ≤ 9.0%; Gen II ≤ 5.8%; Access ≤ 10.7%; and Elecsys ≤ 2.8%. The Passing-Bablok regression equations (pmol/L) were y (Access) = 0.128 + (0.781 × Gen II); and y (Access) = 0.302 + (0.742 x Ansh). For y (Elecys) = 0.087 + (0.729 x Gen II) and y (Elecys) = 0.253 + (0.688 x Ansh Labs). For y (Elecys) = 0.943 − (0.037 × Access). For all the assays, AMH exhibited a moderate positive correlation with AFC (r = 0.62–0.64); number of cumulus oocyte complexes (r = 0.60–0.64); and metaphase II oocytes (r = 0.48–0.50). Accuracy of pregnancy prediction, as determined by area under the receiver operating characteristic curve, was uniformly low for all assays (0.62–0.63). Conclusion(s): The novel automated assays exhibit strong concordance in calibration, but derived values are substantially lower than those obtained from pre-existing assays, with assay-specific interpretation required for routine clinical use. These results highlight the need for an international standard of measurement of AMH.

Item Type:Articles
Status:Published
Refereed:Yes
Glasgow Author(s) Enlighten ID:Nelson, Professor Scott
Authors: Nelson, S. M., Pastuszek, E., Kloss, G., Malinowska, I., Liss, J., Lukaszuk, A., Plociennik, L., and Lukaszuk, K.
College/School:College of Medical Veterinary and Life Sciences > School of Medicine, Dentistry & Nursing
Journal Name:Fertility and Sterility
Publisher:Elsevier
ISSN:0015-0282
ISSN (Online):1556-5653
Copyright Holders:Copyright © 2015 Elsevier
First Published:First published in Fertility and Sterility 104(4):1016-1021.e6
Publisher Policy:Reproduced in accordance with the copyright policy of the publisher.

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