Two new automated compared with two enzyme linked immunosorbent antimullerian hormone assays

Capsule:
New automated AMH assays provide substantially lower values than existing AMH enzyme-linked immunosorbent assays. Assay-specific interpretation is necessary, along with international standardization.

Authors:
Scott M. Nelson, Ph.D., Ewa Pastuszek, M.S., Grzegorz Kloss, M.S., Iwona Malinowska, M.S., Joanna Liss, Ph.D., Aron Lukaszuk, B.S., Lukasz Plociennik, Ph.D., Krzysztof Lukaszuk, M.D., Ph.D.

Volume 104, Issue 4, Pages 1016-1021

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/MIS ELISA (Ansh Labs; MIS) assays.

Design:
Prospective assay evaluation.

Setting:
A 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; MIS ≤ 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 MIS). For y (Elecys) = 0.087 + (0.729 x Gen II) and y (Elecys) = 0.253 + (0.688 x MIS). 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.

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