Scott M Nelson1, Ewa Pastuszek2, Grzegorz Kloss3, Iwona Malinowska3, Joanna Liss3, Aron Lukaszuk3, Lukasz Plociennik3, Krzysztof Lukaszuk4. 1. School of Medicine, University of Glasgow, Glasgow, United Kingdom. Electronic address: scott.nelson@glasgow.ac.uk. 2. NVICTA Fertility and Reproductive Center, Gdansk, Poland; Department of Nursing, Medical University, Gdansk, Poland. 3. NVICTA Fertility and Reproductive Center, Gdansk, Poland. 4. NVICTA Fertility and Reproductive Center, Gdansk, Poland; Department of Nursing, Medical University, Gdansk, Poland; INVICTA Fertility and Reproductive Center, Warsaw, Poland.
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.
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.
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