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Clinical Chemistry and Laboratory Medicine (CCLM)

Published in Association with the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM)

Editor-in-Chief: Plebani, Mario

Ed. by Gillery, Philippe / Greaves, Ronda / Lackner, Karl J. / Lippi, Giuseppe / Melichar, Bohuslav / Payne, Deborah A. / Schlattmann, Peter


IMPACT FACTOR 2018: 3.638

CiteScore 2018: 2.44

SCImago Journal Rank (SJR) 2018: 1.191
Source Normalized Impact per Paper (SNIP) 2018: 1.205

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1437-4331
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Volume 52, Issue 8

Issues

First fully automated immunoassay for anti-Müllerian hormone

Dieter Gassner / Rebecca Jung
Published Online: 2014-03-13 | DOI: https://doi.org/10.1515/cclm-2014-0022

Abstract

Background: The increasing importance of anti-Müllerian hormone (AMH) for the assessment of ovarian reserve requires accurate AMH measurements. There have been conflicting results about the reliability of currently existing manual AMH assays.

Methods: Development of a high sensitive, fast and fully automated AMH assay on the Elecsys®/cobas e electrochemiluminescence immunoassay platform.

Results: Elecsys® AMH is a monoclonal two-site assay used to measure AMH in 50 µL of serum or lithium heparin plasma in about 18 min. Its measuring range is from 0.01 to 23 ng/mL. The assay detects primarily 140 kDa total AMH (proAMH and AMHN,C). Standardization was against the Beckman AMH Gen II. Recovery against the highly cited Immunotech calibration was about 90%. Within-run imprecision coefficient of variation (CV) calculated on 10 serum samples were between 0.5% and 1.8%. Repeatability and intermediate precision calculated on 14 serum samples ranged from 2.6% to 1.7% and 2.9% to 2.1%, respectively. Limit of detection (LoD) [limit of quantitation (LoQ)] was 0.01 ng/mL (0.03 ng/mL). Percent recovery in dilution studies was <10% and after mixing of high and low AMH pools 94% to 103%. Elecsys® AMH, when compared to revised AMH Gen II (or Ansh Labs ultrasensitive AMH ELISA) using 57 female serum samples yielded a correlation coefficient of 0.98 (0.97) and a slope of 0.81 (0.73). There was no evidence for sample instability or variability. Samples stored at 20–25 °C or 2–8 °C up to 7 days showed no significant storage issues. Freeze-thaw cycles or sample storage at −20 °C and −80 °C for up to 9 months was without any effect on measured AMH.

Conclusions: Availability of an automated Elecsys® AMH assay offers an attractive alternative to the current manual AMH assays.

Keywords: anti-Müllerian hormone (AMH); AMH enzyme-linked immunosorbent assay (ELISA); automated AMH assay

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About the article

Corresponding author: Dr. Dieter Gassner, Roche Diagnostics GmbH DXR-IF Nonnenwald 2 82377 Penzberg, Germany, Phone: +49 8856 603318, Fax: +49 8856 603176, E-mail:


Received: 2013-11-30

Accepted: 2014-02-14

Published Online: 2014-03-13

Published in Print: 2014-08-01


Citation Information: Clinical Chemistry and Laboratory Medicine (CCLM), Volume 52, Issue 8, Pages 1143–1152, ISSN (Online) 1437-4331, ISSN (Print) 1434-6621, DOI: https://doi.org/10.1515/cclm-2014-0022.

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