Comparability of antimüllerian hormone levels among commercially available immunoassays

Abstract

Objective: To compare antimüllerian hormone (AMH) levels among three commercially available AMH immunoassays: AMH Gen II (Beckman Coulter), Ultrasensitive AMH (Ansh Labs), and picoAMH (Ansh Labs).

Design: Cross-sectional.

Setting: Academic reproductive endocrinology program.

Patient(s): 90 newly diagnosed breast cancer patients before cancer treatment.

Intervention(s): None.

Main outcome measure(s): Proportion of detectable AMH levels by immunoassay, and comparability among assays.

Result(s): At a mean age of 38.1 years, the median (interquartile range) AMH level for the cohort was 0.92 [1.35] ng/mL for the Gen II assay, 1.68 [2.30] ng/mL for the Ultrasensitive assay, and 1.52 [2.41] ng/mL for the picoAMH assay. Significantly higher proportions of detectable AMH levels were observed with the picoAMH kit (97%) compared with both the Gen II (84%) and Ultrasensitive (92%) assays. Although the AMH results were highly correlated among the assays (r = 0.92-0.99), the Gen II AMH levels were consistently lower than both Ultrasensitive and picoAMH levels. Moreover, as AMH levels increased, the magnitude of difference grew larger between Gen II and each of the other two assays.

Conclusion(s): Measurement of AMH levels with the picoAMH kit maximized detection at very low levels, particularly in contrast with the Gen II kit. Conversion of AMH levels from different immunoassays using regression equations is potentially highly inaccurate.

Keywords: AMH; breast cancer; immunoassay.

Conflict of interest statement

Conflicts of interest: Swiss Precision Diagnostics (MDS)

Copyright © 2014 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

Figures

Figure 1

Passing and Bablok plots and fit analysis, which depict the linear regression line and 95% CI relative to a slope of 1, compare untransformed Gen II and Ultrasensitive AMH assay results (A); Gen II AMH and picoAMH assay results (B); Ultrasensitive AMH and picoAMH assay results (C). Spearman correlation coefficients (r) are shown for comparisons. Bland-Altman plots, which depict the difference in AMH values relative to the mean of the two assays, compare Gen II and Ultrasensitive AMH assay results (D); Gen II AMH and picoAMH assay results (E); Ultrasensitive AMH and picoAMH assay results (F).