Comparison of the Automated Fluorescent Immunoassay System With Roche Elecsys and Beckman Coulter Access 2 Assays for Anti-Müllerian Hormone Measurement

Abstract

Background: Since 2017, automated assays have been used in most clinical laboratories for anti-Müllerian hormone (AMH) level measurement. We evaluated the analytical performance of the newly developed automated fluorescent immunoassay system (AFIAS) AMH assay (Boditech Med, Gangwon-do, Korea) in comparison with the Roche Elecsys and Beckman Coulter Access 2 AMH assays.Methods: Analytical performance of the AFIAS AMH assay was assessed in terms of linearity, repeatability, and within-laboratory precision (CV%) using human recombinant AMH samples according to the Clinical and Laboratory Standards Institute (CLSI) guidelines EP05 and EP06. Using 293 serum samples collected from an infertility clinic, the AMH levels were compared across AFIAS, Elecsys, and Access 2 AMH assays according to the CLSI EP09 guidelines. Results:The AFIAS AMH assay results were linear across the measurement range of 0.420-72.386 pmol/L AMH, with repeatability of 6.341%. CV% of the AFIAS AMH assay for three levels of control, 1.786, 7.143, and 56.857 pmol/L, were 5.801%, 5.714%, and 6.228%, respectively. The results of the three AMH assays showed strong correlation: AFIAS and Elecsys [slope, 1.055 (95% confidence interval (CI), 1.022-1.088) and Spearman's rho, 0.978 (95% CI, 0.973-0.983)], Elecsys and Access 2 [slope, 0.813 (95% CI, 0.791-0.834) and Spearman's rho, 0.986 (95% CI, 0.983-0.989)], and AFIAS and Access 2 [slope, 0.836 (95% CI, 0.821-0.853) and Spearman's rho, 0.984 (95% CI, 0.980-0.988)].

Reference intervals of anti‐Müllerian hormone in Korean women

“…13 Previous studies performed on Korean women did not include women aged 20-24 years or included limited numbers of study subjects of this age group, whose data were combined with those of women aged 25-29 years (Table 1). 4,7,10 The peak serum AMH level observed in the 25-29-year age group and the decrease to undetectable in the 45-50-year age group were comparable with previous findings that the serum AMH level starts to decline from age 25 years and reaches an undetectable level at menopause. 1 The 2.5th, 5th, and 10th percentile values of the present study were comparable with previously assessed lower limits of reference intervals.…”

“…Previous studies performed with Korean women to determine reference intervals used data from analytical methods with different traceability or included only a limited number of subjects. 4 , 7 , 9 , 10 Considering the differences in absolute AMH values among analytical methods, results of the present study provide important information for use in clinical laboratories and for clinical decision making in fertility treatment. 1 , 3 , 6…”

“…Previous studies concerning reference intervals of serum AMH assessed in Korean women used data from the Access (Beckman Coulter) or Gen II assay (Beckman Coulter), which had different calibration traceability from the Roche Elecsys assay, or data were obtained from limited numbers of subjects. 4 , 7 , 8 , 9 , 10 , 11 …”

“…1,3 Global standardization of serum AMH measurement remains insufficient; different analytical platforms give rise to different AMH concentrations. [3][4][5] Even though the World Health Organization (WHO) reference material for the international standard (IS) by the National Institute for Biological Standards and Control (NIBSC) exists, differences between analytical method results are observed. 1,3,6 studies concerning reference intervals of serum AMH assessed in Korean women used data from the Access (Beckman Coulter) or Gen II assay (Beckman Coulter), which had different calibration traceability from the Roche Elecsys assay, or data were obtained from limited numbers of subjects.…”

Age-specific Reference Intervals for Anti-Müllerian Hormone

“…Had the study not used KNHANES data, procuring such a large number of participants to calculate reference intervals would have been challenging. A previous study that established a reference interval for an automated assay had potential for selection bias because it included women who visited an infertility center [ 13 ]. The strategy used by Ji, et al .…”