Evaluating the Commutability of Reference Materials for α-Fetoprotein: Accurate Value Assignment With Multiple Systems and Trueness Verification
2024; 44(6): 507-517
Ann Lab Med 2022; 42(6): 617-618
Published online November 1, 2022 https://doi.org/10.3343/alm.2022.42.6.617
Copyright © Korean Society for Laboratory Medicine.
Department of Laboratory Medicine, Bucheon St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea
Correspondence to: Haeil Park, M.D., Ph.D. https://orcid.org/0000-0002-1092-0607
Department of Laboratory Medicine, Bucheon St. Mary’s Hospital, The Catholic University of Korea, 327 Sosa-ro, Wonmi-gu, Bucheon 14647, Korea
Tel: +82-32-340-2093, Fax: +82-32-340-2219
E-mail: phi@catholic.ac.kr
This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
Readers who are considering having their ovarian reserve tested will be interested in the study by Ji,
As the serum AMH level decreases with age, reference intervals should be determined according to narrow age bins. Therefore, establishing reference intervals is more cumbersome for AMH than for other analytes. Ji,
Given that KNHANES targets the general population, most examinees are likely to be healthy. Healthy participants for reference were selected by applying inclusion criteria. The authors carefully considered factors that may potentially affect the reference AMH levels by measuring serum progesterone levels and performing bone morphogenetic protein-15 genetic testing [1]. The Roche assay used by the authors has a relatively large market share among automated assays [14]. Therefore, many researchers will be able to reference the study results.
The greatest significance of this study is that the authors considered ethnic differences in serum AMH levels [9, 15, 16]. The reference interval mentioned in the package insert of the AMH assay reagent may not be suitable for the target population. This is evident from the reference interval calculated by the authors, which was wider than that mentioned in the package insert, exceeding the limits at both ends of the range. The median serum AMH level in the 25–34-year-old Korean population tended to be slightly higher than that in the Caucasian population [1].
More extensive use of KNHANES participant data or samples in studies to establish reference intervals for analytes would be beneficial; however, it has some limitations. First, depending on the analyte, the information required to identify reference individuals may be lacking. Second, for an analyte that does not have a premeasured value, it may be impossible to measure it because of the limited amount of sample stored. In the study by Ji,
Park H accepts responsibility for the content of this manuscript and has approved its submission.
No potential conflicts of interest relevant to this paper were reported.