Lab Med Qual Assur.  2020 Dec;42(4):211-217. 10.15263/jlmqa.2020.42.4.211.

Production of External Quality Assessment Materials for Anti-Müllerian Hormone Assay

• Lee A
• Kim HJ

• KMID: 2510303
• DOI: http://doi.org/10.15263/jlmqa.2020.42.4.211

Abstract

Background
Anti-Müllerian hormone (AMH) is regarded as a sensitive and specific biomarker for assessing the ovarian reserve and has gained widespread clinical use. However, discrepancies between methods, different reference values, and inter-laboratory variation complicate the interpretation of AMH values and their clinical implications. To resolve these problems, external quality assessment (EQA) is important for standardizing AMH assays, thereby ensuring accurate and precise results. To conduct an EQA program, a large amount of quality control (QC) material is required. This study aimed to produce AMH QC materials for an EQA program and evaluate their homogeneity and stability.
Methods
QC materials for three different concentrations of AMH were produced from the collected remnant sera of 632 patients in whom AMH assays were performed. These materials were evaluated for homogeneity between vials and short-term stability over 7 days at three different storage conditions.
Results
The total coefficient of variation of the AMH QC materials at the three different concentrations ranged 2.09%–2.48%. No significant inhomogeneity was noted between vials; therefore, the samples were considered to be homogenous. With respect to short-term stability, three levels of AMH QC materials were found to be stable for at least 7 days when refrigerated or frozen condition.
Conclusions
The AMH QC materials produced from remnant sera were found to be homogenous between vials and remained stable in a refrigerated and frozen condition for at least 7 days. The findings of this study may be practically applied for producing AMH EQA materials.

Keyword

Anti-Müllerian hormone; Ovarian reserve; External quality assess ment; Quality control