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Production of External Quality Assessment Materials for Anti-Müllerian Hormone Assay
Anna Lee,Hee-Jung Kim 대한임상검사정도관리협회 2020 Journal of Laboratory Medicine And Quality Assuran Vol.42 No.4
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.
Jinsook Lim,권계철 대한임상검사정도관리협회 2021 Journal of Laboratory Medicine And Quality Assuran Vol.43 No.2
In the 2018 and 2019 glucose analysis by point-of-care testing, an external quality assessment was performed in two sessions. Quality control (QC) materials available on the market were used in these programs, and three levels of concentration were used during each session. Based on the data and results of the test items reported by each institution, statistical analyses were conducted by the manufacturers and with a test analyzer. From the analysis results, each institution was provided with an overall report and an institution-tailored report. The average response rate was 98.8%. After the number of instruments that could be registered by an institution increased to 30 in 2017, the number of participating institutions spiked to 3,808 during the second round in 2019. The coefficients of variation (CVs) differed among the manufacturers and among different instruments from the same manufacturer, and such differences were comparatively greater than the CV of glucose of the routine chemistry program. Due to the fact that the commutability of the QC materials used for this program is not secured between different instruments as well as between test strips with different lot numbers within the same instrument, it is deemed necessary to obtain lot numbers when inputting institution results.