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Jeonghyun Chang,Hye Ryun Lee,Je Eun Song,Tae-Hyun Um,김솔잎 대한임상검사정도관리협회 2021 Journal of Laboratory Medicine And Quality Assuran Vol.43 No.4
External quality assessment (EQA) of peripheral blood smear test for malaria was conducted as a pilot project in 2020 by the Korean Association of EQA Service. Two trials were performed with three different cases per trial. Scanned images for the whole slide with brief patient histories were distributed to the participating laboratories online. In total, 208 and 232 laboratories participated in the two trials, respectively. The acceptable rates for malaria detection were 96.1%–100.0% and those for identifying malarial species were 68.1%–97.6%. The acceptable rates for parasitemia count were 87.2%–94.6%. The EQA scheme assessing peripheral blood smear test for malaria can contribute to the improvement of the diagnostic ability of the participating laboratories.
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.