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KMID : 0375320000220020293
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Journal of Clinical Pathology and Quality Control
2000 Volume.22 No. 2 p.293 ~ p.301
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External Quality Assessment in anti-HIV Enzyme Immuno Assay in Korea
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Kim Sung-Soon
Suh Soon-Duk
Kim Ok-Jin
Lee Min-Woo
Lee Joo-Shill
Kim Hyun-Sook
Kim Young-Ran
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Abstract
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Background : We performed the quality assessment of HIV antibody test since 1998 to improve the quality of laboratory testing and to identify problems in laboratory testing processes. This report is the result from May 1999 to April 2000.
Methods : The quality assessment panels for HIV antibody testing were composed of undiluted 5 HIV antibody positive sera and 5 negative sera for 3rd and 4th panel. The panels were distributed to 260 participating laboratories of hospital, blood bank, public health. Among the sera, one positive serum showing low titer obtained from blood donor of early HIV infection and duplicated negative sera were included to challenge the high accuracy and to evaluate the reproducibility of HIV testing respectively.
Results : Enzyme immunoassay (EIA) method was used by 230 out of 260 laboratories for 3rd panel and 244 out of 251 laboratories for the 4th panel. The analytic sensitivity and specificity of EIA HIV1/2 antibody test were 98.55% and 99.78% in 3rd trial and 100% and 98.08% in 4th trial. Analytic accuracies in EIA were similar those of previous year. The data of each sample were analyzed by traditional (mean ±2 standard deviation) and robust statistics to find outliers. Robust statistics detected more outlier. Youden analysis for duplicate negative sample was represented that 22 out of 75 laboratories using B assay were positioned outside the 99% ellipse confidence showing 10 laboratories of random error and 12 laboratories of systemic error.
Conclusions : Robust statistics about single and duplicate negative sample seems to be more efficient for the identification of some results showing significant variation from the median than traditional statistics by mean and standard deviation. Further studies are needed for analysis of the quality assessment results including the advanced analysing method.
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KEYWORD
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Quality assessment, HIV antibody test, Enzyme immunoassay, Robust statistics, Youden plot
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