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KMID : 0981820060260060436
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Korean Journal of Laboratory Medicine
2006 Volume.26 No. 6 p.436 ~ p.441
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Evaluation of HBs Ag, HCV and HIV Ag-Ab Assays using Bio-Rad Elite Microplate Analyzer
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Hwang Sang-Hyun
Oh Heung-Bum
Kim Hyon-Suk
Lee Eun-Yup
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Abstract
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Background: In this study, we evaluated the performance of Elite microplate analyzer (Bio-Rad Laboratories, France) and the related assays (ULTRA line) for the detection of hepatitis B virus (HBV), hepatitis C virus (HCV) and human immunodeficiency virus (HIV).
Methods: Seroconversion panels, HBsAg positive/HBsAg negative (n=99/n=1,422), anti-HCV positive/negative (n=97/n=1,670), and anti-HIV positive/negative (n=112/n=1,704) samples were used to evaluate the performance of Monolisa HBsAg ULTRA, Monolisa HCV Ag-Ab ULTRA, and Genscreen ULTRA HIV Ag-Ab, respectively. The agreement of Elite microplate analyzer with CODA analyzer (Bio-Rad Laboratories, CA, USA) was also evaluated.
Results: The detection limit of Monolisa HBsAg ULTRA was 0.034 IU/mL. For Monolisa HBsAg ULTRA, Monolisa HCV Ag-Ab ULTRA, and Genscreen ULTRA HIV Ag-Ab, diagnostic sensitivities were all 100%, diagnostic specificities were 100%, 99.8% and 99.9%, and total CVs (coefficients of variation) were 13.8-17.5%, 3.4-5.2%, and 7.5-9.5%, respectively. The agreement of Elite microplate analyzer with CODA analyzer was 99.5%.
Conclusion: The performance of Elite microplate analyzer and the related assays on analytical sensitivity, precision, early detection, diagnostic sensitivity and specificity was all adequate for a mass screening. However, further large multi-center studies should be performed to validate our results. (Korean J Lab Med 2006;26:436-41)
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KEYWORD
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Hepatitis B virus, Hepatitis C virus, Human immunodeficiency virus, Evaluation, Sensitivity, Specificity, Elite Microplate Analyzer
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