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Korean J Clin Microbiol. 2009 Jun;12(2):72-77. Korean. Original Article.
Cho YS , Kim YH , Lee KH , Jang HS , Hwang KA , Kim YL , Chi HY .
Samkwang Medical Laboratories, Seoul, Korea. chumgang@smlab.co.kr
Biosewoom Institute of Bioscience & Biotechnology, Seoul, Korea.
Abstract

BACKGROUND: Hepatitis C virus (HCV) RNA quantification is necessary for predicting the therapeutic response and assessing treatment results in patients with chronic HCV infection. Recently, real-time PCR technology for HCV RNA quantification displayed good linearity within the dynamic range. Thus, it is gradually replacing branched-DNA (bDNA) and PCR- hybridization assays. In this study, we evaluated the performance of the Real-QTM HCV quantification kit (biosewoom. Inc., Seoul, Korea) developed in Korea. METHODS: We evaluated the HCV quantification kit for detection limit, specificity, linearity, accuracy, and recovery rate of HCV RNA standard material. The results were analyzed for a correlation with those of Cobas Amplicor HCV Monitor 2.0. RESULTS: The HCV quantification kit showed a high recovery rate of HCV RNA standard material of various concentrations and amplication of HCV RNA equally in all genotypes. Hepatitis B virus and human immunodeficiency virus showed no cross-reactivity with HCV. Within-run and between-run coefficients of variation (CV) were 9.52~15.84% and 9.40~17.53%, respectively. Between-day coefficients of variation were 11.62~18.04%, and detection limit was 44 IU/mL. It showed a good correlation with Cobas Amplicor HCV Monitor 2.0 (R2=0.8954). CONCLUSION: The Real-Q HCV quantification kit showed a good specificity, sensitivity, linearity, and accuracy; therefore, we propose that it is fully adequate for monitoring antiviral therapy in patients with chronic HCV infection.

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