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KMID : 0829320090120020072
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Korean Journal of Clinical Microbiology
2009 Volume.12 No. 2 p.72 ~ p.77
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Evaluation of the Real-Q HCV Quantification Kit
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Cho Young-Sook
Kim Young-Hoon
Lee Kyung-Hee
Jang Hye-Sun
Hwang Kyung-Ah
Kim Yoo-Li
Chi Hyun-Young
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Abstract
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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 PCRhybridization 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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KEYWORD
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Real-time PCR, HCV RNA Quantitation, Cobas amplicor, Hepatitis C virus
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