Annals of Clinical Microbiology, The official Journal of the Korean Society of Clinical Microbiology

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Indexed in KCI, KoreaMed, Synapse, DOAJ
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pISSN 2288-0585 eISSN 2288-6850

Evaluation of the Real-Q HCV Quantification Kit

Original article

Annals of Clinical Microbiology (Ann Clin Microbiol) 2009 June, Volume 12, Issue 2, pages 72-77.

https://doi.org/10.5145/ACM.2009.12.2.72

Evaluation of the Real-Q HCV Quantification Kit

Young-Sook Cho1, Young-Hoon Kim1, Kyung-Hee Lee1, Hye-Sun Jang1, Kyung-Ah Hwang1, Yoo-Li Kim2, Hyun-Young Chi1
1Samkwang Medical Laboratories, 2Biosewoom 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. (Korean J Clin Microbiol 2009;12:72- 77)

Keywords

Real-time PCR, HCV RNA Quantitation, Cobas amplicor, Hepatitis C virus