Evaluation of the Real-Q HCV Quantification Kit.
10.5145/KJCM.2009.12.2.72
- Author:
Young Sook CHO
1
;
Young Hoon KIM
;
Kyung Hee LEE
;
Hye Sun JANG
;
Kyung Ah HWANG
;
Yoo Li KIM
;
Hyun Young CHI
Author Information
1. Samkwang Medical Laboratories, Seoul, Korea. chumgang@smlab.co.kr
- Publication Type:Original Article
- Keywords:
Real-time PCR;
HCV RNA Quantitation;
Cobas amplicor;
Hepatitis C virus
- MeSH:
Chimera;
Genotype;
Hepacivirus;
Hepatitis B virus;
HIV;
Humans;
Limit of Detection;
Organothiophosphorus Compounds;
Real-Time Polymerase Chain Reaction;
RNA;
Sensitivity and Specificity
- From:Korean Journal of Clinical Microbiology
2009;12(2):72-77
- CountryRepublic of Korea
- Language:Korean
-
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.
