Performance evaluation of the nanoquant real-time HCV assay for quantitation of hepatitis C virus RNA by real-time RT-PCR

Authors

  • Nguyen Hoang Chuong University of Science, National University Ho Chi Minh city
  • Doan Chinh Chung University of Science, National University Ho Chi Minh city
  • Do Minh Si University of Science, National University Ho Chi Minh city
  • Pham Hung Van University of Medicine and Pharmacy Ho Chi Minh city

DOI:

https://doi.org/10.15625/0866-7160/v36n1se.4367

Keywords:

HCV, molecular assay, NanoQuant real-time HCV, real-time RT-PCR, RNA quantitation.

Abstract

Accurate quantitation of Hepatitis C virus (HCV) RNA level is essential for measurement of active viremia in chronic HCV-infected patients undergoing antiviral therapy. In Vietnam, two molecular assays based on real-time reverse transcription-polymerase chain reaction (RT-PCR) technique are widely used to quantify HCV RNA level: Cobas Taqman HCV (Roche) and Abbott RealTime HCV (Abbott). Recently, a third assay has been introduced for HCV RNA quantitation: NanoQuant real-time HCV. In this study, performance characteristics of this assay were evaluated using methods for validation of newly developed molecular assays for infectious diseases. Evaluating results showed that NanoQuant real-time HCV was able to quantify HCV in a linear range from 102 to 108 IU/mL with the detection limit of 28.2 IU/mL. None of the other viruses, bacteria, fungi and human genetic materials showed cross-reactivity with HCV. The assay gave no positve result with HCV-negative sera. No interference in the performance of the assay was observed in the presence of inhibitory endogenous and exogenous substances. Intra-assay and interassay coefficients of variation were 4.18% and 9.18%, respectively. All of HCV genotypes (1a, 1b, 2a, 2b, 3a, 6a, 6e, 6f) which are prevalent in Vietnam were detected by the assay. HCV quantitation results showed a good correlation with those determined with Cobas Taqman HCV (R2=0.94). These results indicate that NanoQuant real-time HCV is reliable for monitoring HCV RNA level in the treatment of patients with chronic HCV infection.

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Published

06-08-2014

How to Cite

Chuong, N. H., Chung, D. C., Si, D. M., & Van, P. H. (2014). Performance evaluation of the nanoquant real-time HCV assay for quantitation of hepatitis C virus RNA by real-time RT-PCR. Academia Journal of Biology, 36(1se), 62–69. https://doi.org/10.15625/0866-7160/v36n1se.4367

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