Abstract
Accurate quantitative detection of hepatitis C virus (HCV) RNA is critical for diagnosis of acute or chronic HCV infection, and for follow-up of virologic response during HCV targeted therapy. In the present study, traceability and reproducibility of a novel China-certified domestic Sansure HCV RNA diagnostic assay (Sansure, Changsha, Hunan, China) was evaluated and the clinical performance of this assay was also analyzed. Traceability of the Sansure HCV RNA assay to the WHO international standard for HCV (genotype 1a) was detected across multiple centers. Reproducibility, accuracy (the differences of observed average concentrations and expected concentrations) and precision were assessed using series dilutions of World HCV RNA performance panel WWHV303-02 (HCV-1b), WWHV303-04(HCV-2a), WWHV303-11(HCV-3a) and WWHV303-19 (HCV-6a). In addition, both Sansure HCV RNA and CAP/CTM HCV (Roche, Branchburg, NJ, USA) assays were used to detect HCV RNA in 346 EDTA anti-coagulated plasma samples from previous HCV-infected patients, during and after antiviral therapy. The Sansure assay showed good traceability by agreeing with the HCV-1a WHO standard across all five concentrations tested (25, 50, 100, 1000, 10,000 IU/ml). The differences bet...Continue Reading
References
Aug 2, 2006·Journal of Hepatology·Joseph F PerzBeth P Bell
Nov 23, 2007·Journal of Clinical Microbiology·Kimberly Page-ShaferMichael P Busch
Apr 1, 2011·The New England Journal of Medicine·Fred PoordadUNKNOWN SPRINT-2 Investigators
Apr 1, 2011·The New England Journal of Medicine·Bruce R BaconUNKNOWN HCV RESPOND-2 Investigators
Apr 15, 2011·Vox Sanguinis·S A BaylisUNKNOWN Collaborative Study Group
Jun 24, 2011·The New England Journal of Medicine·Ira M JacobsonUNKNOWN ADVANCE Study Team
Jun 24, 2011·The New England Journal of Medicine·Stefan ZeuzemUNKNOWN REALIZE Study Team
Dec 18, 2012·Journal of Clinical Microbiology·Heike ZitzerChristoph Sarrazin
Apr 24, 2013·The New England Journal of Medicine·Eric LawitzEdward J Gane
Jul 3, 2013·Nature Reviews. Gastroenterology & Hepatology·Behzad HajarizadehGregory J Dore
Jul 24, 2013·Journal of Gastroenterology and Hepatology·Yan Cui, Jidong Jia
Oct 5, 2013·Journal of Gastroenterology and Hepatology·Huiying RaoHui Zhuang
Oct 8, 2013·Journal of Clinical Virology : the Official Publication of the Pan American Society for Clinical Virology·Harald H KesslerBrigitte I Santner
May 14, 2014·Journal of Hepatology
Apr 4, 2015·PloS One·Behzad HajarizadehUNKNOWN InC3 Study Group