Tools for the diagnosis of hepatitis C virus infection and hepatic fibrosis staging

Table 2 Hepatitis C virus-RNA qualitative assays approved for in vitro diagnostics

Assay and manufacturer	Method	Reaction sample volume (μL)	Lower limit of detection (IU/mL)	Instrumentation for automated processing	IVD registration
COBAS® AMPLICOR HCV Test v2.0, Roche Molecular Systems	RT-PCR	500	50 (plasma) 60 (serum)	COBAS® AMPLICOR® Analyzer (amplification and detection)	CE, FDA, Japan, Canada
COBAS® AmpliPrep/COBAS® AMPLICOR HCV Test v2.0, Roche Molecular Systems	RT-PCR	250	50 (plasma) 60 (serum)	COBAS® AmpliPrep (extraction), COBAS® AMPLICOR® Analyzer (amplification and detection)	CE, FDA, Canada
COBAS® AmpliPrep/COBAS® TaqMan® HCV Qualitative Test v2.0, Roche Molecular Systems	Real-time RT-PCR	650	15	Fully automated: cobas p 630 Instrument (primary tube handling), COBAS® AmpliPrep (extraction and MM setup), COBAS® TaqMan® Analyzer or the COBAS® TaqMan® 48 Analyzer (amplification and detection)	CE, FDA
APTIMA HCV RNA Qualitative Assay1, Hologic - Gen-Probe	TMA	500	5.3	Not automated. PANTHER System’s functionality currently in development	FDA
VERSANT® HCV RNA Qualitative Assay, Siemens	TMA	50	5.3	TMA modules (TCS, luminometer HC+, etc.)	CE, FDA

¹The performance of this assay has not been demonstrated for monitoring hepatitis C virus (HCV) infected patients. IVD: Certified as in vitro diagnostic test or device; CE: Conformité Européenne (European Union); FDA: Food and Drug Administration (United States of America); RT-PCR: Reverse transcription-polymerase chain reaction; MM: Master mix.