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

Table 3 Hepatitis C virus-RNA quantitative assays approved for in vitro diagnostics

Assay and manufacturer	Method	Reaction sample volume (μL)	Lower limit of detection (IU/mL)	Linear range of quantification (IU/mL)	Instrumentation for automated processing	IVD registration
Abbott RealTime HCV, Abbott Molecular	Real-time RT-PCR	500	12	12 - (1 × 108)	m2000sp (extraction and assay setup), m2000rt (amplification and detection)	CE, FDA
artus HCV RG RT-PCR Kit, Qiagen	Real-time RT-PCR	500	34	65 - (1 × 106)	Manual extraction (QIAamp DSP Virus Kit) and assay setup, Rotor-Gene Q (amplification and detection)	CE
artus HCV QS-RGQ Kit, Qiagen	Real-time RT-PCR	1000	21	35 - (1.77 × 107)	QIAsymphony RGQ: QIAsymphony SP (extraction), QIAsymphony AS (assay setup), Rotor-Gene Q (amplification and detection)	CE
COBAS® AmpliPrep/COBAS® TaqMan® HCV Test, Roche Molecular Systems	Real-time RT-PCR	850	15	43 - (6.9 × 107)	COBAS® AmpliPrep (extraction), COBAS® TaqMan® Analyzer or COBAS® TaqMan® 48 Analyzer (amplification and detection)	CE, FDA, Canada, Japan
COBAS® AmpliPrep/COBAS® TaqMan® HCV Quantitative Test v2.0, Roche Molecular Systems	Real-time RT-PCR	650	15	15 - (1 × 108)	Fully automated: cobas p 630 (primary tube handling), COBAS® AmpliPrep (extraction), COBAS® TaqMan® Analyzer or COBAS® TaqMan® 48 Analyzer (amplification and detection)	CE, FDA
COBAS® TaqMan® HCV Test v2.0 for use with the High Pure System, Roche Molecular Systems	Real-time RT-PCR	500	10	25 - (3.9 × 108) (CE)	Manual extraction (High Pure System Viral Nucleic Acid Kit), COBAS® TaqMan® Analyzer (amplification and detection)	CE, FDA
				25 - (3.0 × 108) (FDA)
VERSANT® HCV RNA 1.0 Assay (kPCR), Siemens	Real-time RT-PCR	500	15	15 - (1.0 × 108)	VERSANT® kPCR Molecular System Sample	CE
					Preparation (SP) Module and Amplification/Detection (AD) Module
VERSANT® HCV RNA 3.0 Assay, Siemens	bDNA	50	6151	615 - (7.7 × 106)	No nucleic acid extraction needed. System 340 bDNA Analyzer (S340) (US) or VERSANT™ 440 Molecular System (CE)	CE, FDA

¹The intended use of this assay is limited to the measurement of hepatitis C virus (HCV) viral loads at baseline and after 12 wk of therapy. IVD: Certified as in vitro diagnostic test or device; CE: Conformité Européenne (European Union); FDA: Food and Drug Administration (United States of America); kPCR: Real-time kinetic polymerase chain reaction; bDNA: Branched DNA; RT-PCR: Reverse transcription-polymerase chain reaction.