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

Table 4 Hepatitis C virus genotyping assays approved for in vitro diagnostics

Assay and manufacturer	Method	Reaction sample volume (μL)	Lower limit of detection (IU/mL)	Target	Instrumentation	IVD registration
Abbott HCV Genotype II, Abbott Molecular	Real-time RT-PCR	500	500	5'UTR	m2000sp (extraction and assay setup), m2000rt (amplification and detection)	CE, FDA
				NS5B
LINEAR ARRAY Hepatitis C Virus Genotyping Test, Roche Molecular Systems	RT-PCR and hybridization	200	500	5'UTR	AMPLICOR® and COBAS® AMPLICOR HCV Test v2.0 (amplification and detection). Manual hybridization.	CE
VERSANT HCV Genotype 2.0 Assay Line Probe Assay (LiPA), Siemens	RT-PCR and hybridization	500–1000	2000	5'UTR core	Conventional PCR instrument, Auto-LiPA 48 or AutoBlot 3000H automated Systems (hybridization), LiPA Scan Software CD (reading)	CE

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.