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

Table 1 Main commercial immunoassays to detect anti-hepatitis C virus antibodies approved for in vitro diagnostics

Analyzer and manufacturer	Assay principle	Solid phase	HCV antigens	Reaction sample volume (μL)	Time of reaction (min)	IVD registration
Architect i2000SR, Abbott Laboratories	CMIA	Paramagnetic particles	HCr43 (Core and NS3), c100-3 (NS4A)	20	20	FDA, CE
AxSYM, Abbott Laboratories	MEIA	Paramagnetic particles	HCr43 (Core), c200 (NS3), c100-3 (NS4A)	33	30	FDA, CE
LiaisonXL, DiaSorin	CLIA	Paramagnetic particles	Core, NS3, NS4	25	46	CE
VITROS ECi, VITROS 3600, Ortho-Clinical Diagnostics	CLIA	Microwell	c22-3 (Core), c200 (NS3 and NS4), NS5	20	55	FDA, CE
Elecsys, Roche Diagnostics	ECLIA	Paramagnetic particles	Core, NS3, NS4	40	18	FDA, CE
ADVIA Centaur, Siemens	CLIA	Magnetic particles	c22-3 (Core), NS3, c200, NS5	10	58	FDA, CE

IVD: Certified as in vitro diagnostic test or device; CE: Conformité Européenne (European Union); FDA: Food and Drug Administration (United States of America); ECLIA: Electrochemiluminescence immunoassay; CMIA: Chemiluminescent microparticle immunoassay; CLIA: Chemiluminescence immunoassay; HCV: Hepatitis C viru; MEIA: Microparticle capture enzyme immunoassay.