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Table 1 Characteristics of studies focused on evaluating diagnostic accuracy of HCV antibody tests

From: Diagnostic accuracy of tests to detect Hepatitis C antibody: a meta-analysis and review of the literature

First author Year Settings Sample type Manufacturer Study type Sample size POC (Y/N) Reference standard Still on the market? PRODUCT NAME
Al-Tahish et al. 2013 Egypt Venous blood HCV one step test device (ACON Laboratories, USA), Fourth- generation HCV TRI_DOT (J. Mitra Co, India) and ImmunoComb II HCV (Inverness Medical Innovations, USA) CS 100 Y PCR Yes Foresight® HCV EIA test kit; Yes, HCV TRI_DOT
Bonacini et al. 2001 USA Venous blood Ortho Clinical Diagnostics (Raritan, NJ, USA) CS 222 N Chiron IMMUNOBLOT HCV 3.0 SIA Not available
Buti et al. 2000 Sprain Serum Not available CS 188 Y IMMUNOBLOT Not avaliable
Caudai et al. 1998 USA Serum or plasma samples ELISA 2nd generation Abbott Laboratories, Abbott park, IL, USA) CS 682 N PCR Not avaliable
Cha et al. 2013 Korea Oral fluids and serum OraQuick (OraSure Technologies, PA USA) CC 437 Y PCR Yes, The OraQuick® HCV
Croom et al. 2006 Austria Venous blood Monolisa anti-HCV PLUSVersion 2 EIA (Bio-Rad, France) CS 182 N EIA Yes, MONOLISA™ Anti-HCV PLUS Assay Version 2
da Rosa et al. 2013 Brazil Serum Rapid Test Bioeasy® (Standard Diagnostics, Yongin, Korea) and Imuno-Rapido HCV® (Wama Diagnostica, Brazil). CS 307 Y Architect HCV, PCR Not available for Rapid Test Bioeasy; Yes, Imuno-Rapido HCV
Daniel et al. 2005 India Serum TRI DOT (J. MITRA &Co. Ltd., New Delhi, India) CS 2590 Y EIA, IMMUNOBLOT, PCR YES, HCV TRI_DOT
Denoyel et al. 2004 France and Germany Serum or plasma samples AxSYM HCV 3.0 (other information is not available) CS 5700 N IMMUNOBLOT Yes, AXSYM HCV 3.0
Dokubo et al. 2014 USA Blood HCV Version 3.0 ELISA (Ortho®) CS 132 N PCR Yes, ORTHO® HCV 3.0 Elisa
Drobnik et al. 2011 USA Oral fluid OraQuick (OraSure Technologies, PA USA) CS 484 Y EIA, IMMUNOBLOT Yes, The OraQuick® HCV
Eroglu et al. 2000 Turkey Plasma specimens ELISA v3.0(Ortho®) CS 160 N PCR Yes, ORTHO® HCV 3.0 Elisa
Feucht et al. 1995 Germany Plasma specimens Abbott HCV second-generation enzyme immunoassay (other information is not available) CS 262 N IMMUNOBLOT Not avaliable
Gao et al. 2014 USA Serum OraQuick (OraSure Technologies, PA USA) CS 289 Y EIA Yes, The OraQuick® HCV
Hess et al. 2014 USA whole blood DPP HIV-HCV-Syphilis Assay (Chembio Diagnostic Systems, Inc., Medford, NY) CS 948 Y EIA Not avaliable
Hui et al. 2002 Hong kong, China Whole blood OraQuick (OraSure Technologies, PA USA) CS 197 Y EIA Yes, The OraQuick® HCV
Ibrahim et al. 2015 Saudi Arabia Oral fluid OraQuick (OraSure Technologies, PA USA) CC 160 Y PCR Yes, The OraQuick® HCV
Ivantes et al. 2010 Brazil Whole blood HCV Rapid Test Bioeasy (Bioeasy Diagnostica Ltda, Minas Gerais, Brazil) CS 71 Y CLIA Not available
Jewett et al. 2012 USA Oral fluids Chembio DPP HCV test (Chembio Diagnostic Systems,USA) and Rapid HIV/HCV antibody test (Medmira Laboratories, Canada) CS 407 Y IMMUNOBLOT/NAT Not available for Chembio DPP HCV test; Yes, Multiplo HBc/HIV/HCV
Kant et al. 2012 Germany Whole blood Toyo anti-HCV test (Turklab, Izmir, Turkey) CS 185 Y Architect HCV Yes, anti-HCV TEST
Kaur et al. 2000 India Serum HCV Bidot (J. Mitra Co., India) CS 2754 Y EIA 3rd generation YES, DIAGNOS HCV BI-DOT
Kim et al. 2013 Republic of Korea Serum GENEDIA® HCV Rapid LF (Green Cross medical science corp., Korea) CC 200 Y IMMUNOBLOT Yes, GENEDIA HCV Rapid LF test kit
Kosack et al. 2014 Germany Serum The ImmunoFlow HCV test (Core Diagnostics,United Kingdom) CS 81 Y IMMUNOBLOT Yes, ImmunoFlow HCV
Lakshmi et al. 2007 India Blood Beijing United Biomedical, Ortho Clinical Diagnostics, General Biologicals; other information is not avaliable CS 69 N PCR Not avaliable
Larrat et al. 2012 France FSB (fingerstick blood) and oral fluid cEIA: the Monolisa® HCV-Ag-Ab-ULTRA (Bio-Rad, Marnes-la-Coquette, France) CC 201 Y PCR Yes, MONOLISA™ HCV Ag-Ab ULTRA
Lee et al. 2010 USA Oral fluid OraQuick (OraSure Technologies, PA USA) CS 572 Y EIA, IMMUNOBLOT Yes, The OraQuick® HCV
Lee et al. 2011 USA Serum, plasma, venous blood, figerstick blood and oral fluid Or Quick (OraSure Technologies, PA USA) CS 2183 Y EIA, IMMUNOBLOT, PCR Yes, The OraQuick® HCV
Lee et al. 2011 USA Oral fluid OraQuick (OraSure Technologies, PA USA) CS 2180, 2178 Y EIA Yes, The OraQuick® HCV
Maity et al. 2012 India Serum J Mitra & Co. Pvt. Ltd., SPAN Diagnostics Ltd. and Standard Diagnostics, INC, other information is not available CC 100 Y EIA Not avaliable
Montebugnoil et al. 1999 Italy whole blood Anti-HCV Ab rapid test (1st IRP 75/537 by Thema Ricerca, WHO Geneva) CC 100 Y EIA, IMMUNOBLOT Not avaliable
Mvere et al. 1996 Zimbabwe Serum HCV-SPOT (Genelabs Diagnostics, Singapore) CS 206 Y EIA 2nd generation, INNO-LIA HCV ab III Not avaliable
Nalpas et al. 1992 France Serum Ortho Diagnostics, other information is not available CS 62 N PCR Not avaliable
Njouom et al. 2006 Cameroon Plasma ImmunoComb® II HCV assay (Orgenics Ltd.,); ImmunoComb® II HCV assay (Orgenics Ltd., Not reported manufacturer located country) CS 329 Y EIA 3rd generation, PCR Not avaliable
Nyirenda et al. 2008 Malawi Serum Monoelisa HCV Ag/Ab ultra-microplate EIA (Bio-Rad, France) CS 202 Y EIA Yes, MONOLISA™ HCV Ag-Ab ULTRA
O’Connell et al. 2013 USA Plasma, whole blood (normal) and whole blood (cold storge) OraQuick (OraSure Technologies, PA USA); CORE (CORE Diagnostics, United Kingdom); Axiom (Axiom Diagnostics, Burstadt,Germany); FirstVue (AT First Diagnostic, Woodbury,NY, USA) and Instant View Cassette (Alfa Scientific Designs, Poway) CC 674, 168 Y EIA, IMMUNOBLOT, and when available viral load) Yes, The OraQuick® HCV; Yes, Core HCV; Not avaliable for Axiom; Yes, FirstVue™ Hepatitis “C” Rapid Test; Yes, Instant-view™ Hepatitis C Virus (HCV) Serum Test
O’Flynn et al. 1997 Ireland, Germany, UK Plasma and serum AxSYM (Abbott Laboratories, other information is not available) CC 5554, 1421, 643 N ABBOTT MATRIX HCV, Chiron IMMUNOBLOT HCV 2.0 or 3.0 Yes, AXSYM HCV 3.0
Park et al. 2012 Korea Serum Vitros anti-HCV assay kits (Ortho-Clinical Diagnostics, Buckinghamshire, UK) and Elecsys (Roche Diagnostics GmbHMannheim, Germany) CS 1008 N IMMUNOBLOT HCV 3.0 and Cobas Ampliprep/Taqman HCV RNA Not avaliable
Poovorawari et al. 1994 Thailand Serum HCV-SPOT assay (Genelabs Diagnostics Pty Ltd., Singapore) CS 192 Y EIA 2nd generation or IMMUNOBLOT Not avaliable
Prayson et al. 1993 USA Serum C100-3 HCV EIA (Abbott Laboratories, other information is not available) CS 123 N IMMUNOBLOT 2.0 Not avaliable
Rihn et al. 2000 France serum MATRIX hcv2 (Abbott Laboratories, other information is not available) CS 146 N PCR Not avaliable
Scalioni Lde et al. 2014 Brazil Serum,whole blood and oral fluid WAMA Imuno-Rápido HCV Kit (WAMA Diagnóstica, Brazil); Bioeasy HCV Rapid Test, (Bioeasy Diagnóstica Ltd., Brazil) and OraQuick (OraSure Technologies, PA USA) CS 194 or 172 Y PCR Yes, Imuno-Rapido HCV; Not avaliable for Rapid Test Bioeasy; Yes, The OraQuick® HCV
Smith et al. 2011 USA Whole blood, oral fluid Multiplo Rapid HIV/HCV Antibody Test (MedMira, Canada); Chembio DPP HCV test (Chembio Diagnostic Systems, USA) and OraQuick (OraSure Technologies, USA) CS 476, 385, 432, 549, 266 Y MEIA/EIA/CLIA, IMMUNOBLOT Yes, Multiplo HBc/HIV/HCV; Not avaliable for Chembio DPP HCV test; Yes, The OraQuick® HCV
Smith et al. 2011 USA Oral fluid and blood Multiplo Rapid HIV/HCV Antibody Test (MedMira, Canada); Chembio DPP HCV test (Chembio Diagnostic Systems, USA) CS 1081 Y Chiron IMMUNOBLOT HCV 3.0 SIA; Bayer Advia Centaur HCV Chemiluminescent immunoassay Yes, Multiplo HBc/HIV/HCV; Not avaliable for Chembio DPP HCV test
Sommese et al. 2014 Italy Blood CMIA assays (Abbott Diagnostics, Wiesbaden, Germany) CS 17,894 N INNO-LIA (Innogenetics, Ghent, Belgium), NAT Not avaliable
Tagny et al. 2014 Cameron Plasma HCV Ag/Ab combination assay (Monolisa HCV Ag-Ab Ultra, BioRad, Marnes La Coquette, France) CS 1998 Y EIA Yes, MONOLISA™ HCV Ag-Ab ULTRA
Vrielink et al. 1996 Netherlands Blood Abbott HCV EIA 3.0 (Abbott laboratories, Murex anti-HCV VK47 (Murex Diagnostic) and Ortho HCV 3.0 elisa (Ortho Diagnostic Systems; other information is not available CS 403, 212, 253 03 1055 N PCR Not available for Abbott HCV EIA 3.0; Yes, Murex anti-HCV (version 4); Yes, ORTHO® HCV 3.0 Elisa
Vrielink et al. 1995 Netherlands Blood Monolisa anti-HCV new antigens (Sanofi Diagnostics Pasteur), Abbott HCV EIA 3.0 (Abbott Laboratories); other information is not available CS 403, 212, 253 N PCR Not avaliable
Yang et al. 2011 China Serum AxSYM HCV 3.0 (Abbott Laboratories), Murex Ag/Ab test (Abbott Laboratories); other information is not available CC 101 or 100 N HCV RNA test (COBAS AMPLICOR Hepatitis C Virus Test, version 2.0 Yes, AXSYM HCV 3.0; Not avaliable for Murex Ag/Ab test
Yang et al. 2013 China Serum Elecsys anti-HCV II (Roche Diagnostics GmbH), Architect anti-HCV (Abbott) and Vitros anti-HCV (Ortho-Clinical Diagnostics), other information is not available CS 859 or 167 N IMMUNOBLOT 3.0 test or the Realtime HCV RNA assay Yes, Elecsys® Anti-HCV II; Yes, ARCHITECT i1000SR I; Not available for Ortho-Clinical Diagnostics
Yarri et al. 2006 Israel Serum and oral fluid ImmunoComb II HCV (Inverness Medical Innovations, USA) CS 37 Y PCR Not avaliable
Yoo et al. 2015 South Korea; China; China/Taiwan; Thailand; Australia; Malaysia; Indonesia Serum Elecsys® Anti-HCV II assay; (Roche Diagnostics GmbH, other information is not avaliable) CS 7726 Y 1 or more of the following comparator assays at 9 centers: ARCHITECTTM Anti-HCV; Serodia®-HCV Particle Agglutination; Vitros® ECi Anti-HCV; Elecsys® Anti-HCV; ADVIA Centaur® HCV; InTec® HCV EIA; or Livzon® Anti-HCV. Yes, Elecsys® Anti-HCV II
Yuen et al. 2001 China Serum SM-HCV Rapid Test (SERO-Med Laborspezialita¨ten GmbH, Eichsta ¨tt, Germany) CC 290 Y EIA, PCR Not avaliable
  1. Notes: CC case–control study, CS cross-sectional study