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 |