|
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
|
