Skip to main content

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