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Table 2 Study characteristics of rapid-diagnostic tests (RDTs) against laboratory reference standards [RDT vs EIA]

From: Diagnostic accuracy of tests to detect hepatitis B surface antigen: a systematic review of the literature and meta-analysis

Study [author, year]

Total participants, n (substudy size, n)

Location [country, city]

Study design

Setting

Sample

RDT under evaluation [type, brand]

Reference test [type, brand]

Mvere, 1996 [36]

206

Zimbabwe

CS

Blood Bank

S

Dipstick (PATH)

SimpliRed

EIA, Auszyme

Sato, 1996 [42]

462

Japan

CC

Hospital

S

Dainascreen

Serodia

EIA, Auszyme

Abraham, 1998 [20]

450

(50)

India, Vellore

CC– Panel

Hospital patients (Multiply transfused; chronic liver disease; preop and antenatal patients)

S

QuickChaser

Virucheck

EIA, Auszyme or Hepanostika

(400)

CS– Screen

Oh, 1999 [38]

250

Korea

CC - Panel

Blood donor panel

S

Genedia

Serodia

EIA, Cobas Core

Kaur, 2000 [30]

2754

India

CS - CSQ

Hospital Surgery patients; blood donors; patients ruling out HBV

S

Hepacard

EIA, Ortho 3rd generation

Lien, 2000 [33]

328

(328)

Vietnam

CC

High risk volunteers High-risk volunteers; pregnant women; patients with other infectious diseases (including 10 with HIV); preselected HBsAg pos (101), HBsAg neg (99)

SP

Dainascreen

Determine

Serodia

EIA, Monolisa

MEIA for discordant

(128)

CS

S

P

WB

Determine

Raj, 2001 [40]

999

India, Vellore

CS

Hospital laboratory samples (emergency preop screening; antenatal women in labour; haemodialysis; urgent donor screening)

S

Hepacard

EIA, Auszyme

MEIA, AxSYM v2

Clement, 2002 [27]

942

Belgium

CC

Hospital - Patients with biopsy proven HBV; healthy volunteers from a vaccine evaluation trial; blood donors

WB, S

BinaxNOW

MEIA, AxSYM v2

Lau, 2003 [32]

2463

(1011)

USA

CS - CSQ

Hepatology clinics

S fresh

BinaxNOW

EIA, ETI-MAK2

(827)

CS

Incarcerated offenders

S frozen

(625)

CS - CSQ

Chinese Community Health Fair (random patients); known HBV-positive patients (liver clinic)

WB

Akanmu, 2006 [21]

137

(101)

Nigeria, Lagos

CS - CSQ

Blood donors (male)

WB

BinaxNOW

ELISA, Monolisa

(36)

Chronic liver disease

Nyirendra, 2008 [37]

194

Malawi

CS - CSQ

Hospital Hospital patients including 152 HIV+

P

Determine

EIA, Bioelisa

Neutralisation (positives)

Lin, 2008 [34]

1250

(671)

China

CC

Blood donors (500); Clinical specimens HBsAg + (171)

S

Determine

DRW

EIA, Hepanostika Ultra

(579)

Guinea

CC

Blood donors (491); Stored positives (88)

SP

Randrianirina, 2008 [41]

200

Madagascar

CC

Not specified

S

Cypress

Determine

Hexagon

Virucheck

EIA, AxSYM

Ola, 2009 [39]

80

(25)

Nigeria

CS - CSQ

Medical clinic

WB

AMRAD GWHB

ELISA, Wellcozyme Kit

(55)

Blood donors

S

Biotec Latex

Khan, 2010 [31]

57

Pakistan

CC

NS

S

Accurate

Onecheck

ELISA, 2nd generation

Davies, 2010 [26]

75

Malawi

CS - CSQ

HIV-positive adults (ART naïve)

S

Determine

EIA, Biokit

Neutralisation (positives)

Bjoerkvoll, 2010 [22]

2400

(1200)

Cambodia

CS - CSQ

General screen - Blood donors (rural)

S

ACON

EIA, Monolisa Ultraa

(1200)

Vietnam

Geretti, 2010 [47]

838

Ghana, Kumasi

CS - CSQ

HIV-clinic (1/3 lamivudine)

S

Determine

VIKIA

CMIA, Architect/ Liason

EIA, Murex v3

Hoffman, 2012 [45]

973

South Africa

CS - CSQ

HIV-positive adults (ART naïve) - Antenatal or primary care

WB (cap)

Determine

ELISA, AxSYM

Bottero, 2013 [23]

3956

(2472)

France, Paris

CS - CSQ

General Screening (healthcare centres) [General population prevention, screening, vaccination]

WB(ven)

Determine

ELISA, Monolisa Ultra

Neutralisation (positives)

(3922)

QUICK PROFILE

(3928)

VIKIA

Chameera, 2013 [24]

50

Sri Lanka

CS

Hospital (surgical, orther)

S

Cortez

Onsite

EIA, Surase B-96 (TMB)

Franzeck, 2013 [44]

272

Tanzania, Ifakara

CS - CSQ

HIV-clinic (ART naïve)

WB(ven)

P

Determine

EIA, Murex v3

Neutralisation (positives)

Chevaliez, 2014 [25]

1768

(558)

Various

CC

Chronic Hep B (known mutants, blood donors); HBsAg negative (mix, including HIV, 34; HCV, 48)

SP

DRW v2.0

CMIA, Architect

(408)

CS

Acute hepatitis

(802)

CS

Pregnant - women at delivery

Erhabor, 2014 [28]

130

Nigeria, Sokoto

CC

Blood donors

SP

ACON

ELISA, HBsAg Ultra

Gish, 2014 [29]

297

Australia, Melbourne

CS - CSQ

At risk Health fairs, outreach; Vietnamese (72%)

S

Nanosign

EIA, Quest Diagnostics

Honge, 2014 [46]

438

Guinea-Bissau

CS - CSQ

HIV clinic - mixed ART/ naïve

S

VEDA LAB

CMIA, Architect

Liu, 2014 [14]

250

China

CC

Hospital patients; outpatients

(Preselected based on CMIA quantitative results)

S

Intec One Step

CMIA, Architect

Mutocheluh, 2014 [35]

150

Ghana

CS - CSQ

Blood donors

P

Abon

Acull-Tell

Core TM

Rapid care

Wondfo

ELISA, Human Gesellschaft

Upretti, 2014 [43]

347

Nepal

CS - CSQ

Children - pre and post vaccination; mothers (8)

S

SD Bioline

EIA, Surase B-96 (TMB)

Njai, 2015 [18]

1000

(178)

Gambia

CS

Hepatitis patients CHB carriers (study 3), incl 3 co-infected HIV (treatment naïve)

S

Determine

CMIA (quantitative), Architect

(203)

Espline

(773)

CS - CSQ

General Community Screen

WB

Determine

EIA (DBS), AxSym +

Neutralisation

(476)

VIKIA

  1. aValidated random sample with CMIA, Abbott
  2. ART antiretroviral therapy, CC case-control study, CHB chronic hepatitis B, CMIA chemiluminescent microparticle enzyme immunoassay, CS cross-sectional study, CSQ consecutive patients, DBS dried blood spot, ECLIA electrochemiluminescent immunoassay, EIA enzyme immunoassay, ELISA enzyme linked immunosorbent assay, HBV hepatitis B virus, HCV hepatitis C virus, HIV human immunodeficiency virus, MEIA microparticle enzyme immunoassay, S serum, P plasma, WB (cap) capillary whole blood, WB (ven) venous whole blood