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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)
EIA, Auszyme
Sato, 1996 [42] 462 Japan CC Hospital S Dainascreen
EIA, Auszyme
Abraham, 1998 [20] 450 (50) India, Vellore CC– Panel Hospital patients (Multiply transfused; chronic liver disease; preop and antenatal patients) S QuickChaser
EIA, Auszyme or Hepanostika
(400) CS– Screen
Oh, 1999 [38] 250 Korea CC - Panel Blood donor panel S Genedia
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
EIA, Monolisa
MEIA for discordant
(128) CS S
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
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
EIA, Hepanostika Ultra
(579) Guinea CC Blood donors (491); Stored positives (88) SP
Randrianirina, 2008 [41] 200 Madagascar CC Not specified S Cypress
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
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
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)
(3928) VIKIA
Chameera, 2013 [24] 50 Sri Lanka CS Hospital (surgical, orther) S Cortez
EIA, Surase B-96 (TMB)
Franzeck, 2013 [44] 272 Tanzania, Ifakara CS - CSQ HIV-clinic (ART naïve) WB(ven)
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
Core TM
Rapid care
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 +
(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