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 |