Table 1.
Author (Reference) | Year | Location | Index test | Reference standard | Study design | Source | Size | Patient population | CRSb | Analytical analysis |
---|---|---|---|---|---|---|---|---|---|---|
Nakata29 | 1990 | NK | Hybritch | EIA | Cross sectional | Prison inmates | 300 | NK | No | No |
Sato15 | 1996 | Japan | Dainascreen | EIA | Case control | Hospital samples | 462 | NK | NK | Yes; Dainabot panel |
Mvere30 | 1996 | Zimbabwe | SimpliRed, Dipstick (PATH) | EIA | Cross sectional | Blood Bank | 206 | NK | No | No |
Abraham31 | 1998 | India | Virucheck, QuickChaser | ELISA | Cross sectional | NK | 400 | NK | No | No |
Oh32 | 1999 | Korea | Genedia | EIA | Case control | Blood donors | 250 | NK | NK | No |
Palmer33 | 2000 | Honduras, Dominican Republic Trinidad, Jamaica | Determine | EIA | Case control | NK | 298 | NK | No | No |
Kaur34 | 2000 | India | Hepacard | EIA | Cross sectional | Hospital samples | 2754 | NK | Nil | No |
Lien35 | 2000 | Vietnam | Dainascreen, Determine, Serodia | EIA | Case control | High risk volunteers | 328 | NK | Yes, 128 sera | No |
WHO11 | 2001 | Global | Ten testsg | EIAc | Serum panel study (Case control) | Africa, Asia, Europe, Latin America | 277 | Well described | No | Low titer panel, Seroconversion panel |
Raj36 | 2001 | India | Hepacard | EIA/MEIA | Cross sectional | Hospital samples | 1000 | NK | No | No |
Clement16 | 2002 | Belgium | BinaxNOW | MEIA | Cross sectional | Hospital samples | 942 | Chronic hepatitis | No | in-house standards sera panel |
Lau37 | 2003 | USA | BinaxNOW | EIA | Cross sectional | Criminals, Hepatology clinic, Health fair, | 2463 | NK | Fresh & frozen sera | No |
Whang38 | 2005 | Korea | Daewoong, Genedia | MEIA | Case control | NK | 200 | NK | No | No |
Cha39 | 2006 | Korea | Asan, Genedia, SD | MEIA | Case Control | NK | 40 | NK | No | No |
Akanmu40 | 2006 | Nigeria | Binax Now | ELISA | Cross sectional | Donors | 101 | HBV carriers | No | No |
Ansari41 | 2007 | Iran | 6 testsh | EIA/PCR | Case control | Hospital Patients | 240 | NK | No | No |
ICBS12 | 2007 | Global | 19 testsi | ICBS panel testingf | Serum panel study (Case control) | ICBS master panelf | 346 | NK | No | ICBS Quantitative panel |
Lin17 | 2008 | China, Guinea | Determine, DRW | EIA | Case Control | Blood donors (Stanford & Ghana) | 1250 | NK | No | WHO sera, Seroconversion panel |
Randrianirina42 | 2008 | Madagascar | Cypress, Determine, Hexagon, Virucheck | EIA | Case control | NK | 200 | NK | No | No |
Torane43 | 2008 | India | Hepacard | ELISA | Case control | Blood bank | 60 | NK | No | No |
Ola45 | 2009 | Nigeria | GWHB | ELISA | Cross sectional | Medical clinic | 25 | NK | No | No |
Davies46 | 2010 | Malawie | Determine | EIAc | Cross sectional | HIV clinic | 75 | NK | HIV | No |
Khan13 | 2010 | Pakistan | OneCheck, Accurate | ELISA | Case control | NK | 57 | NK | No | No |
Maity48 | 2012 | India | Hepacard, Span, SD | ELISAc | Case control | NK | 100 | NK | No | No |
Bottero49 | 2013 | France | Determine, QuickProfile VIKIA | ELISAd | Cross sectional | Health care centers | 3956 | NK | No | No |
Franzeck50 | 2013 | Tanzania | Determine | EIA | Cross sectional | HIV Clinic | 272 | Chronic carriers | HIV | No |
Chemeera51 | 2013 | Sri Lanka | Cortez Onsite | EIA | Cross sectional | Hospital samples | 50 | NK | No | No |
NK = Not known or not specified in the report, EIA = Enzyme immunoassay, MEIA = Micro-particle enzyme immunoassay, ELISA = Enzyme-Linked Immunosorbent Assay, PCR = Polymerase Chain Reaction.
2 studies44,47 were excluded for duplicate publications.
CRS = Cross reactive sera included in serum panel.
Neutralization test for all positive sera performed.
All positive sera had HBsAg quantification and HBV DNA quantification.
Sera collected in Malawi and tested in UK.
ICBS clinical master panel sera were collected in blood banks from diverse regions of world and have been extensively analyzed by serology, HBV DNA, HBV genotyping, HBV subtyping and sequencing.
WHO 10 tests: 1. Advanced, 2. Determine, 3. DoubleCheck, 4. Genedia, 5. HEP B STAT-PAK, 6. Hepacard, 7. Immunocomb II, 8. Rapid, 9. Serodia, 10. Unigold.
Ansari 6 tests: 1. Acon; 2. Atlas; 3. Intec, 4. Blue Cross, 5. DIMA, 6. Cortex.
ICBS 19 tests: 1. Acon, 2. Assure, 3. Bioline, 4. Cassette, 5. Cypress, 6. Determine, 7. Equipar, 8. HBsAg (WB), 9. Hepacard, 10. Hep-Alert-B, 11. HepaScan, 12. Hep-Check-1 Miniclip, 13. Hep-Check-1 Strip, 14. i + LAB, 15. Line test, 16. Newmarket, 17. QuickChaser, 18. QuickTest, 19. SD.