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. 2014 Aug 28;4(3):226–240. doi: 10.1016/j.jceh.2014.07.008

Table 1.

Characteristics of the 27 Studiesa.

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.

a

2 studies44,47 were excluded for duplicate publications.

b

CRS = Cross reactive sera included in serum panel.

c

Neutralization test for all positive sera performed.

d

All positive sera had HBsAg quantification and HBV DNA quantification.

e

Sera collected in Malawi and tested in UK.

f

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.

g

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.

h

Ansari 6 tests: 1. Acon; 2. Atlas; 3. Intec, 4. Blue Cross, 5. DIMA, 6. Cortex.

i

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.