Denoyel et al.,15 2004 | France (low) | NR | NR | 5228 participants: 5015 random blood donors and 213 inpatients | Not specified; based on results, all samples underwent both index and reference tests | CLIA (Advia Centaur HCV assay) | MEIA (AxSYM HCV version 3.0 assay, Abbott) |
Tashkandy et al.,22 2007 | Saudi Arabia (high) | Immunology and Serology Department, Al-Noor Specialist Hospital, Makkah; study period NR | NR | 106 male blood donors; samples from patients with diabetes or other endocrine diseases and autoimmune diseases excluded | All samples were aliquoted into 2 portions, 1 for PCR, the other for serological testing | ELISA version 3.0 (Murex anti-HCV, Abbott) | LIA (Inno-LIA HCV Ab III Update, Innogenetics) RT-PCR (high pure viral nucleic acid reagent set, Roche) |
Benouda et al.,23 2009 | Morocco (high) | Workplace blood specimen collection; December 2005 to April 2007 | NR | 8326 adults from general population with unknown HCV serology | Subset of 158/161 ELISA-positive and 100/8165 ELISA-negative adults recalled to undergo reference standard test (verification bias); 3/161 lost to follow-up; interval between tests not specified | ELISA version 3.0 (Murex anti-HCV, Abbott) | MEIA (AxSYM HCV version 3.0 assay, Abbott) RT-PCR (Amplicor HCV version 2.0, Roche) |
Rao et al.,24 2009 | China (high) | Beijing Red Cross Blood Center and Peking University Hepatology Institute; study period NR | Grants from Chinese Basic Research Foundation, National Science and Technology Key Project, and Key Clinical Research Program of Ministry of Health; conflict(s) of interest NR, but 1 author affiliated with Aldatis | 2559 participants: 2082 blood donors and 477 patients including those with various HCV genotypes and non-C hepatitis, pregnant women and lipidemia serum samples | All samples underwent both index and reference tests "side-by-side" | ELISA version 4.0 (EIAgen, Adaltis) | ELISA version 3.0 (HCV version 3.0 ELISA test system, Ortho) |
Ol et al.,25 2009 | Cambodia (moderate) | Rural areas of 2 Cambodian provinces (Battambang and Pailin); May to June 2007 | Sponsored by European Plasma Fraction Foundation and Tromsø Mine Victim Resource Center, University Hospital, North Norway; conflict(s) of interest NR | 1200 potential volunteer blood donors: 677 women, 523 men, mean age 32.8 (range 18-52) yr; sample stratified by province (600 each) | Subset of 80/176 ELISA-positive and 40/1024 ELISA-negative samples selected to undergo reference test (verification bias); all samples underwent both index and reference tests | ELISA version 4.0 (Monolisa, BioRad) | CMIA (Abbott) |
Kosan et al.,26 2010 | Turkey (high) | Turkish Red Crescent Çapa Blood Centre of Istanbul; February 2007 to March 2008 | None declared | 18 200 volunteer blood donors: 546 women, 17 654 men, mean age 40 (range 18-60) yr, 18 198 were first-time donors; participants underwent mandatory physical examination before blood drawing | 2 sets of blood samples collected from each participant: 1 underwent serological testing and the other, NAT testing | ELISA version 3.0 (Innotest HCV Ab III, Innogenetics) | NAT (Procleix Ultrio kit, Chiron) |
Park et al.,27 2012 | South Korea (low) | "Routine HCV screening"; August 2009 to January 2011 | Funding source not reported, but Ortho provided CLIA assay kits; conflict(s) of interest NR | 1011 serum samples from participants undergoing routine HCV screening | Not specified; based on results, all samples underwent both index and reference tests | CLIA (Vitros Anti-HCV assay, Ortho) | ECLIA (Elecsys anti-HCV test, Roche) |
Sommese et al.,28 2014 | Italy (low) | Second University of Naples; January to June 2013 | None declared | 840 volunteer blood donors: 275 women, 564 men,† mean age 37.7 yr | All samples underwent both index and reference tests in parallel | CMIA (Architect i2000SR, Abbott) | ECLIA (Cobas e411, Roche) |
Arora et al.,29 2016 | India (moderate) | Blood bank; January 2013 to March 2014 | None declared | 21 115 blood donors | All samples underwent both index and reference tests in parallel | ELISA version 4.0 (Monolisa HCV Ag-Ab Ultra, BioRad) | NAT (Procleix Ultrio kit, Chiron) |