Table 1.
Characteristics of the Studies Included in Meta-Analysis for Antibody Detection.
| Year | Author | HCV-GT | HIV status | Country | Age (years) | Males (%) | Assay in DBS samples | Gold standard | Sample (n) | HCV-infected (n) | Se (%) | Sp (%) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| ELISA | ||||||||||||
| 2013 | Brandao et al.25 | — | No | Brazil | 40 | 43.8 | Monolisa HCV AgAb ULTRA Assay (Bio-Rad) | Monolisa HCV AgAb ULTRA Assay (Bio-Rad) | 386 | 40 | 95 | 100 |
| 2013 | Brandao et al.25 | — | No | Brazil | 40 | 43.8 | Murex HCV AgAb combination EIA (Diasorin) | Murex HCV AgAb combination EIA (DiaSorin) | 386 | 40 | 82.5 | 98 |
| 2006 | Croom et al.26 | — | No | Australia | — | — | Monolisa anti-HCV PLUS Version 2 EIA (Bio-Rad) | Monolisa anti-HCV PLUS Version 2 EIA (Bio-Rad) | 183 | 75 | 100 | 100 |
| 2014 | Dokubo el al27 | — | No | USA | < 30 | — | ELISA HCV Version 3.0 (Ortho-Clinical Diagnostics) | Third-generation ELISA or CLA (Unspecified) | 148 | 77 | 70.1 | 100 |
| 2017 | Flores et al.28 | — | Yes | Brazil | 50.9 | 52 | Murex anti-HCV (DiaSorin) | Murex anti-HCV (DiaSorin) | 524 | 278 | 92.1 | 99.2 |
| 2003 | Judd et al.29 | — | Yes | UK | — | — | HCV 3.0 SAVe ELISA (Ortho-Clinical Diagnostics) | HCV 3.0 SAVe ELISA (Ortho-Clinical Diagnostics) | 633 | 252 | 99.2 | 100 |
| 2013 | Kania et al.30 | — | No | Burkina Faso | 29.8 | 37.2 | Monolisa HCV Ab-Ag ULTRA Assay (Bio-Rad) | Monolisa HCV Ab-Ag ULTRA Assay (Bio-Rad) | 218 | 5 | 100 | 100 |
| 2012 | Larrat et al.31 | — | Yes | France | 46.5 | 61.9 | Monolisa HCV Ab-Ag ULTRA Assay (Bio-Rad) | Monolisa HCV Ab-Ag ULTRA Assay (Bio-Rad) | 201 | 113 | 98.2 | 100 |
| 2013 | Lima41 | — | No | Brazil | 38.5 | 39.8 | Murex anti-HCV v.4.0, (DiaSorin) | Murex anti-HCV v.4.0 (DiaSorin) | 1043 | 7 | 57.1 | 100 |
| 2013 | Lima41 | — | No | Brazil | 38.5 | 39.8 | Murex anti-HCV v.4.0, (DiaSorin) | Murex anti-HCV v.4.0 (DiaSorin) | 491 | 5 | 40.0 | 99.8 |
| 2013 | Lima41 | — | No | Brazil | 38.5 | 39.8 | Murex anti-HCV v.4.0, (DiaSorin) | Murex anti-HCV v.4.0 (DiaSorin) | 254 | 228 | 91.7 | 92.3 |
| 2016 | Marques et al.32 | 1b, 1a, 3 | No | Brazil | 47.3 | 43.5 | HCV Ab (RADIM diagnostic) | HCV Ab (RADIM diagnostic) | 99 | 59 | 94.9 | 100 |
| 2012 | Marques et al.33 | — | No | Brazil | 40 | 43.8 | HCV Ab (RADIM diagnostic) | HCV Ab (RADIM diagnostic) | 411 | 40 | 97.5 | 99.5 |
| 2012 | Marques et al.33 | No | Brazil | 40 | 43.8 | ETI-AB-HCVK-4 (DiaSorin) | ETI-AB-HCVK-4 (DiaSorin) | 411 | 45 | 88.9 | 96.1 | |
| 1999 | McCarron et al.34 | — | No | UK | Monolisa anti-HCV (Sanofi Pasteur) | AxSYM HCV version 3.0 (Abbott Diagnostics) | 220 | 108 | 100 | 87.5 | ||
| 2014 | Nandagopal et al.35 | — | No | India | — | — | Anti-HCV ELISA (Murex Biotech S.A) | Anti-HCV ELISA (Murex Biotech S.A) | 60 | 31 | 100 | 100 |
| 2001 | O’Brien42 | No | USA | 44.8 | 38 | Third-generation EIA in DBS | Third-generation EIA in blood | 1090 | 404 | 98.3 | 100 | |
| 2012 | Rice et al.43 | — | No | UK | — | — | Chiron V3.0 SaVE assay (Ortho-Clinical Diagnostics) | Unspecified | 93 | 59 | 98.3 | 100 |
| 2016 | Soulier et al.9 | 1, 2, 3, 4, 5a, 6 | No | France | 54 | 55.2 | aHCV VITROS ECi (Ortho-Clinical Diagnostics) | aHCV VITROS ECi (Ortho-Clinical Diagnostics) | 511 | 341 | 99.1 | 98.2 |
| 2015 | Tejada-Strop et al.36 | 1a, 1c, 2, 3 | No | USA | — | — | HCV 3.0 EIA (Ortho-Clinical Diagnostics) | HCV 3.0 EIA (Ortho-Clinical Diagnostics) | 103 | 52 | 90 | 100 |
| 2010 | Tuaillon et al.37 | 1, 2, 3, 4 | Yes | France | — | — | HCV 3.0 EIA (Ortho-Clinical Diagnostics) | HCV 3.0 EIA (Ortho-Clinical Diagnostics) | 200 | 100 | 99 | 98 |
| 2018 | Vázquez-Morón et al.24 | 1a, 1b, 2, 3, 4, 5 | Yes | Spain | 44.3 | 66.9 | Murex anti-HCV kit, v.4.0 (DiaSorin,) | ADVIA Centaur® HCV assay | 139 | 108 | 92.6 | 100 |
| Chemiluminescence immunoassays | ||||||||||||
| 2016 | Mössner et al.38 | — | Yes | Denmark | — | — | Architect anti-HCV assay (Abbott Diagnostics) | Architect anti-HCV assay (Abbott Diagnostics) | 404 | 116 | 96.6 | 100 |
| 2013 | Ross et al.39 | — | No | Germany | — | — | Architect anti-HCV assay (Abbott Diagnostics) | Architect anti-HCV assay (Abbott Diagnostics) | 339 | 179 | 97.8 | 100 |
| 2015 | Tejada-Strop et al.36 | 1a, 1c, 2, 3 | No | USA | — | — | VITROS anti-HCV IgG CLA (Ortho-Clinical Diagnostics) | VITROS anti-HCV IgG CLA (Ortho-Clinical Diagnostics) | 103 | 52 | 92 | 100 |
| Rapid diagnostic tests | ||||||||||||
| 2012 | Larrat et al.31 | — | Yes | France | 46.5 | 61.9 | OraQuick HCV Rapid Antibody Test (OraSure Technologies) | Monolisa HCV AbAg ULTRA Assay (Bio-Rad) | 201 | 113 | 97.4 | 100 |
| 2016 | Poiteau et al.40 | 1a, 1b, 2, 3a, 4, 6 | No | France | — | — | OraQuick HCV Rapid Antibody Test (OraSure Technologies) | aHCV VITROS ECi (Ortho-Clinical Diagnostics | 207 | 139 | 100 | 100 |
| 2016 | Poiteau et al.40 | 1a, 1b, 2, 3a, 4, 6 | No | France | — | — | First Response® HCV Card Test (Premier Medical Corporation Ltd) | aHCV VITROS ECi (Ortho-Clinical Diagnostics | 207 | 139 | 99.3 | 100 |
| 2016 | Poiteau et al.40 | 1a, 1b, 2, 3a, 4, 6 | No | France | — | — | Assure HCV Rapid Test (MP Diagnostics) | aHCV VITROS ECi (Ortho-Clinical Diagnostics | 207 | 139 | 98.6 | 100 |
| 2016 | Poiteau et al.40 | 1a, 1b, 2, 3a, 4, 6 | No | France | — | — | MultiSure HCV Antibody Assay (MP Diagnostics) | aHCV VITROS ECi (Ortho-Clinical Diagnostics) | 207 | 139 | 98.6 | 100 |
Abbreviations: Ab, antibody; Ag, antigen; Anti-HCV, HCV antibodies; CLA, chemiluminescence assay; DBD, dried blood spot; EIA, enzyme immunoassay; ELISA, enzyme-linked immunosorbent assay; GT, genotype; HCV, hepatitis C virus; HIV, human immunodeficiency virus; Se, sensitivity; Sp, specificity; TMA, transcription mediated amplification.