| Author, year | Index test | Serological reference test | No. of TP | No. of FP | No. of FN | No. of TN | Pr, % | % (95% CI) | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sn | Sp | PPV | NPV | FP rate | FN rate | ||||||||
| Immunoassays that detect only antibodies to HCV | |||||||||||||
| Denoyel et al.,15 2004 | CLIA (Advia Centaur HCV assay) | MEIA (AxSYM HCV version 3.0 assay, Abbott) | NR | 9 | NR | 5199 | - | - | 99.8 (99.7-99.9) | - | - | 0.2 (0.1-0.3) | - |
| Tashkandy et al.,22 2007 | ELISA version 3.0 (Murex anti-HCV, Abbott) | LIA (Inno-LIA HCV Ab III Update, Innogenetics) | 19 | 1 | 8* | 78 | 25.5 | 70.4 (53.1-87.6) | 98.7 (96.3-100) | 95.0 (85.4-100) | 90.7 (84.6-96.8) | 1.3 (0-3.7) | 29.6 (12.4-46.9) |
| Benouda et al.,23 2009 | ELISA version 3.0 (Murex anti-HCV, Abbott) | MEIA (AxSYM HCV version 3.0 assay, Abbott) | 100 | 58 | 0 | 100 | 38.8 | 71.6 (13.6-97.6)† | 99.3 (99.0-99.5)† | 63.3 (55.8-70.8) | 100 (100-100) | 0.7 (0.5-1.0)† | 28.4 (2.4-86.4)† |
| Park et al.,27 2012 | CLIA (Vitros Anti-HCV assay, Ortho) | ECLIA (Elecsys anti-HCV test, Roche) | 213 | 3 | 1 | 794 | 21.2 | 99.5 (98.6-100) | 99.6 (99.2-100) | 98.6 (97.1-100) | 99.9 (99.6-100) | 0.4 (0-0.8) | 0.5 (0-1.4) |
| Sommese et al.,28 2014 | CMIA (Architect i2000SR, Abbott) | ECLIA (Cobas e411, Roche) | 17 | 8 | 2 | 813 | 2.3 | 89.5 (75.7-100) | 99.0 (98.4-99.7) | 68.0 (49.7-86.3) | 99.8 (99.4-100) | 1.0 (0.3-1.6) | 10.5 (0-24.3) |
| Immunoassays that detect both antibodies to HCV and viral antigen | |||||||||||||
| Rao et al.,24 2009 | ELISA version 4.0 (EIAgen, Adaltis) | ELISA version 3.0 (HCV version 3.0 ELISA test system, Ortho) | 216 | 4 | 10 | 2329 | 8.8 | 95.6 (92.9-98.3) | 99.8 (99.7-100) | 98.2 (96.4-99.9) | 99.6 (99.3-99.8) | 0.2 (0-0.3) | 4.4 (1.7-7.1) |
| Ol et al.,25 2009 | ELISA version 4.0 (Monolisa, BioRad) | CMIA (Abbott) | 77 | 3 | 6 | 34 | 69.2 | 52.4 (34.1-70.1)† | 99.2 (96.4-99.8)† | 96.3 (92.1-100) | 85.0 (73.9-96.1) | 0.8 (0.2-3.6)† | 47.6 (29.9-65.9)† |
Note: CI = confidence interval, CLIA = chemiluminescent immunoassay, ECLIA = electrochemiluminescent immunoassay, CMIA = chemiluminescent microparticle immunoassay, ELISA = enzyme-linked immunosorbent assay, FN = false-negative result, FP = false-positive result, HCV = hepatitis C virus, LIA = line immunoassay, MEIA = microparticle enzyme immunoassay, NAT = nucleic acid amplification test, NPV = negative predictive value, NR = not reported, PCR = polymerase chain reaction, PPV = positive predictive value, Pr = prevalence, RT-PCR = reverse-transcription polymerase chain reaction, Sn = sensitivity, Sp = specificity, TN = true-negative result, TP = true-positive result.
*The authors reported the number of samples positive on the recombinant immunoblot assay as 22 ± 5 (i.e., 5 borderline-positive samples) and excluded those 5 samples from their analyses, whereas the preferred and more conservative analysis would include the 5 borderline samples, so that the number of false-negative results is 8 rather than 3.
†Adjusted for verification bias.31