Table 2.
Diagnostic accuracy by HCV core antigen (HCVcAg) index test type for diagnosis of active HCV infection compared to nucleic acid testing as the reference standard. Results from bivariate, univariate, range of studies, and single studies are all reported.
| Index Test | HCV Ab Status | # Studies (# Samples) | Sensitivity 95% CI | Specificity 95% CI | Positive LR 95% CI | Negative LR 95% CI |
|---|---|---|---|---|---|---|
| Abbott ARCHITECT1 | All | 23 (12,670) | 93.4%1 (90.1, 96.5) | 98.8%1 (97.4, 99.5) | 80.6 (36.4, 178.8) | 0.06 (0.04, 0.1) |
| Abbott ARCHITECT2 | All | 33 (13,638) | 94.3%2 (92.8, 95.9) | ND | NA | NA |
| Abbott ARCHITECT1 | Known Ab Positive | 16 (5,246) | 92.5%1 (86.9, 95.8) | 97.8%1 (94.7, 99.1) | 42 (16.4, 106.4) | 0.05 (0.03, 0.08) |
| Abbott ARCHITECT2 | Known Ab positive | 27 (6,189) | 93.4%2 (91.4, 95.4) | ND | NA | NA |
| Abbott ARCHITECT1 | Known Ab Negative | 5 (3,415) | 92.3%1 (3.7, 99.9) | 98.8%1 (97.3, 99.4) | 73.9 (32.6, 167.9) | 0.08 (0.004, 15.7)) |
| Ortho ELISA-Ag1 | All | 5 (1,177) | 93.2%1 (81.6, 97.7) | 99.2%1 (87.9, 100) | 116.5 (6.7, 977) | 0.06 (0.02, 0.07) |
| Ortho ELISA-Ag2 | All | 6 (1,423) | 90.8%2 (83.5, 98.2) | ND | NA | NA |
| EIKEN Lumispot HCV Ag3 | All | 2 (235) | 97.5–98.1%3 | ND | NA | NA |
| Fujirebio Lumipulse Ortho HCV Ag4 | All | 1 (80) | 95.0%4 (90.2, 99.8) | ND | NA | NA |
| Hunan Jynda Bioengineering Group HCV Core Ag ELISA1 | All | 4 (562) | 59.5%1 (46.0, 71.7) | 82.9%1 (58.6, 94.3) | 3.5 (1.1, 12.6) | 0.28 (0.2, 0.3) |
HCV = Hepatitis C Virus, cAg = Core Antigen, Ab = Antibody, CI = Confidence Interval, LR = likelihood ratio, ELISA = enzyme linked immunosorbent assay, ND = no data, NA = Not applicable—if sensitivity and specificity results were not available from meta-analysis, likelihood ratios were not calculated.
Determined by bivariate meta-analysis – “metandi” command in STATA
Determined by univariate meta-analysis – “metan” command in STATA
Meta-analysis not possible, range of results seen across studies reported
Results from one study only