Table 3.
Performance evaluation of commercial HBeAg RDTs using a plate ELISA as a reference test
| Diagnostic performance characteristics (95% confidence interval) | |||
|---|---|---|---|
| SD BIOLINE HBeAg (Alere) | HBeAg serum rapid test (Creative Diagnostics) | HBeAg Rapid Test (Biopanda Reagents) | |
| Overall (n = 194) | |||
| κ statistica | 1.0 (1.0–1.0) | 0.96 (0.92–1.0) | 0.89 (0.80–0.98) |
| Sensitivity (%) | 27.7 (15.6–42.6) | 72.3 (57.4–84.4) | 53.2 (38.1–67.9) |
| Specificity (%) | 100 (97.5–100) | 99.3 (96.3–100) | 95.9 (91.3–98.5 |
| Community study (n = 100) | |||
| κ statistic a | 1.0 (1.0–1.0) | 1.0 (1.0–1.0) | 0.71 (0.41–1.0) |
| Sensitivity (%) | 36.4 (10.9–69.2) | 63.6 (30.8–89.1) | 36.4 (10.9–69.2) |
| Specificity (%) | 100 (95.9–100) | 100 (95.9–100) | 98.9 (93.9–100) |
| Positive predictive value (%) | 100 (39.8–100) | 100 (59–100) | 80.0 (28.4–99.5) |
| Negative predictive value (%) | 92.7 (85.6–97.0) | 95.7 (89.4–98.8) | 92.6 (85.4–97.0) |
| Diagnostic accuracy (%) | 93.0 (86.1–97.1) | 96.0 (90.1–98.9) | 92.0 (84.8–96.5) |
| Hospital study (n = 94) | |||
| κ statistica | 1.0 (1.0–1.0) | 0.95 (0.88–1.0) | 0.92 (0.83–1.0) |
| Sensitivity (%) | 25.0 (12.1–42.2) | 75.0 (57.8–87.9) | 58.3 (40.8–74.5) |
| Specificity (%) | 100 (93.8–100) | 98.3 (90.8–100) | 91.4 (81.0–97.1) |
| Positive predictive value (%) | 100 (66.4–100) | 96.4 (81.7–99.9) | 80.8 (60.6–93.4) |
| Negative predictive value (%) | 68.2 (57.2–77.9) | 86.4 (75.7–93.6) | 77.9 (66.2–87.1) |
| Diagnostic accuracy (%) | 71.3 (61.0–80.1) | 89.4 (81.3–94.8) | 78.7 (69.1–86.5) |
Abbreviations: AROC Area under the receiver operating curve, RDT rapid diagnostic test, ELISA enzyme linked immunosorbent assay
aCohens’ κ statistic demonstrates inter-rater agreement