Table 4 Performance characteristics of POCTs for HIV compared to reference assays by site
| Â | Bioline | Chembio | Chembio (MR) | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sites | I | P | N | FP | FN | Sensitivity (%) | Specificity (%) | I | P | N | FP | FN | Sensitivity (%) | Specificity (%) | I | P | N | FP | FN | Sensitivity (%) | Specificity (%) |
4001 – Italy 1 | 0 | 31 | 252 | 1 | 0 | 100 (88.43–100) | 99.60 (97.82–99.99) | 0 | 35 | 248 | 5 | 0 | 100 (88.43–100) | 98.02 (95.45–99.36) | 0 | 32 | 251 | 2 | 0 | 100 (88.43–100) | 99.21 (97.17–99.90) |
4002 – Italy 2 | 0 | 24 | 184 | 0 | 0 | 100 (85.75–100) | 100 (98.02–100) | 1 | 24 | 183 | 0 | 0 | 100 (85.75–100) | 100 (98.00–100) | 1 | 24 | 183 | 1 | 1 | 95.83 (78.88–99.89) | 99.45 (96.99–99.99) |
4005 – Malta | 0 | 66 | 448 | 0 | 3 | 95.65 (87.82–99.09) | 100 (99.17–100) | 0 | 64 | 450 | 0 | 5 | 92.75 (83.89–97.61) | 100 (99.17–100) | 0 | 64 | 450 | 1 | 6 | 91.30 (82.03–96.74) | 99.78 (98.75–99.99) |
4006 – Peru 1 | 0 | 119 | 257 | 0 | 1 | 99.17 (95.44–99.98) | 100 (98.57–100) | 0 | 120 | 256 | 1 | 1 | 99.17 (95.44–99.98) | 99.61 (97.84–99.99) | 4 | 118 | 254 | 1 | 1 | 99.15 (95.37–99.98) | 99.61 (97.83–99.99) |
4007 – Peru 2 | 0 | 168 | 345 | 0 | 1 | 99.41 (96.75–99.99) | 100 (98.93–100) | 0 | 169 | 344 | 1 | 1 | 99.41 (96.75–99.99) | 99.71 (98.39–99.99) | 0 | 168 | 345 | 0 | 1 | 99.41 (96.75–99.99) | 100 (98.93–100) |
4032 – UK | 1 | 138 | 382 | 1 | 0 | 100 (97.34–100) | 99.74 (98.55–99.99) | 0 | 140 | 381 | 3 | 1 | 99.28 (96.03–99.98) | 99.22 (97.73–99.84) | 0 | 139 | 383 | 2 | 2 | 98.56 (94.90–99.83) | 99.48 (98.13–99.94) |
4034 – Peru 3 | 0 | 54 | 78 | 9 | 2 | 95.74 (85.46–99.48) | 89.41 (80.85–95.04) | 0 | 46 | 86 | 1 | 2 | 95.74 (85.46–99.48) | 98.82 (93.62–99.97) | 0 | 47 | 85 | 2 | 2 | 95.74 (85.46–99.48) | 97.65 (91.76–99.71) |
Fixed effect model | 1 | 600 | 1946 | 11 | 7 | 98.83 (97.60–99.53) | 99.44 (98.99–99.72) | 1 | 598 | 1948 | 11 | 10 | 98.33 (96.73–99.15) | 99.44 (98.93–99.70) | 5 | 592 | 1951 | 9 | 13 | 97.82 (96.09–98.79) | 99.54 (99.06–99.77) |
Meta-analysis (random effects model) | 98.95 (96.83–99.66) | 99.89 (98.48–99.99) |  | 98.66 (96.15–99.54) | 99.55 (98.79–99.84) |  | 98.09 (95.35–99.23) | 99.54 (99.11–99.76) | |||||||||||||
|  | Between sites variability—SD (p-value) | 8.04 (0.5223) | 9.99 (0.2529) | Between sites variability—SD (p-value) | 8.30 (0.3436 | 8.08 (0.4099 | Between sites variability—SD (p-value) | 8.13 (0.3031) | [fixed effect for specificity) | ||||||||||||
|  | DOR | 87,728.21 (3897.99–1,974,412.05) |  | DOR | 16,415.20 (3757.28–71,716.48) |  | DOR | 9656.87 (3789.06–24611.69) | |||||||||||||
LR +  | 925.95 (64.03–13390.24) | LR +  | 220.75 (81.47–598.15) | LR +  | 211.61 (103.69–431.89) | ||||||||||||||||
LR- | 0.01 (0.00–0.03) | LR- | 0.01 (0.01–0.04) | LR- | 0.02 (0.012–0.04) | ||||||||||||||||