Table 6 Performance characteristics of POCTs for syphilis compared to reference assays by site
Sites | Bioline | Chembio | Chembio (MR) | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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 | 74 | 210 | 0 | 20 | 78.72 (69.07–86.49) | 100 (98.08–100) | 0 | 77 | 207 | 0 | 17 | 81.91 (72.63–89.10) | 100 (98.08–100) | 0 | 74 | 210 | 0 | 20 | 78.72 (69.07–86.49) | 100 (98.08–100) |
4002 – Italy 2 | 0 | 56 | 152 | 1 | 21 | 72.37 (60.91–82.01) | 99.24 (95.85–99.98) | 1 | 61 | 146 | 1 | 16 | 78.95 (68.08–87.46) | 99.24 (95.82–99.98) | 1 | 60 | 147 | 1 | 17 | 77.63 (66.62–86.40) | 99.24 (95.82–99.98) |
4005 – Malta | 0 | 81 | 434 | 3 | 45 | 63.41 (54.25–71.91) | 99.23 (97.78–99.84) | 0 | 88 | 427 | 6 | 41 | 66.67 (57.60–74.91) | 98.47 (96.70–99.44) | 0 | 97 | 418 | 7 | 33 | 73.17 (64.43–80.76) | 98.21 (96.36–99.28) |
4006 – Peru 1 | 0 | 163 | 210 | 0 | 24 | 87.17 (81.51–91.60) | 100 (98.04–100) | 0 | 167 | 206 | 0 | 20 | 89.30 (83.97–93.34) | 100 (98.04–100) | 4 | 167 | 202 | 1 | 18 | 90.22 (84.98–94.10) | 99.46 (97.03–99.99) |
4007 – Peru 2 | 0 | 179 | 335 | 1 | 48 | 78.76 (72.85–83.91) | 99.65 (98.08–99.99) | 0 | 194 | 320 | 1 | 33 | 85.40 (80.11–89.73) | 99.65 (98.08,99.99) | 0 | 196 | 318 | 2 | 32 | 85.84 (80.60–90.11) | 99.31 (97.51–99.92) |
4032 – UK | 0 | 60 | 425 | 1 | 65 | 47.58 (38.54–56.74) | 99.72 (98.47–99.99) | 0 | 71 | 414 | 2 | 55 | 55.65 (46.45–64.56) | 99.45 (98.01–99.93) | 0 | 77 | 408 | 3 | 50 | 59.68 (50.49–68.39) | 99.17 (97.59–99.83) |
4034 – Peru 3 | 0 | 56 | 75 | 1 | 15 | 78.57 (67.13–87.48) | 98.36 (91.20–99.96) | 0 | 58 | 73 | 1 | 13 | 81.43 (70.34–89.72) | 98.36 (91.20–99.96) | 0 | 63 | 68 | 3 | 10 | 85.71 (75.29–92.93) | 95.08 (86.29–98.97) |
Fixed effect model | 0 | 669 | 1841 | 7 | 238 | 73.56 (70.28–76.59) | 99.57 (99.03–99.81) | 1 | 716 | 1793 | 11 | 195 | 78.33 (75.24–81.13) | 99.32 (98.70–99.64) | 5 | 734 | 1771 | 17 | 180 | 79.93 (76.91–82.65) | 98.94 (98.23–99.37) |
Meta-analysis (random effects model) | 73.79 (63.98–81.70) | 99.57 (99.09–99.79) |  | 78.60 (69.73–85.41) | 99.48 (98.69–99.80) |  | 80.10 (72.30–86.13) | 99.01 (98.13–99.48) | |||||||||||||
|  | Between sites variability—SD (p-value) | 7.64 (0.0946) | _ | Between sites variability—SD (p-value) | 7.64 (0.0967) | 7.54 (0.5719) | Between sites variability—SD (p-value) | 7.55 (0.1097) | 7.34 (0.7180) | ||||||||||||
|  | DOR | 244.05 (268.89–1546.09) |  | DOR | 401.59 (185.03–871.63) |  | DOR | 704.14 (216.28–2292.50) | |||||||||||||
LR +  | 169.72 (80.18–359.25) | LR +  | 80.72 (42.48–153.37) | LR +  | 151.47 (57.41–399.65) | ||||||||||||||||
LR- | 0.26 (0.19–0.37) | LR- | 0.20 (0.14–0.28) | LR- | 0.22 (0.15–0.31) | ||||||||||||||||