Table 2.
Accuracy metrics (point estimates and 95%CIs) of three rapid tests compared to results obtained by enzyme immunoassay ETI-MAK-4® in serum samples according to the characteristics of the study population
| Profile/Manufacturer (n) | TP | FN | TN | FP | Sensitivity | Specificity | PPV | NPV | K |
|---|---|---|---|---|---|---|---|---|---|
| Group I | |||||||||
| Vikia HBsAg ®(371) | 160 | 7 | 204 | 0 | 95.81 % (91.54–98.30) | 100.00 % (98.21–100.00) | 100.00 % (97.72–100.00) | 96.68 % (93.30–98.65) | 96.17 % (93.36–98,98) |
| Imuno-rápido HBsAg® (371) | 157 | 10 | 203 | 1 | 94.01 % (89.27–97.09) | 99.51 % (97.30–99.99) | 99.37 % (96.53–99.98) | 95.31 % (91.53–97.72) | 93.98 % (90.48–97.48) |
| HBsAg Teste rápido® (371) | 156 | 11 | 203 | 1 | 93.41 % (88.53–96.67) | 99.51 % (97.30–99.99) | 99.36 % (96.51–99.98) | 94.86 % (90.99–97.41) | 93.43 % (89.77–97.09) |
| Group II | |||||||||
| Vikia HBsAg ®(881) | 3 | 2 | 875 | 1 | 60.00 % (14.67–94.73) | 99.89 % (99.37–100.00) | 75.00 % (19.42–99.37) | 99.77 % (99.18–99.97) | 66.50 % (28.65–100.00) |
| Imuno-rápido HBsAg® (881) | 3 | 2 | 852 | 24 | 60.00 % (14.67–94.73) | 97.26 % (95.94–98.24) | 11.11 % (23.55–29.18) | 99.77 % (99.16–99,97) | 17.96 % (0.00–49.02) |
| HBsAg Teste rápido® (881) | 3 | 2 | 857 | 19 | 60.00 % (14.67–94.73) | 97.83 % (96.63–98.69) | 13.64 % (29.04–34.94) | 99.77 % (99,16–99.97) | 21.50 % (0.00–54.67) |
| Group III | |||||||||
| Vikia HBsAg ®(251) | 4 | 2 | 245 | 0 | 66.67 % (22.27–95.67) | 100.00 % (98.51–100.00) | 100.00 % (39.76–100.00) | 99.19 % (97.11–99.90) | 79.61 % (51.46–100.00) |
| Imuno-rápido HBsAg® (251) | 4 | 2 | 244 | 1 | 66.67 % (22.27–95.67) | 99.59 % (97.75–99.99) | 80.00 % (28.35–99.49) | 99.19 % (97.11–99.90) | 72.12 % (40.76–100.00) |
| HBsAg Teste rápido® (251) | 4 | 2 | 243 | 2 | 66.67 % (22.27–95.67) | 99.18 % (97.08–99.90) | 66.67 % (22.27–95.67) | 99.19 % (97.11–99.90) | 65.85 % (32.65–99.05) |
| Overall | |||||||||
| Vikia HBsAg ® (1503) | 167 | 11 | 1324 | 1 | 93.82 % (89.21–96.87) | 99.92 % (99.58–100.00) | 99.40 % (96.73–99.98) | 99.18 % (98.53–99.59) | 96.08 % (93.87–98.29) |
| Imuno-rápido HBsAg® (1503) | 164 | 14 | 1299 | 26 | 92.13 % (87.14–95.63) | 98.04 % (97.14–98.71) | 86.32 % (80.57–90.86) | 98.93 % (98.21–99.42) | 87.62 % (83.83–91.41) |
| HBsAg Teste rápido® (1503) | 163 | 15 | 1303 | 22 | 91.57 % (86.50–95.21) | 98.34 % (97.49–98.96) | 88.11 % (82.57–92.39) | 98.86 % (98.13–99.36) | 88.41 % (84.72–92.1) |
Legends: TP True positive, FN False negative, TN True negative, FP False positive, PPV Positive Predictive Value, NPV Negative Predictive Value, k kappa statistics, n number of samples, CI confidence interval