Table 1.
RDT | Sensitivity% (n = 150)
|
Specificity% (n = 150)
|
||||
---|---|---|---|---|---|---|
Manufacturer’s SEN* | SEN† | Manufacturer’s SPE* | SPE (95% CI)† | NPV% (95% CI)† | PPV% (95% CI)† | |
Determine | 100 | 100 | 99.9 | 85.2 (77.4, 91.1) | 100 (96.3, 100) | 67.3 (52.9, 79.7) |
STAT-PAK | 100 | 100 | 100 | 99.1 (95.3, 99.9) | 100 (96.8, 100) | 97.2 (85.5, 99.9) |
Uni-Gold | 100 | 100 | 99.7 | 97.4 (92.6, 99.5) | 100 (96.8, 100) | 92.1 (78.6, 98.3) |
First Response | 100 | 100 | 99.2 | 97.4 (92.6, 99.5) | 100 (96.8, 100) | 92.1 (78.6, 98.3) |
Advanced Quality | 100 | 100 | 100 | 100 (96.8, 100) | 100 (96.8, 100) | 100 (90.0, 100) |
PPV = positive predictive value; NPV = negative predictive value; CI = confidence interval; RDT = rapid diagnostic test; SEN = sensitivity; SPE = specificity
Manufacturers’ test characteristic performance (kit inserts) on serum; PPV and NPV dependent on the prevalence of population tested
Evaluation findings