Table 1.
Sensitivity, Specificity, Positive and Negative Predictive Values of Rapid and Immunoassay Tests.
| Tests Performed (N) | Sensitivity (95% CI) | Specificity (95% CI) | Positive Predictive Value (95% CI) |
Negative Predictive Value (95% CI) |
|
|---|---|---|---|---|---|
| Determine™ HIV−1/2a | 72,196 | n =401 | n =71,795 | n = 388 | n =71,808 |
| 88.78 | 99.96 | 91.75% | 99.94% | ||
| (85.27, 91.70) | (99.94, 99.97) | (88.56, 94.29) | (99.92, 99.95) | ||
| OraQuick® ADVANCEa | 16,854 | n = 26 | n = 16,828 | n = 17 | n = 16,837 |
| 61.54% | 99.99% | 94.12% | 99.94% | ||
| (40.57, 79.77) | (99.97, 100.00) | (71.31, 99.85) | (99.89, 99.97) | ||
| Uni-Gold™ Recombigen®a | 61,075 | n =389 | n =60,686 | n = 352 | n =60,723 |
| 85.86% | 99.97% | 94.89% | 99.91% | ||
| (82.00, 89.17) | (99.95, 99.98) | (92.04, 96.94) | (99.88, 99.93) | ||
| FDA-Approved Determine™ Combob | 229 | n = 71 | n = 158 | n = 19 | n = 210 |
| 23.94% | 98.73% | 89.47% | 74.29% | ||
| (14.61, 35.54) | (95.50, 99.85) | (66.86, 98.70) | (67.82, 80.05) | ||
| CE-Marked HIV Combob | 229 | n = 71 | n = 158 | n = 32 | n = 197 |
| 42.25% | 98.73% | 93.75% | 79.19% | ||
| (30.61, 54.56) | (95.50, 99.85) | (79.19, 99.23) | (72.84, 84.63) | ||
| GS HIV−1/2 + O EIAb | 229 | n = 71 | n = 158 | n = 23 | n = 206 |
| 30.99% | 99.37% | 95.65% | 76.21% | ||
| (20.54, 43.08) | (96.52, 99.98) | (78.05, 99.89) | (69.80, 81.85) | ||
| GS HIV Combo Ag/Ab EIAb | 229 | n = 71 | n = 158 | n = 42 | n = 187 |
| 57.75% | 99.37% | 97.62% | 83.96% | ||
| (45.44, 69.39) | (96.52, 99.98) | (87.43, 99.94) | (77.90, 88.91) |
a
Tests performed at trial sites during VOICE using fingerstick or venous-collected whole blood.
b
Tests performed as part of post-trial analysis using stored plasma.