Table 5.
Test | Number of specimens* |
Specimen Type |
Sensitivity % (95% CI) |
Specificity % (95% CI) |
CLIA Classification |
---|---|---|---|---|---|
OraQuick ADVANCE Rapid HIV- 1/2 Antibody Test |
>3,700 | Oral fluid | 99.3 (98.4−99.7) |
99.8 (99.6−99.9) |
Waived |
>1,100 | Whole Blood | 99.6 (98.5−99.9) |
100 (99.7−100) |
Waived | |
>1,400 | Plasma | 99.0 (98.9−99.8) |
99.9 (99.6−99.9) |
Moderate | |
Uni-Gold Recombigen HIV |
>1,000 | Whole Blood | 100 (99.5−100) |
99.7 (99.0−100) |
Waived |
>1,000 | Serum/Plasma | 100 (99.5−100) |
99.8 (99.3−100) |
Moderate | |
Reveal G-3 Rapid HIV-1 Antibody Test |
>3,300 | Serum | 99.8 (99.2−100) |
99.1 (98.8−99.4) |
Moderate |
>500 | Plasma | 99.8 (99.0−100) |
98.6 (98.4−98.8) |
Moderate | |
MultiSpot HIV-1/HIV-2 Rapid Test |
Serum | 100 (99.94−100) |
99.93 (99.79−100) |
Moderate | |
Plasma | 100 (99.94−100) |
99.9 (99.77−100) |
Moderate | ||
Clearview HIV 1/2 STAT-PAK or Clearview COMPLETE* HIV 1/2 |
>1,300 | Whole Blood | 99.7 (98.9−100) |
99.9 (99.6−100) |
Waived |
>1,300 | Serum/Plasma | 99.7 (98.9−100) |
99.9 (99.6−100) |
Moderate |
Exact number of specimens varies for sensitivity and specificity estimates; see text for details.