Table 3.
Assay performances with clinical patient samples compared between the developed Anti-HIV-1/2 UCNP-LFA and Alere HIV Combo.
| Anti-HIV UCNP-LFA | Alere HIV Combo (n = 200) | Anti-HIV UCNP-LFA (n = 200) | |
|---|---|---|---|
| Number of tested positive samples | 145 | 100 | 100 |
| Anti-HIV-1 | 123 | 83 | 83 |
| Anti-HIV-2 | 22 | 17 | 17 |
| Number of tested negative samples | 309 | 100 | 100 |
| Number of samples with agreeing results | |||
| True positive | 140 | 98 | 95 |
| Anti-HIV-1 | 81 | 80 | |
| Anti-HIV-2 | 17 | 15 | |
| True negative | 305 | 100 | 100 |
| Number of samples with disagreeing result | |||
| False positive | 4 | 0 | 0 |
| False negative | 5 | 2 | 5 |
| Anti-HIV-1 | 2 | 3 | |
| Anti-HIV-2 | 0 | 2 | |
| Total number of samples | 449 | 10 0 | 100 |
| Sensitivity | 96.6% (95% CI: 92.1–98.8%) |
98.0% (95% CI: 93.0–99.8%) |
95.0% (95% CI: 88.7–98.4%) |
| Anti-HIV-1 detection | - | 97.6% (95% CI: 91.6–99.7%) |
96.4% (95% CI: 89.8–99.3%) |
| Anti-HIV-2 detection | - | 100% (95% CI: 80.5–100%) |
88.2% (95% CI: 63.6–98.5%) |
| Specificity | 98.7% (95% CI: 96.7–99.7%) |
100% (95% CI: 96.4–100%) |
100% (95% CI: 96.4–100%) |