Table 2.
Performance characteristics of 12 different testing kits granted with emergency authorization status by the FDA. Source: Author calculations based on publicly available FDA dataset at https://www.fda.gov/medical-devices/emergency-situations-medical-devices/eua-authorized-serology-test-performance?mod=article_inline.
| Test characteristic | Min | Median | Mean | Max | |
|---|---|---|---|---|---|
| True positive rate () | Point estimate | 77.4% | 91.1% | 90.6% | 100% |
| 95% CI, low endpoint | 60.2% | 81% | 80.1% | 95.8% | |
| 95% CI, high endpoint | 88.5% | 96.7% | 95.3% | 100% | |
| False positive rate () | Point estimate | 0% | 0.35% | 1.07% | 5.6% |
| 95% CI, low endpoint | 0% | 0.1% | 0.52% | 2.7% | |
| 95% CI, high endpoint | 0.3% | 1.6% | 3.18% | 11.1% | |