Table 2.
Sensitivity of lateral flow devices: Approach 1 (known positives). Estimates based on analysis of 268 individuals self-reporting previous PCR confirmed infection. CI = confidence interval, UI = uncertainty interval based on percentiles from Monte Carlo simulation, TPs = true positives, FNs = false negatives, “Probability best” = the proportion of Monte Carlo simulations in which the test had the highest sensitivity. Note: these AbC-19TM results have been published previously (21) and are reproduced here for comparative purposes.
| Lateral flow immunoassay |
|||||||
| AbC-19TM | Orient Gene 1 band | Orient Gene 2 bands | SureScreen 1 band | SureScreen 2 bands | Biomerica 1 band | Biomerica 2 bands | |
| TPs | 248 | 252 | 252 | 238 | 252 | 253 | 255 |
| FNs | 20 | 16 | 16 | 30 | 16 | 15 | 13 |
| Sensitivity (95% CI) |
92.5% (88.8, 95.1) | 94.0% (90.5, 96.3) | 94.0% (90.5, 96.3) | 88.8% (84.5, 92.0) | 94.0% (90.5, 96.3) | 94.4% (91.0, 96.6) | 95.1% (91.9, 97.1) |
| Rank (95% UI) |
6 (2, 6) |
4 (1, 6) |
4 (1, 6) |
7 (7, 7) |
3 (1, 6) |
3 (1, 6) |
1 (1, 5) |
| Probability best |
0.01 | 0.08 | 0.08 | 0.00 | 0.14 | 0.04 | 0.64 |
| False negatives by days since between symptom onset and blood sample: | |||||||
| Asymptomatic (n=12) | 5 | 3 | 3 | 5 | 4 | 4 | 4 |
| 8-21 days (n=5) | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 22-35 days (n=20) | 1 | 1 | 1 | 2 | 1 | 1 | 1 |
| 36-70 days (n=142) | 6 | 4 | 4 | 12 | 5 | 2 | 1 |
| ≥71 days (n=89) | 8 | 8 | 8 | 11 | 6 | 8 | 7 |