Table 2. Comparison of the two assay readouts: Fluorescence versus color assessment.
| Positive | Negative | Inconclusive | ||
|---|---|---|---|---|
| Fluorescence | COVID Tt | ≤ 26 min | > 26 min | > 26 min or N/A |
| Actin Tt | ≤ 26 min | ≤ 26 min | > 26 min or N/A | |
| Sample Number | 157 (4.3%) | 3486 (95.4%) | 11 (0.3%) | |
| Color | COVID | Yellow | Pink/Orange | Pink/Orange |
| Actin | Yellow | Yellow | Pink/Orange | |
| Operator 1 | 149 (4.1%) | 3497 (95.7%) | 8 (0.2%) | |
| Operator 2 | 152 (4.2%) | 3491 (95.5%) | 11 (0.3%) | |
| Operator 3 | 152 (4.2%) | 3496 (95.7%) | 6 (0.2%) |
A blinded study was performed on 3,654 samples using two readouts, namely fluorescence and endpoint color. The endpoint color readout was scored by 3 different operators. The number of samples (and percent of total) scored as positive, negative, or inconclusive are shown.