Table 3.
Summary of Clinical Performance Specificity and Sensitivity
| Characteristic, Specimen | Negative | Positive | Negative Agreement |
|
|---|---|---|---|---|
| Samples, Proportion | Percentage (95% CI) | |||
| Specificity | ||||
| Normal serum panels | 131 | 7 | 131/138 | 94.9 (89.8–97.9) |
| Finger stick | 39 | 1 | 39/40 | 97.5 (86.8–99.9) |
| Whole-blood replicates | 226 | 8 | 226/234 | 96.6 (93.4–98.5) |
| Serum replicates | 200 | 49 | 200/249 | 80.3 (93.4–98.5) |
| Positive Agreement |
||||
| Samples, Proportion | Percentage (95% CI) | |||
| Spiked sensitivity, ng/test | ||||
| Whole blood | ||||
| 9.4 | 46 | 71 | 71/117 | 60.7 (51.2–69.6) |
| 18.8 | 2 | 90 | 90/92 | 97.8 (92.2–99.7) |
| Serum | ||||
| 4.7 | 16 | 123 | 107/123 | 92.9 (79.8–91.9) |
| 9.4 | 6 | 93 | 93/99 | 93.9 (87.2–97.4) |
Abbreviation: CI, confidence interval.