TABLE 3.
Performance of Chagas Detect Plus in whole blood and serum compared to confirmed infection status defined by conventional serology
| Parameter | CDP in serum |
CDP in whole blood |
||
|---|---|---|---|---|
| No. negative | No. positive | No. negative | No. positive | |
| Conventional serologya | ||||
| Negative | 284 | 9 | 170 | 2 |
| Positive | 2 | 290 | 8 | 205 |
| CDP performance | ||||
| Kappa statistic (95% CI) | 0.962 (0.940, 0.984) | 0.948 (0.916, 0.98) | ||
| Sensitivity (95% CI) | 99.3 (97.5, 99.9) | 96.2 (92.7, 98.4) | ||
| Specificity (95% CI) | 96.9 (94.2, 98.6) | 98.8 (95.9, 99.9) | ||
| Positive predictive value (95% CI) | 97.0 (94.4, 98.6) | 99.0 (96.5, 99.9) | ||
| Negative predictive value (95% CI) | 99.3 (97.5, 99.9) | 95.5 (91.3, 98.0) | ||
a
Serological status based on indirect hemagglutination assay, immunofluorescent-antibody test, and enzyme-linked immunosorbent assay. Final status was defined as positive if results were positive by at least two of the three tests and negative if results were positive by none or one of the assays.