TABLE 6.
C. pneumoniae, L. pneumophila, M. pneumoniae, and P. jirovecii detected or not detected by SoC testing and by Unyvero
| Species | Study arm | No. (%) tested by SoC testing | No. (%) not tested by SoC testing | No. positive by Unyvero and SoC testing/no. positive by SoC testing | PPA (%) (95% CI) | No. negative by Unyvero and SoC testing/no. negative by SoC testing | NPA (%) (95% CI) |
|---|---|---|---|---|---|---|---|
| C. pneumoniae | Prospective | 1 (0.1) | 1,015 (99.9) | 0/0 | 1/1 | 100.0 (20.7–100.0) | |
| Archived | 0 | ||||||
| Total | 0/0 | ||||||
| L. pneumophila | Prospective | 238 (23.4) | 778 (76.6) | 0/1 | 0.0 (0.0–79.3) | 237/237 | 100.0 (98.4–100.0) |
| Archived | 19 | 17/19 | 89.5 (68.6–97.1) | ||||
| Total | 17/20 | 85.0 (64.0–94.8) | |||||
| M. pneumoniae | Prospective | 28 (2.8) | 988 (97.2) | 0/0 | 28/28 | 100.0 (87.9–100.0) | |
| Archived | 6 | 5/6 | 83.3 (43.7–97.0) | ||||
| Total | 5/6 | 83.3 (43.7–97.0) | |||||
| P. jirovecii | Prospective | 105 (10.3) | 911 (89.7) | 5/5 | 100.0 (56.6–100.0) | 99/100a | 99.0 (94.6–99.8) |
| Archived | 19 | 16/19 | 84.2 (62.4–94.5) | ||||
| Total | 21/24 | 87.5 (69.0–95.7) |
a
For one additionally detected P. jirovecii result, analyte presence was confirmed by PCR/sequencing.