TABLE 3.
Performance of Xpert Flu+RSV Xpress versus ProFlu+ on NP swab specimens for CLIA-waived sites only
| Specimen type (n)a | Target | No. of results by typeb |
PPA (% [95% CI]) | NPA (% [95% CI]) | |||
|---|---|---|---|---|---|---|---|
| TP | FP | TN | FN | ||||
| Fresh (1,871) | Influenza A virus | 215 | 85 | 1,571 | 0 | 100 (98.3–100) | 94.9 (93.7–95.9) |
| Influenza B virus | 56 | 10 | 1,805 | 0 | 100 (93.6–100) | 99.4 (99.0–99.7) | |
| RSV | 112 | 6 | 1,750 | 3 | 97.4 (92.6–99.5) | 99.7 (99.3–99.9) | |
| Preselected frozen (209) | Influenza A virus | 0 | 4 | 205 | 0 | NAc | 98.1 (95.2–99.5) |
| Influenza B virus | 78 | 2 | 129 | 0 | 100 (95.4–100) | 98.5 (94.6–99.8) | |
| RSV | 31 | 0 | 177 | 1 | 96.9 (83.8–99.9) | 100 (97.9–100) | |
| All NP swabs (2,080) | Influenza A virus | 215 | 89 | 1,776 | 0 | 100 (98.2–100) | 95.2 (94.2–96.1) |
| Influenza B virus | 134 | 12 | 1,934 | 0 | 100 (97.2–100) | 99.4 (98.5–99.7) | |
| RSV | 143 | 6 | 1,927 | 4 | 97.3 (93.2–98.9) | 99.7 (99.3–99.9) | |
a
Fresh, specimen prospectively collected from consented/assented subjects; preselected frozen, specimen deidentified, frozen, and known to be positive or negative for a specific analyte. n, number of specimens.
b
TP, true positive; FP, false positive; TN, true negative; FN, false negative.
c
NA, not applicable.