TABLE 3.
Performance summary of the QIAstat-Dx Respiratory Panel for retrospective specimensa
| Analyte | No.b | PPA |
NPA |
||||
|---|---|---|---|---|---|---|---|
| TP/(TP + FN) | % | 95% CI | TN/(TN + FP) | % | 95% CI | ||
| Viruses | |||||||
| Adenovirus | 313 | 9/9 | 100.0 | 70.1–100.0 | 297/304 | 97.8 | 95.4–98.9 |
| Coronavirus 229E | 313 | 26/27 | 96.3 | 81.7–99.3 | 286/286 | 100.0 | 98.7–100.0 |
| Coronavirus HKU1 | 313 | 14/14 | 100.0 | 78.5–100.0 | 298/299 | 99.7 | 98.1–99.9 |
| Coronavirus NL63 | 312 | 24/24 | 100.0 | 86.2–100.0 | 286/288 | 99.3 | 97.5–99.8 |
| Coronavirus OC43 | 310 | 28/28 | 100.0 | 87.9–100.0 | 282/282 | 100.0 | 98.6–100.0 |
| Human metapneumovirus | 313 | 2/2 | 100.0 | 34.2–100.0 | 311/311 | 100.0 | 98.7–100.0 |
| Rhinovirus/enterovirus | 313 | 44/49 | 89.8 | 78.2–95.5 | 254/264 | 96.2 | 92.3–97.9 |
| Influenza A | 313 | 17/17 | 100.0 | 81.5–100.0 | 296/296 | 100.0 | 98.7–100.0 |
| Influenza A H1 | 313 | 0/0 | NAc | NA | 313/313 | 100.0 | 98.8–100.0 |
| Influenza A H1N1/2009 | 312 | 7/8 | 87.5 | 52.9–97.8 | 304/304 | 100.0 | 98.9–100.0 |
| Influenza A H3 | 313 | 8/8 | 100.0 | 67.5–100.0 | 305/305 | 100.0 | 98.8–100.0 |
| Influenza B | 313 | 1/1 | 100.0 | 20.7–100.0 | 312/312 | 100.0 | 98.8–100.0 |
| Parainfluenza virus 1 | 307 | 40/40 | 100.0 | 91.2–100.0 | 267/267 | 100.0 | 98.8–100.0 |
| Parainfluenza virus 2 | 312 | 3/3 | 100.0 | 100.0 | 309/309 | 100.0 | 98.8–100.0 |
| Parainfluenza virus 3 | 313 | 1/4 | 25.0 | 4.6–69.9 | 309/309 | 100.0 | 98.8–100.0 |
| Parainfluenza virus 4 | 302 | 22/24 | 91.7 | 74.2–97.7 | 278/278 | 100.0 | 98.6–100.0 |
| Respiratory syncytial virus | 313 | 11/12 | 91,7 | 64.6–98.5 | 300/301 | 99.7 | 98.4–99.9 |
| Bacteria | |||||||
| Bordetella pertussis | 294 | 33/33 | 100.0 | 89.6–100.0 | 261/261 | 100.0 | 98.5–100.0 |
| Chlamydophila pneumoniae | 311 | 54/61 | 88.5 | 78.2–94.3 | 250/250 | 100.0 | 98.5–100.0 |
| Mycoplasma pneumoniae | 313 | 25/25 | 100.0 | 86.7–100.0 | 287/288 | 99.7 | 98.1–99.9 |
a
These data are presented based on a comparator assay (BioFire FilmArray Respiratory Panel version 1.7) only and do not reflect any discordant analysis.
b
In instances where the internal control failed and was not resolved upon repeat, any target that was “detected” was maintained within the data set and used in performance calculations. All targets that were not detected were considered failed and excluded from the data analysis; therefore, the final N value will vary by analyte.
c
NA, not applicable.