TABLE 6.
Comparison of FilmArray BCID resistance gene results to the prespecified comparator assay (PCR/sequencing directly from blood culture bottle)
| Antimicrobial resistance gene(s) | Isolates detected: BCID/comparator |
No. of results: BCID/comparator |
Sensitivity or PPAa: TP/(TP + FN) (%) | 95% CI | Specificity or NPAa: TN/(TN + FP) (%) | 95% CI | ||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical arm | Seeded arm | TP +/+ | FP +/− | FN −/+ | TN −/− | |||||
| mecA in association with: | ||||||||||
| All Staphylococcus isolates detectedb | 491/494 | 2/2 | 488 | 5 | 8 | 281 | 488/496 (98.4) | 96.8–99.3 | 281/286 (98.3) | 96.0–99.4 |
| Staphylococcus and S. aureus isolates detected | 137/139 | 0/0 | 137 | 0 | 2 | 118 | 137/139 (98.6) | 94.9–99.8 | 118/118 (100) | 96.9–100 |
| vanA/B in association with Enterococcus isolates detected | 36/36 | 28/28 | 64 | 0 | 0 | 67 | 64/64 (100)c | 94.4–100 | 67/67 (100) | 94.6–100 |
| blaKPC in association with Enterobacteriaceae and/or A. baumannii and/or P. aeruginosa isolates detected | 6/6d | 33/33 | 39 | 0 | 0 | 558 | 39/39 (100)e | 91.0–100 | 558/558 (100) | 99.3–100 |
a
Sensitivity and specificity refer to performance with the prospective specimens only. PPA and NPA refer to performance with the seeded specimens. These are unresolved data.
b
Either Staphylococcus or S. aureus isolates detected or both.
c
Of the 64 Enterococcus isolates, 11 (17.2%) carried the vanB gene as determined by bidirectional sequence analysis.
d
All six isolates were identified as K. pneumoniae.
e
These isolates included 30 of K. pneumoniae, 2 of E. cloacae, and 1 of E. coli.