TABLE 2.
Monomicrobial call performance comparison with FDA-cleared Accelerate Pheno system software and postclearance 2017 software update
| Parametera | Value for software |
|
|---|---|---|
| FDA-cleared | 2017 software update | |
| No. of total valid samples | 793 | 872 |
| Total no. of MONO by Accelerate PhenoTest BC kit | 557 | 775 |
| Total no. of MONO by Accelerate PhenoTest BC kit and confirmed by reference | 545 | 754 |
| No. of false MONOs | 12 | 21 |
| No. of false MONO, resolved by Gram staining | 10 | 16 |
| No. of false MONO, unresolved by Gram staining | 2 | 5 |
| Positive predictive value (95% CI) | 97.8 (96.3–98.8) | 97.3 (95.9–98.2) |
| Positive predictive value after resolving with Gram staining (95% CI) | 99.6 (98.7–99.9) | 99.4 (98.5–99.7) |
a
MONO, monomicrobial calls. The positive predictive value is the percentage correct.