TABLE 2.
Comparison of FDA-cleared molecular methods for detection of microorganisms in positive blood culture broths
| Test | Targets | Sensitivity (%) | Specificity (%) | Time to result (h) | Format and setup | References |
|---|---|---|---|---|---|---|
| Verigene BC-GP | 12 Gram-positive genus or species targets and 3 resistance markers (mecA, vanA, vanB) | 92–100 | 98–100 | 2.5 | On-demand, microarray, automated sample processor, manual transfer of array to analyzer | 95–97, 107 |
| Verigene BC-GN | 8 Gram-negative genus or species targets and 6 resistance markers (KPC, NDM, CTX-M, VIM, IMP, OXA) | 81–100 | 98–100 | 2 | On-demand, microarray, automated sample processor, manual transfer of array to analyzer | 101, 102 |
| FilmArray BCID | 8 Gram-positive, 11 Gram-negative, and 5 yeast genus or species targets, 4 resistance markers (mecA, vanA/B, KPC, NDM) | 88–100 | 94–100 | 1 | On-demand, parallel miniaturized singleplex RT-PCR, full sample-to-result capability | 85, 90 |
| GeneOHM StaphSR | S. aureus, MRSA | 50–100 | 98–99 | 2 | Batch, RT-PCR, offline manual sample lysis, extraction, and RT-PCR setup | 63, 78–80 |
| Xpert MRSA/SA Blood Culture | S. aureus, MRSA | 69–100 | 98–100 | 1 | On-demand, RT-PCR, full sample-to-result capability | 259–261 |
| Septifasta | 6 Gram-positive, 8 Gram-negative, and 5 yeast targets and A. fumigatus | 42–79 | 67–97 | 6 | Batch, 1.5–10 ml whole blood; offline extraction and setup of 3 parallel RT-PCRs | 75–77 |
a
Not cleared by FDA for clinical use. Data are from direct analysis of whole blood.