Background:
Use of molecular techniques to accurately identify the infectious disease is well established. Molecular techniques like PCR or RT PCR rely on specific gene targets in a designated pathogen for detection. In contrast, PCR with universal targets along with Next generation sequencing can cover a broad range of organisms including anerobic, fastidious and slow growing organisms and is not limited to a single organism or panel of pathogens. The Bactfast product from Credence Genomics has been previously evaluated for the diagnosis of infections in the clinical samples and showed sensitivity of 91.8% when compared with conventional cultures. The aim of this study is to evaluate the use of Bactfast and Fungifast for the diagnosis of infectious disease in a clinical ICU setting while using conventional culture as a gold standard.
Methods:
Clinical samples from sterile sites including blood were collected and processed using Bactfast and Fungifast product. Results were compared with conventional culture techniques including MALDI-TOF (VITEK-MS, Biomerieux), VITEK-2 compact.
Results:
A total of 490 samples were processed, 111 samples processed with Bactfast showed concordance with culture positive results. 322 samples and 472 samples processed with Bactfast and Fungifast respectively showed a concordance with culture negative results. Bactfast showed sensitivity of 94.1% and specificity of 86.6% compared with culture results. Only 12 fungal culture positives were observed in the total of 490, which is not sufficient to calculate the sensitivity of Fungifast and further studies required.
Conclusion:
Since the fungal culture positive samples are low, the sensitivity of the Fungifast could not be concluded in this study. However, it is clear that these products can be used for the diagnosis of infectious agents within 36 hours in the sterile samples and blood where there are limitations to culture. Furthermore, as these products are designed as pan bacterial and fungal assays, it is a versatile tool that is able to identify rare pathogens as well as conventional microbes. Therefore, Bactfast and Fungifast are useful diagnostic tools for use in the clinical ICU setting.