639. Performance Characteristics of an FDA Cleared Multiplex Panel for the Rapid Identification of Fungal Pathogens From Positive Blood Culture

BACKGROUND: Routine identification of fungal pathogens from positive blood cultures by conventional culture-based methods can be time-consuming, delaying effective treatment of appropriate antifungal agents. The GenMark Dx ePlex(®) Investigational Use Only Blood Culture Identification Fungal Pathogen Panel (BCID-FP) was assessed in a multicenter study to determine the performance of all 15 fungal targets on the BCID-FP sample-to-answer cartridge, which incorporates extraction, amplification, digestion, hybridization and detection using GenMark eSensor(®) technology, in approximately 100 minutes. METHODS: Ten sites across the United States collected samples that were tested at 4 clinical sites comparing the BCID-FP to traditional culture, MALDI-TOF MS, microbiological and biochemical techniques. Discrepant results were analyzed by a bi-directional PCR/sequencing directly in residual blood culture samples. Sensitivity and specificity were determined for each fungal target. RESULTS: A total of 725 contrived samples along with 120 retrospective and 21 prospective collected (fresh/frozen) clinical samples were tested with the BCID-FP. Of the 11 Candida species on the panel (C. albicans, C. auris, C. dubliniensis, C. famata, C. glabrata, C. guilliermondii, C. kefyr, C. krusei, C. lusitaniae, C. parapsilosis, and C. tropicalis), sensitivity and specificity ranged from 97.1 to 100% and 99.8 to 100%, respectively. For the other organisms detected on the panel, sensitivity and specificity were 100% for both Cryptococcus neoformans and C. gattii. Sensitivity and specificity for Fusarium sp. and Rhodotorula sp. were 98.6% and 100% and 96.2% and 99.9%, respectively. In 4 of the 141 clinical samples, the ePlex BCID-FP panel correctly identified an additional Candida species that was undetected by traditional methods. CONCLUSION: The ePlex BCID-FP panel offers a faster turnaround time than a standard of care methods for the detection of important fungal pathogens in positive blood cultures in a time frame that may allow for earlier antifungal interventions. The BCID-FP panel also is the only FDA-cleared panel available to date containing the highly anti-fungal drug-resistant C. auris target. DISCLOSURES: All authors: No reported disclosures.