Multicenter Evaluation of a PCR-Based Digital Microfluidics and Electrochemical Detection System for the Rapid Identification of 15 Fungal Pathogens Directly from Positive Blood Cultures
Open Access
- 23 April 2020
- journal article
- research article
- Published by American Society for Microbiology in Journal of Clinical Microbiology
- Vol. 58 (5)
- https://doi.org/10.1128/jcm.02096-19
Abstract
Routine identification of fungal pathogens from positive blood cultures by culture-based methods can be time-consuming, delaying treatment with appropriate antifungal agents. The GenMark Dx ePlex investigational use only blood culture identification fungal pathogen panel (BCID-FP) rapidly detects 15 fungal targets simultaneously in blood culture samples positive for fungi by Gram staining. We aimed to determine the performance of the BCID-FP in a multicenter clinical study. Blood culture samples collected at 10 United States sites and tested with BCID-FP at 4 sites were compared to the standard-of-care microbiological and biochemical techniques, fluorescence in situ hybridization using peptide nucleic acid probes (PNA-FISH) and matrix-assisted laser desorption ionization–time of flight mass spectrometry (MALDI-TOF MS). Discrepant results were analyzed by bi-directional PCR/sequencing of residual blood culture samples. A total of 866 clinical samples, 120 retrospectively and 21 prospectively collected, along with 725 contrived samples were evaluated. Sensitivity and specificity of detection of Candida species (C. albicans, C. auris, C. dubliniensis, C. famata, C. glabrata, C. guilliermondii, C. kefyr, C. krusei, C. lusitaniae, C. parapsilosis, and C. tropicalis) ranged from 97.1 to 100% and 99.8 to 100%, respectively. For the other organism targets, sensitivity and specificity were as follows: 100% each for Cryptococcus neoformans and C. gattii, 98.6% and 100% for Fusarium spp., and 96.2% and 99.9% for Rhodotorula spp., respectively. In 4 of the 141 clinical samples, the BCID-FP panel correctly identified an additional Candida species, undetected by standard-of-care methods. The BCID-FP panel offers a faster turnaround time for identification of fungal pathogens in positive blood cultures that may allow for earlier antifungal interventions and includes C. auris, a highly multidrug-resistant fungus.Keywords
This publication has 31 references indexed in Scilit:
- Fusariosis, a complex infection caused by a high diversity of fungal species refractory to treatmentEuropean Journal of Clinical Microbiology & Infectious Diseases, 2013
- Evaluation of PNA-FISH Yeast Traffic Light for Rapid Identification of Yeast Directly from Positive Blood Cultures and Assessment of Clinical ImpactJournal of Clinical Microbiology, 2013
- Epidemiology ofRhodotorula: An Emerging PathogenInterdisciplinary Perspectives on Infectious Diseases, 2012
- Clinical Practice Guidelines for the Management of Cryptococcal Disease: 2010 Update by the Infectious Diseases Society of AmericaClinical Infectious Diseases, 2010
- Fusarium Infections in Immunocompromised PatientsClinical Microbiology Reviews, 2007
- Invasive CandidiasisInfectious Disease Clinics of North America, 2006
- Time to Initiation of Fluconazole Therapy Impacts Mortality in Patients with Candidemia: A Multi‐Institutional StudyClinical Infectious Diseases, 2006
- Delaying the Empiric Treatment of Candida Bloodstream Infection until Positive Blood Culture Results Are Obtained: a Potential Risk Factor for Hospital MortalityAntimicrobial Agents and Chemotherapy, 2005
- Early Detection and Identification of Commonly Encountered Candida Species from Simulated Blood Cultures by Using a Real-Time PCR-Based AssayThe Journal of Molecular Diagnostics, 2004
- The Changing Epidemiology of Cryptococcosis: An Update from Population‐Based Active Surveillance in 2 Large Metropolitan Areas, 1992–2000Clinical Infectious Diseases, 2003