Journal ArticleDOI
T2 Magnetic Resonance Assay for the Rapid Diagnosis of Candidemia in Whole Blood: A Clinical Trial
Eleftherios Mylonakis,Cornelius J. Clancy,Luis Ostrosky-Zeichner,Kevin W. Garey,George Alangaden,Jose A. Vazquez,Jeffrey S. Groeger,Marc A. Judson,Yuka Marie Vinagre,Stephen O. Heard,Fainareti N. Zervou,Ioannis M. Zacharioudakis,Dimitrios P. Kontoyiannis,Peter G. Pappas +13 more
TLDR
T2MR is the first fully automated technology that directly analyzes whole blood specimens to identify species without the need for prior isolation of Candida species, and represents a breakthrough shift into a new era of molecular diagnostics.Abstract:
BACKGROUND Microbiologic cultures, the current gold standard diagnostic method for invasive Candida infections, have low specificity and take up to 2-5 days to grow. We present the results of the first extensive multicenter clinical trial of a new nanodiagnostic approach, T2 magnetic resonance (T2MR), for diagnosis of candidemia. METHODS Blood specimens were collected from 1801 hospitalized patients who had a blood culture ordered for routine standard of care; 250 of them were manually supplemented with concentrations from <1 to 100 colony-forming units (CFUs)/mL for 5 different Candida species. RESULTS T2MR demonstrated an overall specificity per assay of 99.4% (95% confidence interval [CI], 99.1%-99.6%) with a mean time to negative result of 4.2 ± 0.9 hours. Subanalysis yielded a specificity of 98.9% (95% CI, 98.3%-99.4%) for Candida albicans/Candida tropicalis, 99.3% (95% CI, 98.7%-99.6%) for Candida parapsilosis, and 99.9% (95% CI, 99.7%-100.0%) for Candida krusei/Candida glabrata. The overall sensitivity was found to be 91.1% (95% CI, 86.9%-94.2%) with a mean time of 4.4 ± 1.0 hours for detection and species identification. The subgroup analysis showed a sensitivity of 92.3% (95% CI, 85.4%-96.6%) for C. albicans/C. tropicalis, 94.2% (95% CI, 84.1%-98.8%) for C. parapsilosis, and 88.1% (95% CI, 80.2%-93.7%) for C. krusei/C. glabrata. The limit of detection was 1 CFU/mL for C. tropicalis and C. krusei, 2 CFU/mL for C. albicans and C. glabrata, and 3 CFU/mL for C. parapsilosis. The negative predictive value was estimated to range from 99.5% to 99.0% in a study population with 5% and 10% prevalence of candidemia, respectively. CONCLUSIONS T2MR is the first fully automated technology that directly analyzes whole blood specimens to identify species without the need for prior isolation of Candida species, and represents a breakthrough shift into a new era of molecular diagnostics. CLINICAL TRIALS REGISTRATION NCT01752166.read more
Citations
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Clinical Practice Guideline for the Management of Candidiasis: 2016 Update by the Infectious Diseases Society of America
Peter G. Pappas,Carol A. Kauffman,David R. Andes,Cornelius J. Clancy,Kieren A. Marr,Luis Ostrosky-Zeichner,Annette C. Reboli,Mindy G. Schuster,Jose A. Vazquez,Thomas J. Walsh,Theoklis E. Zaoutis,Jack D. Sobel +11 more
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Revision and Update of the Consensus Definitions of Invasive Fungal Disease From the European Organization for Research and Treatment of Cancer and the Mycoses Study Group Education and Research Consortium
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TL;DR: These updated definitions of IFDs should prove applicable in clinical, diagnostic, and epidemiologic research of a broader range of patients at high-risk.
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A Guide to Utilization of the Microbiology Laboratory for Diagnosis of Infectious Diseases: 2018 Update by the Infectious Diseases Society of America and the American Society for Microbiology
J. Michael Miller,Matthew J. Binnicker,Sheldon Campbell,Karen C. Carroll,Kimberle C. Chapin,Peter H. Gilligan,Mark D. Gonzalez,Robert C. Jerris,Sue C. Kehl,Robin Patel,Bobbi S. Pritt,Sandra S. Richter,Barbara Robinson-Dunn,Joseph D. Schwartzman,James W. Snyder,Sam R. Telford,Elitza S. Theel,Richard B. Thomson,Melvin P. Weinstein,Joseph D. Yao +19 more
TL;DR: This document, developed by experts in laboratory and adult and pediatric clinical medicine, provides information on which tests are valuable and in which contexts, and on tests that add little or no value for diagnostic decisions.
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Candida albicans - Biology, molecular characterization, pathogenicity, and advances in diagnosis and control - An update.
Maryam Dadar,Ruchi Tiwari,Kumaragurubaran Karthik,Sandip Chakraborty,Youcef Shahali,Kuldeep Dhama +5 more
TL;DR: The present review highlights the etiology, epidemiology, molecular typing, commensalism and virulence factors, along with the appropriate prevention and control strategies regarding this widespread pathogen.
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Epidemiology of Invasive Candidiasis: a Persistent Public Health Problem
TL;DR: Improved non-culture-based diagnostics are needed to expand the potential for preemptive (or early directed) therapy and improve diagnostic, preventive, and therapeutic strategies is necessary to reduce the considerable morbidity and mortality associated with IC.
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