Mylonakis, EleftheriosClancy, Cornelius J.Ostrosky-Zeichner, LuisGarey, Kevin W.Alangaden, George J.Vazquez, Jose A.Groeger, Jeffrey S.Judson, Marc A.Vinagre, Yuka-MarieHeard, Stephen O.Zervou, Fainareti N.Zacharioudakis, Ioannis M.Kontoyiannis, Dimitrios P.Pappas, Peter G.2022-08-232022-08-232015-03-152016-01-13Clin Infect Dis. 2015 Mar 15;60(6):892-9. doi: 10.1093/cid/ciu959. Epub 2015 Jan 12. <a href="http://dx.doi.org/10.1093/cid/ciu959">Link to article on publisher's site</a>1058-4838 (Linking)10.1093/cid/ciu95925586686https://hdl.handle.net/20.500.14038/25760BACKGROUND: 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.en-USAdultAgedAntifungal AgentsCandidaCandida albicansCandida glabrataCandida tropicalisCandidemiaFemaleHumansLimit of DetectionMagnetic Resonance SpectroscopyMaleMiddle AgedReproducibility of ResultsSensitivity and SpecificityAnesthesiologyInfectious DiseaseT2 magnetic resonance assay for the rapid diagnosis of candidemia in whole blood: a clinical trialJournal Articlehttps://escholarship.umassmed.edu/anesthesiology_pubs/1768008790anesthesiology_pubs/176