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Mortality from candidemia increases with delay in initiating appropriate antifungal therapy. Current diagnostic methods are either time-consuming or nonspecific. However, an assay that uses T2 magnetic resonance (T2MR) has been shown to have high sensitivity and specificity, with results in <3 hours. This technology has been used to develop an automated platform, allowing detection of five Candida species from a single blood specimen without culture or sample preparation. Now, results from a manufacturer-supported study — the first extensive clinical trial of this technology — have been reported.
Participants were inpatients aged 18 to 95 with a blood culture ordered at any of 12 centers between July 2013 and April 2014. Among the 2046 patients who completed the study, 245 (12%) were excluded because of indeterminate T2MR results; in addition, 300 had contrived samples — 250 spiked with various Candida species and 50 Candida-negative controls. The remaining 1501 patients were prospectively followed.
The mean time to a negative result among those prospectively followed was 4.2±0.9 hours for T2MR versus ≥120 hours for standard blood culture. For the four patients with T2MR and blood culture positivity for the same species, the mean time to species identification was 4.4±1.0 hours for T2MR versus 129.9±26.3 hours for standard blood culture (P<0.001). Among the 31 discordant cases, 29 were T2MR-positive and blood culture–negative. Analysis of the spiked specimens revealed an overall sensitivity of 91%, an overall specificity of 99%, and a limit of detection of one to three colony-forming units per mL, depending on the species.
Mylonakis E at al.T2 magnetic resonance assay for the rapid diagnosis of candidemia in whole blood: A clinical trial. Clin Infect Dis 2015 Jan 12; [e-pub ahead of print]. (http://dx.doi.org/10.1093/cid/ciu959)
Comment
As the authors note, the ability to rapidly and accurately exclude the possibility of candidemia can profoundly affect clinical management, and T2MR appears to achieve this goal. In addition, when T2MR is positive, rapid identification of Candida at the species level allows for an informed choice of antifungal agents. However, more clarity on the clinical significance of an indeterminate result would be helpful in defining optimal use of the assay.