Abstract

BackgroundT2Bacteria assay uses T2 magnetic resonance (T2MR) technology for the rapid diagnosis of bacterial bloodstream infections (BSIs). This FDA cleared technology can detect 5 of the most prevalent pathogens causing bacteremia (Escherichia coli, Staphylococcus aureus, Klebsiella pneumoniae, Pseudomonas aeruginosa, and Enterococcus faecium). Because the significance of discordant results between the T2Bacteria assay and blood culture (BC) remains a challenge, in this case series we reviewed the medical records of patients who had a positive T2Bacteria test and a concurrent negative BC.MethodsAmong 233 participants, we identified 20 patients with 21 (9%) discordant T2Bacteria-positive/BC-negative (T2+/BC-) results. We classified these results based on clinical cultures and clinical evidence.ResultsWhen we analyzed these 21 discordant results in-depth, 11 (52.5%) fulfilled criteria for probable BSI, 4 (19%) for possible BSI, and 6 (28.5%) were presumptive false positives. Among the probable/possible BSIs, discordant results were often associated with patients diagnosed with closed space and localized infections [pyelonephritis (n = 7), abscess (n = 4), pneumonia (n = 1), infected hematoma (n = 1), and osteomyelitis (n = 1)]. Also, within the preceding 2 days of the T2+/BC- blood sample, 80% (16/20) of the patients had received at least one dose of an antimicrobial agent which was active against the T2Bacteria-detected pathogen.ConclusionsIn the majority of discrepant results, the T2Bacteria assay detected a plausible pathogen that was supported by clinical and/or microbiologic data. Discrepancies appear to be associated with closed space and localized infections and the recent use of effective antibacterial agents. The clinical significance and potential implications of such discordant results should be further investigated.

Highlights

  • T2Bacteria assay uses T2 magnetic resonance (T2MR) technology for the rapid diagnosis of bacterial bloodstream infections (BSIs)

  • The sensitivity and specificity of the T2Bacteria assay were determined based on the results of concurrent blood culture, which is the standard of care for diagnosing BSIs

  • In this study we reviewed in detail patients with discordant T2+/blood culture (BC)- results, in an effort to evaluate the robustness of T2Bacteria positive results, in the context of a concurrent negative BC

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Summary

Introduction

T2Bacteria assay uses T2 magnetic resonance (T2MR) technology for the rapid diagnosis of bacterial bloodstream infections (BSIs) This FDA cleared technology can detect 5 of the most prevalent pathogens causing bacteremia (Escherichia coli, Staphylococcus aureus, Klebsiella pneumoniae, Pseudomonas aeruginosa, and Enterococcus faecium). The US Food and Drug Administration (FDA) cleared the T2Bacteria assay (T2 Biosystems, Lexington, MA) This diagnostic panel is capable of detecting 5 important ESKAPE pathogens (Escherichia coli, Staphylococcus aureus, Klebsiella pneumoniae, Pseudomonas aeruginosa, and Enterococcus faecium), by using T2 magnetic resonance (T2MR) directly on whole blood samples. These pathogens represent the majority of healthcare-associated infections and often exhibit multiple drug resistance [5,6,7]. Discordant T2Bacteria-positive/blood culture (BC)-negative results (T2+/BC-) represented 10% (146/1427) of all reported tests [8], while the clinical significance of these results is still undetermined

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