Performance of the T2Bacteria Panel for Diagnosing Bloodstream Infections. A Diagnostic Accuracy Study
M. Hong Nguyen, C.J. Clancy, A. William Pasculle, P.G. Pappas, G. Alangaden, G.A. Pankey, B.H. Schmitt, A. Rasool, M.P. Weinstein, R.Widen, D.R. Hernandez, D.M. Wolk, T. J. Walsh, J.R. Perfect, M. N. Wilson, and E. Mylonakis.
What is sepsis? The definition of sepsis is described as a serious condition resulting from the presence of harmful microorganisms in the blood or other tissues and the body’s response to their presence, potentially leading to the malfunctioning of various organs, shock, and death.
Sepsis may begin with a blood infection, and the clinician’s treatment for sepsis most often today is the initiation of empiric therapy, a probability-based approach with broad-spectrum antibiotics for sepsis in the absence of species-specific information about the cause of sepsis. Despite the successes of empiric therapy, it is still severely limited by a lack of actionable diagnostic information, with studies demonstrating that up to 40% of blood infections receive incorrect treatment.
Blood infections or bloodstream infections (BSI) leading to sepsis are associated with significant morbidity and mortality, and the timely administration of appropriate antibiotics improves outcomes.1, 2 While blood culture is considered the gold standard for diagnosing blood infections, it has several well-documented limitations, including suboptimal sensitivity and long turnaround time. Given the limitations of blood culture, it may be more accurate and timely to use composite microbiologic data and clinical criteria in administering faster and targeted therapy to the patient.
The T2Bacteria® Panel (T2Bacteria) prospective multicenter pivotal clinical trial evaluated the performance of T2Bacteria for diagnosing blood infections as compared to blood culture. The prospective trial included 1427 unique adult patients who were suspected of blood infections and had a diagnostic blood culture ordered per standard of care at 11 U.S. medical centers. Paired blood culture and T2Bacteria blood samples were drawn from each patient, with the blood culture samples drawn first. T2Bacteria sepsis test target organisms include those responsible for >50% of bloodstream infections: E. faecium, S. aureus, K. pneumoniae, P. aeruginosa, and E. coli.3
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1. Seymour CW et al. N Engl J Med 2017;376:2235-44. 2. Kumar A et al. Crit Care Med. 2006 Jun;34(6):1589-96. 3. Pien BC et al. Am J Med. 2010 Sep;123(9):819-28.
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Sepsis has been included in the federal budget, thanks to the advocacy of organizations like @EndSepsis. The budget directs funding for comprehensively studying the burden of sepsis in the US healthcare system and a review of sepsis quality measures.