MedicalResearch.com Interview with:
Minh-Hong Nguyen, MD
Professor of Medicine
Director, Transplant Infectious Diseases
Director, Antimicrobial Management Program
Department of Medicine
University of Pittsburgh School of Medicine
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Blood cultures, the gold standard for diagnosing blood stream infections, are insensitive and limited by prolonged time to results. Early institution of appropriate antibiotics is a crucial determinant of improved outcomes in patients with sepsis and blood stream infections (BSI). For these reasons, development of rapid non-culture diagnostic tests for blood stream infections is a top priority.
The T2Bacteria panel is the first direct from blood, non-culture test cleared by FDA for diagnosis of blood stream infections . It detects within 4-6 hours the 5 most common ESKAPE bacteria that are frequent causes of hospital infection, and which are often multi-drug resistant. This study shows that the T2Bacteria panel rapidly and accurately diagnosed and identified ESKAPE bacterial BSIs, and identified probable and possible BSIs that were missed by blood cultures (in particular among patients who were already receiving antibiotics).
MedicalResearch.com: What should readers take away from your report?
Response: Physicians should understand the advantages and limitations of T2Bacteria panel. The panel should be used in conjunction with blood cultures, in order to provide the best likelihood of diagnosing the cause of bloodstream infection. It is imperative to know the epidemiology of ESKAPE blood stream infections at individual hospitals, and to target T2Bacteria testing to the population of patients at risk and in whom results may impact antibiotic treatment decisions. Integrating the T2Bacteria panel into clinical practice will provide opportunities to enhance patients’ management, but the best use of the test will be in coordination with antimicrobial stewardship teams to assure that results are interpreted quickly and incorporated into real-time decision-making.
MedicalResearch.com: What recommendations do you have for future research as a result of this work?
Response: Now that the test has been proven to have excellence performance, a top priority is to understand how to incorporate the panel into rational patient management and antibiotic stewardship strategies. Other important questions that require future clinical studies are whether T2Bacteria-based strategies improve patients’ outcomes and are cost-efficient.
MedicalResearch.com: Is there anything else you would like to add?
Response: T2Bacteria and its companion test, T2Candida, are the first FDA-cleared diagnostic tests for bacterial and fungal causes of bloodstream infection that do not require cultivation of microbes in blood cultures. By avoiding the need for blood cultures, the tests can shorten time to diagnoses and antimicrobial treatment, and identify cases that may be missed by cultures. As first-of-their-kind, direct-from-blood technologies, T2Bacteria and T2Candida are harbingers of a new era in clinical microbiology and medical practice, in which the diagnosis and treatment of bloodstream infections will be improved by molecular assays that complement traditional cultures.
Performance of the T2Bacteria Panel for Diagnosing Bloodstream Infections
A Diagnostic Accuracy Study
Published: Ann Intern Med. 2019.
M. Hong Nguyen, MD; Cornelius J. Clancy, MD; A. William Pasculle, ScD; Peter G. Pappas, MD; George Alangaden, MD; George A. Pankey, MD; Bryan H. Schmitt, DO; Altaf Rasool, MD; Melvin P. Weinstein, MD; Raymond Widen, MD †; Diana R. Hernandez, PhD; Donna M. Wolk, PhD; Thomas J. Walsh, MD; John R. Perfect, MD; Mollie N. Wilson, MS; Eleftherios Mylonakis, MD
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