Advertisement

The T2Bacteria Assay Is a Sensitive and Rapid Detector of Bacteremia That Can Be Initiated in the Emergency Department and Has Potential to Favorably Influence Subsequent Therapy

      Abstract

      Background

      Bacteremia causes a major worldwide burden, in terms of financial and productivity costs, as well the morbidity and mortality it can ultimately cause. Proper treatment of bacteremia is a challenge because of the species-dependent response to antibiotics. The T2Bacteria Panel is a U.S. Food and Drug Administration–cleared and culture-independent assay for detection of bacteremia, including common ESKAPE pathogens—Escherichia coli, Enterococcus faecium, Staphylococcus aureus, Klebsiella pneumoniae, and Pseudomonas aeruginosa—and provides species identification in as little as 3.6 h directly from blood.

      Objective

      Our aim was to evaluate the T2Bacteria assay performance and potential to affect patient care in the emergency department (ED).

      Methods

      ED patients from a Louisiana and Florida center were enrolled as part of the T2Bacteria Panel clinical study, which was prospective and noninterventional. Blood samples for blood culture (BC) and T2Bacteria were matched in time and anatomic location.

      Results

      Data from 137 ED patients were evaluated. Relative to BC, T2Bacteria showed 100% positive percent agreement and 98.4% negative percent agreement. In addition, for species on the T2Bacteria Panel, the T2Bacteria assay detected 25% more positives associated with infection, and on average identified the infectious species 56.6 h faster. The T2Bacteria assay covered 70.5% of all species detected by BC. Finally, relative to actual care, the T2Bacteria assay could have potentially focused therapy in 8 patients, reduced time to a species-directed therapy in 4 patients, and reduced time to effective therapy in 4 patients.

      Conclusions

      In this ED population, the T2Bacteria assay was a rapid and sensitive detector of bacteremia from common ESKAPE pathogens and showed the theoretical potential to influence subsequent patient therapy, ranging from antibiotic de-escalation to faster time to effective therapy.

      Keywords

      To read this article in full you will need to make a payment

      Purchase one-time access:

      Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
      One-time access price info
      • For academic or personal research use, select 'Academic and Personal'
      • For corporate R&D use, select 'Corporate R&D Professionals'

      Subscribe:

      Subscribe to Journal of Emergency Medicine
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect

      References

        • Kumar A.
        • Roberts D.
        • Wood K.E.
        • et al.
        Duration of hypotension before initiation of effective antimicrobial therapy is the critical determinant of survival in human septic shock.
        Crit Care Med. 2006; 34: 1589-1596
        • Perez K.K.
        • Olsen R.J.
        • Musick W.L.
        • et al.
        Integrating rapid pathogen identification and antimicrobial stewardship significantly decreases hospital costs.
        Arch Pathol Lab Med. 2013; 137: 1247-1254
        • Huang A.M.
        • Newton D.
        • Kunapuli A.
        • et al.
        Impact of rapid organism identification via matrix-assisted laser desorption/ionization time-of-flight combined with antimicrobial stewardship team intervention in adult patients with bacteremia and candidemia.
        Clin Infect Dis. 2013; 57: 1237-1245
        • Perez K.K.
        • Olsen R.J.
        • Musick W.L.
        • et al.
        Integrating rapid diagnostics and antimicrobial stewardship improves outcomes in patients with antibiotic-resistant Gram-negative bacteremia.
        J Infect. 2014; 69: 216-225
        • Paul M.
        • Shani V.
        • Muchtar E.
        • Kariv G.
        • Robenshtok E.
        • Leibovici L.
        Systematic review and meta-analysis of the efficacy of appropriate empiric antibiotic therapy for sepsis.
        Antimicrob Agents Chemother. 2010; 54: 4851-4863
        • Tabak Y.P.
        • Vankeepuram L.
        • Ye G.
        • Jeffers K.
        • Gupta V.
        • Murray P.R.
        Blood culture turnaround time in US acute care hospitals and implications for laboratory process optimization.
        J Clin Microbiol. 2018; 56
        • Seymour C.W.
        • Liu V.X.
        • Iwashyna T.J.
        • et al.
        Assessment of clinical criteria for sepsis: for the Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3).
        JAMA. 2016; 315: 762-774
        • Seymour C.W.
        • Gesten F.
        • Prescott H.C.
        • et al.
        Time to Treatment and mortality during mandated emergency care for sepsis.
        N Engl J Med. 2017; 376: 2235-2244
      1. National action plan for combating antibiotic-resistant bacteria. The White House, Washington, DC2015
        • Clancy C.J.
        • Nguyen M.H.
        T2 magnetic resonance for the diagnosis of bloodstream infections: charting a path forward.
        J Antimicrob Chemother. 2018; 73: iv2-iv5
        • Opota O.
        • Jaton K.
        • Greub G.
        Microbial diagnosis of bloodstream infection: towards molecular diagnosis directly from blood.
        Clin Microbiol Infect. 2015; 21: 323-331
        • Finegold S.M.
        • White M.L.
        • Ziment I.
        • Winn W.R.
        Rapid diagnosis of bacteremia.
        Appl Microbiol. 1969; 18: 458-463
        • Minejima E.
        • Wong-Beringer A.
        Implementation of rapid diagnostics with antimicrobial stewardship.
        Expert Rev Anti Infect Ther. 2016; 14: 1065-1075
        • Boucher H.W.
        • Talbot G.H.
        • Bradley J.S.
        • et al.
        Bad bugs, no drugs: no ESKAPE! An update from the Infectious Diseases Society of America.
        Clin Infect Dis. 2009; 48: 1-12
        • Nguyen M.H.
        • Clancy C.J.
        • Pasculle A.W.
        • et al.
        Performance of the T2Bacteria Panel for diagnosing bloodstream infections. A Diagnostic accuracy study.
        Ann Intern Med. 2019; 170: 845-852
        • Wilson E.B.
        Probable inference, the law of succession, and statistical inference.
        J Am Stat Assoc. 1927; 22: 209-212
        • Seabold S.
        • Perktold J.
        Statsmodels: Econometric and Statistical Modeling with Python.
        in: Proceedings of the 9th Python in Science Conference. 57. 2010: 61
        • Jones E.
        • Oliphant E.
        • Peterson P.
        SciPy.
        Open Source Scientific Tools for Python, 2001
        scipy.org
        Date accessed: February 17, 2019
        • Clancy C.J.
        • Pappas P.G.
        • Vazquez J.
        • et al.
        Detecting Infections Rapidly and Easily for Candidemia Trial, Part 2 (DIRECT2): a prospective, multicenter study of the T2Candida Panel.
        Clin Infect Dis. 2018; 66: 1678-1686
        • Beyda N.D.
        • Amadio J.
        • Rodriguez J.R.
        • et al.
        In vitro evaluation of BacT/Alert FA blood culture bottles and T2Candida assay for detection of Candida in the presence of antifungals.
        J Clin Microbiol. 2018; 56
        • Hall K.K.
        • Lyman J.A.
        Updated review of blood culture contamination.
        Clin Microbiol Rev. 2006; 19: 788-802
        • Metzgar D.
        • Frinder M.W.
        • Rothman R.E.
        • et al.
        The IRIDICA BAC BSI assay: rapid, sensitive and culture-independent identification of bacteria and candida in blood.
        PLoS One. 2016; 11: e0158186
        • Ozenci V.
        • Patel R.
        • Ullberg M.
        • Stralin K.
        Demise of polymerase chain reaction/electrospray ionization-mass spectrometry as an infectious diseases diagnostic tool.
        Clin Infect Dis. 2018; 66: 452-455
        • Karanika S.
        • Paudel S.
        • Grigoras C.
        • Kalbasi A.
        • Mylonakis E.
        Systematic review and meta-analysis of clinical and economic outcomes from the implementation of hospital-based antimicrobial stewardship programs.
        Antimicrob Agents Chemother. 2016; 60: 4840-4852
        • Zervou F.N.
        • Zacharioudakis I.M.
        • Pliakos E.E.
        • Grigoras C.A.
        • Ziakas P.D.
        • Mylonakis E.
        Adaptation of cost analysis studies in practice guidelines.
        Medicine (Baltimore). 2015; 94: e2365
        • Ohji G.
        • Doi A.
        • Yamamoto S.
        • Iwata K.
        Is de-escalation of antimicrobials effective? A systematic review and meta-analysis.
        Int J Infect Dis. 2016; 49: 71-79
        • Caliendo A.M.
        Editorial commentary: rapid blood culture identification: the value of a randomized trial.
        Clin Infect Dis. 2015; 61: 1081-1083
        • Caliendo A.M.
        • Gilbert D.N.
        • Ginocchio C.C.
        • et al.
        Better tests, better care: improved diagnostics for infectious diseases.
        Clin Infect Dis. 2013; 57: S139-S170