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
Acknowledgment: The authors thank the patients who participated in this study; the research staff (Debbie Ashcraft, Kailey Hughes, Theresa Lingg, Ines Hamilton, Fei Chen, Amanda Styer, Michail Alevizakos, Styliani Karanika, and Myrto E. Flokas), who assisted with recruitment and review of medical records; and Drs. Tom Lowery and Joseph E. Marturano for helpful discussions.
Financial Support: By T2 Biosystems.
Disclosures: Dr. Clancy reports other support from T2 Biosystems during the conduct of the study. Dr. Schmitt reports nonfinancial support from T2 Biosystems during the conduct of the study and personal fees from T2 Biosystems outside the submitted work. Dr. Weinstein reports other support from T2 Biosystems during the conduct of the study. Dr. Wolk reports grants from Cepheid, OpGen, Streck, GenMark, La Jolla Pharmaceutical Company, Accelerate Diagnostics, DiaSorin, and Roche and other support from OpGen, Streck, DiaSorin, and Safeguard outside the submitted work. Dr. Perfect reports grants from Pfizer, Merck, Minnetronix, Amplyx, and Mayne; nonfinancial support from Astellas Pharma; and other support from Astellas Pharma, Merck, Viamet, Minnetronix, F2G, Amplyx, Vical, Matinas, and Cidara during the conduct of the study. Authors not named here have disclosed no conflicts of interest. Disclosures can also be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M18-2772.
Editors' Disclosures: Christine Laine, MD, MPH, Editor in Chief, reports that her spouse has stock options/holdings with Targeted Diagnostics and Therapeutics. Darren B. Taichman, MD, PhD, Executive Editor, reports that he has no financial relationships or interests to disclose. Cynthia D. Mulrow, MD, MSc, Senior Deputy Editor, reports that she has no relationships or interests to disclose. Jaya K. Rao, MD, MHS, Deputy Editor, reports that she has stock holdings/options in Eli Lilly and Pfizer. Catharine B. Stack, PhD, MS, Deputy Editor, Statistics, reports that she has stock holdings in Pfizer, Johnson & Johnson, and Colgate-Palmolive. Christina C. Wee, MD, MPH, Deputy Editor, reports employment with Beth Israel Deaconess Medical Center. Sankey V. Williams, MD, Deputy Editor, reports that he has no financial relationships or interests to disclose. Yu-Xiao Yang, MD, MSCE, Deputy Editor, reports that he has no financial relationships or interest to disclose.
Reproducible Research Statement:Study protocol: See the Supplement. Statistical code: Available from Dr. Nguyen (e-mail, firstname.lastname@example.org). Data set: Relevant data are provided in the tables, figures, and appendix materials. More details are available from Dr. Nguyen (e-mail, email@example.com).
Corresponding Author: M. Hong Nguyen, MD, University of Pittsburgh School of Medicine, 3550 Terrace Street, Suite 871, Pittsburgh, PA 15261; e-mail, firstname.lastname@example.org.
Current Author Addresses: Drs. Nguyen and Clancy: University of Pittsburgh School of Medicine, 3550 Terrace Street, Suite 871, Pittsburgh, PA 15261.
Dr. Pasculle and Ms. Wilson: Microbiology Laboratory, UPMC Presbyterian, 3477 Euler Way, Pittsburgh, PA 15213.
Dr. Pappas: University of Alabama at Birmingham, 1900 University Boulevard, 229 THT, Birmingham, AL 35294-0006.
Dr. Alangaden: Henry Ford Hospital, 2799 West Grand Boulevard, CFP 316, Detroit, MI 48202.
Dr. Pankey: Ochsner Health System, 1514 Jefferson Highway, New Orleans, LA 70121.
Dr. Schmitt: Indiana University School of Medicine, 350 West 11th Street, Room 6027D, Indianapolis, IN 46202.
Drs. Rasool and Weinstein: Rutgers Robert Wood Johnson Medical School, 125 Patterson Street, New Brunswick, NJ 08903.
Drs. Hernandez and Wolk: Geisinger Health, 100 North Academy Avenue, Danville, PA 17822.
Dr. Walsh: Weill Cornell Medicine of Cornell University, NewYork–Presbyterian Hospital, 1300 York Avenue, Room A-421, New York, NY 10065.
Dr. Perfect: Duke University Medical Center, Hanes House, Trent Drive, Durham, NC 27710.
Dr. Mylonakis: Division of Infectious Diseases, Rhode Island Hospital, 593 Eddy Street, Physicians Office Building, 3rd Floor, Suite 328/330, Providence, RI 02903.
Author Contributions: Conception and design: M.H. Nguyen, C.J. Clancy, P.G. Pappas, R. Widen, D. Wolk.
Analysis and interpretation of the data: M.H. Nguyen, C.J. Clancy, A.W. Pasculle, G. Alangaden, G.A. Pankey, B.H. Schmitt, A. Rasool, M.P. Weinstein, D.R. Hernandez, J.R. Perfect, E. Mylonakis.
Drafting of the article: M.H. Nguyen, C.J. Clancy, G. Alangaden, G.A. Pankey, B.H. Schmitt, E. Mylonakis.
Critical revision of the article for important intellectual content: M.H. Nguyen, C.J. Clancy, P.G. Pappas, B.H. Schmitt, M.P. Weinstein, D.R. Hernandez, T.J. Walsh, E. Mylonakis.
Final approval of the article: M.H. Nguyen, C.J. Clancy, A.W. Pasculle, P.G. Pappas, G. Alangaden, G.A. Pankey, B.H. Schmitt, A. Rasool, M.P. Weinstein, D.R. Hernandez, D.M. Wolk, T.J. Walsh, J.R. Perfect, M.N. Wilson, E. Mylonakis.
Provision of study materials or patients: M.H. Nguyen, A.W. Pasculle, P.G. Pappas, G. Alangaden, G.A. Pankey, B.H. Schmitt, M.P. Weinstein, R. Widen, D.R. Hernandez, E. Mylonakis.
Statistical expertise: M.H. Nguyen, C.J. Clancy.
Administrative, technical, or logistic support: A.W. Pasculle, R. Widen, D.R. Hernandez, E. Mylonakis.
Collection and assembly of data: M.H. Nguyen, A.W. Pasculle, G.A. Pankey, B.H. Schmitt, A. Rasool, M.P. Weinstein, R. Widen, D.R. Hernandez, M.N. Wilson, E. Mylonakis.
Blood cultures, the gold standard for diagnosing bloodstream infections (BSIs), are insensitive and limited by prolonged time to results. The T2Bacteria Panel (T2 Biosystems) is a direct-from-blood, nonculture test that identifies the most common ESKAPE bacteria (Enterococcus faecium, Staphylococcus aureus, Klebsiella pneumoniae, Pseudomonas aeruginosa, and Escherichia coli).
To assess performance of the T2Bacteria Panel in diagnosing suspected BSIs in adults.
Prospective patient enrollment (8 December 2015 through 4 August 2017).
Eleven U.S. hospitals.
1427 patients for whom blood cultures were ordered as standard of care.
Paired blood culture and T2Bacteria testing.
Performance of T2Bacteria compared with a single set of blood cultures in diagnosing proven, probable, and possible BSIs caused by T2Bacteria-targeted organisms.
Blood culture and T2Bacteria results were positive for targeted bacteria in 3% (39 of 1427) and 13% (181 of 1427) of patients, respectively. Mean times from start of blood culture incubation to positivity and species identification were 38.5 (SD, 32.8) and 71.7 (SD, 39.3) hours, respectively. Mean times to species identification with T2Bacteria were 3.61 (SD, 0.2) to 7.70 (SD, 1.38) hours, depending on the number of samples tested. Per-patient sensitivity and specificity of T2Bacteria for proven BSIs were 90% (95% CI, 76% to 96%) and 90% (CI, 88% to 91%), respectively; the negative predictive value was 99.7% (1242 of 1246). The rate of negative blood cultures with a positive T2Bacteria result was 10% (146 of 1427); 60% (88 of 146) of such results were associated with probable (n = 62) or possible (n = 26) BSIs. If probable BSIs and both probable and possible BSIs were assumed to be true positives missed by blood culture, per-patient specificity of T2Bacteria was 94% and 96%, respectively.
Low prevalence of positive blood cultures, collection of a single set of culture specimens, and inability of T2Bacteria to detect nontargeted pathogens.
The T2Bacteria Panel rapidly and accurately diagnoses BSIs caused by 5 common bacteria.
Nguyen MH, Clancy CJ, Pasculle AW, et al. Performance of the T2Bacteria Panel for Diagnosing Bloodstream Infections: A Diagnostic Accuracy Study. Ann Intern Med. 2019;170:845–852. [Epub ahead of print 14 May 2019]. doi: https://doi.org/10.7326/M18-2772
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Published: Ann Intern Med. 2019;170(12):845-852.
Published at www.annals.org on 14 May 2019
Hospital Medicine, Infectious Disease, Multi-Organ Failure and Sepsis, Pulmonary/Critical Care.
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