In the Lab

Rapid species-specific diagnostics direct from whole blood complements blood culture methods

Hospital laboratories face ever-increasing pressure for cost control as well as demands from clinicians for faster diagnostic results. Until now, laboratories have had to rely on methods that were introduced almost 100 years ago to determine the presence and identification of bacterial and fungal infections.

Results in hours instead of days: New direct-from-whole blood T2Direct Diagnostics™ have been proven to complement traditional blood culture methods by identifying the most common and deadly organisms resistant to empiric therapy. With T2Direct Diagnostics tools, laboratories can now provide species-specific results in 3 to 5 hours instead of 1 to 5 or more days. The benefits include more rapid targeted treatments for patients,* a potential to de-escalate drug use, and length of stay.

Automated, compact convenience: Designed with the laboratory in mind, the T2Dx® Instrument fits within the most space-constrained environment. The fully automated, walkaway T2Dx is a clinical multiplex benchtop diagnostic system capable of running tests directly from 3-4 mL of whole blood. The T2Dx is:

  • Rapid: Species-specific results in 3 to 5 hours with no upfront sample preparation.
  • Easy to operate: Fully automated system with minimal hands-on time.
  • Accurate: >90% sensitivity, >98% specificity with limit of detection as low as 1 CFU/mL using only 4 mL of blood.1
  • One instrument, multiple applications: Runs the FDA-cleared and CE-marked T2Bacteria® and T2Candida® Panels.
  • FDA-cleared and CE-marked, peer-reviewed, clinically validated diagnostics: T2Direct Diagnostics are the first and only FDA-cleared and CE-marked diagnostic tests that identify bloodstream infections directly from whole blood. These tests have a proven clinical sensitivity of 90-100% for 10 bacterial and fungal pathogens: C. albicans, C. tropicalis, C. parapsiolosis, C. krusei, C. glabrata, E. coli, E. faecium, K. pneumoniae, A. baumanni, P. aeruginosa, and S. aureus.1,2
  • Coming soon- rapid detection of resistance markers: The T2Resistance® Panel detects 13 resistance genes from both gram-positive and gram-negative pathogens. These include detection of the most clinically important carbapenem resistance genes (KPC, OXA-48, NDM, VIM, IMP); detection of CTXM-14 and CTXM-15, a major source of extended spectrum beta lactamases (ESBLs); detection of the AmpC beta-lactamase genes (CMY, DHA); detection of vanA/B resistance genes, which are responsible for vancomycin resistant gram-positive enterococcus; and the detection of the methicillin resistance genes mecC and mecA, which cause methicillin resistant Staphylococcus aureus (MRSA). This panel is expected to be CE-marked by the end of 2019.

Industry resources: For more information on T2Direct Diagnostics, see the latest publications, posters, and white papers. Learn how about T2 Biosystems' T2MR® technology works or read in the Medical Laboratory Observer’s cover story and the Healio Infectious Disease News story.

* Henry Ford Health System demonstrated patients tested with the T2Candida Panel were treated in a median of 5 hours – more than an eightfold improvement compared to blood culture.3 Similarly, Lee Health found the time to initiation of appropriate antifungal therapy was only 6 hours from the time of blood draw in the T2Candida-positive patients.
‡ T2Direct Diagnostics tools can help de-escalate therapy, leading to pharmacy savings and reduced nephrotoxic side effects on patients. Hospitals, including Lee HealthHuntsville Hospital, and University of Pittsburgh Medical Center have reported antifungal savings that more than covered the full cost of testing at their institutions, with as much as a 2.1 day reduction of micafungin therapy per patient.4,5,6 

Contact us to request a demo of the T2Dx Instrument!

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1. Mylonakis E, et al. Clinical Infectious Diseases, 2015
2. Nguyen MH, et al. Annals of Internal Medicine 2019
3. Wilson NM, et al. Journal of Antimicrobial Stewardship, 2017
4. Patch ME, et al. Journal of Antimicrobial Chemotherapy, 2018
5. Edwards JD. Poster Presentation, ASM Microbe, 2017
6. Shields R, et al. Poster Presentation, IDWeek, 2018