T2Dx fast sepsis diagnostics device and PCR tests

Molecular identification of Sepsis causing species in hours directly from whole blood

T2 Biosystems is focused on addressing critical unmet needs in healthcare starting with sepsis, one of the deadliest and most expensive conditions in hospitals today.

With T2 Magnetic Resonance (T2MR) technology the most challenging sepsis pathogens can be reliably identified from whole blood.

CE-marked/FDA-cleared T2Dx® Instrument is a fully automated, walk away, clinical multiplex benchtop diagnostic system capable of running tests directly from whole blood with random access.

  • Rapid results: Species-specific results in 3 to 5 hours with no up-front sample preparation
  • Easy to operate: Fully automated system with minimal hands-on time; a sample tube and a reagent tray snap onto a cartridge, which is then inserted into the instrument
  • Performs with 4 mL whole blood: No blood culture is required to receive T2 identification results for targeted pathogens
  • Random access: 7 individual, random access drawers can be loaded at any time. No batching is required.
  • Simple user interface: User-friendly touchscreen display provides step-by-step text and illustrative prompts that guide the operator to load a sample, all in 10 minutes or less
  • One instrument, multiple tests: The T2Dx Instrument runs the FDA-cleared and CE-marked T2Bacteria and T2Candida Panels as well as CE-marked T2Resistance Panel

The T2Bacteria® Panel is CE-marked/FDA-cleared test to identify sepsis-causing bacteria directly from whole blood without the wait for blood culture.

  • Highly accurate results – identifying 3 times more infections than the paired blood culture draw
  • Positive and negative results more than 2 days faster than blood culture
  • Opportunities to de-escalate therapy and improve time to targeted therapy by days
  • No detection interference when patients are on antibiotic therapy, a well-known limitation of blood culture
  • Targets: Enteroccus faecium, Staphylococcus aureus, Klebsiella pneumoniae, Acinetobacter baumannii, Pseudomonas aeruginosa, Escherichia coli
  • Sensitivity 90 %, specificity 98 %

Manufacturer’s product page

The T2Candida® Panel is CE-marked/FDA-cleared test to identify sepsis-causing Candida directly from whole blood without the wait for blood culture.

  • Mortality rates are reduced with a clear and compelling solution, when the results are available in just hours without waiting for slow-growing fungal infections
  • Unprecedented speed and accuracy allows positive and negative results much faster than blood culture
  • Opportunities to de-escalate therapy and improve time to targeted therapy by days
  • Targets: Candida albicans, Candida tropicalis, Candida krusei, Candida glabrata, Candida parapsilosis
  • Sensitivity 91 %, specificity 99 %

Manufacturer’s product page

T2Resistance® Panel CE-marked/FDA-cleared, and designed for the direct-from-blood detection of antibiotic resistance genes associated with sepsis-causing pathogens.

  • Accelerated identification to combat antibiotic resistance
  • Culture-independent detection of resistance genes
  • Opportunities to de-escalate therapy and improve time to targeted therapy by days
  • Targets are 13 resistance genes from both gram-positive and gram-negative pathogens: Gram positive vanA/B, mecA/C and Gram negative KPC, OXA-48, NDM/VIM/IMP, CTX-M 14/15, AmpC (CMY/DHA)
  • Sensitivity 91 %, specificity 98 %

Manufacturer’s product page

Product is available in the following countries:

  • Finland

Links and documents

Manufacturer’s product page

Keywords

sepsis

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