The FDA-cleared T2Dx® Instrument from T2 Biosystems is a fully automated, walk-away, random-access, clinical multiplex benchtop diagnostic system capable of running tests directly from whole blood that enhances sepsis management with rapid, actionable species identification.
Delivering T2Direct Diagnostics™, the first and only FDA-cleared, CE-marked system to identify deadly sepsis-causing pathogens (for 92% of infections due to deadly ESKAPE pathogens and the most common fungal infections) directly in whole blood—without the need to wait for blood culture results—provides faster results in 3 to 5 hours with a sensitivity greater than 90%.
The T2Bacteria® Panel is the first and only FDA-cleared and CE-marked panel to detect five clinically relevant bacterial pathogens in 3 to 5 hours, directly from a whole blood sample.
E. faecium, S. aureus, K. pneumoniae, P. aeruginosa, and E. coli represent the majority of bacteremia seen in the emergency department and those causing hospital-acquired infections. In addition, several of these species are known as ESKAPE pathogens, characterized as virulent and difficult to treat with empiric antimicrobial therapy, making faster species identification and targeted treatment critical to improving patient outcomes.
The T2Candida® Panel is the first and only FDA-cleared diagnostic test for the detection of sepsis-causing fungal pathogens, direct from whole blood. Species identification is provided within 3 to 5 hours of the first blood draw and independent of a positive blood culture, often before the second dose of antimicrobials is administered.
T2Candida Panel includes Candida albicans, Candida tropicalis, Candida krusei, Candida glabrata, and Candida parapsilosis.
The T2Resistance® Panel is designed for the direct-from-blood detection of antibiotic resistance genes associated with sepsis-causing pathogens. The Panel detects many of the resistance mechanisms described in the 2019 CDC Urgent Threat list. In 2019, the FDA granted “Breakthrough Device” designation for the T2Resistance Panel, reflecting the purpose of the panel to rapidly identify resistant infections.
T2Resistance Panel includes: Gram-negative markers; KPC, OXA-48 Group, NDM /VIM/IMP, CTX-M 14/15 AmpC(CMY/DHA) and Gram-positive markers vanA/B mecA/C
The Molecular Mouse system from ALIFAX is the world’s first handheld platform for Real-Time PCR.
The largest Sepsis panel, with 64 different targets, for the rapid detection of microorganisms of major clinical relevance and their antibiotic resistance genes, starting from positive blood cultures. Rapid results in about 1 HOUR.
Ready-to-use lab-on-chip cartridges, with all lyophilized reagents in each micro-well, it is possible to perform up to 6 simultaneous multiplex reactions and up to 6 instruments can be managed independently with one software session.
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