T2Dx T2 Biosystems
T2Dx™ T2 Biosystems®
DIRECT FROM BLOOD DIAGNOSTICS THAT ENABLE CHANGES IN CLINICAL DECISIONS AND OUTCOMES
The FDA-cleared T2Dx® Instrument is a fully automated, walk away, clinical multiplex benchtop diagnostic system capable of running tests directly from whole blood.
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.
DIRECT FROM BLOOD DIAGNOSTICS THAT ENABLE CHANGES IN CLINICAL DECISIONS AND OUTCOMES
The FDA-cleared T2Dx® Instrument is a fully automated, walk away, clinical multiplex benchtop diagnostic system capable of running tests directly from whole blood.
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.
T2SARS-CoV-2™ Panel
DIRECT DETECTION OF SARS-COV-2 FROM UPPER RESPIRATORY SAMPLES
The T2SARS-CoV-2 Panel, run on the T2Dx® Instrument is a qualitative T2 Magnetic Resonance (T2MR®) test. This test is designed for the direct detection of nucleic acid from SARS-CoV-2 in upper respiratory specimens in transport media from individuals with signs and symptoms of COVID-19. The panel is commercially available and has been validated in accordance with Emergency Use Authorization requirements from the FDA. Results are for the identification of SARS-CoV-2 RNA, which is generally detectable in respiratory specimens during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2 RNA.
95% Sensitivity | 100% Specificity
• Sample to answer
• Results in <2 hours
• Throughput of up to 60 samples/day
• Utilizes RT-PCR and T2MR Technology
DIRECT DETECTION OF SARS-COV-2 FROM UPPER RESPIRATORY SAMPLES
The T2SARS-CoV-2 Panel, run on the T2Dx® Instrument is a qualitative T2 Magnetic Resonance (T2MR®) test. This test is designed for the direct detection of nucleic acid from SARS-CoV-2 in upper respiratory specimens in transport media from individuals with signs and symptoms of COVID-19. The panel is commercially available and has been validated in accordance with Emergency Use Authorization requirements from the FDA. Results are for the identification of SARS-CoV-2 RNA, which is generally detectable in respiratory specimens during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2 RNA.
95% Sensitivity | 100% Specificity
• Sample to answer
• Results in <2 hours
• Throughput of up to 60 samples/day
• Utilizes RT-PCR and T2MR Technology
➤ This test has not been FDA cleared or approved;
➤ This test has been authorized by FDA under an EUA for use by authorized laboratories;
➤ This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens; and
➤ This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
➤ This test has been authorized by FDA under an EUA for use by authorized laboratories;
➤ This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens; and
➤ This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.