The T2SARS-CoV-2 Panel, run on the T2Dx® Instrument, is a qualitative reverse transcriptase-polymerase chain reaction (RT-PCR) and 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 was awarded Emergency Use Authorization (EUA) by the FDA on August 31, 2020. The T2SARS-CoV-2 Panel was validated in accordance with the EUA requirements from the FDA and is being distributed in accordance with the FDA guidance on Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised).
Panel 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.
The SARS-CoV-2 virus has been shown to mutate or change over time, which has resulted in multiple variants of the virus. Some changes may provide an advantage for the virus to spread or cause disease, leading to increased prevalence of a given variant. The Centers for Disease Control and Prevention continually monitor SARS-CoV-2 infections and indicates variants with increased transmissibility or causing more severe disease as Variants of Concern. To confirm that the T2SARS-CoV-2 Panel should be able to detect the Variants of Concern, T2 Biosystems routinely conducts an in silico analysis using genome sequences available from the GISAID database. To date this analysis has demonstrated that the T2SARS-CoV-2 Panel should detect all current Variants of Concern, including the recent Omicron BA.5 and BA.4 variants.
T2SARS-CoV-2:
Critically ill COVID-19 patients are susceptible and at high risk of developing bacterial or fungal co-infections and secondary infections that can lead to sepsis. The T2Dx platform can now be used to identify acute COVID-19 infections and optimize outcomes for patients under intensive care. Patients treated in the ICU are exposed to countless risk factors that can lead to secondary infections or co-infections, including exposure to numerous antimicrobial therapies, which are often unnecessary. Early data has indicated that bacterial and fungal infections are present in 25% and 11% of critically ill patients with severe cases of COVID-19, respectively.1 The results provided by the T2SARS-CoV-2, T2Bacteria, and T2Candida Panels will enable faster identification of infections and targeted therapy.
Contact us to learn more about the T2SARS-CoV-2 Panel.
EUA201947 T2 Patient Fact Sheet 08272020
EUA201947 T2 HCP Fact Sheet 08272020
1. Zhang, et al. 2020
2. T2SARS-CoV-2 clinical data on file
Sensitivity: 95%2
Specificity: 100%2
Awarded Emergency Use Authorization (EUA) by the FDA
T2 Biosystems, an emerging leader in the field of in vitro diagnostics, is dedicated to saving lives and reducing the cost of healthcare by empowering clinicians to effectively treat patients faster than ever before. 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.
The T2Dx Instrument, the T2Bacteria and T2Candida Panels have received marketing authorization from the U.S. Food and Drug Administration. All other T2 Biosystems products are considered investigational and for research use only.
T2 Biosystems®, T2MR®, T2Bacteria®, T2Candida®, T2Resistance® and T2Dx® are registered trademarks of T2 Biosystems, Inc. “T2Biosystems” and the T2 Biosystems, Inc. logo design are registered trademarks or trademarks of T2Biosystems, Inc. All software and documentation is subject to T2 Biosystems, Inc. copyrights. All rights reserved. T2Direct Diagnostics™, T2HemoStat™, T2Plex™, T2Cauris™, T2Lyme™ and T2SARS-CoV-2™ are trademarks of T2 Biosystems, Inc.
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