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 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.

Multiple SARS-CoV-2 variants have been detected around the globe, including Mu (B.1.621), lota (B.1.526), Delta (B.1.617.2) United Kingdom (B.1.1.1), South Africa (B.1.351), and Brazil (P.1). The CDC has highlighted the ability to evade detection by specific viral diagnostic tests as a potential consequence of emerging variants. To confirm that the T2SARS-CoV-2 Panel should detect these newly identified variants of the SARS-CoV-2 virus, an in silico analysis was performed using genome sequences available from the GISAID database. The analysis showed that the Panel should detect all currently identified variants of the SARS-CoV-2 virus.

T2SARS-CoV-2:

  • Not on allocation
  • Sample to answer
  • Results in <2 hours
  • Throughput of up to 60 samples/day
  • Utilizes RT-PCR and T2MR Technology

Comprehensive detection of primary and secondary/co-infections associated with COVID-19

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.

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Request password to download T2SARS-CoV-2 Instructions for Use.

1. Zhang, et al. 2020
2. T2SARS-CoV-2 clinical data on file