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. The Panel can detect 99.99% of all variants of the SARS-CoV-2 virus, including those identified in the United Kingdom (B.1.1.7), South Africa (B.1.351), and Brazil (P.1), according to a recent in silico analysis.

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