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Globally changing the face of healthcare

T2 Biosystems has developed the T2SARS-CoV-2 Panel in response to the COVID-19 pandemic. The Panel is commercially available and was awarded Emergency Use Authorization by the FDA on August 31, 2020. The Panel was validated in accordance with the Emergency Use Authorization requirements from the FDA. The Panel is being distributed in accordance with the FDA guidance on Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised).

Background on COVID-19

There is a lot of uncertainty surrounding COVID-19, but we know that COVID-19 can lead to sepsis1. The World Health Organization declared COVID-19 a global health emergency, calling it an “unprecedented outbreak.” Millions of people have been diagnosed, and many remain in critical condition suffering from acute respiratory failure, septic shock, and/or multiple organ dysfunction and failure. These patients are treated in the ICU, where they 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. T2 Biosystems’ diagnostic panels enable clinicians to identify sepsis-causing pathogens in 3 to 5 hours and provide targeted therapy faster, thus reducing unnecessary exposure to the virus and optimizing outcomes for COVID-19 patients with secondary bacterial or fungal infections or co-infections.

There are a variety of human coronaviruses, some of which can cause respiratory infections ranging from the common cold to Middle East Respiratory Syndrome (MERS) or Severe Acute Respiratory Syndrome (SARS). The most recent coronavirus (SARS-CoV-2) that was discovered in Wuhan, China, in December 2019, is responsible for COVID-19.

The symptoms of COVID-19 can vary greatly, but many of those infected will experience fever, tiredness, and dry coughs. Other symptoms include aches and pains, nasal congestion, runny nose, sore throat, and diarrhea, while some people do not develop any symptoms at all. Around 80% of people recover from the disease without requiring special treatment, but 1 out of every 6 people that are infected with COVID-19, develop difficulty in breathing and become very ill.2

SARS-CoV-2 Variants

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 monitors 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.

How COVID-19 is Transmitted

The virus is most likely to spread when people are in close contact. COVID-19 spreads when its causative virus is passed from person to person, usually through respiratory droplets that occur when someone that is infected coughs or sneezes. When a person is nearby, when this happens, the droplets may be inhaled into the lungs.Although a person may contract the virus from touching a surface or object that has the virus on it and then touching their face, it is not thought to be the primary method of transmission.

COVID-19 Prevention

There are a number of preventative measures recommended by the CDC for COVID-19. Staying up to date with COVID-19 vaccines significantly lowers the risk of contracting the virus.4

Vaccines help the body protect itself from the virus that causes COVID-19. The CDC recommends that everyone who is eligible, and especially those with weakened immune systems get the vaccine and boosters.

If you have COVID-19 symptoms, a rapid test or laboratory test can detect the SARS-CoV-2 virus. Knowing you have the virus will help keep those around you safe by taking preventative measures.

Improving ventilation and air filtration can help prevent particles from accumulating in the air indoors. Improving these areas can help stop the spread of the virus that causes COVID-19

Avoid close contact with anyone who is sick and stay at home as much as you can. If you are out in public, keep your distance from people. If you have a confirmed case of COVID-19, it’s best to stay home for at least 5 days (or possibly more) after a positive test.

Cover your nose and mouth with a face covering when you are around others. It is possible to spread COVID-19 even if you don’t feel sick; the mask is to protect other people in case you are infected, in addition to protecting yourself.  Note: a face covering is not a substitute for social distancing.

Cover coughs and sneezes with a tissue or the inside of your elbow, be sure to throw away any used tissues, and wash your hands for at least 20 seconds with soap and water.

Wash your hands with soap and water for at least 20 seconds, especially after going out in public. If you need to use hand sanitizer instead of soap, make sure that it contains at least 60% alcohol and cover all surfaces of your hands until they are dry.


Clean and disinfect any frequently touched surfaces every day (tables, doorknobs, light switches, countertops, desks, and phones). For more information on cleaning and disinfecting for households, read the CDC’s Cleaning and Disinfection for Households Guide.

Please contact us for questions related to COVID-19 testing.


Sensitivity: 95%2 
Specificity: 100%2

Awarded Emergency Use Authorization (EUA) by the FDA