November 1, 2022
Shield T3 Prepares for a Tripledemic; Test Kit Eliminates Confusion over Illnesses with Similar Symptoms
As you may know, the FDA has recently required that all antigen tests be used in a serial manner, when testing for COVID-19. This requires anyone taking an antigen test to take the test two-three times over three-five days depending on the user’s clinical scenario. This is largely due to antigen’s lower accuracy when detecting early COVID-19 infections. Additionally, most antigen manufacturers will be required to revalidate clinical performance and reflect changes on their product instructions to maintain their FDA EUA approval.
User impact when comparing Antigen testing to PCR testing.:
- Cost– due to the need for multiple antigen tests for an accurate result, a single PCR test becomes as, or more, cost-effective as multiple antigen tests.
- Safety– PCR tests only require a single use to detect COVID-19 infections, with very strong accuracy. If a user does not follow the multiple antigen test protocol, there is a significant chance of missing a positive infection. This delays care and raises the risk of spreading infection.
- Convenience– multiple testing with antigen tests places a significant burden on users to remember and repeat. A single PCR test is fast, easy, and ensures results that are accurate.
At Shield T3, we remain committed to providing accurate and cost-effective tests to protect the communities we serve. Our saliva-based PCR tests remain the best option to detect and prevent COVID spread.
FDA Source www.fda.gov
Christopher Lemelle, MD, MBA
Chief Medical Officer