TotalWellness is utilizing the Sofia 2 for our COVID-19 antigen testing. Sofia 2 SARS Antigen FIA is a rapid point-of-care test for the detection of COVID-19. These diagnostic tests quickly detect fragments of proteins found on or within the virus by testing samples collected from the nasal cavity using swabs. The same approach is used in rapid tests for flu, strep throat and other infections that are run at the doctor’s office. It has received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for the COVID-19 diagnosis. Antigen tests are very specific for the virus, but are not as sensitive as molecular PCR tests. This test has 96.7% sensitivity and 100% specificity.
For more information on the Sofia SARS Antigen FIA test, please review the Patient Fact Sheet at https://www.fda.gov/media/137887/download.
TotalWellness is utilizing the Xpert Xpress SARS-CoV-2 test, which is a rapid, real-time reverse transcriptase polymerase chain reaction (RT-PCR) test intended for the qualitative detection of nucleic acid from SARS-CoV-2 in upper respiratory specimens collected from individuals suspected of COVID-19. The test has been designed to operate on any of Cepheid's automated GeneXpert Systems worldwide, with a detection time of approximately 45 minutes. The test performs real-time PCR to extract RNA from the sample and detect SARS-CoV-2. This test has 97.9% sensitivity and 100% specificity. Cepheid received emergency use authorization from the U.S. FDA.
For more information on the Xpert Xpress SARS-CoV-2 test, please review the Patient Fact Sheet at https://www.fda.gov/media/136312/download.