The Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) to 2 new coronavirus disease 2019 (COVID-19) diagnostics.
Rutgers Clinical Genomics Laboratory has received an EUA for their prescription only molecular diagnostic test, TaqPath SARS-CoV-2 Assay, which now includes at-home collection of saliva samples. A clinician will first need to determine if the test is appropriate and will prescribe the test and arrange for delivery to the patient. Once the sample is collected by the patient, using a designated self-collection kit, it is returned to the lab for testing. Currently, the testing can only be performed at the Rutgers Clinical Genomics Laboratory. Results will then be sent to the clinician.
“This provides an additional option for the easy, safe and convenient collection of samples required for testing without traveling to a doctor’s office, hospital or testing site,” said FDA Commissioner Stephen M. Hahn, MD.
Additionally, the Agency has issued the first EUA for a COVID-19 antigen test, developed by Quidel Corporation. The Sofia 2 SARS Antigen FIA test, which uses nasal and nasopharyngeal swab specimens, is designed for rapid detection of SARS-CoV-2, the virus that causes COVID-19. While not as sensitive as polymerase chain reaction (PCR) tests, antigen tests can deliver results often within minutes. However, they may also result in a greater number of false negatives. As such, a negative result may need to be confirmed with a PCR test in order to prevent possible spread of the virus.
According to the FDA, antigen tests can also be produced at a lower cost and at a much larger scale, allowing for faster testing. “This is just the first antigen test to be authorized and we expect more to follow. We also anticipate providing an EUA template for antigen tests, similar to ones we’ve released for other test types, to help manufacturers streamline submissions and help expedite our review and issuance of additional EUAs,” the FDA noted in a statement.
In addition to molecular and antigen testing, the FDA has also authorized a number of serological tests for the detection of antibodies to SARS-CoV-2. A list of COVID-19 diagnostic tests with EUAs can be found here.
For more information visit fda.gov.