Everlywell At Home Test are Approved by the FDA
This week, Everlywell gets approval from the U.S. Food and Drug Administration authorizing its COVID-19 Test Home Collection Kit to be used by individuals at home, according to KVUE. This collection kit allows people who believe they could have COVID-19 to send their samples to laboratories for diagnostic testing.
Director of the FDA’s Center for Devices and Radiological Health, Jeffrey Shuren said, “The authorization of this COVID-19 at-home collection kit not only provides increased patient access to tests but also protects others from potential exposure. … It saves precious time as we continue our fight against this pandemic.”
The kits allow people to collect via a nasal swab, which is then deposited into a tube filled with saline to be sent back to a CLIA-certified lab that is authorized to test these kits. Results are returned through Everlywell’s independent physician network and an online portal.
Previously, two diagnostic tests that use at-home collection obtained emergency use authorizations (EUA), one that uses a nasal swab that is transported in saline and another that permits testing of a saliva sample collected by the patient at home.
Everlywell uses polymerase chain reaction (PCR) testing instead of antibody testing. The Texas Medical Association and Austin Public Health both do not recommend antibody test because they are not 100% reliable.