More Than A Year Into The Pandemic, You Can Finally Now Test Yourself From Home
An employee of a new Lufthansa corona quick test center shows the test device to the camera at the airport in Munich, Germany, on Nov. 12, 2020.
Matthias Schrader/AP
At-home COVID-19 tests are now for sale at local pharmacies.
And while it may feel like quick, at-home testing is available a year too late, experts say if it catches on, this kind of testing could be a crucial tool to finally bringing an end to the pandemic.
Rapid antigen tests, as theyâre called, can quickly detect the presence of molecules found on the surface of the COVID-19 virus. At-home versions made by Abbott, Quidel and Ellume just recently hit the market. The tiny Cambridge-based start-up E25Bio has an application pending with the U.S. Food and Drug Administration and hopes to be joining those ranks soon.
Modern Healthcare Illustration / Getty Images
With rapid antigen tests for SARS-CoV-2 slow to come to market, officials at the US Food and Drug Administration have tried to signal via a number of public comments that the agency would be flexible regarding test performance requirements and use models.
These indications of flexibility have largely failed to speed development and commercialization of rapid antigen tests, however, as test vendors, wary of falling short of agency requirements, have instead stuck to the more stringent specifications presented in the FDA s test templates.
Early in the COVID-19 pandemic, rapid antigen tests were identified as a potentially key technology for slowing transmission of SARS-CoV-2 with calls for these tests growing as it became evident that molecular test capacity was not able to keep up with demand and was unlikely to ever reach a level where regular testing at population scale would be possible.
The first COVID-19 test that can be performed entirely at home was cleared by U.S. regulators on Tuesday, and it can be acquired without a prescription.
While availability will be limited initially, the new test and others in development could make virus screenings as accessible as over-the-counter pregnancy tests in the U.S. for the first time. The advance follows months of criticism that the Food and Drug Administration has been too slow to approve rapid home tests for the virus.
Manufactured by East Brisbane, Australia-based Ellume, the self-administered, single-use nasal swab test is small enough to fit in the palm of a person’s hand. It detects proteins on the virus’s surface in 15 minutes and delivers results to an app.