One of the core metrics of accuracy for a COVID-19 test is what’s known as the “limit of detection.” This refers to the lower limit of how many viral copies must be present in a given quantity of a sample in order for the test to detect the presence of COVID-19. (The lower the limit of detection, the more sensitive and therefore better the test.)
On November 25th, a third-party lab verified that Aptavid At Home™ (rapid home-use COVID-19 test kit that is in development has reached a limit of detection of 100,000 viral copies per milliliter. This beats the published limit of detection of other tests for which the FDA has already granted Emergency Use Authorization. With this limit of detection achieved, Aptavid now has in place what we believe are the major scientific milestones necessary to secure Emergency Use Authorization.If authorized, Aptavid At Home™ has the potential to be the first at-home COVID-19 test that will not require a prescription.
Of the 270 COVID-19 tests that have currently received EUA, only one is a home test, and it requires a prescription. Seven more are point-of-care, requiring a technician. And the other 262 require submitting a sample to a lab. None of the currently-existing tests are saliva tests.There is high anticipation for a saliva-based test, because nasal swabs are painful and it’s difficult to collect a proper sample. There is also high anticipation for an at-home test that doesn’t require a prescription, and which therefore could be purchased at any drugstore or supermarket. Aptavid At Home™ is being developed to fill the demand for both of these solutions in one. The kit was designed to be incredibly easy and fast to use, requiring nothing more than a small saliva sample and 5 minutes.