The US Food and Drug Administration (FDA) gave Emergency Use Authorization (EUA) to Ellume for its OTC home COVID-19 test. Last month the FDA gave EUA to Lucira Health’s at home COVID test but that test required a doctor’s prescription.
Ellume’s rapid antigen test is approved for use in children and adults whether they have symptoms or not. A mid-turbinate nasal swab is used for the test. This means the swab won’t need to go as far as a nasopharyngeal swab but needs to go deeper than the usual nasal swab. The analyzer connects to an app which provides instructions and produces a result in about 20 minutes. To use the app, individuals will need to input their zip code and birthdate. This information will be send to public health authorities for the purposes of monitoring COVID-19 prevalence.
The test was studied in a group of 198 individuals (ages 2-82). When people had symptoms, the test correctly identified 96% of positive samples and 100% of negative samples. For people without symptoms, the test correctly identified 91% of positive samples and 96% of negative samples. As with all tests, some individuals will experience false positives or negatives.
Ellume is an Australian based firm and is aiming to produce 100,000 tests per day starting in the new year. The cost is estimated to be $30 per test.