The first at-home COVID-19 test, which does not require any prescription to take, has been cleared by FDA, ABC News reported.
The test, made by California-based Ellume, will sell for around $30 and the company plans to roll out three million units in January 2021, and millions more in subsequent months.
The announcement by the Food and Drug Administration(FDA) represents another important step in efforts to expand testing options.
“Patient can buy it, swab their nose, run the test and find out their results in as little as 20 minutes,” said FDA Commissioner Stephen Hahn.
The Ellume test uses a nasal swab that doesn’t go as far back as the nasopharyngeal swabs used in clinical settings, and is therefore more comfortable to self-administer.The sample is then inserted into a single-use cartridge.
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According to the FDA, it correctly identified 96% of positive samples and 100% of negative samples in individuals with symptoms.In people without symptoms, the test correctly identified 91% of positive samples and 96% of negative samples, AFP reported.
The FDA said that for patients without symptoms, “positive results should be treated as presumptively positive until confirmed by another test as soon as possible.”