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First FDA Approved Covid19 rapid test, pers. not required


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This is indeed great news, a lot of doctors have been pushing these take-home, rapid tests. This can ease the burden of those drive-through test sites.

https://www.health.com/condition/infectious-diseases/coronavirus/ellume-at-home-covid-19-test-fda-approved?did=590815-20201217&utm_campaign=hth-thedaily3_newsletter&utm_source=health.com&utm_medium=email&utm_content=121720&cid=590815&mid=46935854851&fbclid=IwAR0HPplVvttG3wahnNkMiGi7K_9CmVve7ADC3tt1C6sfCsn4_G4PKUXlrkg

There's a question/answer already addressing the accuracy of these home tests, and it's good news:

Pretty accurate—the test correctly identified 96% of positive samples and 100% of negative samples in individuals with symptoms, says the FDA. And in people without symptoms, the test correctly identified 91% of positive samples and 96% of negative samples.

According to a small study by Stanford Medicine, published July in the Journal of the American Medical Association, at-home test kits are just as accurate as those administered by medical professionals.

Like other antigen tests, a small percentage of results—both positive and negative—from the Ellume test may be false. With that in mind, the FDA recommends that patients who are not displaying COVID-19 symptoms treat positive results as "presumptively positive until confirmed by another test as soon as possible." This is likely to be particularly relevant if there are fewer infections in your community, because false positive results can be more common when antigen tests are used in populations where there is low prevalence of COVID-19.

 

 

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