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Guidance for positive at-home COVID-19 test results


A recent FDA report highlights the potential for false positive results in some Ellume at-home COVID-19 tests. For patients who test positive with an at-home kit, the result can have a significant impact on their and their loved ones’ lives. The FDA recommendations are that people who test positive with the Ellume home test should contact their doctor and follow up with a standard molecular diagnostic test to confirm the result. This may be especially important if the patient is asymptomatic, which means they have a higher chance of having a false positive Ellume COVID-19 test result.
Source: Potential for False Positive Results with Certain Lots of Ellume COVID-19 Home Tests Due to a Manufacturing Issue: FDA Safety Communication, U.S. Food & Drug Administration

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