The FDA has cleared Acon Laboratories' over-the-counter at-home COVID-19 antigen test, the second test authorized through the traditional premarket review pathway. It is the first test approved for use in children under 18. The test was initially granted emergency-use authorization in 2021 to be available without a prescription. In a FDA-reviewed study, the test showed 89.8% accuracy in identifying positive samples and 99.3% accuracy in identifying negative samples in individuals with upper respiratory infection symptoms.
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by Clinical Rev... klo www.medscape.com 11-09-2023
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