FDA grants EUA for Lighthouse COVID-19 assay

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December 2021—Lighthouse Lab Services announced that the FDA has granted emergency use authorization for its CovidNow SARS-CoV-2 assay kit. The EUA covers use for symptomatic and asymptomatic patients with a provider’s order.

The assay is a real-time RT-PCR test intended for the qualitative detection of nucleic acid from SARS-CoV-2 in human upper respiratory specimens collected from nasopharyngeal swabs, anterior nasal swabs, or midturbinate nasal swabs from individuals suspected of having COVID-19 by their health care provider. Testing is limited to laboratories designated by Lighthouse Lab Services and certified under CLIA ’88 to perform high-complexity tests.