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FDA Grants Emergency Use Authorization for Lighthouse Lab Services SARS-CoV-2 PCR Test

NEW YORK — The US Food and Drug Administration last week granted Emergency Use Authorization for Lighthouse Lab Services' CovidNow SARS-CoV-2 Assay.

The RT-PCR-based test is designed to detect SARS-CoV-2 nucleic acid in upper respiratory specimens in both symptomatic and asymptomatic individuals. It may also be used with anterior nasal swab specimens self-collected at home by individuals 18 years of age and older using the CovidNow Collection Kit.

Use of the test is limited to laboratories authorized by Charlotte, North Carolina-based Lighthouse Lab Services and CLIA-certified to perform high-complexity tests.