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FDA Grants EUA for Scope Molecular Laboratory SARS-CoV-2 Test for Serial Testing

NEW YORK — The US Food and Drug Administration recently granted Emergency Use Authorization for Scope Molecular Laboratory's SARS nCoV-2019 Multiplexed Assay for serial COVID-19 testing.

The laboratory-developed test uses RT-PCR to detect SARS-CoV-2 RNA in anterior nasal swab specimens either collected by a healthcare provider or self-collected under the supervision of a healthcare provider. It may only be performed by Sublimity, Oregon-based Scope Molecular Laboratory, according to the FDA.

The test received authorization as an umbrella EUA for serial testing, which allows authorized tests to be used with individual or pooled specimens to test people at least once per week regardless of symptoms or exposure to COVID-19, such as in serial testing programs implemented by schools or workplaces.

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