Quidel Earns FDA EUA for COVID-19 Assay

December 29, 2020

Quidel has been handed Emergency Use Authorization (EUA) by the FDA for its Solana SARS-CoV-2 assay.

The test is an isothermal reverse transcriptase-helicase dependent amplification (RT-HDA) assay that detects the virus from nasopharyngeal and nasal swab specimens. The assay delivers results in 25 minutes for up to 11 samples and reports the results on its display screen with an option to print them.

The agency’s EUA currently limits the test’s use to laboratories certified to perform high- and moderate-complexity tests.

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