On Dec. 23, 2020, Quidel announced that it had received Emergency Use Authorization (EUA) from the FDA to market its Solana SARS-CoV-2 Assay, an isothermal Reverse Transcriptase – Helicase-Dependent Amplification (RT-HDA) assay intended for the qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal and nasal swab specimens in viral transport media from patients suspected of COVID-19 by their healthcare provider.

Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 to perform high and moderate complexity tests.