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FDA Grants Emergency Use Authorization for UCSD Molecular COVID-19 Test

Dec 21, 2021 | staff reporter

NEW YORK — The US Food and Drug Administration last week granted Emergency Use Authorization for a PCR-based SARS-CoV-2 test developed by the University of California, San Diego.

The UCSD EXCITE COVID-19 Test is designed to qualitatively detect SARS-CoV-2 nucleic acid in anterior nasal swab specimens collected either by a healthcare provider or self-collected at home or in a community-based setting. It was developed by the UCSD BCG Expedited Covid Identification Environment (EXCITE) Lab.

Use of the test is limited to the EXCITE Lab, according to the FDA.

According to the authorization letter from the FDA, samples collected from individuals up to 2 years of age should be done with adult assistance. Individuals 15 and older, including those who are asymptomatic, can self-collect samples when deemed appropriate by a healthcare provider.

Filed under

Molecular Diagnostics
Infectious Disease
COVID-19
PCR
emergency use authorization
UCSD
FDA
North America
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