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FDA Grants EUAs for UCSD SARS-CoV-2 Test, D.C. Health Specimen Collection Kit

NEW YORK — The US Food and Drug Administration last week granted separate Emergency Use Authorizations for a PCR-based SARS-CoV-2 test developed by the University of California, San Diego and an at-home nasal specimen collection kit from the Washington D.C. Department of Health.

The UCSD EXCITE COVID-19 EL Test is designed for the qualitative detection of nucleic acid from SARS-CoV-2 in anterior nasal swab specimens, either collected by a healthcare provider or self-collected using the UCSD EXCITE COVID-19 EL Sampling Kit.

The test may only be used by the UCSD BCG Expedited Covid Identification Environment (EXCITE) Lab, which developed it.

The D.C. Health's direct-to-consumer Test Yourself DC At-Home COVID-19 Collection Kit is designed for the self- or adult-collection of anterior nasal swab specimens for use with Laboratory Corporation of America's COVID-19 RT-PCR Test, which received EUA from the FDA in early 2020.

Use of the Labcorp test with samples collected using D.C. Health's collection kit is limited to the Center for Esoteric Testing in Burlington, North Carolina, according to the FDA.

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