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1st March 2021  Product update: rapidmicrobiology staff writer

FDA Authorize At-Home SARS-CoV-2 Rapid Antigen Lateral-Flow Test

The U.S. Food and Drug Administration has issued an emergency use authorization (EUA) for the Quidel QuickVue At-Home COVID-19 Test, another antigen test where certain individuals can rapidly collect and test their sample at home without needing to send a sample to a laboratory for analysis.

The QuickVue At-Home COVID-19 Test is authorized for prescription home use with self-collected anterior nasal (nares) swabs from individuals ages 14 and older or individuals ages 8 and older with swabs collected by an adult. The test is authorized for individuals suspected of COVID-19 by their healthcare provider within the first six days of symptom onset.

Quidel’s QuickVue® At-Home COVID-19 Test will allow patients with a prescription to easily perform the test themselves and get results in 10 minutes.

The QuickVue® At-Home COVID-19 Test shows excellent performance, with positive results agreeing with PCR 84.8% of the time, and negative results agreeing 99.1% of the time, delivering confidence to patients running the test and facilitating informed discussions with doctors.

In addition to this new prescription home test, Quidel also was issued an EUA in December 2020 for their QuickVue SARS Antigen Test which is authorized for use in laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) to perform high, moderate or waived complexity tests, as well as for point-of-care testing by facilities operating under a CLIA Certificate of Waiver.

The QuickVue® At-Home COVID-19 Test employs the same Quidel lateral flow technology used for decades by healthcare professionals and features the same SARS CoV-2 rapid antigen test strip and reagent solution that received an EUA from the FDA for use in professional settings in December 2020.

Quidel’s contract with the National Institutes of Health’s Rapid Acceleration of Diagnostics initiative was expanded in late 2020 to include the QuickVue At-Home COVID-19 test, which expedited its emergency use authorization.

Quidel recently started the buildout of a new manufacturing facility in Carlsbad, CA. The 128,000 square foot facility is expected to be the company’s highest-volume production facility and begin operations in the second half of 2021, initially with a mission to produce more than 50 million QuickVue® rapid antigen tests per month, or 600 million tests per year at full capacity.



Date Published: 1st March 2021

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Note: This content has been edited by a rapidmicrobiology staff writer for style and content.

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