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FDA Accelerates Efforts To Issue EUA For More COVID-19 Home Tests

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The U.S. Food and Drug Administration is hastening its efforts to make available more at-home testing options in response to the ongoing COVID-19 pandemic. All At-Home Covid-19 Tests being used now are authorized only for emergency use, and not cleared or fully approved by the FDA.

The recent granting of EUA for the Quidel Corp.'s QuickVue At-Home COVID-19 Test is one example of the FDA working with test developers to bring important diagnostics to the public. It provides qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2.

The QuickVue At-Home COVID-19 Test is another antigen test where individuals can rapidly collect and test their sample at home, without needing to send a sample to a laboratory for analysis. The easy-to-use at-home test provides results in ten minutes with a doctor's prescription.

The 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. It is authorized for individuals suspected of COVID-19 by their healthcare provider within the first six days of symptom onset.

Quidel claimed that 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.

The at-home 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 EUA from the FDA for use in professional settings in December 2020.

The EUA for the QuickVue At-Home COVID-19 Test was expedited after Quidel's contract with the National Institutes of Health's Rapid Acceleration of Diagnostics initiative was expanded in late 2020 to include the test.

Quidel's new manufacturing facility will begin operations in the second half of 2021, initially with a target to produce more than 50 million QuickVue rapid antigen tests per month, or 600 million tests per year at full capacity.

Quidel has also provided rapid COVID-19 testing through doctors and health care providers throughout the pandemic, manufacturing and shipping millions of Sofia tests last year.

Quidel's QuickVue brand was launched in 1986 with visually read rapid diagnostics focusing on women's health and respiratory diseases. In 1999, QuickVue Influenza A+B was the first visually read rapid test approved by the FDA for professional use. QuickVue was also the first flu test cleared by the FDA.

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