Quidel Rapid Antigen Test For COVID-19 Wins Authorization

Diagnostic healthcare specialist Quidel (NASDAQ:QDEL) (Monday) announced it has received Emergency Use Authorization from the Food and Drug Administration for a rapid COVID-19 antigen test that returns results without the use of a test instrument. Shares were soaring 8% (Monday) on the news.

Quidel's QuickVue SARS Antigen test uses a nasal swab sample taken by a healthcare professional and returns results on a test strip within 10 minutes. The test is designed to be administered to patients suspected of COVID-19 within the first five days of the onset of symptoms and has a positive predictive agreement of 96.6%.

Quidel expects the test will help meet urgent testing needs in school systems and rural locations, saying that it plans to reach a production run rate of 600 million tests by the end of next year. The company's Sofia 2 test instrument also supports a rapid antigen test for the SARS-CoV-2 virus, and the U.S. Department of Health and Human Services is buying 2,000 of the machines for placement in nursing homes.

Shares of Quidel have pulled back 34% from their high this summer as vaccines have come to the forefront and investors have become worried about competition from industry giant Abbott Laboratories (NYSE:ABT). Abbott has rapid test similar to Quidel's and announced last week a service to enable at-home use by consumers. But the demand for COVID-19 testing seems almost limitless at the moment, and investor interest in Quidel rebounded (Monday).

This article originally appeared in the Motley Fool.

Jim Crumly owns shares of Abbott Laboratories and Quidel. The Motley Fool owns shares of and recommends Quidel. The Motley Fool has a disclosure policy.