Abbott and Quidel Rapid COVID-19 Tests Cleared by FDA

The FDA has given emergency-use authorization to two rapid COVID-19 tests, from Abbott Labs and from Quidel.
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The Food and Drug Administration has given emergency-use authorization to COVID-19 tests made by Abbott Laboratories  (ABT) - Get Report and Quidel (QDEL) - Get Report

Customers at retail stores will be able to get Abbott's BinaxNOW COVID-19 rapid antigen self-test without a prescription, which will make it easy for those with or without symptoms to have them on hand for routine use, Bloomberg News reports.

In addition to retail availability, the FDA’s emergency clearance will enable schools and companies to provide BinaxNOW for self-testing, Abbott said in a statement.

Abbott is the Abbott Park, Ill., health-care giant. 

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The test, sold in a box of two, “is a swab-collected diagnostic about the size of a credit card that produces results in 15 minutes, using a technology similar to at-home pregnancy screenings,” Bloomberg reported.

Abbott said that users will need to perform only "a minimally invasive nasal swab (not the deep nasopharyngeal swab)."

As for pricing, Abbott said in its statement that the test would be affordable. 

"Abbott will begin shipping to major food, drug and mass merchandiser retailers in the coming weeks and [expects] the test to be available through some of their online store websites," it said.

The company has determined that BinaxNOW yields a positive result at a rate of 84.6% for those showing COVID-19 symptoms, while accurate negative results were determined at a rate of 98.5%, Abbott said.

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Abbott noted that the test is more accurate in identifying COVID-19 in those who have “larger amounts of virus in their systems,” Bloomberg said.

As for Quidel, the San Diego producer of diagnostic solutions including rapid diagnostic tests received the FDA's emergency-use authorization for its Sofia test.

It, too, is available without prescription. The company says it is easy to use and provides results within 15 minutes.

The test “shows excellent performance within the first five days of the onset of symptoms, with positive results agreeing with [polymerase chain reaction] 96.7% of the time and negative results agreeing 100% of the time,” Quidel said.

At last check Abbott shares were trading 0.4% lower at $119.38. Quidel shares were trading 1.7% higher at $130.14.

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