FDA greenlights COVID-19 point-of-care test

Anjalee Khemlani
Senior Reporter

The U.S. Food and Drug Administration approved emergency use for a portable, fast, swab test for the coronavirus Friday which can provide results in less than 15 minutes.

The IDNOW, from Abbott (ABT), is the first approved portable test and allows for an existing testing instrument used in 18,000 locations around the U.S.,to be used at a point-of-care in doctor’s offices, urgent care and hospitals. This same instrument is already used for flu and strep swabs. It also has the potential to be used at drive-thru tests, according to company officials.

Norman Moore, Abbott’s director of infectious diseases and scientific affairs, told Yahoo Finance that the device can also be used in parking-lot testing facilities currently being used by urgent care facilities.

The device weighs 6.6 pounds and tests a swab taken from the nose or throat, using a cartridge made by Abbott. The time for a positive result is 5 minutes, and a negative result will return in 13 minutes.

Abbott will be able to provide 50,000 tests by April 1 and will be able to provide 1 million per month of this test, Moore said.

‘The more we can test, the better we can isolate those that need to be isolated,” Moore said.

Coronavirus test

Robert Ford, president and COO of Abbott, said in a statement that the test adds a new way for health-care workers to fight the virus.

"With rapid testing on IDNOW, health care providers can perform molecular point-of-care testing outside the traditional four walls of a hospital in outbreak hotspots,” he said.

The move is a game-changer for frontline health workers, who already got a boost from Abbott’s high-throughput test last week, which can provide results in less than an hour.

Testing thus far has been handled primarily by the Centers for Disease Control and Prevention’s (CDC) testing kit, as well as by some commercial labs such as Quest Diagnostic (DGX) and Labcorp (LH)— all of which require mailing swabs to labs for testing. Abbott, along with Thermo Fisher and Roche received emergency-use authorization approval for high-throughput diagnostic tests, which can also be done by labs like Quest and Labcorp.

The U.S. currently has the most confirmed cases of coronavirus in the world—surpassing 100,000. The worldwide confirmed case count is now 550,000.

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