FDA greenlights first COVID-19 point-of-care test

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

The IDNOW test from Abbott (ABT) is the first portable test to be approved, and allows for the existing testing instrument, which is in 18,000 locations around the U.S., to be used at the point-of-care in doctor’s offices, urgent care and hospitals.

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 already being used by urgent care facilities.

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

Abbott is sending 50,000 kits by April 1 and will be able to produce 4 million per month, Moore said.

This same instrument is already used for flu and strep swabs.

Moore said the testing can help frontline health workers who are helping in the U.S. response the outbreak.

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

Robert Ford, president and COO of Abbott, said in a statement that this 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.

Testing has been handled primarily by the Centers for Disease Control and Prevention (CDC) testing kit, as well as 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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