5-Minute Coronavirus Test Now Available

A new point-of-care (PoC) coronavirus test that delivers positive results in as little as five minutes and negative results in 13 minutes, has been authorized by the U.S. Food and Drug Administration (FDA).

This is an important announcement since testing remains a crucial step in controlling the COVID-19 disease pandemic. 

Molecular testing technologies help detect the presence of a virus by identifying a small section of the virus' genome, then amplifying that portion until there's enough for detection. 

Molecular PoC testing offers healthcare workers rapid results in settings where people are seeking care for this new disease.

Announced by Abbott on March 27, 2020, the FDA issued an emergency use authorization (EUA) for the Abbott ID NOW COVID-19 test.

Abbott said in a press release, ‘what makes this test so different is where it can be used outside the walls of a traditional hospital, such as in the physicians' office or urgent care clinics located in pharmacies.’

Because of its small size, it can be used in more non-traditional places where people can have their results in a matter of minutes, bringing an alternate testing technology to combat the novel coronavirus.

The new Abbott ID NOW COVID-19 test runs on Abbott's ID NOWTM platform—a lightweight box (6.6 pounds and the size of a small toaster) that can sit in a variety of locations.

Abbott says they are ramping up production to deliver 50,000 ID NOW COVID-19 tests per day to the U.S. healthcare system, beginning next week.

Combined with ID NOW, Abbott said it expects to produce about 5 million tests in April 2020.

"Through the incredible work of teams across Abbott, we expect to deliver 50,000 COVID-19 tests per day to healthcare professionals on the front lines, where testing capabilities are needed most," said Chris Scoggins, senior vice president, Rapid Diagnostics, in a press release.

This announcement follows the availability of the Abbott RealTime SARS-CoV-2 EUA test under FDA EUA, which runs on m2000 RealTime molecular system, for centralized lab environments.

When not being used for COVID-19 testing, ID NOW is the leading molecular point-of-care platform for Influenza A&B, Strep A, and respiratory syncytial virus testing.

NOTE: The ID NOW COVID-19 EUA has not been FDA cleared or approved. It has been authorized by the FDA under an emergency use authorization for use by authorized laboratories and patient care settings. 

The test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens, and is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

Coronavirus medication, testing, and vaccine development news is published by Precision Vaccination.