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FDA’s emergency use authorisation for rapid COVID-19 diagnostic test

The US Food and Drug Administration (FDA) has issued an emergency use authorisation for a new rapid point-of-care molecular SARS-CoV-2 diagnostic.

The test, which was developed by Abbott Laboratories, delivers positive results for COVID-19 infection in 5 minutes, and negative results in 13 minutes, MD Mag reports.

The newly approved test utilises Abbott's ID NOW platform, a portable 6.6-pound device. The ID NOW platform is already in standard use in the US as a molecular point-of-care device for influenza A and B, Strep A, and respiratory syncytial virus.

The COVID-19 test will be available within days, with Abbott's manufacturing capacity prepared to deliver 50,000 tests per day, the company noted.

"The COVID-19 pandemic will be fought on multiple fronts, and a portable molecular test that offers results in minutes adds to the broad range of diagnostic solutions needed to combat this virus," Robert B Ford, president and chief operating officer, Abbott, said. "With rapid testing on ID NOW, healthcare providers can perform molecular point-of-care testing outside the traditional four walls of a hospital in outbreak hotspots."

The process for using the new test involves placing the sample in a chemical solution, to release genetic material by breaking down the virus. The ID NOW platform then uses isothermal amplification of identified nucleic acids, to allow for detection of the virus. For the test, the diagnostics targets the coronavirus RdRp gene for detection.

"Through the incredible work of teams across Abbott, we expect to deliver 50,000 COVID-19 tests per day to healthcare professionals on the frontlines, where testing capabilities are needed most," Chris Scoggins, senior vice president, Rapid Diagnostics, Abbott, said. "Portable molecular testing expands the country's capacity to get people answers faster."

Earlier this month, Abbott received emergency authorisation for a RealTime SARS-CoV-2 test. Upon approval, the company was capable of shipping 180,000 of these tests, which uses the m2000 RealTime System. Between these two approved tests, Abbott said it is prepared to produce 5m tests for COVID-19 in April.

"This is a game changer," said former FDA commissioner Dr Scott Gottlieb is quoted in the report as saying. "It’s very likely that we’ll see additional approvals of point-of-care diagnostics behind this one, extending testing to doctor offices across the US."

The report says as of 27 March, 2020, the FDA had issued over 19 emergency use authorisations for COVID-19 diagnostics. Additionally, over 110 laboratories have begun testing for the virus under policies put in place by the agency.

The report says additional novel diagnostics are expected to enter the market through the FDA's emergency authorisation programme in the next weeks.

[link url=""]Full MD Mag report[/link]

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