FDA Approves COVID-19 Test that Provides Positive Results in as Little as 5 Minutes

The US Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) to a COVID-19 test that delivers positive results in just five minutes and negative results in 13 minutes.

The device, developed by US pharmaceutical company Abbott, is called ID NOW. It already stands as the leading molecular point-of-care test in the US for detecting Influenza A&B, Strep A, and respiratory syncytial virus (RSV).

ID Now uses samples taken from the nose or back of the throat, which are mixed with a chemical solution that ‘breaks’ the virus and releases its RNA, and identifies selected sequences of the COVID-19 genome while discerning and ignoring contamination from other viruses. The device is about the size of a conventional toaster – making it small and compact enough to be used in facilities other than hospitals – such as urgent care clinics.

“Abbott’s ID NOW COVID-19 test will help battle the pandemic in real-time by bringing vital information in minutes to frontline clinicians who are working to stop the spread of the virus,” John Frels, vice president of research and development at Abbott Diagnostics, said in a Business Insider article.

Robert B. Ford, president, and chief operating officer, Abbott , said: “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. 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 company plans to dramatically ramp up production to manufacture and deliver 50,000 test units per day, starting April 1, to US healthcare facilities.

“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, Abbott said in a press release. “Portable molecular testing expands the country’s capacity to get people answers faster.”