FDA Issues Emergency Use Authorization for ‘Game Changer’ COVID-19 Test

FDA has issued Emergency Use Authorization (EUA) for a 5-minute point-of-care test for SARS-CoV-2, the virus that causes the novel coronavirus, according to a press release. The test could be available for use next week.

Abbott’s ID NOW COVID-19 test, the fastest available molecular point-of-care test, is the size of a small toaster, weighs 6.6 pounds, and is able to deliver positive results in as little as 5 minutes and negative results in 13 minutes.

The test uses the ID NOW platform, the leading molecular point-of-care platform for influenza A and B, streptococcus A, and respiratory syncytial virus testing in the United States. ID NOW uses qualitative data to detect infectious diseases, and will allow health care workers to make evidence-based clinical decisions through detection of nucleic acid from SARS-CoV-2.

In their press release, Abbott said that their COVID-19 test will be available next week to health care providers in US urgent care settings and assured that the company is currently working with the FDA to offer tests in areas in which they will have the greatest impact, ramping up production to deliver 50,000 tests a day.

“Right now, having access to tests that can give results quickly [and] accurately is pivotal in diagnosing #COVID19 [and] helping to #SlowTheSpread,” FDA Commissioner Stephen Hahn, MD, wrote in a tweet. “FDA’s EUA for Abbot’s point of care diagnostic will help to get more rapid tests to medical professional and patients who need them now.”

Former FDA Commissioner Scott Gottlieb, MD, also emphasized the importance of the FDA’s decision. “This is a GAME CHANGER,” Dr Gottlieb tweeted.

The FDA has also recently implemented EUA to address growing concern around the availability of respirators at hospitals. The EUA increased the supply of filtering facepiece respirators by authorizing some imported disposable respirators that do not comply with the National Institute for Occupational Safety and Health’s (NIOSH) standards. In their press release on Saturday, the FDA also recognized the “concerning” situation with personal protective equipment (PPE), mentioning that the need is dire in some cases.

The FDA stressed their continued collaboration with the private health care sector and FEMA in addition to all government resources. Their news release offers the CDC’s published recommendations for optimizing respirator supply and information on using expired respirators.

Other PPE, such as surgical masks, gowns, and gloves, may require creative recycling. The FDA also said in Saturday’s statement that they are “working with textile manufacturers, including clothing designers, about how [they] can repurpose their manufacturing product lines to put them to use to make masks.”

The FDA has also put out a global call to more than 1000 manufacturers for essential devices that are both in high demand due to COVID-19, and those prone to shortage in the event of a supply disruption. EUA policies include facilitating and expediting essential equipment into the country.

The ID NOW COVID-19 has not been FDA cleared or approved, but rather has been authorized by the FDA under EUA for use by authorized laboratories and health care settings during the current pandemic.

References:

1. Abbott launches molecular point-of-care test to detect novel coronavirus in as little as five minutes [news release]. https://abbott.mediaroom.com/2020-03-27-Abbott-Launches-Molecular-Point-of-Care-Test-to-Detect-Novel-Coronavirus-in-as-Little-as-Five-Minutes.
2. Coronavirus (COVID-19) Update: FDA takes further steps to help mitigate supply interruptions of food and medical products [news release]. FDA website. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-takes-further-steps-help-mitigate-supply-interruptions-food-and.