FDA has announced Emergency Use Authorization (EUA) for a 5-minute point-of-care COVID-19 test, the virus that produces the novel coronavirus, according to a press statement. The test could be ready for use next week.
Abbott’s ID NOW COVID-19 test, the most durable possible molecular point-of-care test, is the size of a small toaster, weighs 6.6 pounds, and can deliver positive outcomes in as little as 5 minutes and negative results in 13 minutes.
The Urgent Settings
The test practices 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 employs qualitative data to identify infectious conditions and will allow health care operators to make evidence-based clinical judgments through the discovery of nucleic acid from SARS-CoV-2.
In their press announcement, Abbott announced that their COVID-19 test would be ready next week to health care providers in US urgent care settings and confirmed that the company is currently working with the FDA to offer tests in areas in which they will have the most notable influence, ramping up production to produce 50,000 tests a day.
“Nowadays, having entrance to tests that can give results immediately and truly is pivotal in diagnosing #COVID19 and attending to #SlowTheSpread,” FDA Commissioner Stephen Hahn, MD, recorded in a tweet. “FDA’s EUA for Abbot’s point of care diagnostic will help to get more active tests to medical experts and sufferers who need them now.”
Private Health Care Sector
Former FDA Commissioner Scott Gottlieb, MD, also stressed the significance of the FDA’s judgment. “This is a GAME CHANGER,” Dr. Gottlieb tweeted.
The FDA has also newly completed EUA to address growing concerns around the availability of respirators at clinics.
The EUA expanded the supply of filtering facepiece respirators by allowing some sent disposable respirators that do not comply with the National Institute for Occupational Safety and Health’s (NIOSH) standards. In their press statement on Saturday, the FDA also approved the “concerning” situation with personal protective equipment (PPE), suggesting that the need is dire in some states.
The FDA has emphasized its sustained collaboration with the private health care sector and FEMA in addition to all state reserves. Their news statement offers the CDC’s published instructions for optimizing respirator supply and data on using expired respirators.
Other PPE, such as surgical masks, gowns, and gloves, may need creative recycling. The FDA also stated in Saturday’s statement that they are “working with textile companies, including clothing artists, about how they can repurpose their building product lines to put them to use to make masks.”
Covid-19 Test Supply Disturbance
The FDA has also put out a global call to more than 1000 companies for essential projects that are both in high need due to COVID-19, and those prone to a shortage in the event of a supply disturbance. EU policies include facilitating and promoting essential equipment into the country.
The ID NOW COVID-19 has not been FDA removed or approved but instead has been accepted by the FDA under EUA for use by approved laboratories and health care environments during the current pandemic.