Ellume, an Australian firm that makes a broadly accessible at-home coronavirus check, has recalled practically 200,000 check kits due to considerations a couple of higher-than-expected fee of false positives. That represents about 5.6 p.c of the roughly 3.5 million check kits Ellume has shipped to the US.
The corporate, which detected the issue in mid-September, traced the problem to variations within the high quality of one of many uncooked supplies used within the check equipment, Dr. Sean Parsons, Ellume’s chief govt, stated in a cellphone interview. He declined to specify the fabric in query, citing a need to not publicly disclose exactly how the check kits work.
Roughly 427,000 check kits, together with some supplied to the U.S. Division of Protection, had been affected by the issue, Dr. Parsons stated. Roughly half have already been used, he stated, yielding about 42,000 optimistic outcomes. As many as 1 / 4 of these positives might have been inaccurate, Dr. Parsons stated, though he burdened that it might be tough to find out precisely what number of.
“I’m very sorry that this has occurred,” Dr. Parsons stated. “We’re all about chasing accuracy, and to have these false positives is disappointing.”
The problem didn’t have an effect on all Ellume check kits or the reliability of unfavorable outcomes, the corporate stated.
Ellume’s check is a fast antigen check, designed to detect items of the virus within the nostril. Customers swab their nostrils, insert the swab right into a dropper of fluid after which add the fluid to a Bluetooth-connected analyzer. Outcomes are transmitted to a wise cellphone app in quarter-hour. Final December, it grew to become the primary over-the-counter, fully at-home check to obtain an emergency use authorization from the U.S. Meals and Drug Administration.
The corporate has requested retailers to take away the assessments from cabinets and is within the technique of notifying shoppers, Dr. Parsons stated.
Shoppers who’ve one of many affected assessments can request a substitute on-line. Individuals who attempt to use one of many affected check kits will likely be notified within the app that the check has been recalled. “It actually gained’t be potential to make use of any of these assessments now,” Dr. Parsons stated.
He added that the corporate had put “further controls” in place to forestall the identical downside from cropping up once more sooner or later.
“We’re doing all the things potential to get identified, good product into the palms of shoppers within the U.S.,” Dr. Parsons stated.
The recall comes as demand for testing has soared, and shoppers have complained that at-home check kits are arduous to seek out.
On Monday, the F.D.A. licensed a brand new at-home antigen check, ACON Laboratories’ Flowflex. The authorization “is anticipated to double fast at-home testing capability within the U.S. over the subsequent a number of weeks,” Dr. Jeffrey E. Shuren, who directs the F.D.A.’s Middle for Gadgets and Radiological Well being, stated in an announcement. “By 12 months’s finish, the producer plans to provide greater than 100 million assessments per 30 days, and this quantity will rise to 200 million per 30 days by February 2022.”