Ellume, an Australian firm that makes a extensively accessible at-home coronavirus check, has recalled practically 200,000 check kits due to issues a few higher-than-expected charge of false positives. That represents about 5.6 p.c of the roughly 3.5 million check kits Ellume has shipped to the USA.
The corporate, which detected the issue in mid-September, traced the difficulty to variations within the high quality of one of many uncooked supplies used within the check package, Dr. Sean Parsons, Ellume’s chief govt, mentioned in a cellphone interview. He declined to specify the fabric in query, citing a want to not publicly disclose exactly how the check kits work.
About 427,000 check kits, together with some offered to the U.S. Division of Protection, had been affected by the issue, Dr. Parsons mentioned. Roughly half have already been used, he mentioned, yielding about 42,000 optimistic outcomes. As many as 1 / 4 of these positives might have been inaccurate, Dr. Parsons mentioned, though he careworn that it might be troublesome to find out precisely what number of.
“I’m very sorry that this has occurred,” Dr. Parsons mentioned. “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 mentioned.
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 sensible cellphone app in quarter-hour. Final December, it grew to become the first over-the-counter, completely at-home test to obtain an emergency use authorization from the U.S. Meals and Drug Administration.
The corporate has requested retailers to take away the exams from cabinets and is within the means of notifying shoppers, Dr. Parsons mentioned.
Customers who’ve one of many affected exams can request a replacement 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 doable to make use of any of these exams now,” Dr. Parsons mentioned.
He added that the corporate had put “further controls” in place to stop the identical downside from cropping up once more sooner or later.
“We’re doing every thing doable to get recognized, good product into the fingers of shoppers within the U.S.,” Dr. Parsons mentioned.
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 Heart for Units and Radiological Well being, mentioned in a statement. “By yr’s finish, the producer plans to provide greater than 100 million exams monthly, and this quantity will rise to 200 million monthly by February 2022.”