Ellume, an Australian firm that makes a broadly out there at-home coronavirus check, has recalled practically 200,000 check kits due to issues a couple of higher-than-expected price of false positives. That represents about 5.6 % of the roughly 3.5 million check kits Ellume has shipped to the United States.
The firm, 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 government, 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.
Approximately 427,000 check kits, together with some supplied to the U.S. Department of Defense, 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 confused that it will be troublesome to find out precisely what number of.
“I’m very sorry that this has happened,” Dr. Parsons mentioned. “We’re all about chasing accuracy, and to have these false positives is disappointing.”
The difficulty didn’t have an effect on all Ellume check kits or the reliability of unfavourable outcomes, the corporate mentioned.
Ellume’s check is a speedy antigen check, designed to detect items of the virus within the nostril. Users swab their nostrils, insert the swab right into a dropper of fluid after which add the fluid to a Bluetooth-connected analyzer. Results are transmitted to a wise cellphone app in quarter-hour. Last December, it grew to become the primary over-the-counter, fully at-home check to obtain an emergency use authorization from the U.S. Food and Drug Administration.
The firm has requested retailers to take away the assessments from cabinets and is within the technique of notifying customers, Dr. Parsons mentioned.
Consumers who’ve one of many affected assessments can request a substitute on-line. People who attempt to use one of many affected check kits will probably be notified within the app that the check has been recalled. “It really won’t be possible to use any of those tests now,” Dr. Parsons mentioned.
He added that the corporate had put “extra controls” in place to forestall the identical drawback from cropping up once more sooner or later.
“We are doing everything possible to get known, good product into the hands of consumers in the U.S.,” Dr. Parsons mentioned.
The recall comes as demand for testing has soared, and customers have complained that at-home check kits are laborious to seek out.
On Monday, the F.D.A. approved a brand new at-home antigen check, ACON Laboratories’ Flowflex. The authorization “is expected to double rapid at-home testing capacity in the U.S. over the next several weeks,” Dr. Jeffrey E. Shuren, who directs the F.D.A.’s Center for Devices and Radiological Health, mentioned in a press release. “By year’s end, the manufacturer plans to produce more than 100 million tests per month, and this number will rise to 200 million per month by February 2022.”