Ellume, an Australian company that examines a widely available home coronavirus, has recalled nearly 200,000 exam kits due to a higher than expected false positive rate. This represents about 5.6% of the roughly 3.5 million test kits that Illume shipped to the United States.
The company, which detected the problem in mid-September, attributed the problem to variations in the quality of one of the many uncooked products used in the test equipment, said Dr Sean Parsons, chief executive of ‘Ellume, in a cell phone interview. . He declined to specify the tissue in question, citing the need not to publicly disclose exactly how the test kits work.
About 427,000 test kits, some supplied to the US Department of Defense, have been affected by the problem, Dr Parsons said. About half have already been used, he said, giving around 42,000 optimistic results. As many as 1/4 of those positives could have been inaccurate, Dr Parsons said, although he was concerned that it would be difficult to know precisely what number.
“I am so sorry that this has happened,” said Dr Parsons. “We all strive for precision, and having these false positives is disappointing.”
The challenge did not have an effect on all of Ellume’s tests, nor on the reliability of the negative results, the company said.
The Ellume test is a rapid antigen test, designed to detect elements of the virus in the nostril. Users swab their nostrils, insert the swab directly into a liquid dropper, then add the liquid to an analyzer connected via Bluetooth. The results are transmitted to a sensitive mobile application within a quarter of an hour. Last December, it became the first over-the-counter, all-at-home trial for emergency use clearance from the United States Food and Drug Administration.
The company has asked retailers to remove the checks from the cabinets and is able to notify buyers, Dr Parsons said.
Consumers who have one of the many affected checks can request a replacement online. Individuals attempting to use one of the many affected test kits will be notified in the app that the test has been recalled. “It will really not be possible to use any of these tests now,” Dr. Parsons said.
He added that the company had “extra controls” in place to prevent the same inconvenience from happening again sooner or later.
“We’re doing everything we can to market a good product to American consumers,” said Dr. Parsons.
The recall comes as demand for testing has skyrocketed and buyers have complained that it is difficult to find kits at home.
Monday, the F.D.A. licensed a brand new home antigen, take a look at Flowflex from ACON Laboratories. The authorization “is expected to double the capacity for rapid home tests in the United States over the next few weeks,” Dr. Jeffrey E. Shuren, who heads the Center for Devices and Radiological Health at the F.D.A., said in a statement. “By the end of the year, the automaker plans to produce more than 100 million tests per month, and that number will increase to 200 million per month by February 2022.”