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Ellume, an Australian company that makes a widely available home coronavirus test, has recalled nearly 200,000 test kits over concerns over a higher than expected false positive rate. This represents about 5.6% of the roughly 3.5 million test kits shipped by Ellume 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 raw materials used in the test kit, said Dr Sean Parsons, general manager of Ellume, during a telephone interview. He declined to elaborate on the material in question, citing his desire not to publicly disclose the precise operation of the test kits.
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 positive results. Up to a quarter of those positives may have been inaccurate, Dr Parsons said, although he stressed that it would be difficult to determine exactly how many.
“I am so sorry that this has happened,” said Dr Parsons. “We’re all looking for precision, and having these false positives is disappointing. “
The issue did not affect all Ellume test kits or the reliability of the negative results, the company said.
The Ellume test is a rapid antigen test, designed to detect bits of virus in the nose. Users swab their nostrils, insert the swab into a liquid dropper, then add the liquid to an analyzer connected via Bluetooth. The results are sent to a smartphone app in 15 minutes. Last December, it became the first completely at-home over-the-counter test to receive emergency use authorization from the United States Food and Drug Administration.
The company has asked retailers to remove the tests from the shelves and is in the process of educating consumers, Dr Parsons said.
Consumers who have any of the affected tests can request a replacement online. People trying to use any of the affected test kits will be notified in the app that the test has been recalled. “It really won’t be possible to use any of these tests now,” Dr. Parsons said.
He added that the company has put in “additional controls” to prevent the same problem from happening again in the future.
“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 consumers have complained that home testing kits are hard to find.
On Monday, the FDA cleared a new home antigen test, 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 FDA’s Center for Devices and Radiological Health, 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.”
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