Lab-testing kits sold in stores recalled over false positives

Written by By Erika Peters, CNN

A batch of home virus tests on over 1.3 million kits sold between December 2014 and July 2018 has been recalled over false positives, the Food and Drug Administration announced on Thursday.

The tests — sold under a range of other brand names including Definity, Whatnots, OpenVue, Eden and Tom3s — were sold in stores nationwide and over the internet.

“Some people may have received a false result, believing they were infected with a virus when in fact they were not,” the FDA said in a statement.

The viral proteins at the center of the tests were usually mistaken for common “routine infections like flu, influenza, measles, norovirus, adenovirus, meningitis, and Hepatitis C,” the FDA said. “The protein fragments also overlap with those included in DNA virus tests, which can identify viruses from common sources, such as saliva, blood, and mucus.”

There are currently no reports of people who have been harmed by receiving a false positive test result from a home device, the FDA said.

The company involved in the recall, Midas A/S, says in a statement on its website that it started receiving emails on July 24 “from concerned customers” about faulty results from their Definity kits. Company officials tested the kits and found that they were releasing “a rare virus into the device’s memory instead of detecting real viruses.”

When tests were performed on 31,196 Definity tests, FDA scientists discovered that at least three false positive test results were received in 23,783 cases, according to the statement. The new results were back-dated up to nine months, which means that the makers had been sending out these faulty results for two years, according to the statement.

The company has recalled all 1.3 million kits produced before the June 2018 software update, the FDA said. However, owners of kits that were available before June 2018 are still being asked to check their kits for accuracy.

“Most people with diagnosed H. pylori infection will only need a medication to prevent chronic inflammation or get approved for antiviral medication,” said Dr. David Melzer, the infectious disease medical director at Lenox Hill Hospital in New York. “For those people, Definity is an acceptable test for determining if they’re sick enough to need antiviral medication.”

What is H. pylori?

H. pylori is a bacterium that typically resides in the back of the throat, where it interacts with the lining of the gullet. It is commonly referred to as “the stomach bug” because it’s caused by anaerobic bacteria. This bacterium is believed to cause ulcers and chronic inflammation of the stomach (lye). H. pylori is also responsible for several types of infections of the duodenum (the lower half of the small intestine), which are known as indigestion.

When the bacterium spreads to the stomach, it can cause bacterial ulcers, which can also contribute to stomach cancer. H. pylori infection and ulcers also may be linked to other symptoms, including diarrhea, nausea, vomiting, fever, abdominal pain, or bleeding from the mucous membranes.

These symptoms typically occur within seven to 10 days of exposure to H. pylori, and can last up to three years. Most patients clear up on their own in two to three months.

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