False-positive HIV test kits recalled

Written by By Frances Cha, CNN

“This is a rare case that catches many people by surprise and leaves a major infection control problem. …An individual who receives a false positive result could get infected with a serious and sometimes deadly virus that had nothing to do with his or her home or hotel room.”

That’s how the US Centers for Disease Control and Prevention described the lead-up to a recall of 35 million home virus tests sold in the United States and Canada, and warning one in five people who received an unscheduled result could be infected.

“The device could produce false-positive tests for several dozen commonly found viruses, such as HIV, hepatitis C, and herpes. Infected individuals are encouraged to call a health care provider, as an infected person may have a fever, body aches, a rash, joint pain, and fatigue that is unrelated to the result, which may also not exist in everyone,” the CDC said in an advisory.

The vast majority of the kits, it added, are sold through distributors under the names BeLock, WetSmart, LifeLock, Wandstream and CamSecure.

“The BeLock device can produce false-positive results because some specific viruses are incorrectly coded in the diagnostic process, which is performed by trusted medical staff.”

The FDA also issued an alert to US consumers on the issue Monday.

“As a result of the malfunctioning transmitters, some of these tests produced unnecessary false-positives for many types of bacteria and viruses; therefore, individuals receiving a false-positive result could still be infected with these pathogens and take the dangerous path of unnecessary testing and treatment.”

While alarmingly high, the false-positive rates don’t equate to any real transmission of infection, the CDC said.

“The risk of becoming infected with HIV, hepatitis C or other infectious diseases is very low. Therefore, individuals who receive a false-positive result should not be concerned, even if their home or hotel room has no virus. The risk of getting infectious diseases is small enough that it is not worth getting tested.”

The FDA said it expects the affected products to be withdrawn from the market.

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