Tests for lead poisoning may be faulty, USA regulators warn

Tests for lead poisoning may be faulty, USA regulators warn

The FDA says blood lead tests manufactured by Magellan Diagnostics can give falsely-low results if they are used with blood drawn from a vein, as opposed to a finger or heel prick.

The Food and Drug Administration warned laboratories and healthcare professionals not to use any lead testing device made by Magellan Diagnostics, a company acquired by Meridian in 2016 for $66 million, to test blood drawn from veins.

But Shuren said the investigation is still in its early stages and the agency has not determined the root cause of the inaccurate results. The agency is advising that lead tests using blood samples that are drawn from a vein should no longer be used.

The FDA believes the issue may date back to 2014 when the Flint water crisis began.

FDA cleared the first of Magellan's LeadCare diagnostics in 1997, and has cleared three subsequent versions-LeadCare II in 2005, LeadCare Ultra in 2013 and LeadCare Plus in 2015-for use in different settings. Some laboratories also offer other methods of lead testing, which are not believed to be affected.

Lead poisoning is hard to detect, but exposure to even small amounts of lead can result in serious health issues for children, who are at risk of developing "irreversible" brain damage and seizures, according to the Mayo Clinic.

You may need retesting yourself, too, if you're pregnant or nursing and also underwent this kind of test.

FDA officials did not provide estimates of how many people may have been at risk for a faulty test.

The FDA and the CDC recommended that children younger than six years old be retested if their Magellan venous tests showed lead levels at less than ten micrograms per deciliter. In Flint, Mich., for example, less than 1 percent of children tested for lead had blood samples taken from a vein, the officials said. "There is little evidence that Magellan tests using blood from a finger or heel stick are affected", Dr. Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, said during a morning media briefing.

Lead exposure can affect almost every system in the body, produces no obvious symptoms, and frequently goes unrecognized, potentially leading to serious health issues. He said the company did not alert the FDA to the problem. Shuren added that while the Magellan LeadCare system is the only FDA-cleared test specifically for lead and the primary source of lead testing for doctor's offices and clinics in the US, it is "not the only method of testing", he said. While recommendations for lead screening differ from state to state, all states require children to be screened for lead exposure. But if those levels are elevated, a follow up test is done with blood drawn from the arm.

Lead exposure is risky: It can affect nearly every system in the body while producing no obvious symptoms, and as such, often goes unrecognized.

Children and infants are particularly vulnerable to the neurotoxic effects of lead poisoning.

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