Some Lead Tests Produce Too-Low Results

Certain tests to detect lead poisoning could produce faulty results, regulators warn

The CDC recommends that parents of children younger than six years (72 months) of age, and now pregnant women and nursing mothers who have been tested for lead exposure consult a health care professional about whether they should be retested.

Healthcare professionals and public health laboratories should discontinue using Magellan's LeadCare System Testing System with venous blood samples, due to concerns about inaccurately low results, said the FDA in a safety communication. The FDA believes the testing issue may date to 2014, but said the scope of the problem wasn't clear until March, when Magellan provided new information as part of the FDA's review of its newest lead test.

MDHHS said in a news release Wednesday that less than 2 percent of lead tests performed in MI since 2014 - including 128 in Flint - were done using Magellan equipment that processed blood drawn from veins. The lead poisoning tests are made by Magellan Diagnostics. The most common method of testing lead levels in the blood is done by pricking heels and fingers instead of veins. There are also other blood tests doctors and labs may use that are not Magellan, and those are not affected. He added that "less than 1 percent" of children in places like Flint, Michigan, might be at risk due to the inaccurate lead blood test reporting. They added that now pregnant women and nursing mothers who had a venous blood draw with this system should also be re-tested.

Shuren said that since the beginning of 2014, they estimate that 8 million tests were used with the Magellan system, but "the majority were for capillary blood". The tests should no longer be used for blood samples drawn from a vein, the agencies said.

The Centers for Disease Control is recommending that parents of children younger than six years old talk to their doctors about the possibility of re-testing.

But he said while the FDA and CDC are in the "early stages" of their investigation, they did not want to delay issuing this warning to the public.

The CDC warns that "no safe blood lead level in children has been identified".

"We take this issue very seriously and will be working closely with our local health departments and health care providers to ensure they are aware of the recommendations and offering retesting as appropriate", said Dr. Eden Wells, chief medical executive of MDHHS.

Lead exposure is unsafe: It can affect nearly every system in the body while producing no obvious symptoms, and as such, often goes unrecognized. "It produces no obvious symptoms and can go undetected for years", Patrick Breysee, director of the CDC's National Center for Environmental Health, said during a conference call with reporters. Whether diseases start at home or overseas, are curable or preventable, chronic or acute, stem from human error or deliberate attack, CDC is committed to respond to America's most pressing health challenges.

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