Test may underestimate lead levels in children's blood

Test may underestimate lead levels in children's blood

Test may underestimate lead levels in children's blood

During a conference call with reporters, Shuren said Magellan got complaints about inaccurate results in 2014 but concluded after testing "that the risks were negligible" and took steps to resolve the issue.

On Wednesday, the US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) both issued warnings about the validity of test results from Magellan Diagnostics' LeadCare analyzers.

Lead exposure can lead to serious health problems, and is particularly unsafe to infants and young children.

"FDA is deeply concerned by this situation and is warning laboratories and health care professionals that they should not use any Magellan Diagnostics lead tests with blood drawn from a vein", said Jeffrey Shuren, director of the FDA's Center for Devices & Radiological Health.

The blood tests were made by Magellan Diagnostics and it's the only FDA-approved test used in most doctor's offices, the FDA said.

Between the beginning of 2014 to today, officials say, an estimated 8 million blood lead tests have been run using the Magellan systems, and the majority of those were for capillary blood from finger or heel sticks.

Neither are there problems with other blood tests used to detect lead, which account for about half the total, he said.

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The letter went on to urge that the tests "should not be submitted to the CT DPH for disease reporting purposes".

But earlier this year, when FDA officials became aware of the problem, Shuren says the agency believed that the company had underestimated the risk to the public, and that the data supporting the mitigation plan wasn't sufficient.

A representative from the Centers for Medicare and Medicaid Services said that the Medicaid program "should pay for the cost of re-testing" kids on Medicaid, and that those with private insurance should consult their healthcare plan. "The agency is aggressively investigating this complicated issue to determine the cause of the inaccurate results and working with the CDC and other public health partners to address the problem as quickly as possible".

"There is no safe level of lead exposure for children, and the best "treatment" for lead poisoning is to prevent lead exposure before it happens", said Jennifer Lowry, chair of the American Academy of Pediatrics Council on Environmental Health, according to The Washington Post.

Nursing mothers who were tested using the same method should also be retested. She said the company's Ultra and Plus systems, launched in 2013 and 2015 respectively, are typically used to analyze venous blood, though they can analyze capillary blood as well. In Flint, Mich., for example, less than 1 percent of children tested for lead had blood samples taken from a vein, the officials said. On Nov. 24, the company instructed its customers to implement a 24-hour incubation period with the blood sample before running the test.

Despite decades of US progress in curbing lead poisoning, millions of children remain at risk. If such results find elevated lead levels, the results are confirmed through a venous blood test.

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