Tests for lead poisoning may be faulty, US regulators warn

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

Federal officials are warning that certain lead tests manufactured by Magellan Diagnostics, which have been commonly used to test those affected by the water crisis in Flint, Michigan, may provide inaccurate results that underestimate lead levels.

The CDC recommends healthcare professionals retest children now aged 6 years if their test was done (using blood from a vein) with any Magellan Diagnostics' LeadCare System test and they received a result of 10mcg/dL.

FDA officials believe the problems with the tests may have started in 2014 and are investigating. Now available data indicate that the lead tests, when performed on blood drawn from a vein, could provide results that are lower than the true level of lead in the blood.

However, Shuren said Magellan was aware of the issue as early as August 2014, when it received complaints from customers about the accuracy of the tests.

The FDA's warning was issued for all four lead testing systems from Magellan Diagnostics including LeadCare, LeadCare II, LeadCare Plus and LeadCare Ultra. The agency believes the tests are accurate, however, when used with blood from a finger or heel stick.

Since there are a large number of cases having inaccurate lead test results, CDC health officials recommend all physicians and healthcare professionals retest all children younger than 72 months. It also recommended that women who are pregnant or nursing get retested.

Tests given to 128 Flint residents may have registered falsely low blood lead levels, the Michigan Department of Health and Human Services says. The company stated that only 10 percent blood tests are carried out with blood drawn from the veins and accounts for about $1.8 million of Magellan Diagnostic's revenue.

Though Magellan had identified another inaccuracy issue with an additional product in 2015, that information was not conveyed to the FDA during the 510 (k) process despite repeated interactions, Dr. Shuren said, because the company saw it as a low-risk issue it considered resolved. The agency discovered that the company "significantly underestimated" the amount of risk to the public, and lacked "adequate data and supporting documentation regarding the cause of the problem and effectiveness of mitigation". He added that the agencies are looking into potential causes (such as the type of tubes or chemicals used during processing), and to "confirm there is no problem with the capillary blood test".

Jeffrey Shuren, director of FDA's Center for Devices and Radiological Health (CDRH), said that most patients won't be affected the issue, as the majority of lead testing is done using capillary blood, and about half of all tests are processed using other unaffected methods, such as graphite furnace atomic absorption spectroscopy (GFAAS). If such results find elevated lead levels, the results are confirmed through a venous blood test. "Lead exposure can affect almost every system in the body".

If you think you or your child needs another lead test, talk with your doctor. Lead poisoning is particularly risky to infants and young children. 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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