FDA: Inaccurate Lead Tests ID'd, Retests Necessary for Some

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

The reasons why the tests are inaccurate is still unknown, but Shuren says the FDA is "aggressively" investigating the issue along with the CDC and other public health partners "to address the problem as quickly as possible", according to the statement.

On Wednesday, May 17, the U.S. Food and Drug Administration and the Centers for Disease Control warned Americans that certain blood tests used to monitor lead levels may have delivered inaccurate results.

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. "There is little evidence that Magellan tests using blood from a finger or heel stick are affected", FDA's Jeffrey Shuren stated in a press release.

The FDA published a Safety Communication statement on its website, where they said that people should follow their recommendations instead of the ones issued by Magellan Diagnostics on April 28.

On November 4, 2016, Magellan notified its customers of a similar problem when processing venous blood samples taken with their LeadCare II testing systems, and by November 11 they notified customers by bulletin that the rubber caps of some of the blood collection tubes may introduce a substance into the blood sample when used with the LeadCare II systems.

The letter went on to urge that the tests "should not be submitted to the CT DPH for disease reporting purposes". The FDA and CDC believe that the original blood tests Magellan Diagnostics conducted may have misjudged the lead amount present in the blood and gave parents false assurance.

Patrick Breysse, director of the CDC's National Center for Environmental Health, said, "We understand that parents of children and others affected by this problem will be concerned about what this means for their health".

Shuren says testing should be re-done in kids under 6 years of age who had a blood test result of 10 micrograms per deciliter or less. Children under 6 and pregnant and nursing women may need to be 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 FDA said the "stick" tests by Magellan can still be used, as can other test methods offered by some laboratories.

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. "Lead exposure can affect almost every system in the body".

"While most children likely received an accurate test result, it is important to identify those whose exposure was missed, or underestimated, so that they can receive proper care".

The tests are created to detect lead poisoning that can stunt children's growth and reduce their IQs, according to the Centers for Disease Control and Prevention.

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