Tests for lead poisoning may be faulty, US regulators warn

And the FDA says it's aggressively investigating why these tests can give inaccurate results.

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.

USA health agencies on Wednesday warned that certain blood tests for lead poisoning may give results lower than the actual level of lead.

"The FDA is concerned that Magellan lead tests that use blood drawn from a vein may provide results that are lower than the actual level of lead in the blood".

Shuren said that the FDA first became aware of the issue during a review of a 510 (k) premarket submission for a new LeadCare product received from Magellan in March 2017. It subsequently issued instructions to mitigate problems with its LeadCare II testing system.

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.

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 say women and parents should ask their doctor whether they need to be tested again.

So far the cause of the problem is unclear.

The health officials assert that retesting should only be done for children whose blood was drawn from the vein during the test, which any Magellan Diagnostics' LeadCare System conducted, and the results determined concentration in blood of less than 10 micrograms per deciliter. They added that now pregnant women and nursing mothers who had a venous blood draw with this system should also be re-tested.

However, on April 28, Magellan notified customers they should no longer use the blood collection tubes, and that they should also discontinue the 24-hour incubation method.

Since 2014, 9,363 children under the age of six had tests performed with LeadCare equipment using venous blood samples, which is 1.7 percent of all the blood lead tests performed during that time.

If you fall into any of those categories, the CDC recommends you talk to your doctor or another healthcare professional about whether or not you should be retested. The FDA noted that it hadn't found any evidence of problems with the capillary blood samples. If such results find elevated lead levels, the results are confirmed through a venous blood test. Infants and young children are especially vulnerable to the effects of lead poisoning, which can cause cognitive deficits and affect nearly every system in the body.

"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.

  • Rogelio Lindsey