FDA, CDC warn some lead poisoning tests may not be accurate

Bruno Cirelli
Mag 18, 2017

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.

Data indicate that when all four of Magellan's lead testing systems - LeadCare; LeadCare II; LeadCare Plus; and LeadCare Ultra - are performed on blood drawn from a vein, they may give results that are lower than the actual level of lead in the blood.

The CDC website states that 4 million U.S. households have children that are exposed to high levels of lead and approximately a half-million children under the age of five have lead levels above 5 micrograms per deciliter (µg/dL), a level at which the agency recommends public health actions be taken. "It's important to remember that lead does not stay in the blood for very long, so a low test result today may not tell you if there was past exposure".

Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, said the investigation was in its early stages, and that most people probably won't be affected. "The FDA believes that most people will not be affected by this issue, as a majority of Magellan lead tests now in use in the United States are conducted using blood obtained from a finger or heel stick", Kotz said.

FDA spokesperson Deborah Kotz said not everyone who got a lead test needs to worry immediately.

Officials are recommending retesting for certain children, pregnant women and nursing mothers who did get tested using blood from a vein.

Any adult or child who had blood drawn for a lead test since 2014 may have to be re-tested, the FDA said.

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.

However, lead testing using blood taken from a vein is not widespread. In both cases, they recommended implementing a minimum 4-hour incubation step with the samples. Image credit: Harborview School of Phlebotomy III.

FDA officials did not provide estimates of how many people may have been at risk for a faulty test.

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. Families with concerns should speak with their doctor to determine if retesting is necessary.

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.

Lead testing in children is typically done by a finger or heel stick known as capillary test.

If a child is found to have high blood lead levels, pediatricians should follow the management guidance in the 2016 AAP policy Prevention of Childhood Lead Toxicity They also can reach out to their local Pediatric Environmental Health Specialty Unit for additional support.

Studies have shown many USA public water supplies are contaminated by lead. Lead can impair cognitive abilities and cause other damage in children.

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