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

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

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

In the wake of a lead contamination crisis affecting cities across the country, the US Food and Drug Administration (FDA) on Wednesday warned that a commonly used line of lead testing systems may provide falsely low results under certain circumstances. The CDC recommends that parents of children younger than six years (72 months) of age, and now pregnant women and nursing mothers who have been tested for lead exposure consult a health care professional about whether they should be retested.

But Shuren said the investigation is still in its early stages and the agency has not determined the root cause of the inaccurate results.

At this time, any of those tests performed with blood drawn from a finger or heel stick - which is how most lead tests are conducted in the USA - should be accurate.

The tests, manufactured by Magellan Diagnostics, are commonly used in doctors' offices and clinics, and on its website the company calls itself "the most trusted name in lead testing".

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.

On the heels of the FDA warning, the American Academy of Pediatrics (AAP) released a statement urging parents of children 6 years of age and younger who received a venous blood test for lead to discuss with their child's pediatrician whether a new test is needed. They added that now pregnant women and nursing mothers who had a venous blood draw with this system should also be re-tested. Federal officials said that while the company has. Although the majority of children tested were subject to a finger prick or a heel stick, a small percentage had blood drawn from a vein. About 8 million tests were conducted using Magellan devices since 2014.

The agency "did not feel that the data was either adequate regarding what they thought may have been the cause of the problem, the extent of the problem or the effectiveness of the mitigation they put in place", the FDA's Shuren said.

"The FDA is deeply concerned by this situation", said Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health.

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.

So far the cause of the problem is unclear. Other adults anxious about lead exposure should talk to their doctors about possible retests.

The CDC's threshold for elevated lead is 5 micrograms per deciliter of blood.

Lead exposure is risky: It can affect nearly every system in the body while producing no obvious symptoms, and as such, often goes unrecognized.

Since past year, Reuters has identified more than 3,300 USA neighborhood areas with documented childhood lead poisoning rates double those found in Flint, Michigan.

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