FDA Warns Tests for Lead Poisoning May Be Faulty

Pregnant or breast-feeding women and children younger than six years old should be retested for lead poisoning due to inaccurate test results, according to the Food and Drug Administration and the Centers for Disease Control and Prevention.

Magellan Diagnostics Inc. sells millions of tests, most of them are heel-stick or finger-stick tests. Yet the ones in question are tests for lead in blood taken from people’s veins. These tests may give results that are lower than the actual level of lead in the blood. The FDA believes this issue may be going back to 2014.

The FDA and CDC are saying that some lead tests could be misleading, and might underestimate the amount of lead in people's blood.

Jeffrey Shuren, director of the FDA’s medical-device center believes most people will not be affected. But the agency still warns laboratories and health-care professions against using any Magellan Diagnostics lead tests with blood drawn from a vein. Here’s Patrick Breysse, director of the CDC’s National Center for Environmental Health in a press release:

“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. For this reason, because every child’s health is important, the CDC recommends that those at greatest risk be retested.”

According to Breysse, fewer than 1% of the lead tests administered on the residents of Flint, Michigan—a city whose water system was tainted with lead—were the venous type. Don’t miss NOVA’s “Poisoned Water,” airing May 31, 2017, at 9/8c on PBS.