FDA Warns About Risk of Inaccurate Results From Certain Lead Tests

  • FDA Warns About Risk of Inaccurate Results From Certain Lead Tests

FDA Warns About Risk of Inaccurate Results From Certain Lead Tests

The warning includes all four of Magellan Diagnostics' lead testing systems: LeadCare; LeadCare II; LeadCare Plus; and LeadCare Ultra.

It is unclear why Magellan lead tests perform differently with venous blood than with capillary blood from a finger or heel stick, FDA said. Finger-prick tests are exempt for now. The students were being tested for lead after the metal was found in the city's drinking water.

Studies have shown many USA public water supplies are contaminated by lead.

"The FDA is deeply concerned by this situation and is warning laboratories and health care professionals that they should not use any Magellan Diagnostics' lead tests with blood drawn from a vein", Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, said in a statement.

"Children are particularly vulnerable to lead exposure due to the effect on their developing brains and organ systems", the Centers for Disease Control and Prevention said. Reuters has identified more than 3,300 areas with childhood lead poisoning rates at least double those found in the MI city. Lead poisoning is particularly unsafe to infants and young children.

Awareness of lead poisoning escalated following widespread exposure in Flint, Michigan. Low-level lead exposure, even at blood lead concentrations below 5 g/dL, can increase the risk of intellectual and academic disabilities in children, and is linked to higher rates of behavioral disorders such as hyperactivity and attention deficits, and lower birth weight.

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. Breysse estimated that "less than 1 percent" of children in Flint might be at risk for having lead levels that were reported using inaccurate tests.

However, Shuren said Magellan was aware of the issue as early as August 2014, when it received complaints from customers about the accuracy of the tests.

But the FDA is also checking to make sure those tests are accurate.

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 US - should be accurate. Other adults who are concerned about their risk or the risk to an older child should speak to their health care professional about whether they should be retested.

Common blood tests for lead can give falsely-low results in certain cases, according to a new warning from the Food and Drug Administration.

The CDC recommends that parents of children who were under the age of six, women who were pregnant, and mothers who were nursing at the time they were tested should ask their doctor if they should be retested.

Lead kills developing brain cells and the consequences are permanent. Studies increasingly link conduct disorder, delinquency, and criminal behaviors to lead toxicity. It can also cause miscarriages and premature births.