Tests for lead poisoning may be faulty, US regulators warn

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

As NBC News reports, many children and pregnant women may need to get new lead tests because one of the most common lab tests may have given falsely low readings, the Food and Drug Administration said Wednesday.

"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, the director of the FDA Center for Devices and Radiological Health, said in the statement.

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

"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".

The FDA and CDC revealed that Magellan Diagnostics manufactured the faulty lead tests that are under scrutiny.

FDA cleared the first of Magellan's LeadCare diagnostics in 1997, and has cleared three subsequent versions-LeadCare II in 2005, LeadCare Ultra in 2013 and LeadCare Plus in 2015-for use in different settings. The company makes the only lead test used in doctor offices and clinics and that test uses blood from finger or heel sticks.

Eden Wells, chief medical executive of MDHHS, said that while less than 2 percent of the lead tests performed in the state were performed with these devices using a venous blood sample, his department is taking the issue very seriously.

"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", Patrick Breysse, director of the CDC's National Center for Environmental Health, said in a statement. They added that now pregnant women and nursing mothers who had a venous blood draw with this system should also be re-tested.

Shuren says testing should be re-done in kids under 6 years of age who had a blood test result of 10 micrograms per deciliter or less.

Shuren said that since the beginning of 2014, they estimate that 8 million tests were used with the Magellan system, but "the majority were for capillary blood". He added that the agencies are looking into potential causes (such as the type of tubes or chemicals used during processing), and to "confirm there is no problem with the capillary blood test". The agency discovered that the company "significantly underestimated" the amount of risk to the public, and lacked "adequate data and supporting documentation regarding the cause of the problem and effectiveness of mitigation". But if those levels are elevated, a follow up test is done with blood drawn from the arm.

Lead exposure can affect almost every system in the body, produces no obvious symptoms, and frequently goes unrecognized, potentially leading to serious health issues.

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

The U.S. Centers for Disease Control and Prevention has more on lead.

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