Health officials in Maine are assuring the public that child lead poisoning tests used in the state are accurate, after a widely-used blood test was the subject of a government recall last year.
An article Thursday in USA Today stated that as many as 7 million tests performed on children nationwide between 2014 and May 2017, when the recall was first announced, could have provided false low results.
However, officials say only one type of the test — blood drawn from a vein — using the “LeadCare” system made by Magellan Diagnostics of Massachusetts has been recalled, and the Maine Department of Health and Human Services has said doctors in Maine aren’t using it.
Even if it is used, positive results get a second look in a state lab.
Magellan manufactures two tests that are widely used, and they are the only tests marketed for “in-office” testing. One is a finger-prick test, which doctors use first to measure whether a child’s blood lead level is higher than the standard of five micrograms of lead per deciliter of blood.
If a child’s blood lead level comes back higher than that mark, a confirmation test is done through blood taken directly from a vein, known as venous blood tests.
In May 2017, the U.S. Food & Drug Administration warned laboratories and health care professionals that they should no longer use Magellan Diagnostics’ LeadCare tests with blood drawn from a vein, and the FDA has since conducted an inspection of the Magellan facility and issued a report.
“The FDA will continue to provide updates on our investigation into the inaccurate test results as more is learned,” Tara Rabin, press officer for the FDA, said Thursday. “In the meantime, the agency encourages people to continue following the Centers for Disease Control and Prevention’s re-testing recommendations and the FDA’s recommendations for health care professionals.”
On Thursday, the FDA sent a warning letter to Becton Dickinson and Co., the manufacturer of a blood collection tube used by Magellan, which cited several violations of federal law.
In Maine, Department of Health and Human Services spokeswoman Emily Spencer said Friday that “Maine families do not need to worry about the accuracy of a child’s blood lead test.”
Spencer said the state is aware of the issue with Magellan’s venous blood tests, however, she said that type of test “rarely happens in Maine.”
She said from having contact with all health care facilities that are approved to perform in-office testing by the state’s Childhood Lead Poisoning Prevention program, “almost all testing is performed on capillary blood specimens” from finger pricks.
“We have sent out information to health care providers using LeadCare to make sure they are aware of the FDA recommendation that this in-office testing device not be used for venous specimens,” she said.
Additionally, she said, even if a venous test is done using the Magellan system at a medical office, Maine law requires that all venous tests to confirm elevated lead levels must be done at the Maine Health and Environmental Testing Lab.
“Fortunately for Maine families, most blood lead analyses and all venous confirmatory samples are analyzed by Maine’s HETL using a sophisticated laboratory instrument and methods that are nationally certified and undergo additional quality assurance through HETL’s participation in a national proficiency testing program,” she said.
Medical professionals have said that no amount of lead in a child’s blood is safe. In Maine, lead poisoning awareness has grown, as has routine testing for children.
Five areas — Lewiston-Auburn, Bangor, Portland, Saco-Biddeford and Sanford — are responsible for 40 percent of childhood lead poisoning in Maine. In those areas, according to the Maine Center for Disease Control, more than 80 percent of lead-poisoned children live in rental housing.
Symptoms of lead poisoning in children include irritability, appetite loss, developmental delay, learning problems, weight loss and more.
Spencer said that health care facilities in Maine can only use LeadCare for in-office blood lead testing if “we approve them to do so – ensuring we know who is performing this practice in Maine.”
Joan Churchill, CEO of Community Clinical Services, which runs the B Street Health Center in Lewiston, said their pediatrics practice manager has been following the recall closely since last year. She said B Street only uses LeadCare for finger-price blood draws, and that all blood draws from veins are processed by the state directly.
“Bottom line — this is not an issue for Maine,” Spencer said.
(Russ Dillingham/Sun Journal)
A LeadCare Ultra blood lead testing system. (Courtesy of FDA)