FDA issues warning for inaccurate blood tests for lead
The three major bloodtesting laboratories in Allegheny County report they do not use testing equipment declared potentially inaccurate by the U.S. Food & Drug Administration on Wednesday, according to the county’s top health official. The FDA said lead tests manufactured by Magellan Diagnostics may underestimate levels of lead in the blood of children and adults.
Following the warning from the FDA, the American Academy of Pediatrics on Wednesday urged parents of children age 6 and under who received a venous blood test for lead — where the blood is drawn from the arm — to talk with their child’s doctor to decide if the test should be redone. Pregnant women and nursing mothers who have been tested are also advised to talk to their doctors.
Lead poisoning is particularly dangerous to infants and young children, causing serious health effects. The U.S. Centers for Disease Control and Prevention advised the pediatricians group to issuethe advice to parents.
The warning applies only to tests made by Magellan — a Massachusetts-based testing company whose products are used in laboratories and doctors’ offices throughout the country — in which blood samples are taken from a vein, not the more common, less invasive tests in which fingers or heels are pricked for a blood sample.
Magellan’s tests using the finger- or heel-pricks methods are considered accurate.
The FDA statement said its warning came after the agency studied data from the Magellan lead testing systems known as LeadCare, LeadCare II, LeadCare Plus and LeadCare Ultra. The FDA said the testing problem may extend back to 2014.
In response to growing concerns of undetected lead poisoning in children, the Allegheny County Board of Health voted May 3 to require testing for lead in children. County council and the county executive are considering approval of the regulation, which mandates that their blood be tested for lead between 9 and 12 months of age and again at 24 months.
Karen Hacker, director of the Allegheny County Health Department, said Wednesday afternoon in an emailed statement the department was contacting pediatricians and laboratories to make sure they knew of the FDA and AAP warning.
“At this time, Quest Diagnostics, UPMC and LabCorps have informed us that they are not using this equipment. We do not know, however, whether other labs or pediatricians offices are currently using this equipment and will continue to reach out to get up-to-date information to informthe public.”
The Health Department doesn’t do its own blood testing for lead, Dr. Hacker said.
In a conference call with reporters, Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said the agency’s investigation was in its early phases, and that most people probably won’t be affected. Still, he said, he was deeply concerned about the inaccurate results and that a “root cause”hasn’t been identified.
The agencies said women and parents should ask their doctor about retesting. Candidates include anyone whose blood was drawn for the test and who had a blood lead level of 10 micrograms or less per deciliter. While no level is considered safe, the federal safety limit is half that level.
“I’m not expecting a lot of retesting,” said John Kraeutler, CEO of Meridian Bioscience Inc., which bought Magellan last year.
Each year, about 300,000 venous blood tests are performed in laboratories using Magellan technology, while more than 2.5 million tests are conducted in physicians’ offices, typically using a finger or heel stick, Mr. Kraeutler said. He said Magellan is working closely with the FDA to resolve the situation, and is offering to move customers to finger-stick testing from vein-based testing.
Dr. Shuren said that Magellan got complaints about inaccurate results involving one of its testing systems in 2014, but that the company concluded “the risks were negligible” and that the problem could be fixed by delaying blood processing for 24 hours. Magellan submitted a malfunction report to the FDA in 2015, agency officials said, but they added they believe the company underestimated the risks involved by characterizing the situation as “not likely to cause adverse health consequences.”
Dr. Shuren said the FDA became concerned about the problem in April 2017, when the company requested changes to a device’s label. (In clearing devices, the agency requires firms to demonstrate that the devices are at least as safe and effective — substantially equivalent — to one already on the market. In the case of diagnostics like blood tests, companies also must demonstrate that the tests are accurate and reliable.)
Patrick Breysse, director of the CDC’s National Center for Environmental Health, noted that the agency has kept a close eye on communities like Flint, Mich., where the water was contaminated by lead. He estimated that “less than 1 percent” of children in Flint might be at risk for having lead levels that were-in-accurately reported.
Tim Hill, an official with the Centers for Medicare and Medicaid Services, said Medicaid would pay for the retesting of children on the program and that people covered by private insurance should ask their health plan about retesting.
Typically, lead testing, especially for children, is done by a finger or heel stick known as a capillary test. If the results show elevated lead levels, the results are confirmed-through a venous test.
“There is no safe level of lead exposure for children, and the best ‘treatment’ for lead poisoning is to prevent lead exposure before it happens,” said Jennifer Lowry, chair of the American Academy of Pediatrics Council on Environmental Health.
The CDC said that 4 million households have children that are exposed to high levels of lead, which can impair cognitive abilities and cause other damage.