Faulty lead testing means that thousands of children may need to be re-tested for lead poisoning after a report found that standard tests may be inaccurate.
On Wednesday, the FDA warned that some blood tests used to check for lead poisoning in both women and children since 2014 may have incorrectly indicated that children were safe from lead exposure.
The New York Times reported that pregnant and nursing women, as well as children under 6-years-old, may need to be re-tested.
The FDA’s concern is that the original tests may have underestimated blood lead levels, thus giving parents false assurance. Young children and infants are particularly vulnerable to the effects of lead poisoning, which can affect almost every system in the body and cause cognitive deficits.
Officials from the Food and Drug Administration said in a news conference that tests conducted by Magellan Diagnostics are now in question.
Magellan Diagnostics discovered back in 2014 that its three-minute test could yield inaccurate results when blood had been drawn from a vein. Lead tests in children are typically taken by pricking the heel or finger to draw samples of capillary blood for testing. According to the FDA, there is no current evidence that heel- and finger-pricking methods have produced inaccurate results. It appears that the inaccurate readings are only associated with venous blood.
Last year, Meridian Biosciences acquired Magellan Diagnostics, and Meridian issued a statement stating that venous blood testing accounts for around 10 percent of Magellan’s revenue – approximately $1.8 million. Officials from the FDA estimate that since 2014, approximately 8 million tests have been completed using the Magellan system. However, most of them were done using capillary blood and not from blood drawn from a vein.
“Meridian and Magellan take these matters very seriously and will continue to work closely and fully with the FDA and CDC to address the concerns identified with venous samples as quickly as possible.”
Dr. Jennifer Lowry is a chairperson of the American Academy of Pediatrics’ council on environmental health. Dr. Lowry said that pediatricians typically draw blood from a vein only if they’ve noticed an elevated level from a heel or finger stick and need to check the result.
She added that the confirmatory venous blood sample would be sent out of the office to be analyzed by a different testing system. Dr. Lowry doesn’t believe there are a large number of people affected overall but admits it is a problem for those whose normal test result was an error.
The FDA wanted to be very clear that it has only just started its investigation and assured people that it is “deeply concerned” about the situation and has issued warnings to laboratories that Magellan Diagnostics lead tests that draw blood from a vein should not be used.
“The agency is aggressively investigating this complicated issue to determine the cause of the inaccurate results.”
Health officials are suggesting that children under 6-years-old who had blood drawn from a vein using Magellan Diagnostics LeadCare systems, and whose test results were less than 10 micrograms/deciliter, should be re-tested. In addition, officials suggest that pregnant and breastfeeding women with similar test results should be re-tested.
Magellan became aware in August of 2014 that there were problems with its LeadCare tests after they received complaints that blood samples tested more than once produced higher results on repeat tests.
FDA officials said that in October that same year, Magellan was informed that validation studies comparing LeadCare results with other analyzer systems produced differing results. In November of 2014, customers were notified by Magellan that the problem could be resolved by incubating blood samples with the reagent mixture for 24 hours before running the test.
They reassured their customers that “this phenomenon appears to be limited to a small percentage of samples.” According to FDA officials, the agency was not notified about the problem at that time, and Magellan only filed a report saying there had been a malfunction of the device in April of 2015. According to Magellan, the safety risk was low.
Then, in March of 2016, Magellan requested changes to the labeling of testing systems, and it was at this point that the agency became concerned.
“It wasn’t until we started to ask more questions of the company, to peel back the onion, that we found the company had underestimated the amount of risk to the public. The company did not have adequate data and supporting documentation regarding the cause of the problem and the effectiveness of the mitigation they had put in place in the past.”
Mark Massaro is an analyst with Canaccord Genuity. He said the Magellan test is the only FDA device approved for fast in-office testing.
“The primary reason why these customers were using Magellan is you can get a very rapid test result in the clinic. A three-minute result is nice to have.”
WebMD reported that lead exposure can lead to serious health problems, especially in infants and young children. While all states require that children be screened for lead exposure, recommendations for screening differ from state to state.
It’s not just Flint. Lead taints water across the U.S., EPA records show – The Washington Post https://t.co/KGjPQ2zQ2K
— PureWaterWarrior (@PWwarrior) May 10, 2017
Patrick Breysse, the director of the CDC’s National Center for Environmental Health, said the CDC understands that parents and “others affected by this problem” will be concerned and that it is recommended that “those at greatest risk” be retested.
“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.”
Officials said that adults who work with materials or products containing lead are also at risk for lead exposure. They said it’s safe to use all LeadCare systems that use blood from a heel or finger stick, including the LeadCare ll system, which most clinics and doctors’ offices use.
MA School Lead in Water Testing Shows that Over Half of Schools have Elevated Levels of Lead in Drinking Water – https://t.co/0BagPXQZM1
— Tap Water Watch (@TapWaterWatch) May 9, 2017
The Daily Mail reported that there’s been a huge increase in the number of people infected with chemicals over the last three years, especially in Flint, Michigan, where the entire water supply was contaminated.
In Flint, Michigan, lead seeped into the water, and it’s believed that almost 8,000 children have been exposed to lead poisoning due to water contamination.
— Rachel Bianco (@10NewsRBianco) May 17, 2017
In children, lead exposure can cause serious long-term health problems. Lead exposure can damage the central nervous system and is particularly dangerous to children with possible learning disabilities.
Pregnant mothers are also at risk because drinking contaminated lead water can harm the fetus. According to the EPA, adults can be affected by increased blood pressure, cardiovascular effects, reproductive problems, and decreased kidney function.
In 2014, in an attempt to save money, Flint switched its water supply to a local river instead of relying on Detroit’s water. The river water was more corrosive than the Detroit system’s and caused more lead to leach from Flint’s aging pipes.
— CT State Med Society (@CSMSNews) May 19, 2017
Almost immediately after the change, the complaints began. Residents complained about the smell, and it was later revealed that the water supply was contaminated by lead. With so many children being exposed to lead poisoning, the scandal has drawn national attention, with criminal charges already being laid against six state employees.
[Featured Image by Africa Studio/Shutterstock]