By Steven Reinberg Robert Preidt
WEDNESDAY, May 17, 2017 (HealthDay News) — Lead checks made by Magellan Diagnostics might yield inaccurate outcomes for some youngsters and adults, U.S. health officers warned Wednesday.
Parents of youngsters youthful than 6 years previous, pregnant women and nursing moms who’ve been examined for lead publicity utilizing these checks ought to seek the advice of a health care supplier about whether or not they need to be retested, the officers stated.
Data point out that when all 4 of Magellan’s lead testing techniques — LeadCare; LeadCare II; LeadCare Plus; and LeadCare Ultra — are carried out on blood drawn from a vein, they could give outcomes which are decrease than the precise degree of lead within the blood.
However, lead testing utilizing blood taken from a vein just isn’t widespread. Most testing is completed with finger pricks and heel pricks, the officers stated.
“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. There is little evidence that Magellan tests using blood from a finger or heel stick are affected,” Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, stated throughout a morning media briefing.
Finger pricks are used on most youngsters. Since 2014, about eight million exams have been carried out, with the overwhelming majority based mostly on blood from finger or heel samples. In Flint, Mich., for instance, lower than 1 % of youngsters examined for lead had blood samples taken from a vein, the officers stated.
Still, Shuren stated the FDA is “deeply involved by this example and is warning laboratories and health care professionals that they need to not use any Magellan Diagnostics’ lead exams with blood drawn from a vein.”
Shuren added that “the agency is aggressively investigating this complicated issue to determine the cause of the inaccurate results and working with the CDC [Centers for Disease Control and Prevention] and other public health partners to address the problem as quickly as possible.”
Patrick Breysse, director of the CDC’s National Center for Environmental Health, stated, “We perceive that oldsters of youngsters and others affected by this drawback might be involved about what this implies for his or her health.
“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,” Breysse stated.
Lead publicity can result in critical health issues, and is especially harmful to infants and younger youngsters. Recommendations for lead screening differ from state to state, however all states require youngsters to be screened for lead publicity.
Some adults are additionally in danger for lead publicity, together with those that work with merchandise or supplies that include lead, the FDA stated.
It’s protected to make use of all LeadCare methods that depend on blood from a finger or heel stick, together with the LeadCare II system, which is discovered in lots of docs’ workplaces and clinics, the officers stated.