The Food and Drug Administration has expanded access to portable lead testing devices, which will allow for rapid screening of children and adults at more than 115,000 community clinics, mobile health units, schools, and work sites across the country.
Until now, the LeadCare II Blood Lead Test System (ESA Biosciences, Chelmsford, Mass.) had been available only at select hospitals and testing facilities with clearance to perform highly complex assays.
The FDA has recategorized the device so that it is waived under the Clinical Laboratory Improvement Amendment (CLIA), permitting it to be distributed to nontraditional sites to allow for more widespread testing.
Easy access to the portable device, which delivers results from either fingerstick or venous blood samples in 3 minutes, now “allows us to overcome the very real logistical challenges of testing children who may have been exposed to lead contamination,” Dr. John Agwunobi said at a press conference.
Access to lead testing has been particularly challenging for children in poor urban communities, where the risk for lead poisoning is highest.
For many of their families, it is a hardship to get to a hospital or physician's office for the initial blood testing.
The need to acquire confirmatory testing and medical follow-up poses further inconveniece and barriers to care, Dr. Agwunobi pointed out.
“Approximately 310,000 U.S. children aged 1–5 years have blood lead levels greater than 10 mcg of lead per deciliter of blood, a level at which harmful health effects are known to occur,” according to estimates from the Centers for Disease Control and Prevention.
About 24 million homes in the United States are believed to have significant lead-based paint hazards, according to estimates from the U.S. Department of Housing and Urban Development.