Testing kids for lead gets easier

FDA decision could aid efforts at prevention in Baltimore

September 19, 2006|By Jonathan D. Rockoff and Frank D. Roylance | Jonathan D. Rockoff and Frank D. Roylance,SUN REPORTERS

WASHINGTON -- Federal regulators made it easier yesterday for health clinics to test children for lead poisoning, which could bolster prevention efforts - particularly in cities such as Baltimore with high levels of lead in older buildings.

The Food and Drug Administration announced that it was allowing widespread sales of a laptop-size kit that indicates within three minutes whether a person has elevated levels of lead in the blood.

"We don't have to wait [while] the lead level in a child's blood is affecting their development," said Dr. John O. Agwunobi, an assistant secretary for health who has worked as a pediatrician in city health clinics.

But health authorities and providers in Baltimore were reserving judgment until they know more about the costs and reliability of the new technology.

"We're going to be looking at it very carefully to see what its role could be in Baltimore," said the city's health commissioner, Dr. Joshua Sharfstein. "A number of kids who probably should be tested for lead poisoning aren't being tested. Technology that makes it easier to test should reverse those trends."

Lead poisoning affects 310,000 American children under 6 years of age each year and can cause learning disabilities, developmental delays and even death. It is a particular, although not exclusive, problem for cities such as Baltimore, with old houses and buildings, because children are exposed by eating or drinking dust found in lead-based paint or corroding plumbing.

Until now, the LeadCareII Blood Lead Test System was used only at hospitals and other facilities with highly trained staff. Without such staff, samples needed to be sent to a laboratory that analyzed the blood and provided the results.

The FDA's decision makes it possible for clinics, schools, doctors' offices and health fairs with minimally trained staff to use the device. It could expand access to more than 115,000 locations nationwide, the FDA said.

According to federal health officials, the kit is simple to use, requiring a small amount of blood drawn from a finger prick or vein. It detects elevated lead levels by running an electric current through the sample. Studies, on 516 blood samples taken over two months, showed the device was 98 percent accurate.

The rapid results should prove helpful to clinics in Baltimore, said Madeleine Shea, an assistant city health commissioner, who oversees the lead poisoning prevention and lead hazard reduction programs. She said city hospitals have had trouble tracking down some children that test results later indicate have high lead levels.

"If they are changing addresses, it's hard to follow up," Shea said. "The immediate result helps them get on with treatment and" helps city lead abatement officials identify the source and clean it up.

Baltimore had 854 cases of child lead poisoning last year. Statewide, 1.3 percent of children who were tested for lead exposure registered dangerous levels, which are classified as 10 or more micrograms of lead per deciliter of blood. The numbers of cases declined in the city and state, but health officials said there was still a long way to go to reach the goal of eliminating lead poisoning by 2010.

At a news conference, Dr. Andrew C. von Eschenbach, the acting FDA commissioner, hailed the kit as "simple, accurate and reasonably free of harm." He also submitted to a quick test.

Officials said each kit, manufactured by ESA Biosciences of Chelmsford, Mass., will cost $2,200, and each test will cost $7.

The $7 price is only half of what it currently costs doctors to send the samples to outside laboratories, according to the company, but the kits may prove expensive for cash-strapped health departments and local clinics.

"That's a big outlay, and I doubt Medicaid will pay for it, so who will?" Shea asked.

Shea said Baltimore's Health Department didn't have the funding to buy the kit for clinics.

Instead, she said, the agency may try to demonstrate the cost-effectiveness of the device in an effort to encourage clinics to buy it.

It may take some persuasion. Placing the testing technology in a doctor's office would require not only the costly machine, but also the reagents required to run the tests, and the labor to operate it, said Dr. Charles I. Shubin, director of children's health at Mercy FamilyCare.

"We would almost have to have a full-time person for the number [of tests] we do," he said. And that would be hard to justify given the meager reimbursement rates provided by Medicaid.

Any new testing technology would also have to be reliable enough to hold up in court, he said. That's because children are usually not treated for very low blood levels because of "significant and serious side effects" from the drugs.

Instead, public health officials seek to clean up the child's home environment by pressing the landlord to do lead abatement work. That, Shubin said, is going to require a test result that will survive legal scrutiny.

The new technology, Shubin said, "is going to be a relatively hard sell without striking advantages."

Ruth Ann Norton, executive director of the Coalition to End Childhood Lead Poisoning, said that if cost and accuracy issues are resolved, the new LeadCare II test system should bring the tests to community settings where they can reach children and adults who are not now being tested.

"From that standpoint we're pretty excited about the possibilities," she said.

jonathan.rockoff@baltsun.com frank.roylance@baltsun.com

Baltimore Sun Articles
Please note the green-lined linked article text has been applied commercially without any involvement from our newsroom editors, reporters or any other editorial staff.