On March 23, 2006, the Centers for Disease Control and Prevention (CDC) issued a special edition of its Morbidity and Mortality Weekly Report (MMWR). It outlined the case of a four-year-old Minnesota boy, who died from acute lead poisoning after swallowing a heart-shaped charm. It had been part of a metal bracelet provided as a free gift with the purchase of Reebok shoes. Laboratory testing showed that the trinket was 99 percent lead.1 If there is any good news that can come out of one family's tragedy, it is that this case has been a loud wake-up call to focus attention on the "silent epidemic" of lead poisoning. Reducing the levels of lead poisoning in children has been a major public health priority since the 1960s – and our progress to date has made it one of the greatest public health success stories in history. Efforts such as banning lead in paints and gasoline, incentives to eliminate lead in older housing stock, and mandatory screening programs have dramatically reduced the instances of childhood lead poisoning over the past 30 years. Today, approximately 310,000 U.S. children aged 1-5 years have blood-lead levels greater than the CDC-limit of 10 micrograms of lead per deciliter (μg/dL),2 although the CDC states in its latest report that, in fact, there is no "safe" threshold for lead in blood. Recent studies suggest adverse health effects exist in children at blood-lead levels significantly lower than 10 μg/dL. Lead poisoning remains the number one environmental threat to children, particularly affecting low-income people of color living in poor, often urban, neighborhoods. For example, in Detroit during the last 10 years, a disproportionately small number of housing units – only 657 addresses – accounted for nearly 1,500 children with blood-lead levels greater than 20 μg/dL. In Louisville, Kentucky, 35 percent of children identified with elevated blood-lead levels during the last five years resided in 79 housing units; these units represent less than 0.3 percent of all housing units in the community. These experiences are typical of high-risk communities across the country.3
	The facts A lead-poisoned child is six times more likely to suffer from a reading disability and seven times more likely to drop out of high school.5 20 to 30 percent of the special education caseload in urban centers results from lead poisoning.6 Children with even low blood-lead levels, below current CDC standards, show poorer performance on tests of math and reading skills, nonverbal reasoning, and short-term memory.7 Poor children, children of color, and those living in older housing are disproportionately affected by lead. For example, nationwide, three percent of African American children compared to one percent of white children have elevated blood-lead levels.8

Silent, but potentially deadly

Lead poisoning can affect nearly every system in the body. Called the silent epidemic because it often occurs without obvious symptoms, it frequently goes unrecognized. But lead poisoning is devastating to children and families, and has serious economic consequences for the nation. Lead poisoning can cause learning disabilities, behavioral problems, and, at very high levels as in the Minnesota case – seizures, coma, and even death. A 2002 study estimated the total economic impact of lead poisoning in the U.S. at $43 billion per year.⁴

While lead-based paints were banned for use in housing in 1978, lead paint and lead-contaminated dust found in older buildings are still the primary sources of lead exposure among U.S. children. According to the CDC's Web site, approximately 24 million housing units in the U.S. have deteriorating lead paint and elevated levels of lead-contaminated dust and soil. More than four million of these dwellings are homes to one or more young children. However, older housing stock is not the only source. One report determined that 34 percent of children under the age of six with lead poisoning in Los Angeles County had been exposed to items containing lead that had been brought into the home, including candy, folk and traditional medicines, ceramic dinnerware, and metallic toys and trinkets.⁹ Children can also be exposed to lead from their parents' clothes. A National Institute for Occupational Safety and Health (NIOSH) study found that children of lead-exposed construction workers were six times more likely to have blood-lead levels over the recommended limit than children whose parents did not work in lead-related industries.¹⁰ In addition to construction workers and others who work with lead, police, military, and firing-range personnel can also be exposed to high lead levels, putting their young children at risk. Children under the age of six are particularly vulnerable because lead affects their rapidly growing brains and bodies, and they are more likely than older children to ingest lead by putting their hands and objects into their mouths.

Lead poisoning is an eminently preventable – and treatable disease. The key is early detection through screening and immediate intervention when testing identifies elevated blood-lead levels. Studies show that in most cases, early detection and treatment of lead exposure can eliminate the potential for permanent damage. The United States has taken a targeted approach to lead screening, focusing on populations living in older homes and those eligible for Medicaid. Massachusetts, New York, and New Jersey require that all one- and two-year-olds be tested. (Massachusetts also requires testing at age three.) Many other states have initiatives to help fund lead-abatement in low-income, private housing, and other programs to reduce childhood lead poisoning. Federal mandates require that 100 percent of Medicaid children be tested for lead poisoning at one- and two-years of age, however fewer than 25 percent receive these lead tests – a failure rate of 75 percent.

While funding availability varies from state to state, tests are reimbursable through Medicaid and through other public funding sources and private insurance. However, regardless of how well-funded a state's lead-prevention program is, a major problem is getting to the targeted population. As Ruth Ann Norton, the executive director of the Coalition to End Childhood Lead Poisoning, put it: "On one level, lead is one of the most simple issues around, but the complexity of reaching the audiences it impacts is immense."

The CDC's strategic plan to eliminate lead poisoning by 2010 establishes a goal to increase screening to 80 percent of the target population, nearly three-times the current level of testing. It is not an easy task. Reaching at-risk children even once to collect a blood sample is challenging enough. Reaching them a second time to follow up and initiate treatment can sometimes be impossible. Estimates are that 50 percent of children enrolled in Medicaid move every six months.

While there are approximately 900 laboratories nationwide certified to perform lead analysis, the experts agree that the only way to achieve the target screening rates and improve health outcomes is with a rapid test that can be performed in the community, where and when children receive healthcare and other social services – in doctors' offices, community health centers, schools, hospitals, clinics, workplaces, and outreach programs. The best, and perhaps only way to accomplish this is with a waived, point-of-care test.

Waived test gives new hope for the future of blood-lead screening

In 1997, ESA introduced the original LeadCare®, the first FDA-cleared, portable, point-of-care blood-lead-testing system. Today, LeadCare is the most widely used blood-lead-testing system in the world. In fact, nearly half of the laboratories and clinics that perform these tests use the LeadCare system. Over the years, LeadCare has been a vital tool in the effort to reduce lead poisoning, helping to identify thousands of children with elevated blood-lead levels. However, since many pediatricians, public health clinics, and others serving at-risk children lack the certification for moderately complex tests required by federal law through the Clinical Laboratory Improvement Amendments (CLIA), the CDC funded ESA to develop a compact, portable CLIA-waived device – LeadCare II.

CLIA-waived LeadCare II removes all the complications formerly associated with blood-lead testing. It is designed so that it can be operated without special training by any healthcare professional. No more waiting days for expensive lab analysis, or spending hours in vain trying to locate families for important education and follow-up testing or care. LeadCare II delivers quantitative blood-lead results equivalent to those reported by reference laboratories from only two drops of blood in just three minutes. More cost-effective than sending samples out to a lab, LeadCare II saves both financial and human resources: the cost per test is lower, and on-the-spot results reduce tracking and administrative time.

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