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BLOOD-LEAD SCREENING: New Hope for the Future
| Article Date: 11/1/2007 |
The FDA announced it had granted a CLIA waiver to LeadCare II at a September 18, 2006, press briefing held at the headquarters of the U.S. Department of Health and Human Services (HHS) in Washington, D.C. At the briefing, U.S. Assistant Secretary for Health, Admiral John O. Agwunobi, MD, Andrew C. von Eschenbach, MD, Commissioner of the FDA; and Jon L. Gant, Director of the Office of Healthy Homes and Lead Hazard Control of the U.S. Department of Housing and Urban Development (HUD), all spoke of LeadCare II as a vital tool to bring lead testing to more than 115,000 physicians offices and community settings nationwide, a key strategy in achieving the public health goal of eliminating lead poisoning in children by 2010.
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. If there is any good news that can come out of one familyÕs tragedy, it is that this case has been a loud wake-up call to focus attention on the Òsilent epidemicÓ of lead poisoning.
Reducing the levels of lead poisoning in children has been a major public health priority since the 1960s Ð 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.
Still, lead poisoning remains the number one environmental threat to children. 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), although the CDC states in its latest report that, in fact, there is no ÒsafeÓ threshold for lead in blood. Indeed, recent studies suggest adverse health effects exist in children at blood-lead levels significantly lower than 10 μg/dL.
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 Ð 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.
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, 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. Children can also be exposed to lead from their parentsÕ 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. 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.
CLIA-Waived LeadCare II means no more compromises
Lead testing used to be a compromise, with tough choices for physicians:
¥ Do I collect blood samples and send them out for analysis Ð or send patients directly to a lab, knowing that patient compliance will be very low?
¥ Do I collect a capillary sample (easier on patient, but requires another visit for a venous sample to confirm if high) Ð or do I go ahead and do venous samples for all?
¥ Do I get the laboratory accreditation necessary to do lead testing on-site Ð or do I send samples out, adding days or even weeks to the test cycle?
Called, Òa truly innovative application of technology to an entirely important public health challengeÓ by Dr. Agwunobi of HHS, CLIA-waived LeadCare II removes all the complications formerly associated with blood-lead testing. LeadCare II can be operated at the point of care, without special training or certification, by any healthcare professional.
LeadCare II improves results Ð for patients, and the busy physiciansÕ office. 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.
Most important, it provides healthcare professionals and parents with the information they need to focus their attention on the children truly at risk. Studies show that this approach is the most-effective way to stem the adverse effects of lead exposure and prevent permanent damage. A waived test educates and empowers the people who can make a difference.
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. If there is any good news that can come out of one familyÕs tragedy, it is that this case has been a loud wake-up call to focus attention on the Òsilent epidemicÓ of lead poisoning.
Reducing the levels of lead poisoning in children has been a major public health priority since the 1960s Ð 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.
Still, lead poisoning remains the number one environmental threat to children. 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), although the CDC states in its latest report that, in fact, there is no ÒsafeÓ threshold for lead in blood. Indeed, recent studies suggest adverse health effects exist in children at blood-lead levels significantly lower than 10 μg/dL.
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 Ð 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.
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, 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. Children can also be exposed to lead from their parentsÕ 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. 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.
CLIA-Waived LeadCare II means no more compromises
Lead testing used to be a compromise, with tough choices for physicians:
¥ Do I collect blood samples and send them out for analysis Ð or send patients directly to a lab, knowing that patient compliance will be very low?
¥ Do I collect a capillary sample (easier on patient, but requires another visit for a venous sample to confirm if high) Ð or do I go ahead and do venous samples for all?
¥ Do I get the laboratory accreditation necessary to do lead testing on-site Ð or do I send samples out, adding days or even weeks to the test cycle?
Called, Òa truly innovative application of technology to an entirely important public health challengeÓ by Dr. Agwunobi of HHS, CLIA-waived LeadCare II removes all the complications formerly associated with blood-lead testing. LeadCare II can be operated at the point of care, without special training or certification, by any healthcare professional.
LeadCare II improves results Ð for patients, and the busy physiciansÕ office. 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.
Most important, it provides healthcare professionals and parents with the information they need to focus their attention on the children truly at risk. Studies show that this approach is the most-effective way to stem the adverse effects of lead exposure and prevent permanent damage. A waived test educates and empowers the people who can make a difference.