Medical Devices

Rapid Lead Screening Test

There is now a test that provides immediate results on lead levels in children and adults that can be used at thousands of places nationwide, including health clinics, mobile healthcare units and doctors’ offices. Broader availability and easier access to this test means lead exposure can be detected and treated earlier before the damaging effects of lead poisoning occur.

U.S. Department of Health and Human Services is allowing the LeadCare II Blood Lead Test System, made by ESA Biosciences ( Chelmsford, Mass.), to be used at more than 115,000 certified point-of-care settings because the company proved to the U.S. Food and Drug Administration that the test is simple, accurate and poses very little risk of harm to a patient. The test was only available for use in certain laboratories and patients oftentimes had to wait several days or more to find out their results. Doctors have said that it is sometimes difficult to reach patients to give them their results or to discuss treatment options when they have elevated blood lead levels.

The Centers for Disease Control and Prevention (CDC) has found that more than 300,000 children under age six each year have blood levels that exceed 10μg/dL, the threshold used to indicate lead poisoning. The American Academy of Pediatrics (AAP) estimates one out of four homes with children under age six has lead contamination. The CDC and AAP recommend screening children at ages one and two who live in high-risk homes.

Lead poisoning in children typically results from drinking water from corroding plumbing, and inhaling or ingesting dust from deteriorating lead-based paint. Symptoms of lead poisoning include headaches, stomach cramps, fatigue, memory loss, high blood pressure, and seizures. Lead poisoning in children has been linked to learning disabilities and developmental delays.

The LeadCare II Blood Test System measures lead in blood samples using a finger stick or taking a blood sample from a person’s vein, and gives results in as little as three minutes. The rapid result means a second sample for further testing can be obtained quickly if needed, reducing the need for a follow-up visit.

Page Last Updated: 06/05/2014
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