Test for Lead Gives Quick Result

The test, called the LeadCare II blood lead test system, developed by ESA Biosciences (Chelmsford, MA, USA), a subsidiary of Magellan Biosciences, is used to screen children and adults for harmful levels of lead, using a finger stick or venous whole blood sample. The test is performed in three minutes, while the patient is present. The rapid result means a second sample for further testing can be obtained quickly, if needed, reducing the need for a follow-up visit.

The ease and accuracy of the test system was evaluated by testing 516 blood samples over a two-month period at 11 sites. The test instrument applies an electrical current to the patient's blood sample, causing lead to collect on disposable sensors. Studies show nearly 98 % of the values measured by the test instrument were within the U.S. Occupational Safety and Health Administration's recommendations for blood lead proficiency testing. Blood lead values above 10 mg per deciliter need to be confirmed with another laboratory method.

The U.S. Food and Drug Administration (FDA) has approved the test for wider use. Schools, clinics, labs, and other facilities that have a U.S. Clinical Laboratory Improvement Amendment (CLIA) waiver can perform the test. The FDA hopes that this step will allow more at-risk people to be screened, that the speed of the test will prevent the need for additional visits for follow-up testing (to confirm a high level), and that those in need of treatment can be more quickly identified and started on therapy.

Lead poisoning is a preventable condition that results from environmental exposure to lead. It can cause permanent health damage, especially among children, in whom problems with cognitive development can occur, leading to learning disabilities and behavioral problems.

According to Magellan's president and CEO, Robert J. Rosenthal, "Educating parents on the dangers of lead at the same time they see their child's lead-levels come up on the screen has had a dramatic effect in reducing future lead exposure. Parents understand the implications and take action. Further, in cases where clinics have used LeadCare to identify children with significantly elevated lead levels, they have taken the children directly to the hospital for follow-up, allowing life-saving treatment to start in a matter of hours, rather than days or weeks.”



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