The U.S. Food and Drug Administration (FDA) has approved for wider user a rapid, portable test that can measure the level of lead in a person’s blood sample. The test provides results within three minutes, rather than the two weeks required by the traditional blood test. Now, schools, clinics, labs, and other facilities that have a Clinical Laboratory Improvement Amendment (CLIA) waiver can perform the test, providing increased availability for screening children and adults for lead poisoning. 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. Lead is a soft, corrosion-resistant metal that is present in small quantities throughout the environment. Prior to 1978, it was a major ingredient in household paints and gasoline, used in water pipes, used to solder canned foods, and put into pesticides that were used in orchards. While these uses have been banned in the U.S. and lead is much more carefully controlled, it is still used in more than 100 industries and a variety of hobbies. It can cause permanent health damage, especially among children, in whom problems with cognitive development can occur, leading to learning disabilities and behavioral problems.

The FDA is especially hopeful that wider availability of the rapid test will prevent the loss to follow-up that occurs when some patients who have borderline or positive lead test results never make a second visit to have their first test confirmed. These patients do not return when scheduled or cannot be reached to discuss results and therefore may miss important information about their health and potentially necessary treatment.

Sources
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FDA News (September 18, 2006): "FDA Broadens Access to Lead Screening Test That Gives Immediate Results; Waiver Allows Community-Based Testing." Available online: http://www.fda.gov/bbs/topics/NEWS/2006/NEW01456.html

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“FDA Clears Blood Test For Lead Exposure.” The Washington Post. September 19, 2006. A2.