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Date: Wednesday, September 10, 1997
FOR IMMEDIATE RELEASE
Contact: FOOD AND DRUG ADMINISTRATION, Print Media: 301­827­6242, Broadcast Media:  301­827­3434,Consumer Hotline: 800­532­4440

FDA Approves Simpler, More Accessible Lead Poisoning Test Kit; New Device Has Big Potential for Overseas Use

The Food and Drug Administration today announced the clearance of a portable, easy to use device that can quickly detect high lead levels in blood.

The LEADCARE In Office Test System was developed by ESA, Inc. of Chelmsford, Mass. and AndCare, Inc. of Durham, N.C., in conjunction with the U.S. Centers for Disease Control and Prevention (CDC), for use by health professionals in areas which may lack the refrigeration and other equipment needed to conduct more conventional tests.

"Lead poisoning is a common health threat to children around the world, and early detection and treatment are critical for preventing serious damage to the developing nervous system," said Donna E. Shalala, Secretary of Health and Human Services. "Thanks to the work of FDA and CDC, and to memorandums of understanding we have developed with other countries, this new technology can soon be applied to fighting lead poisoning throughout many areas of the world."

The LEADCARE System consists of a compact battery­powered instrument, a testing kit and whole blood controls. A sample of a patient's blood obtained by a finger stick can be analyzed by the system within three minutes, and the results are instantly displayed.

Clinical studies conducted by the company indicate that the test is as reliable as established laboratory test methods for detecting lead poisoning.

Note: HHS press releases are available on the World Wide Web at: www.hhs.gov.