HHS NEWS

P97-31                             FOOD AND DRUG ADMINISTRATION

FOR IMMEDIATE RELEASE              Print Media:      301-827-6242

September 10, 1997                 

                                   Consumer Hotline: 800-532-4440





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 battery-powered

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.                  

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