FDA BROADENS ACCESS TO PORTABLE LEAD TEST

The FDA said Sept. 18 that it is making the first simple and portable lead test system accessible to more certified healthcare outlets, including healthcare clinics, mobile health units and schools.

The test, called the LeadCare II Blood Lead Test System, is made by ESA Biosciences, the FDA said. The test screens children and adults for harmful levels of lead using a finger stick or a venous whole-blood sample.

Currently, it is only available at certain hospitals, private and public health laboratories and other testing facilities with the capability of performing moderate- and high-complexity testing, the agency said.

To broaden access to the test, the FDA granted an application to categorize the test as waived under the Clinical Laboratory Improvement Amendment (CLIA). "This permits widespread distribution to nontraditional laboratory sites that have a CLIA waiver certificate," the agency said.

The FDA notice can be viewed at www.fda.gov/bbs/topics/NEWS/2006/NEW01456.html (http://www.fda.gov/bbs/topics/NEWS/2006/NEW01456.html).