FDA Grants CLIA
Waiver to Lead Screening Test
[Posted
9/21/06]
The
U.S. Food and Drug Administration (FDA) recently
approved the use of LeadCare II Blood Lead Test
System, a simple and portable lead screening test
system by ESA Biosciences of Chelmsford, MA, at
more than 115,000 certified point-of-care locations
nationwide, including healthcare clinics, mobile
health units, and schools. The test, which can be
used by children and adults, uses a finger stick or
venous whole blood sample and can be completed in
as little as three minutes. The rapid test result
would allow collection of a second sample for
further testing if needed right after the first
test is done, thereby eliminating the need for a
follow-up visit. Hopefully, greater access to the
test will result in earlier detection of children
and adults exposed to lead in their homes, school,
or work.
FDA
granted the manufacturer’s application to
categorize the test as waived under the Clinical
Laboratory Improvement Amendment (CLIA), which
permits its distribution to nontraditional
laboratory sites that have a CLIA-waiver
certificate. A CLIA waiver is given if a test is
proven to be simple, accurate, and reasonably
free of harm. Without the waiver, a test will
only be available at certain hospitals, private and
public health laboratories, and other testing
facilities with the capability of performing
moderate- and high-complexity testing.
The product was evaluated by testing 516 blood
samples over a two-month period at 11 sites.
Results showed that nearly 98% of the values
measured by the test instrument were within
Occupational Safety and Health Administration’s (OSHA)
recommendations for blood lead proficiency testing.
Confirmatory tests using another laboratory method
is required for blood lead values above 10
milligrams per deciliter.
Related Links:
FDA Press Release
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