HemoCue granted FDA waiver for point-of-care test

This clears the way for non laboratory personnel to use the system to test and screen patients for low levels of albumin at the point of care.  BD 

Jun 19, 2008 (Datamonitor via COMTEX)-- HemoCue, a wholly owned subsidiary of Quest Diagnostics, has announced that its HemoCue Albumin 201 System is the first quantitative point-of-care test for screening, diagnosing and monitoring microalbuminuria to be granted a CLIA waiver by the FDA.

With the FDA CLIA waiver, non-laboratory trained physicians and other health care professionals in any health care facility with a Clinical Laboratory Improvement Amendments (CLIA) certificate of waiver in the US will be able to use the HemoCue Albumin 201 System to screen patients for microalbuminuria and begin treatment based on the test's results during a single office visit.

HemoCue granted FDA waiver for point-of-care test