HemoCue Granted FDA Waiver for Point-of-Care Test
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.
The HemoCue Albumin 201 System, which produces results within 90 seconds, enables physicians to identify and quantify low levels of albumin at the point of care for the purpose of screening, diagnosing, monitoring and to supplement clinical evidence in the treatment of microalbuminuria.
Stephen Suffin, interim chief laboratory officer of Quest Diagnostics, said: “The availability of a fast, reliable point-of-care test that physicians can perform in their own offices to quantitatively assess microalbumin may help patients at risk for chronic kidney disease to begin receiving the care they need at the time of their appointment with their physician.”