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HemoCue Receives First FDA CLIA Waiver in Diagnostics Industry for Quantitative Point-of-Care Test for Microalbuminuria, a Kidney and Cardiovascular Disease Risk Marker
Date:6/18/2008

those with diabetes or hypertension."

Microalbuminuria is a condition characterized by the presence of albumin, a protein, excreted in urine. As the albumin excretion increases, so does the risk of CKD or cardiovascular disease onset and progression. 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 for, diagnosing, monitoring and to supplement clinical evidence in the treatment of microalbuminuria. Unlike semiquantitative urine "dipstick" methods, which indicate if a patient's microalbumin levels fall within pre-defined ranges, the HemoCue Albumin 201 System provides the actual concentration present in the sample. Using the HemoCue Albumin 201 System, physicians may monitor changes in microalbumin excretion in a patient over time.

A study in the American Journal of Nephrology (2008;28:324-329) published online in November 2007 concluded that the "HemoCue Albumin 201 System is a valid and precise method for UAE (urinary albumin excretion) determination, exhibiting a performance similar to laboratory ACR (albumin-to-creatinine) estimations and far better than the widely used dipsticks ... the HemoCue Albumin 201 System appears to be a convenient solution for detection of abnormal UAE levels." The study involved 165 adult subjects under treatment for hypertension at the Rush University Medical Center in Chicago. Dr. Bakris was the study's lead investigator. HemoCue AB financially supported the study.

According to the American Diabetes Association (ADA) and the National Kidney Foundation (NKF), physicians should assess urine albumin excretion annually in patients with type 2 diabetes commencing at the time of diagnosis as well as in patients with type 1 diabetes who have had the disease for five years. The NKF further recommends that patients at increased risk for chronic kidney disease, such as those with hyp
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SOURCE Quest Diagnostics Incorporated
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