Study Reports Point-of-Care Test to be as Accurate as Conventional Laboratory Analysis in Detecting Kidney Disease in Patients With Diabetes and Cardiovascular Disease

PRESS RELEASE 2007-05

A study presented today at the American Society of Hypertension, Inc. (ASH) Twenty-Second Annual Scientific Meeting and Exposition (ASH 2007) in Chicago reports that the HemoCue^® Albumin 201 system, a point-of-care diagnostic test developed by HemoCue^® AB, can detect microalbuminuria, a biological marker for kidney and cardiovascular disease as accurately as conventional laboratory tests. HemoCue^®, a Quest Diagnostics (NYSE:DGX) company, is the developer and provider of the HemoCue^® Albumin 201 system for measuring albumin in urine.

The investigators found that quantitative test results using the HemoCue^® Albumin 201 system are as accurate as laboratory albumin-to-creatinine (ACR) estimations and are at least as sensitive and specific for microalbuminuria detection. These results, together with the simplicity of handling and processing speed of the HemoCue^® Albumin 201 device, support the value of this system for microalbuminuria detection at the point of care or in the laboratory.

In the study, the HemoCue^® Albumin 201 system showed a sensitivity of 92% and a specificity of 98% for the diagnosis of elevated urine albumin excretion (UAE). Estimation of ACR, a method typically performed in a laboratory setting, displayed sensitivity of 73% and specificity of 96% for the diagnosis of elevated UAE. The positive predictive value and negative predictive value of each test for the diagnosis of elevated UAE were 92% and 98% for the HemoCue^® system and 85% and 92% for ACR. The study involved 165 subjects with various risk factors for cardiovascular and chronic kidney disease.

"The availability of a point-of-care test method that is as accurate as a lab test in quantitatively measuring albumin in urine is expected to have a positive impact on the diagnosis and treatment of chronic kidney disease in at-risk populations," said the study’s lead investigator professor George L. Bakris, M.D., director of the Hypertensive Diseases Center at the University of Chicago-Pritzker School of Medicine. "We anticipate that the study’s results will be a catalyst for improving the diagnosis and treatment of kidney disease in the early treatable stages, preventing further damage."

"This study highlights the growing potential of point-of-care technologies to provide test results that are as reliable as laboratory tests," said Paul Rust, vice president, Point-of-Care Testing, for Quest Diagnostics. "We have demonstrated that HemoCue^® Albumin 201 system is an effective screening tool that can help physicians work more effectively with their patients with diabetes and cardiovascular disease to manage health risks and provide appropriate treatment."

Microalbuminuria is a condition characterized by increased level of excretion of albumin in urine. It is a well-recognized marker for endothelial dysfunction, and is well established as the first indication of diabetic nephropathy. Microalbuminuria is also associated with higher risk for cardiovascular events and overall mortality, both in the general population and in patients at risk of cardiovascular disease.

Conventional laboratory methods of detecting microalbuminuria employ a urine test to assess ACR, However, ACR estimations can vary widely due to differences in muscle mass, age and gender between patients.

The HemoCue^® Albumin 201 system enables physicians to quantify albumin levels in urine using an immunoturbidimetric reaction, which creates a cloudy specimen due to a reaction between antigens and antibodies. Practitioners can perform the test with minimal training on a urine sample collected at their offices. The test can be easily interpreted, enabling physician to give immediate feedback to the patient and make treatment decisions at the point of care. The study was supported by a grant from HemoCue^® to the Rush University Medical Center, where the study was conducted.

About The American Society of Hypertension, Inc. (ASH)

The American Society of Hypertension, Inc. (ASH) is the largest U.S. organization devoted exclusively to hypertension and related cardiovascular diseases. ASH is committed to alerting physicians, allied health professionals and the public about new medical options, facts, research

findings and treatment choices designed to reduce the risk of cardiovascular disease. For more information, visit www.ash-us.org