HemoCue (Angelholm, Sweden), a point-of-care (POC) diagnostic test manufacturer and a subsidiary of Quest Diagnostics (Madison, New Jersey), reported that its HemoCue Albumin 201 system is the first quantitative POC test for screening for, diagnosing and monitoring microalbuminuria to be granted a CLIA waiver by FDA.

With the waiver, non-laboratory trained doctors and other healthcare professionals in any healthcare facility with a CLIA Certificate of Waiver in the U.S. will be able to use the HemoCue Albumin 201 system to screen patients for microalbuminuria, a biological marker for kidney and cardiovascular disease, and begin treatment based on the test's results during a single office visit.

Last year the company reported at the American Society of Hypertension (New York) annual scientific meeting and exposition in Chicago that the HemoCue Albumin 201 system can detect microalbuminuria as accurately as conventional laboratory tests (Medical Device Daily, May 23, 2007).

HemoCue said microalbuminuria may indicate the presence of chronic kidney disease (CKD), a life-threatening condition that affects nearly 26 million Americans. Diabetes and hypertension are the two leading risk factors for developing CKD. Microalbuminuria also is an independent risk factor for developing cardiovascular disease in patients with or without diabetes or hypertension, the company noted.

Quest Diagnostics told Medical Device Daily in an e-mail that the POC market represents an important aspect for the future of diagnostic testing.

"Technology is enabling diagnostic testing to move closer to the patient, whether in the doctor's office or at a hospital bedside, so that physicians can diagnose and treat certain conditions in the same visit, enhancing patient care and reducing healthcare costs by avoiding unnecessary treatments that may be initiated before test results are received," the company said.

Quest also said that POC testing complements its clinical laboratory services, enabling it to meet the demands of healthcare practitioners worldwide.

"Accordingly, we see the point-of-care testing business as an opportunity to strategically expand our presence in the overall diagnostics market, both technologically and geographically," the company said.

Now that the HemoCue Albumin 201 system has received a CLIA waiver, Quest said patients would benefit from the availability of a fast POC test that doctors could perform in their own offices and by being able to begin treatment at the time of their appointment with their doctor.

"POC tests, which typically produce results within minutes, allow patients to receive counsel and work with their physician to determine treatment during a single office visit," Quest said. "Some patients may respond better to face-to-face counsel from a physician than advice they receive later."

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, the company said. Using the Albumin 201 system, doctors may monitor changes in microalbumin excretion in a patient over time.

"Given that microalbuminuria is a risk marker for cardiovascular disease, and its increase over time can indicate kidney disease, it is important that physicians have a fast, easy, reliable test to assess changes in their patients," said professor George Bakris, MD, director of the hypertensive diseases unit at the University of Chicago Pritzker School of Medicine. "The availability of a point-of-care test that accurately measures albumin in urine is expected to have a positive impact on physicians' ability to screen in-office and then begin treatment for patients at risk for microalbuminuria, such as those with diabetes or hypertension."

A study in the American Journal of Nephrology 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, which HemoCue paid for, involved 165 adults under treatment for hypertension at the Rush University Medical Center (Chicago). Bakris was the study's lead investigator.

According to the American Diabetes Association (ADA; Alexandria, Virginia) and the National Kidney Foundation (NKF; New York), 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 hypertension, be offered microalbumin screening during periodic health evaluations. Microalbuminuria screening can help physicians detect CKD in the early stages before symptoms appear when treatment can halt or reverse its progression.

Despite evidence-based medical guidelines, a Quest Diagnostics Health Trends Report on Chronic Kidney Disease issued in March found that only 32.7% of patients with Type 1 or Type 2 diabetes and/or hypertension received a microalbumin test for CKD during the twelve-month period ending in October 2006. The study is based on results of tests performed by Quest Diagnostics on patients in the U.S. Diabetes affects 7% of the U.S. population and more than 21% of adults over 60. Hypertension affects nearly 30% of American adults and more than half of those over 60.

"Our recent Health Trends data suggest that fewer at-risk patients are receiving microalbumin tests than would be expected if the established medical guidelines were universally applied," said Stephen Suffin, MD, interim chief laboratory officer and corporate clinical pathologist science and technology, Quest Diagnostics. "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 CKD to begin receiving the care they need at the time of their appointment with their physician."

In addition to CKD and cardiovascular disease, microalbuminuria may also suggest the potential development of pre-eclampsia, a potentially life-threatening condition that can affect a pregnant woman, particularly those with Type 1 diabetes, and her fetus. In patients with diabetes, microalbuminuria may suggest the potential to develop diabetic retinopathy, the leading cause of blindness among adults in the U.S.

The HemoCue Albumin 201 system received FDA 510(k) clearance in the first quarter of 2006. It was CE marked for distribution to more than 30 countries in Europe during the fourth quarter of 2005.

According to the company, the FDA grants CLIA waivers to FDA 510(k)-cleared tests that are considered "simple" and have an "insignificant risk of producing an erroneous result." CLIA waived tests may be performed by non-laboratory trained health care workers at any facility that fulfills certain minimal requirements, such as holding a CLIA Certificate of Waiver and following manufacturer instructions.

When asked if this waiver might set a trend for diagnostic testing, Quest told MDD it is difficult to know how physicians will adopt POC testing. "However, what we do know is that this diagnostics technology may be useful to a wide variety of physicians, including general practitioners, family physicians, nephrologists, endocrinologists, cardiologists and other healthcare providers involved in screening, diagnosing, monitoring and treating patients with diabetes, hypertension or those at risk for these diseases," the company said. "The POC test allows physicians to quickly receive diagnostics information that is essential to making healthcare decisions and providing good patient care."