US pharma Abbott has announced it has received CE Marking (Conformité Européene) for a new diagnostic test for acute kidney injury (AKI). The test detects an important protein in urine, neutrophil gelatinase-associated lipocalin (NGAL), an early marker or indicator for AKI.
The CE marking
certifies that a product has met EU consumer safety, health or environmental requirements.
NGAL is a novel biomarker that can be detected in urine in as little as two hours instead of days. Early detection can aid in the diagnosis of AKI - a common condition that can quickly progress to kidney failure if left untreated - and help physicians better manage patient care. Current tests lack the clinical and timely precision that can help physicians intervene quickly and mitigate the effect of any potential injury.
AKI is a common and often devastating illness that quickly reduces the ability of the kidneys to filter waste, a condition which can then progress to kidney failure. Common causes of AKI include sepsis, major surgery, cardiogenic shock, trauma and medications toxic to the kidneys. Prompt diagnosis of AKI is critical in reducing mortality, which is as high as 80 percent in post-operative settings. In addition, AKI predisposes those surviving to an increased incidence of chronic kidney disease and end-stage renal disease
''Earlier and more accurate differential diagnosis of evolving AKI could result in quicker changes in patient management to make potentially life-saving therapeutic interventions and stop harmful progression,'' said Patrick Murray, M.D., professor, University College Dublin and Mater Misericordiae University Hospital.
Today AKI is diagnosed with a serum test to measure levels of creatinine, a molecule that is generated from muscle metabolism. However, the test is neither sensitive nor specific for detecting kidney injury. As much as half of normal kidney function could be lost before serum creatinine elevations are detected. This delay in diagnosis prevents physicians from intervening to regulate medications or using hydration or blood pressure support in a timely manner to lower the risk of patient harm.
''Published studies show that NGAL levels in patients with AKI are 30 times higher compared to normal patients, and urine NGAL measurements assist in the specific and rapid diagnosis of AKI while creatinine blood tests are not able to accurately distinguish AKI from chronic kidney disease,'' said Sudarshan Hebbar, M.D., senior medical director, Abbott Diagnostics. ''From as little as a single drop of urine, we obtain vital information when time is critical to improve patient management. Early information provided by the NGAL urine test could make treatments more timely and effective and reduce costs due to early intervention.''
A landmark study published in Annals of Internal Medicine
in May 2008 reported that urine NGAL can aid in distinguishing acute kidney injury from other forms of kidney dysfunction in emergency room patients. The study showed that urine NGAL is a highly sensitive and specific test that assists in the differential diagnosis of AKI that helps distinguish acute injury from normal kidney function, dehydration and chronic kidney disease.
Abbott's Urine NGAL assay is performed on the company's flagship automated laboratory instrument, the ARCHITECT system. The test is now available to hospital laboratories in a targeted group of European countries and will be made more broadly available later this year.