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FDA Accepts Abbott NGAL Test For Review

Abbott has reported that a new diagnostic test to rapidly detect neutrophil gelatinase-associated lipocalin (NGAL), an early biomarker that identifies patients at risk for acute kidney injury (AKI), has been accepted for review by the FDA.

Abbott’s test would be able to detect NGAL about two days earlier than the widely used method for the detection of AKI, a serum creatinine blood test.

According to a landmark study published in Annals of Internal Medicine in May 2008, NGAL is a highly sensitive and specific test for differential diagnosis of AKI that helps distinguish acute injury from normal function and chronic kidney disease.

Abbott’s new test has received CE Mark certification in Europe previous year and is being used by nephrologists and other physicians in the European Union. It is currently an investigational device in the US. Abbott’s Urine NGAL assay is performed on the company’s automated laboratory instrument, the Architect system.

Sudarshan Hebbar, medical director of Abbott Diagnostics, said: “With the help of a new diagnostic test that can aid in detecting NGAL, physicians can significantly reduce the risk of AKI by using simple measures such as hydration or blood pressure support to lower the risk of harm.

“From the single drop of urine, we obtain vital information when time is critical to improve patient management. Early information provided by an NGAL urine test could make treatments more timely and effective and reduce costs due to early intervention.”