The Sentinel pancreatic amylase reagent and calibrator from Beckman Coulter Diagnostics, Brea, Calif, recently received FDA premarket notification (510(k)) clearance. The liquid, ready-to-use reagent, distributed by Beckman Coulter and manufactured by Sentinel Diagnostics, Milan, Italy, is available for use on Beckman Coulter’s AU480, AU680, and AU5800 clinical chemistry analyzers.

“The availability of the pancreatic amylase assay allows Beckman Coulter Diagnostics to provide laboratories with the tools needed to confidently diagnose and monitor acute pancreatitis and acute attacks during chronic pancreatitis,” says John Blackwood, senior vice president of the chemistry and immunoassay business unit at Beckman Coulter Diagnostics.

Pancreatic amylase is an enzyme produced by the exocrine tissue of the pancreas and aids in the digestion of starches. Beckman Coulter’s assay is an in vitro diagnostic test intended for the quantitative determination of pancreatic amylase in serum and plasma, using an enzymatic colorimetric method. The assay features a limit of detection of 0.5 U/L, an assay range of 4.7–2,000 U/L, 30-day reagent onboard stability, and 14-day calibration frequency

“While amylase is a standard test for the diagnosis of pancreatitis, we remember that there are two primary sources of amylase in the human body: the pancreas and salivary glands. The pancreatic amylase test is specific to pancreas as the tissue of origin, and therefore provides a more targeted test for the diagnosis of pancreatitis,” says Jack Zakowski, PhD, FACB, director of scientific affairs and professional relations at Beckman Coulter Diagnostics.

“The partnership with Beckman Coulter allows us to reach and assist more laboratories globally to meet their diagnostic needs,” says Ugo De Luca, MD, chief executive of Sentinel Diagnostics. “We look forward to providing laboratories with specialized options and moving healthcare forward.”

For more information, visit Beckman Coulter.