A new certified material for quality control of alpha-amylase clinical measurements
1 October 2019The JRC released a new Certified Reference Material (CRM) ERM-AD456/IFCC containing the enzyme alpha-amylase which is a biomarker for disorders of the pancreas. This quality control material supports the standardisation of in vitro diagnostic tests and subsequently the comparability of results from routine clinical measurements.
Alpha-amylase is a digestive enzyme that breaks down the carbohydrates in our food. The enzyme is mainly secreted by the exocrine pancreas and the salivary glands. Medical laboratories frequently measure this enzyme in human sera to check for disorders affecting the pancreas such as acute pancreatitis and pancreatic trauma. Accurate measurement results over time and across laboratories are therefore of utmost importance.
There are different In Vitro Diagnostic tests (IVDs) measuring alpha-amylase in serum available for the medical laboratories. Standardisation is needed to ensure that these IVD's provide comparable results. The reference system for the standardisation of alpha-amylase measurements in serum is based on the primary reference method that was established by the International Federation of Clinical Chemists (IFCC). ERM–AD456/IFCC will support the reference system as it can be used by laboratories world-wide to assess their performance on the primary reference method.
Further details on the CRM ERM®-AD456/IFCC, can be found in the certificates and certification reports available in our on-line catalogue.
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