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News article25 September 2018

Towards a new certified reference material for the biomarker pancreatic α-amylase

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JRC scientists, in collaboration with researchers from European clinical diagnostic laboratories, have carried out a commutability study on five candidate reference materials for the enzyme α-amylase. This enzyme is measured in human serum to detect and diagnose pancreas and gastrointestinal tract disorders.

The enzyme α-amylase is mainly secreted by the exocrine pancreas and the salivary glands.

This biomarker is frequently measured by medical laboratories in human sera for the diagnosis of acute pancreatitis and pancreatic trauma.

Accurate measurement results over time and across laboratories are therefore of utmost importance.

As medical laboratories can use different In Vitro Diagnostic tests (IVDs) to measure α-amylase in serum, standardisation is important to ensure that the IVDs provide comparable results. This can be achieved by calibration of the IVDs with suitable reference materials. A suitable reference material should be commutable: it should behave in the same way as the real clinical samples when analysed with different IVDs.

To support harmonisation of measurements in this field, the JRC performed a commutability study on five candidate reference materials for α-amylase in collaboration with scientists from European diagnostic and reference laboratories. The work was achieved by applying guidelines recently published by a working group of the International Federation of Clinical Chemists (IFCC).

The results of this study demonstrated that the composition of the background solution (so called matrix) has a major effect on the commutability of a reference material for α-amylase. Therefore it is important to choose the most suitable matrix for the candidate reference material to ensure accurate and comparable measurements of α-amylase in human sera.

Read more in: Liesbet Deprez et al.: Commutability Assessment of Candidate Reference Materials for Pancreatic α-Amylase. Clinical Chemistry 64 (2018)1193-1202, Doi:10.1373/clinchem.2018.289744

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Commutability Assessment of Candidate Reference Materials for Pancreatic α-Amylase


Publication date
25 September 2018