Title: CERTIFICATION REPORT: The certification of the catalytic activity concentration of alpha-amylase in ERM® AD456/IFCC
Authors: DEPREZ LIESBETZEGERS INGRIDSCHIMMEL HEINZTRAPMANN STEFANIE
Publisher: Publications Office of the European Union
Publication Year: 2019
JRC N°: JRC117927
ISBN: 978-92-76-11236-5 (online)
ISSN: 1831-9424 (online)
Other Identifiers: EUR 29857 EN
OP KJ-NA-29857-EN-N (online)
URI: https://publications.jrc.ec.europa.eu/repository/handle/JRC117927
DOI: 10.2760/740548
Type: EUR - Scientific and Technical Research Reports
Abstract: This report describes the production of ERM®-AD456/IFCC, which is a material certified for the catalytic activity concentration of alpha-amylase. This material was produced following ISO 17034:2016 and is certified in accordance with ISO Guide 35:2017. The starting material was pancreatic alpha-amylase purified from human tissue. The enzyme was diluted in a buffered solution which was filled into glass vials and lyophilised. Between unit-homogeneity was quantified and stability during dispatch and storage were assessed in accordance with ISO Guide 35:2017. The material was characterised by an interlaboratory comparison of laboratories of demonstrated competence and adhering to ISO/IEC 17025. Uncertainties of the certified values were calculated in accordance with the Guide to the Expression of Uncertainty in Measurement (GUM) and include uncertainties related to possible inhomogeneity, instability and characterisation. The material is intended for the assessment of method performance of the primary reference measurement procedure (PRMP) for the catalytic activity concentration of alpha–amylase at 37 °C established by the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) [ , ]. In addition the material can also be used as trueness control or external quality control material for routine measurement systems if commutability has been proven for the assay concerned. As with any reference material, it can be used for establishing control charts or in validation studies. The CRM is available in glass vials containing lyophilised material from 1 mL of alpha-amylase solution which were sealed under an atmosphere of nitrogen. The minimum amount of sample to be used is 5 µL after reconstitution of the whole content of 1 vial in 1 mL.
JRC Directorate:Health, Consumers and Reference Materials

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