Certification of the catalytic activity concentration of aspartate transaminase in buffered solution: ERM®-AD457k/IFCC
ERM-AD457k/IFCC is a material certified for the catalytic activity concentration of aspartate transaminase (AST), produced within the scope of ISO 17034:2016 accreditation. The starting material was recombinant AST cytosolic isoform (originating from human liver) expressed in Escherichia coli. The certified reference material (CRM) is available in amber glass vials containing the lyophilised form of 1.0 mL of AST solution.
Between-unit homogeneity and stability during transport and storage were assessed in accordance with ISO 33405:2024. The minimum sample size is 9 µL. The material was characterised by an interlaboratory comparison of laboratories who had demonstrated competence and adhering to ISO/IEC 17025:2017. Ten out of twelve datasets were used to calculate the assigned value. The uncertainty of the certified value was estimated in accordance with ISO 17034:2016 [1], and includes uncertainties related to possible inhomogeneity, instability and characterisation. The material is intended for assessment of the method performance of the primary reference measurement procedure (PRMP) for the catalytic activity concentration of AST at 37 °C, established by the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC). The material can also be used as trueness control or external quality control material for routine measurement systems, if the material has been proven to be commutable in the assay concerned. Before the release of the CRM, the certification project was subjected to peer-review involving both internal and external experts.
LUQUE PEREZ Encarnacion;
DEPREZ Liesbet;
2025-03-03
Publications Office of the European Union
JRC140606
978-92-68-23168-5 (online),
OP KJ-01-24-227-EN-N (online),
https://publications.jrc.ec.europa.eu/repository/handle/JRC140606,
10.2760/6491531 (online),
Additional supporting files
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