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First certified reference materials for the Alzheimer's biomarker amyloid-β

1 December 2017

The early diagnosis and treatment of Alzheimer's Disease (AD) remain challenging. The use of cerebrospinal fluid (CSF) biomarkers could contribute to an early diagnosis. However, there are still large variations among results from different assays for CSF biomarkers. This is partly due to lack of standardization of those assays. Therefore, the Working Group for CSF Proteins of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) and the Joint Research Centre (JRC) of the European Commission have developed three Certified Reference Materials (CRMs) based on human CSF, with low, middle and high concentrations of Aβ1-42.

The EU Directive on In Vitro Diagnostic Medical Devices (IVD-MD) (Directive 98/79/EC) requires traceability of calibrants and control materials to common reference measurement procedures and/or reference materials of higher order. The three CRMs released by the JRC (ERM®-DA480/IFCC, ERM®-DA481/IFCC and ERM®-DA482/IFCC) are intended to be used by assay manufacturers to calibrate their diagnostic assays for Aβ1-42 for CSF analysis.

The reference materials ERM®-DA480/IFCC, ERM®-DA481/IFCC and ERM®-DA482/IFCC were processed, characterised and certified in accordance to ISO Guide 34:2009. An inter-laboratory comparison exercise was performed with adherence to the quality requirements of ISO/IEC 17025. Details about material sampling, processing, characterisation and certification are described in the certification report, available together with the certificate in our online catalogue (https://crm.jrc.ec.europa.eu).


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