CERTIFICATION REPORT: The certification of Amyloid β1-42 in CSF in ERM®-DA480/IFCC, ERM®-DA481/IFCC and ERM®-DA482/IFCC
This report describes the production of ERM®-DA480/IFCC, ERM®-DA481/IFCC and ERM®-DA482/IFCC, which are human cerebrospinal fluid (CSF) materials certified for the mass concentration of amyloid β1-42 peptide (Aβ1-42). These materials were produced by the European Commission, Joint Research Centre (EC-JRC) in collaboration with the International Federation for Clinical Chemistry and Laboratory Medicine (IFCC) following ISO Guide 34:2009 and are certified in accordance with ISO Guide 35:2006.
The starting material used to prepare ERM-DA480/IFCC, ERM-DA481/IFCC and ERM-DA482/IFCC was human CSF collected from normal pressure hydrocephalus patients by continuous lumbar drainage. After collection, the CSF was aliquoted and frozen at -80 °C. For the preparation of each certified reference material (CRM) a selected number of CSF donations were thawed, pooled, mixed, filled in microvials and stored at (-70 ± 10) °C immediately thereafter.
Between unit-homogeneity was quantified and stability during dispatch and storage were assessed in accordance with ISO Guide 35:2006 [ ].
The material was characterised by an interlaboratory comparison of laboratories of demonstrated competence and adhering to ISO/IEC 17025 [ ]. Technically invalid results were removed but no outlier was eliminated on statistical grounds only.
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 materials are intended for the calibration of methods, quality control and/or the assessment of method performance. As with any reference material, they can be used for establishing control charts or validation studies. The CRMs are available in microvials containing at least 0.5 mL of frozen liquid. The minimum amount of sample to be used is 15 µL.
KUHLMANN Julia;
BOULO Sébastien;
ANDREASSON Ulf;
BJERKE Maria;
PANNEE Josef;
CHAROUD-GOT Jean;
AUCLAIR Guy;
MAZOUA Stephane;
TRAPMANN Stefanie;
SCHIMMEL Heinz;
EMONS Hendrik;
FLORIAN Doris;
QUAGLIA Milena;
PORTELIUS Erik;
KORECKA Magdalena;
SHAW Leslie M;
LAME Mary;
CHAMBERS Erin;
VANDERSTICHELE Hugo;
STOOPS Erik;
LEINENBACH Andreas;
BITTNER Tobias;
JENKINS Rand;
KOSTANJAVECKI Vesna;
LEWCZUK Piotr;
ZETTERBERG Henrik;
ZEGERS Ingrid;
BLENNOW Kaj;
2017-12-19
Publications Office of the European Union
JRC107381
978-92-79-70556-4,
1831-9424,
EUR 28691 EN,
OP KJ-NA-28691-EN-N,
https://publications.jrc.ec.europa.eu/repository/handle/JRC107381,
10.2760/621427,
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