Certification of the concentration of anti-tissue transglutaminase IgA and IgG antibodies in human serum: ERM®-DA487/IFCC
ERM®-DA487/IFCC is a matrix reference material produced in accordance with ISO 17034:2016. It is certified for the binding activity concentration of anti-tissue transglutaminase (tTG) IgA and anti-tTG IgG antibodies in human serum.
The starting material was human serum from a consenting donor with coeliac disease. The certified reference material (CRM) is available in glass vials containing the lyophilised form of 0.5 mL of human serum which were sealed under an atmosphere of argon.
Between-unit homogeneity was quantified and stability during transport and storage were assessed in accordance with ISO 33405:2024.
The certified values were directly transferred from the first WHO International Standard 23/274 which had assigned arbitrary values in international units (IU) for the binding activity of anti-tTG IgA and anti-tTG IgG antibodies. ERM-DA487/IFCC and 23/274 were produced as a single batch by the JRC.
Uncertainties of the certified values include uncertainties related to possible inhomogeneity and instability.
The material is intended for the calibration of immunoassay-based measurement procedures quantifying the binding activity concentration of anti-tTG IgA and anti-tTG IgG antibodies in human serum or plasma.
Before release of the CRM, the certification project was subjected to peer-review involving JRC-internal and external experts.
DEPREZ Liesbet;
MONOGIOUDI Evanthia;
PINSKI Gregor;
2025-04-30
Publications Office of the European Union
JRC141842
978-92-68-26079-1 (online),
OP KJ-01-25-208-EN-N (online),
https://publications.jrc.ec.europa.eu/repository/handle/JRC141842,
10.2760/0544207 (online),
Additional supporting files
| File name | Description | File type | |
|---|
