Certification of the amount-of-substance fraction of haemoglobin A2 versus total haemoglobin in blood haemolysate: ERM®-DA485/IFCC and ERM®-DA486/IFCC
ERM-DA485/IFCC and ERM-DA486/IFCC are blood hemolysate materials certified for the ratio between haemoglobin A2 over total haemoglobin, produced within the scope of ISO 17034 accreditation and ISO Guide 35:2017.
The CRMs are available in glass vials containing at least 2 mL of blood hemolysate that was then lyophilised into a dried powder. The vials were sealed under an atmosphere of argon.
Between-unit homogeneity was quantified and stability during transport and storage was assessed in accordance with ISO Guide 35:2017. Within-unit homogeneity was quantified to determine the minimum sample size. The minimum sample size for one measurement is 20 µL.
The material was characterised by a reference method through an interlaboratory comparison of laboratories of demonstrated competence and adhering to ISO/IEC 17025:2017. Technically invalid results were removed but no outlier was eliminated unless a technical reason for the deviation was found.
Uncertainties of the certified values were calculated in accordance with ISO 17034:2016 and ISO Guide 35:2017 and include uncertainties related to possible inhomogeneity, instability and characterisation.
The materials are intended for the calibration of methods.
Before release of the CRMs, the certification project was subjected to peer-review involving both internal and external experts.
AUCLAIR Guy;
MUNOZ PINEIRO Amalia;
CHAROUD-GOT Jean;
PALEARI Renata;
KAISER P;
ARSENE Christian-Gabriel;
TRAPMANN Stefanie;
MOSCA Andrea;
DEPREZ Liesbet;
2024-09-06
Publications Office of the European Union
JRC137824
978-92-68-14954-6 (online),
OP KJ-02-24-456-EN-N (online),
https://publications.jrc.ec.europa.eu/repository/handle/JRC137824,
10.2760/877530 (online),
Additional supporting files
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