Premium
A WHO reference reagent to standardize haemagglutination testing for anti‐A and anti‐B in serum and plasma: international collaborative study to evaluate a candidate preparation
Author(s) -
Thorpe S. J.,
Fox B.,
Sharp G.,
White J.,
Milkins C.
Publication year - 2016
Publication title -
vox sanguinis
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.68
H-Index - 83
eISSN - 1423-0410
pISSN - 0042-9007
DOI - 10.1111/vox.12399
Subject(s) - titer , hemagglutination , serial dilution , reagent , titration , medicine , chromatography , haemagglutination inhibition , antibody , chemistry , immunology , pathology , serology , alternative medicine , inorganic chemistry
Background and Objectives The aim of the study was to evaluate a lyophilized serum preparation, 14/300, for its suitability to serve as a World Health Organization ( WHO ) Reference Reagent to standardize and control haemagglutination titrations for anti‐A and anti‐B in serum and plasma, in an international collaborative study. Materials and Methods Serum preparation 14/300 and two plasma‐based reserve preparations, 14/304 (high titre anti‐A) and 14/208 (high titre anti‐B), were titrated by 24 laboratories in 13 countries using direct ( DRT ) and indirect ( IAT ) haemagglutination techniques. Results There was eightfold to 64‐fold variation in reported titres per preparation and method across laboratories, that is, titres extended over 4–7 dilutions, although intralaboratory variability was generally good, with over 90% of replicate titres within a twofold range. There was a reduction in interlaboratory variability when titres of the reserve preparations were adjusted relative to those of the candidate Reference Reagent. Conclusion The establishment of 14/300 as a WHO Reference Reagent for high titre anti‐A and anti‐B in serum, with nominal anti‐A and anti‐B titres of 128 for DRT , and nominal anti‐A and anti‐B titres of 256 for IAT , will facilitate global standardization of haemagglutination titrations for anti‐A and anti‐B in patient samples and blood components.