European Sero-Epidemiology Network: standardisation of the results of diphtheria antitoxin assays

A European Sero-Epidemiological Network (ESEN) was established with the aim to co-ordinate and harmonise serological surveillance of immunity to communicable diseases in Europe. In this study the inter-laboratory standardisation of diphtheria toxin antibody measurements is reported. A standard panel...

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Bibliographic Details
Published in:Vaccine 2000-08, Vol.18 (28), p.3287-3296
Main Authors: von Hunolstein, C, Aggerbeck, H, Andrews, N, Berbers, G, Fievet-Groyne, F, Maple, P.A.C, Ölander, R.M, Raux, M, Tischer, A
Format: Article
Language:English
Subjects:
Animals
Bacteriology
Biological and medical sciences
Cercopithecus aethiops
Corynebacterium diphtheriae
Diphtheria Antitoxin - analysis
Diphtheria toxin antibodies
Enzyme-Linked Immunosorbent Assay - standards
Fundamental and applied biological sciences. Psychology
Humans
Immunoassay - standards
Microbiology
Neutralization Tests
Regression Analysis
Serology
Standardisation
Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies
Vero Cells
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Summary:A European Sero-Epidemiological Network (ESEN) was established with the aim to co-ordinate and harmonise serological surveillance of immunity to communicable diseases in Europe. In this study the inter-laboratory standardisation of diphtheria toxin antibody measurements is reported. A standard panel of 162 sera was tested by the participating laboratories using an in vitro assay of their choice: VERO cell toxin neutralisation assay (NT), double-antigen delayed time-resolved fluorescence immuno-assay (DA-DELFIA), double-antigen enzyme-linked immunosorbent assay (DAE), toxin binding inhibition test (ToBI) and an indirect enzyme-linked immunosorbent assay (ELISA). The results were standardised using regression against the NT. The variations due to inter-laboratory and inter-assay variation, which would otherwise make it difficult directly to compare the main serum bank results by the different laboratories and the various assays were successfully minimised by the standardisation. The regression equations obtained will be used to transform the respective local results of testing the main serum bank into the reference test unitages. This study also gave the opportunity to compare the various assays within and between laboratories. This demonstrated a very high correlation between DA-DELFIA, DAE, ToBI and the NT. The ELISA showed a good correlation, too, however sera below some 0.1 IU/ml were overestimated.
ISSN:0264-410X
1873-2518
DOI:10.1016/S0264-410X(00)00125-0