Authors: A A Zasada W Rastawicki K Śmietańska N Rokosz M Jagielski
Publish Date: 2013/01/26
Volume: 32, Issue: 7, Pages: 891-897
Abstract
Determination of immune status of patients to diphtheria toxin is based mainly on the results of commercially available ELISA kits The aim of the present study was to compare the results obtained by ELISAs from seven different manufacturers Mikrogen Immunolab Sekisui Virotech NovaTec VirionSerion IBL International and Euroimmun All assays were performed according to the manufacturers’ instructions The concentrations of the antidiphtheria toxin antibodies in 72 serum samples were calculated on the basis of curves constructed from standards supplied by manufacturers and the new reference material—International Standard for Diphtheria Antitoxin 10/262 The repeatability and reproducibility of all the ELISA kits tested were good Number of sera with concentrations of the antidiphtheria toxin antibodies below the WHOrecommended level of protection 01 IU/ml were dependent on the ELISA used Mikrogen 20/72 samples 277 Immunolab 11/72 samples 153 Sekisui Virotech 0/72 samples 0 NovaTec 18/72 samples 250 Serion 12/72 samples 167 IBL International 7/72 samples 97 and Euroimmun 17/72 samples 236 However the results obtained in particular ELISAs with the exception of Sekisui Virotech were much more consistent when the concentrations of the antidiphtheria toxin antibodies in 72 sera measured by using curves constructed from the International Standard 10/262 The data obtained clearly demonstrated that manufacturerdependent differences between antidiphtheria IgG ELISA kits exist The differences in recommendations accepted by the individual manufacturers together with differences shown in our studies in sensitivity greatly affect the clinical interpretation of results
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