Validation of a diphtheria toxoid multiplex bead assay for serosurveys

•We developed and validated a multiplex bead assay (MBA) for diphtheria IgG antibodies.•MBA values correlated well (R = 0.88) with the toxin neutralization test (TNT).•MBA sensitivity was 95% and specificity was 83%, compared with TNT (≥0.01 IU/mL).•MBAs including diphtheria facilitate integrated se...

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Bibliographic Details
Published in:Diagnostic microbiology and infectious disease 2021-07, Vol.100 (3), p.115371-115371, Article 115371
Main Authors: Scobie, Heather M., Khetsuriani, Nino, Efstratiou, Androulla, Priest, Jeffrey W.
Format: Article
Language:English
Subjects:
Animals
Antibodies, Bacterial - blood
Chlorocebus aethiops
Diphtheria
Diphtheria Toxoid
Immunity
Immunoglobulin G - blood
Multiplex assay
Neutralization Tests - methods
Reproducibility of Results
Sensitivity and Specificity
Serologic Tests - methods
Serologic Tests - standards
Serological test
Serology
Serosurveillance
Vero Cells
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Summary:•We developed and validated a multiplex bead assay (MBA) for diphtheria IgG antibodies.•MBA values correlated well (R = 0.88) with the toxin neutralization test (TNT).•MBA sensitivity was 95% and specificity was 83%, compared with TNT (≥0.01 IU/mL).•MBAs including diphtheria facilitate integrated serosurveys and program monitoring. We validated a multiplex bead assay for diphtheria toxoid IgG antibodies against the Vero cell toxin neutralization test using 1300 specimens (correlation = 0.88). At the ≥0.01 IU/mL cutoff for minimal seroprotection, sensitivity was 95% and specificity was 83%. Agreement for three categories (
ISSN:0732-8893
1879-0070
DOI:10.1016/j.diagmicrobio.2021.115371