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 (<0.01, 0.01–<0.1, ≥0.1 IU/mL) was 81% (kappa = 0.71).
|Journal||Diagnostic Microbiology and Infectious Disease|
|Early online date||13 Mar 2021|
|Publication status||E-pub ahead of print - 13 Mar 2021|
Bibliographical noteFunding Information:
We would like to thank Kathleen Wannemuehler and Minal Patel at CDC for technical advice on evaluation design. We also thank Paul Stickings at National Institute for Biological Standards and Control, UK; Christina Von Hunolstein at National Institute of Health (ISS), Italy; Jarad Schiffer and Rania Tohme at CDC for helpful discussion about the interpretation of results.
- Multiplex assay
- Serological test