Dear all,
Based on a recent Bioanalytical Community thread about biomarker validation versus qualification, I wanted to discuss how we talk about immunogenicity assays for ADA versus vaccines. For ADA, we use the term validation for the pre-study assay performance, and only use qualification for an incomplete assessment of performance (which per the biomarker discussion is really just a difference context of use so still technically a validation with different use conditions).
For vaccines, however, the pre-study assay performance assessment is called a qualification because it is limited to the assay performance, and validation is when there is clinical data to demonstrate utility. With all the discussion around alternate paradigms and adjusting thresholds to reflect clinical impact rather than a statistical cut point based on false positive rates, would shifting to this terminology make sense for ADA as well? Then the method performance characteristics would be qualification, while the subsequent validation reflects clinical impact?
One challenge I already see with this is that a key experimental difference for vaccine studies is that the validation uses a positive control pooled across vaccinated individuals (an endogenous positive control), while that isn't typically possible for ADA methods. Although the thought of a reference standard for ADA with clinical impact is honestly quite compelling as a step towards monitoring patients for high risk consequences.
I'd love to have this conversation here on the community with pros/cons/what abouts/you're nuts rather than side emails. So if you aren't interested in commenting publicly but have something to add, please do post anonymously rather than by private chat or email.
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Joleen White Ph.D.
Bioanalytical 101 Course Development
Senior Advisor
BioData Solutions LLC
[email protected]Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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