ArticleDiagnostic microbiology and infectious disease2025
Interlaboratory study to assess precision and reproducibility of the meningococcal antigen surface expression (MEASURE) assay to quantify factor H binding protein expression at the surface of meningococcal serogroup B strains.
Article in Diagnostic microbiology and infectious disease, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
backgroundThe serum bactericidal antibody using human complement (hSBA) assay, the accepted surrogate measure of meningococcal vaccine efficacy, is limited by human sera and complement requirements. Pfizer developed and validated the flow-cytometry-based Meningococcal Antigen Surface Expression (MEASURE) assay to quantify surface-expressed factor H binding protein (fHbp) levels on intact meningococci. Surface expression of fHbp is correlated with hSBA assay killing by MenB-fHbp (Trumenba
methodsThe MEASURE assay was transferred to UK Health Security Agency (UKHSA) and US Centers for Disease Control and Prevention (CDC) laboratories. MEASURE assay results from 42 MenB strains encoding sequence-diverse fHbp variants that express fHbp at different levels were compared between the UKHSA, CDC, and Pfizer laboratories. Intermediate precision within each laboratory was determined.
resultsPairwise comparisons of fHbp expression levels for all 42 MenB test strains showed >97 % agreement across the 3 laboratories when strains were grouped above or below a mean fluorescence intensity level of 1000, the threshold previously established as indicative of susceptibility to MenB-fHbp-induced antibodies in the hSBA assay. Each laboratory met assay precision criteria of ≤30 % total relative standard deviation.
conclusionsQuantification of fHbp surface expression using the MEASURE assay is robust and reproducible across different laboratories. Previously determined cutoffs corresponding to predicted susceptibility to vaccine-induced antibodies can be applied to MEASURE data generated across laboratories.
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