Enhanced Antipneumococcal Antibody Electrochemiluminescence Assay: Validation and Bridging to the WHO Reference ELISA

• DOI: 10.4155/bio-2020-0023
• Publication Date: 2020-09-25T15:21:00Z
• Authors: Katrina M Nolan; Yuhua Zhang; Joseph M Antonello; Adrienne H Howlett; Cyrille J Bonhomme; Rebecca Greway; Tina Green; Polly de Gorguett...; David Goldblatt; Rocio D Murphy
• Keywords: Electrochemiluminescence; Conjugate

Aim: To re-optimize the pneumococcal (Pn) electrochemiluminescence (ECL) assay and to validate bridge enhanced WHO ELISA, support Phase III clinical trial program for V114, a 15-valent Pn conjugate vaccine. Materials & methods: The ECL was re-optimized, validated formally bridged ELISA. Results: met all prespecified validation acceptance criteria demonstrated concordance with corresponding threshold value remains at 0.35 μg/ml 15 serotypes. Conclusion: has been measurement of antibodies capsular polysaccharides is concordant supporting its use in trials.