Enhanced antipneumococcal antibody electrochemiluminescence assay: validation and bridging to the WHO reference ELISA.

To re-optimize the pneumococcal (Pn) electrochemiluminescence (ECL) assay and to validate and bridge the enhanced assay to the WHO ELISA, to support the Phase III clinical trial program for V114, a 15-valent Pn conjugate vaccine. The Pn ECL assay was re-optimized, validated and formally bridged to the WHO ELISA. The enhanced Pn ECL assay met all prespecified validation acceptance criteria and demonstrated concordance with the WHO ELISA.