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

Nolan, KM; Zhang, Y; Antonello, JM; Howlett, AH; Bonhomme, CJ; Greway, R; Green, T; ... Murphy, RD; + view all (2020) Enhanced antipneumococcal antibody electrochemiluminescence assay: validation and bridging to the WHO reference ELISA. Bioanalysis , 12 (19) pp. 1363-1375. 10.4155/bio-2020-0023. Green open access

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Abstract

AIM: 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. MATERIALS & METHODS: The Pn ECL assay was re-optimized, validated and formally bridged to the WHO ELISA. RESULTS: The enhanced Pn ECL assay met all prespecified validation acceptance criteria and demonstrated concordance with the WHO ELISA. The corresponding threshold value remains at 0.35 μg/ml for all 15 serotypes. CONCLUSION: The enhanced Pn ECL assay has been validated for the measurement of antibodies to 15 Pn capsular polysaccharides and is concordant with the WHO ELISA, supporting its use in clinical trials.

Type: Article
Title: Enhanced antipneumococcal antibody electrochemiluminescence assay: validation and bridging to the WHO reference ELISA
Location: England
Open access status: An open access version is available from UCL Discovery
DOI: 10.4155/bio-2020-0023
Publisher version: https://doi.org/10.4155/bio-2020-0023
Language: English
Additional information: This version is the author accepted manuscript. For information on re-use, please refer to the publisher’s terms and conditions.
Keywords: ELISA, Meso Scale Discovery, electrochemiluminescence, multiplex, optimization, pneumococcal, vaccine, validation
UCL classification: UCL
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > UCL GOS Institute of Child Health
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > UCL GOS Institute of Child Health > Infection, Immunity and Inflammation Dept
URI: https://discovery.ucl.ac.uk/id/eprint/10111632
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