Bioanalysis, 2020-10, Vol.12 (19), p.1363-1375
2020
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Details
- Autor(en) / Beteiligte
- Titel
- Enhanced antipneumococcal antibody electrochemiluminescence assay: validation and bridging to the WHO reference ELISA
- Ist Teil von
- Bioanalysis, 2020-10, Vol.12 (19), p.1363-1375
- Ort / Verlag
- England: Newlands Press Ltd
- Erscheinungsjahr
- 2020
- Quelle
- MEDLINE
- Beschreibungen/Notizen
- 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. The corresponding threshold value remains at 0.35 μg/ml for all 15 serotypes. 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.
- Sprache
- Englisch
- Identifikatoren
- ISSN: 1757-6180eISSN: 1757-6199DOI: 10.4155/bio-2020-0023Titel-ID: cdi_proquest_journals_2455561285
- Format
- –
- Schlagworte
- Accuracy, Antibodies, Biological Assay - methods, Capsular polysaccharides, Clinical trials, electrochemiluminescence, ELISA, Enzyme-linked immunosorbent assay, Enzyme-Linked Immunosorbent Assay - methods, Humans, Meso Scale Discovery, multiplex, optimization, Pediatrics, pneumococcal, Pneumococcal Vaccines - immunology, Serotypes, Streptococcus infections, vaccine, Vaccines, validation, World Health Organization - organization & administration