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Enhanced antipneumococcal antibody electrochemiluminescence assay: validation and bridging to the WHO reference ELISA.
Nolan, Katrina M; Zhang, Yuhua; Antonello, Joseph M; Howlett, Adrienne H; Bonhomme, Cyrille J; Greway, Rebecca; Green, Tina; de Gorguette d'Argoeuves, Polly; Goldblatt, David; Murphy, Rocio D.
  • Nolan KM; Merck & Co., Inc., Kenilworth, NJ 07033, USA.
  • Zhang Y; Merck & Co., Inc., Kenilworth, NJ 07033, USA.
  • Antonello JM; Merck & Co., Inc., Kenilworth, NJ 07033, USA.
  • Howlett AH; Merck & Co., Inc., Kenilworth, NJ 07033, USA.
  • Bonhomme CJ; Merck & Co., Inc., Kenilworth, NJ 07033, USA.
  • Greway R; Merck & Co., Inc., Kenilworth, NJ 07033, USA.
  • Green T; Merck & Co., Inc., Kenilworth, NJ 07033, USA.
  • de Gorguette d'Argoeuves P; Great Ormond Street Institute of Child Health (ICH), University College London, London, UK.
  • Goldblatt D; Great Ormond Street Institute of Child Health (ICH), University College London, London, UK.
  • Murphy RD; Merck & Co., Inc., Kenilworth, NJ 07033, USA.
Bioanalysis ; 12(19): 1363-1375, 2020 Oct.
Article en En | MEDLINE | ID: mdl-32975436
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.
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Texto completo: 1 Banco de datos: MEDLINE Asunto principal: Organización Mundial de la Salud / Bioensayo / Ensayo de Inmunoadsorción Enzimática / Vacunas Neumococicas Límite: Humans Idioma: En Año: 2020 Tipo del documento: Article
Texto completo
Imprimir
XML
PubMed Links
Search on Google

Texto completo: 1 Banco de datos: MEDLINE Asunto principal: Organización Mundial de la Salud / Bioensayo / Ensayo de Inmunoadsorción Enzimática / Vacunas Neumococicas Límite: Humans Idioma: En Año: 2020 Tipo del documento: Article