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Enhanced antipneumococcal antibody electrochemiluminescence assay: validation and bridging to the WHO reference ELISA
by
Goldblatt, David
, Zhang, Yuhua
, Howlett, Adrienne H
, Greway, Rebecca
, de Gorguette d'Argoeuves, Polly
, Murphy, Rocio D
, Bonhomme, Cyrille J
, Green, Tina
, Nolan, Katrina M
, Antonello, Joseph M
in
Accuracy
/ Antibodies
/ Capsular polysaccharides
/ Clinical trials
/ electrochemiluminescence
/ ELISA
/ Enzyme-linked immunosorbent assay
/ Meso Scale Discovery
/ multiplex
/ optimization
/ Pediatrics
/ pneumococcal
/ Serotypes
/ Streptococcus infections
/ vaccine
/ Vaccines
/ validation
2020
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Enhanced antipneumococcal antibody electrochemiluminescence assay: validation and bridging to the WHO reference ELISA
by
Goldblatt, David
, Zhang, Yuhua
, Howlett, Adrienne H
, Greway, Rebecca
, de Gorguette d'Argoeuves, Polly
, Murphy, Rocio D
, Bonhomme, Cyrille J
, Green, Tina
, Nolan, Katrina M
, Antonello, Joseph M
in
Accuracy
/ Antibodies
/ Capsular polysaccharides
/ Clinical trials
/ electrochemiluminescence
/ ELISA
/ Enzyme-linked immunosorbent assay
/ Meso Scale Discovery
/ multiplex
/ optimization
/ Pediatrics
/ pneumococcal
/ Serotypes
/ Streptococcus infections
/ vaccine
/ Vaccines
/ validation
2020
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Do you wish to request the book?
Enhanced antipneumococcal antibody electrochemiluminescence assay: validation and bridging to the WHO reference ELISA
by
Goldblatt, David
, Zhang, Yuhua
, Howlett, Adrienne H
, Greway, Rebecca
, de Gorguette d'Argoeuves, Polly
, Murphy, Rocio D
, Bonhomme, Cyrille J
, Green, Tina
, Nolan, Katrina M
, Antonello, Joseph M
in
Accuracy
/ Antibodies
/ Capsular polysaccharides
/ Clinical trials
/ electrochemiluminescence
/ ELISA
/ Enzyme-linked immunosorbent assay
/ Meso Scale Discovery
/ multiplex
/ optimization
/ Pediatrics
/ pneumococcal
/ Serotypes
/ Streptococcus infections
/ vaccine
/ Vaccines
/ validation
2020
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Enhanced antipneumococcal antibody electrochemiluminescence assay: validation and bridging to the WHO reference ELISA
Journal Article
Enhanced antipneumococcal antibody electrochemiluminescence assay: validation and bridging to the WHO reference ELISA
2020
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Overview
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.
Publisher
Newlands Press Ltd,Newlands Press
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