Development and Validation of 13-plex Luminex-Based Assay for Measuring Human Serum Antibodies to Streptococcus pneumoniae Capsular Polysaccharides-Reference-Cited by-同舟云学术

Development and Validation of 13-plex Luminex-Based Assay for Measuring Human Serum Antibodies to Streptococcus pneumoniae Capsular Polysaccharides

Published:2018-08-29 Issue:4 Volume:3 Page:
ISSN:2379-5042
Container-title:mSphere
language:en
Short-container-title:mSphere

Author:

Pavliakova Danka¹,Giardina Peter C.¹,Moghazeh Soraya¹,Sebastian Shite²,Koster Maya¹,Pavliak Viliam¹,McKeen Andrew³,French Roger³,Jansen Kathrin U.¹,Pride Michael¹

Affiliation:

1. Vaccine Research and Development and Early Clinical Development Biostatistics, Pfizer Inc., Pearl River, New York, USA

2. Affinivax, Cambridge, Massachusetts, USA

3. Biotechnology Clinical Development Statistics, Pfizer Inc., Pearl River, New York, USA

Abstract

The pneumococcal enzyme-linked immunosorbent assay (ELISA) measures IgG antibodies in human serum, and it is an important assay that supports licensure of pneumococcal vaccines. The immune correlate of protection, 0.35 µg/ml of IgG antibodies, was determined by the ELISA method. Pfizer has developed a new Luminex-based assay platform to replace the ELISA. These papers describe the important work of (i) validating the Luminex-based assay and (ii) bridging the immune correlate of protection (0.35 µg/ml IgG) to equivalent values reported by the Luminex platform.

Funder

Pfizer

Publisher

American Society for Microbiology

Subject

Molecular Biology,Microbiology

Link

https://journals.asm.org/doi/pdf/10.1128/mSphere.00128-18

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