SORA

Advancing, promoting and sharing knowledge of health through excellence in teaching, clinical practice and research into the prevention and treatment of illness

Interlaboratory comparison of a multiplex immunoassay that measures human serum IgG antibodies against six-group B streptococcus polysaccharides.

Le Doare, K; Gaylord, MA; Anderson, AS; Andrews, N; Baker, CJ; Bolcen, S; Felek, A; Giardina, PC; Grube, CD; Hall, T; et al. Le Doare, K; Gaylord, MA; Anderson, AS; Andrews, N; Baker, CJ; Bolcen, S; Felek, A; Giardina, PC; Grube, CD; Hall, T; Hallis, B; Izu, A; Madhi, SA; Maniatis, P; Matheson, M; Mawas, F; McKeen, A; Rhodes, J; Alston, B; Patel, P; Schrag, S; Simon, R; Tan, CY; Taylor, S; Kwatra, G; Gorringe, A (2024) Interlaboratory comparison of a multiplex immunoassay that measures human serum IgG antibodies against six-group B streptococcus polysaccharides. Hum Vaccin Immunother, 20 (1). p. 2330138. ISSN 2164-554X https://doi.org/10.1080/21645515.2024.2330138
SGUL Authors: Le Doare, Kirsty

[img]
Preview
PDF Published Version
Available under License Creative Commons Attribution.

Download (2MB) | Preview
[img]
Preview
PDF (Supplementary materials) Supplemental Material
Available under License Creative Commons Attribution Non-commercial No Derivatives.

Download (428kB) | Preview

Abstract

Measurement of IgG antibodies against group B streptococcus (GBS) capsular polysaccharide (CPS) by use of a standardized and internationally accepted multiplex immunoassay is important for the evaluation of candidate maternal GBS vaccines in order to compare results across studies. A standardized assay is also required if serocorrelates of protection against invasive GBS disease are to be established in infant sera for the six predominant GBS serotypes since it would permit the comparison of results across the six serotypes. We undertook an interlaboratory study across five laboratories that used standardized assay reagents and protocols with a panel of 44 human sera to measure IgG antibodies against GBS CPS serotypes Ia, Ib, II, III, IV, and V. The within-laboratory intermediate precision, which included factors like the lot of coated beads, laboratory analyst, and day, was generally below 20% relative standard deviation (RSD) for all six serotypes, across all five laboratories. The cross-laboratory reproducibility was < 25% RSD for all six serotypes, which demonstrated the consistency of results across the different laboratories. Additionally, anti-CPS IgG concentrations for the 44-member human serum panel were established. The results of this study showed assay robustness and that the resultant anti-CPS IgG concentrations were reproducible across laboratories for the six GBS CPS serotypes when the standardized assay was used.

Item Type: Article
Additional Information: © 2024 The Author(s). Published with license by Taylor & Francis Group, LLC. This is an Open Access article distributed under the terms of the Creative Commons Attribution License http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. The terms on which this article has been published allow the posting of the Accepted Manuscript in a repository by the author(s) or with their consent.
Keywords: Group B streptococcus, correlate of protection, maternal, neonatal, vaccines, Infant, Humans, Reproducibility of Results, Immunoglobulin G, Guillain-Barre Syndrome, Immunoassay, Polysaccharides, Streptococcus agalactiae, Humans, Streptococcus agalactiae, Guillain-Barre Syndrome, Polysaccharides, Immunoglobulin G, Immunoassay, Reproducibility of Results, Infant, 1107 Immunology, 1108 Medical Microbiology, 1115 Pharmacology and Pharmaceutical Sciences, Virology
SGUL Research Institute / Research Centre: Academic Structure > Infection and Immunity Research Institute (INII)
Academic Structure > REF 2021 user group
Journal or Publication Title: Hum Vaccin Immunother
ISSN: 2164-554X
Language: eng
Dates:
DateEvent
12 April 2024Published
9 March 2024Accepted
Publisher License: Creative Commons: Attribution 4.0
Projects:
Project IDFunderFunder ID
INV-008343Bill and Melinda Gates Foundationhttp://dx.doi.org/10.13039/100000865
PubMed ID: 38608170
Go to PubMed abstract
URI: https://openaccess.sgul.ac.uk/id/eprint/116431
Publisher's version: https://doi.org/10.1080/21645515.2024.2330138

Actions (login required)

Edit Item Edit Item