Interlaboratory comparison of a multiplex immunoassay that measures human serum IgG antibodies against six-group B streptococcus polysaccharides
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 as...
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Taylor & Francis Group
2024-12-01
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| Series: | Human Vaccines & Immunotherapeutics |
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| Online Access: | https://www.tandfonline.com/doi/10.1080/21645515.2024.2330138 |
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| author | Kirsty Le Doare Michelle A. Gaylord Annaliesa S. Anderson Nick Andrews Carol J. Baker Shanna Bolcen Arif Felek Peter C. Giardina Christopher D. Grube Tom Hall Bassam Hallis Alane Izu Shabir A. Madhi Pete Maniatis Mary Matheson Fatme Mawas Andrew McKeen Julia Rhodes Bailey Alston Palak Patel Stephanie Schrag Raphael Simon Charles Y. Tan Stephen Taylor Gaurav Kwatra Andrew Gorringe |
| author_facet | Kirsty Le Doare Michelle A. Gaylord Annaliesa S. Anderson Nick Andrews Carol J. Baker Shanna Bolcen Arif Felek Peter C. Giardina Christopher D. Grube Tom Hall Bassam Hallis Alane Izu Shabir A. Madhi Pete Maniatis Mary Matheson Fatme Mawas Andrew McKeen Julia Rhodes Bailey Alston Palak Patel Stephanie Schrag Raphael Simon Charles Y. Tan Stephen Taylor Gaurav Kwatra Andrew Gorringe |
| author_sort | Kirsty Le Doare |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-46ead07e882e4125ad972a32edff7d7d |
| institution | DOAJ |
| issn | 2164-5515 2164-554X |
| language | English |
| publishDate | 2024-12-01 |
| publisher | Taylor & Francis Group |
| record_format | Article |
| series | Human Vaccines & Immunotherapeutics |
| spelling | doaj-art-46ead07e882e4125ad972a32edff7d7d2025-08-20T03:12:43ZengTaylor & Francis GroupHuman Vaccines & Immunotherapeutics2164-55152164-554X2024-12-0120110.1080/21645515.2024.2330138Interlaboratory comparison of a multiplex immunoassay that measures human serum IgG antibodies against six-group B streptococcus polysaccharidesKirsty Le Doare0Michelle A. Gaylord1Annaliesa S. Anderson2Nick Andrews3Carol J. Baker4Shanna Bolcen5Arif Felek6Peter C. Giardina7Christopher D. Grube8Tom Hall9Bassam Hallis10Alane Izu11Shabir A. Madhi12Pete Maniatis13Mary Matheson14Fatme Mawas15Andrew McKeen16Julia Rhodes17Bailey Alston18Palak Patel19Stephanie Schrag20Raphael Simon21Charles Y. Tan22Stephen Taylor23Gaurav Kwatra24Andrew Gorringe25Centre for Neonatal and Paediatric Infection, Institute for Infection and Immunity, St George’s, University of London, London, UKPfizer Vaccine Research & Development, Pearl River, NY, USAPfizer Vaccine Research & Development, Pearl River, NY, USAImmunisation and Vaccine Preventable Diseases Division, United Kingdom Health Security Agency (UKHSA), London, UKDepartment of Pediatrics, Division of Infectious Disease, McGovern Medical School and UT Health, Houston, TX, USAThe Centers for Disease Control and Prevention (CDC), Atlanta, GA, USAVaccine Division, Scientific Research & Innovation Group, MHRA, Potters Bar, UKPfizer Vaccine Research & Development, Pearl River, NY, USAPfizer Vaccine Research & Development, Pearl River, NY, USACentre for Neonatal and Paediatric Infection, Institute for Infection and Immunity, St George’s, University of London, London, UKUK Health Security Agency, Porton Down, UKSouth African Medical Research Council: Vaccines and Infectious Diseases Analytics Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South AfricaSouth African Medical Research Council: Vaccines and Infectious Diseases Analytics Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South AfricaThe Centers for Disease Control and Prevention (CDC), Atlanta, GA, USAUK Health Security Agency, Porton Down, UKVaccine Division, Scientific Research & Innovation Group, MHRA, Potters Bar, UKPfizer Global Biometrics & Data Management, Pearl River, NY, USAThe Centers for Disease Control and Prevention (CDC), Atlanta, GA, USAEagle Global Scientific, Atlanta, GA, USAThe Centers for Disease Control and Prevention (CDC), Atlanta, GA, USAThe Centers for Disease Control and Prevention (CDC), Atlanta, GA, USAPfizer Vaccine Research & Development, Pearl River, NY, USAPfizer Global Biometrics & Data Management, Pearl River, NY, USAUK Health Security Agency, Porton Down, UKSouth African Medical Research Council: Vaccines and Infectious Diseases Analytics Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South AfricaUK Health Security Agency, Porton Down, UKMeasurement 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.https://www.tandfonline.com/doi/10.1080/21645515.2024.2330138Group B streptococcusmaternalneonatalcorrelate of protectionvaccines |
| spellingShingle | Kirsty Le Doare Michelle A. Gaylord Annaliesa S. Anderson Nick Andrews Carol J. Baker Shanna Bolcen Arif Felek Peter C. Giardina Christopher D. Grube Tom Hall Bassam Hallis Alane Izu Shabir A. Madhi Pete Maniatis Mary Matheson Fatme Mawas Andrew McKeen Julia Rhodes Bailey Alston Palak Patel Stephanie Schrag Raphael Simon Charles Y. Tan Stephen Taylor Gaurav Kwatra Andrew Gorringe Interlaboratory comparison of a multiplex immunoassay that measures human serum IgG antibodies against six-group B streptococcus polysaccharides Human Vaccines & Immunotherapeutics Group B streptococcus maternal neonatal correlate of protection vaccines |
| title | Interlaboratory comparison of a multiplex immunoassay that measures human serum IgG antibodies against six-group B streptococcus polysaccharides |
| title_full | Interlaboratory comparison of a multiplex immunoassay that measures human serum IgG antibodies against six-group B streptococcus polysaccharides |
| title_fullStr | Interlaboratory comparison of a multiplex immunoassay that measures human serum IgG antibodies against six-group B streptococcus polysaccharides |
| title_full_unstemmed | Interlaboratory comparison of a multiplex immunoassay that measures human serum IgG antibodies against six-group B streptococcus polysaccharides |
| title_short | Interlaboratory comparison of a multiplex immunoassay that measures human serum IgG antibodies against six-group B streptococcus polysaccharides |
| title_sort | interlaboratory comparison of a multiplex immunoassay that measures human serum igg antibodies against six group b streptococcus polysaccharides |
| topic | Group B streptococcus maternal neonatal correlate of protection vaccines |
| url | https://www.tandfonline.com/doi/10.1080/21645515.2024.2330138 |
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