Development and validation of a 6-plex Luminex-based assay for measuring human serum antibodies to group B streptococcus capsular polysaccharides
| Autor: | Michelle A. Gaylord, Melissa Larrier, Donna Giordano-Schmidt, Christopher D. Grube, Suddham Singh, Ha H. Nguyen, Andrew McKeen, Charles Y. Tan, Annaliesa S. Anderson, Warren V. Kalina, Danka Pavliakova, Peter C. Giardina |
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| Jazyk: | angličtina |
| Rok vydání: | 2024 |
| Předmět: | |
| Zdroj: | Human Vaccines & Immunotherapeutics, Vol 20, Iss 1 (2024) |
| Druh dokumentu: | article |
| ISSN: | 21645515 2164-554X 2164-5515 |
| DOI: | 10.1080/21645515.2024.2311480 |
| Popis: | ABSTRACTSix serotypes (Ia, Ib, II, III, IV, and V) cause nearly all group B streptococcal (GBS) disease globally. Capsular polysaccharide (CPS) conjugate vaccines aim to prevent GBS disease, however, licensure of a vaccine would depend on a standardized serological assay for measuring anti-CPS IgG responses. A multiplex direct Luminex-based immunoassay (dLIA) has been developed to simultaneously measure the concentration of serum IgG specific for the six prevalent GBS CPS serotypes. Assay validation was performed using serum samples obtained from human subjects vaccinated with an investigational 6-valent GBS CPS conjugate vaccine. Results for the assay are expressed as IgG concentrations (µg/mL) using a human serum reference standard composed of pooled sera from vaccinated subjects. The lower limits of quantitation (LLOQ) for all serotypes covered in the 6-plex GBS IgG dLIA fell within the range of 0.002-0.022 µg/mL IgG. Taken together, the 6-plex GBS IgG dLIA platform is specific for the six GBS serotypes included in Pfizer’s investigational vaccine, has a wide dilution adjusted assay range, and is precise ( |
| Databáze: | Directory of Open Access Journals |
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