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- Title
Development and Validation of Enzyme-Linked Immunosorbent Assay for Group B Streptococcal Polysaccharide Vaccine.
- Authors
Jang, A-Yeung; Choi, Min-Joo; Zhi, Yong; Ji, Hyun-Jung; Noh, Ji-Yun; Yoon, Jin-Gu; Cheong, Hee-Jin; Kim, Woo-Joo; Seo, Ho-Seong; Song, Joon-Young
- Abstract
Streptococcus agalactiae (group B Streptococcus, GBS) is a leading cause of neonatal sepsis and meningitis in infants. Limitations of prenatal GBS screening and intrapartum antibiotic prophylaxis render developing GBS vaccines a high priority. In this study, we developed an enzyme-linked immunosorbent assay (ELISA) for the practical and large-scale evaluation of GBS capsular polysaccharide (PS) vaccine immunogenicity against three main serotypes, Ia, III, and V. GBS-ELISA was developed and subsequently validated using a standardized curve-fitting four-parameter logistic method. Specificity was measured using adsorption of serum with homologous and heterologous PS. Homologous adsorption showed a ≥75% inhibition of all three serotypes, whereas with heterologous PS, IgG GBS-ELISA inhibited only ≤25% of serotypes III and V. However, with serotype Ia, IgG antibody levels decreased by >50%, even after adsorption with heterologous PS (III or V). In comparison, the inhibition opsonophagocytic killing assay (OPA) of serotypes Ia GBS exhibited a reduction in opsonophagocytic activity of only 20% and 1.1% for serotypes III and V GBS, respectively. The precision of the GBS-ELISA was assessed in five independent experiments using four serum samples. The coefficient of variation was <5% for all three serotypes. This standardized GBS-ELISA would be useful for GBS vaccine development and its evaluation.
- Subjects
ENZYME-linked immunosorbent assay; STREPTOCOCCUS agalactiae; NEONATAL sepsis; IMMUNOGLOBULIN G; ANTIBIOTIC prophylaxis
- Publication
Vaccines, 2021, Vol 9, Issue 6, p545
- ISSN
2076-393X
- Publication type
Article
- DOI
10.3390/vaccines9060545