Development and validation of a 6-plex Luminex-based assay for measuring human serum antibodies to group B streptococcus capsular polysaccharides
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 r...
| Main Authors: | , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Taylor & Francis Group
2024-12-01
|
| Series: | Human Vaccines & Immunotherapeutics |
| Subjects: | |
| Online Access: | https://www.tandfonline.com/doi/10.1080/21645515.2024.2311480 |
| _version_ | 1797204364402622464 |
|---|---|
| author | 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 |
| author_facet | 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 |
| author_sort | Michelle A. Gaylord |
| collection | DOAJ |
| description | 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 (<18.5% relative standard deviation) for all serotypes, and, therefore, is suitable for quantitatively measuring vaccine-induced or naturally acquired serotype-specific anti-CPS IgG responses against GBS. |
| first_indexed | 2024-04-24T08:34:03Z |
| format | Article |
| id | doaj.art-f4c53aff34804660864c1dfd08279223 |
| institution | Directory Open Access Journal |
| issn | 2164-5515 2164-554X |
| language | English |
| last_indexed | 2024-04-24T08:34:03Z |
| publishDate | 2024-12-01 |
| publisher | Taylor & Francis Group |
| record_format | Article |
| series | Human Vaccines & Immunotherapeutics |
| spelling | doaj.art-f4c53aff34804660864c1dfd082792232024-04-16T18:44:22ZengTaylor & Francis GroupHuman Vaccines & Immunotherapeutics2164-55152164-554X2024-12-0120110.1080/21645515.2024.2311480Development and validation of a 6-plex Luminex-based assay for measuring human serum antibodies to group B streptococcus capsular polysaccharidesMichelle A. Gaylord0Melissa Larrier1Donna Giordano-Schmidt2Christopher D. Grube3Suddham Singh4Ha H. Nguyen5Andrew McKeen6Charles Y. Tan7Annaliesa S. Anderson8Warren V. Kalina9Danka Pavliakova10Peter C. Giardina11Vaccine Research and Development, Pfizer Inc, Pearl River, New York, USAVaccine Research and Development, Pfizer Inc, Pearl River, New York, USAVaccine Research and Development, Pfizer Inc, Pearl River, New York, USAVaccine Research and Development, Pfizer Inc, Pearl River, New York, USAVaccine Research and Development, Pfizer Inc, Pearl River, New York, USAGlobal Biometrics & Data Management, Pfizer Inc, Pearl River, New York, USAGlobal Biometrics & Data Management, Pfizer Inc, Pearl River, New York, USAGlobal Biometrics & Data Management, Pfizer Inc, Collegeville, PA, USAVaccine Research and Development, Pfizer Inc, Pearl River, New York, USAVaccine Research and Development, Pfizer Inc, Pearl River, New York, USAVaccine Research and Development, Pfizer Inc, Pearl River, New York, USAVaccine Research and Development, Pfizer Inc, Pearl River, New York, USAABSTRACTSix 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 (<18.5% relative standard deviation) for all serotypes, and, therefore, is suitable for quantitatively measuring vaccine-induced or naturally acquired serotype-specific anti-CPS IgG responses against GBS.https://www.tandfonline.com/doi/10.1080/21645515.2024.2311480Streptococcus agalactiaegroup B streptococcuscapsular polysaccharideserotypeimmunoassayIgG |
| spellingShingle | 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 Development and validation of a 6-plex Luminex-based assay for measuring human serum antibodies to group B streptococcus capsular polysaccharides Human Vaccines & Immunotherapeutics Streptococcus agalactiae group B streptococcus capsular polysaccharide serotype immunoassay IgG |
| title | Development and validation of a 6-plex Luminex-based assay for measuring human serum antibodies to group B streptococcus capsular polysaccharides |
| title_full | Development and validation of a 6-plex Luminex-based assay for measuring human serum antibodies to group B streptococcus capsular polysaccharides |
| title_fullStr | Development and validation of a 6-plex Luminex-based assay for measuring human serum antibodies to group B streptococcus capsular polysaccharides |
| title_full_unstemmed | Development and validation of a 6-plex Luminex-based assay for measuring human serum antibodies to group B streptococcus capsular polysaccharides |
| title_short | Development and validation of a 6-plex Luminex-based assay for measuring human serum antibodies to group B streptococcus capsular polysaccharides |
| title_sort | development and validation of a 6 plex luminex based assay for measuring human serum antibodies to group b streptococcus capsular polysaccharides |
| topic | Streptococcus agalactiae group B streptococcus capsular polysaccharide serotype immunoassay IgG |
| url | https://www.tandfonline.com/doi/10.1080/21645515.2024.2311480 |
| work_keys_str_mv | AT michelleagaylord developmentandvalidationofa6plexluminexbasedassayformeasuringhumanserumantibodiestogroupbstreptococcuscapsularpolysaccharides AT melissalarrier developmentandvalidationofa6plexluminexbasedassayformeasuringhumanserumantibodiestogroupbstreptococcuscapsularpolysaccharides AT donnagiordanoschmidt developmentandvalidationofa6plexluminexbasedassayformeasuringhumanserumantibodiestogroupbstreptococcuscapsularpolysaccharides AT christopherdgrube developmentandvalidationofa6plexluminexbasedassayformeasuringhumanserumantibodiestogroupbstreptococcuscapsularpolysaccharides AT suddhamsingh developmentandvalidationofa6plexluminexbasedassayformeasuringhumanserumantibodiestogroupbstreptococcuscapsularpolysaccharides AT hahnguyen developmentandvalidationofa6plexluminexbasedassayformeasuringhumanserumantibodiestogroupbstreptococcuscapsularpolysaccharides AT andrewmckeen developmentandvalidationofa6plexluminexbasedassayformeasuringhumanserumantibodiestogroupbstreptococcuscapsularpolysaccharides AT charlesytan developmentandvalidationofa6plexluminexbasedassayformeasuringhumanserumantibodiestogroupbstreptococcuscapsularpolysaccharides AT annaliesasanderson developmentandvalidationofa6plexluminexbasedassayformeasuringhumanserumantibodiestogroupbstreptococcuscapsularpolysaccharides AT warrenvkalina developmentandvalidationofa6plexluminexbasedassayformeasuringhumanserumantibodiestogroupbstreptococcuscapsularpolysaccharides AT dankapavliakova developmentandvalidationofa6plexluminexbasedassayformeasuringhumanserumantibodiestogroupbstreptococcuscapsularpolysaccharides AT petercgiardina developmentandvalidationofa6plexluminexbasedassayformeasuringhumanserumantibodiestogroupbstreptococcuscapsularpolysaccharides |