Qualification of an enzyme-linked immunosorbent assay for quantification of anti-Vi IgG in human sera
Effective vaccines against Salmonella Typhi, targeting the Vi capsular polysaccharide, have been developed and are being introduced into routine immunization in endemic countries. Vi conjugated vaccines are also being tested in new multi-component vaccine formulations. Simple, high-throughput and co...
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| Format: | Article |
| Language: | English |
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Frontiers Media S.A.
2024-10-01
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| Series: | Frontiers in Immunology |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fimmu.2024.1466869/full |
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| author | Martina Carducci Luisa Massai Elisa Lari Bianca Semplici Maria Grazia Aruta Daniele De Simone Pietro Piu Emanuele Montomoli Emanuele Montomoli Francesco Berlanda Scorza Silvia Grappi Miren Iturriza-Gómara Rocio Canals Simona Rondini Omar Rossi |
| author_facet | Martina Carducci Luisa Massai Elisa Lari Bianca Semplici Maria Grazia Aruta Daniele De Simone Pietro Piu Emanuele Montomoli Emanuele Montomoli Francesco Berlanda Scorza Silvia Grappi Miren Iturriza-Gómara Rocio Canals Simona Rondini Omar Rossi |
| author_sort | Martina Carducci |
| collection | DOAJ |
| description | Effective vaccines against Salmonella Typhi, targeting the Vi capsular polysaccharide, have been developed and are being introduced into routine immunization in endemic countries. Vi conjugated vaccines are also being tested in new multi-component vaccine formulations. Simple, high-throughput and cost-effective assays to quantify Vi-specific IgG in clinical sera are needed. In this study we present the development and qualification of a new anti-Vi ELISA with continuous readout, which expresses results as ELISA Unit/mL (EU/mL). We have qualified the assay in terms of precision, linearity and specificity, demonstrating performance in line with a commercially available anti-Vi ELISA. We have also calibrated the assay against the 16/138 anti-Vi international standard and established conversion factor between EU/mL and international units/mL, to allow comparability of results across studies. In summary, this new assay met all the suitability criteria and is being used to evaluate anti-Vi responses in clinical studies. |
| format | Article |
| id | doaj-art-59c624cffe464ee7be797fd26c190bbf |
| institution | OA Journals |
| issn | 1664-3224 |
| language | English |
| publishDate | 2024-10-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Immunology |
| spelling | doaj-art-59c624cffe464ee7be797fd26c190bbf2025-08-20T01:47:40ZengFrontiers Media S.A.Frontiers in Immunology1664-32242024-10-011510.3389/fimmu.2024.14668691466869Qualification of an enzyme-linked immunosorbent assay for quantification of anti-Vi IgG in human seraMartina Carducci0Luisa Massai1Elisa Lari2Bianca Semplici3Maria Grazia Aruta4Daniele De Simone5Pietro Piu6Emanuele Montomoli7Emanuele Montomoli8Francesco Berlanda Scorza9Silvia Grappi10Miren Iturriza-Gómara11Rocio Canals12Simona Rondini13Omar Rossi14GSK Vaccines Institute for Global Health (GVGH) S.r.l., Siena, ItalyGSK Vaccines Institute for Global Health (GVGH) S.r.l., Siena, ItalyVisMederi S.r.l., Siena, ItalyVisMederi S.r.l., Siena, ItalyGSK Vaccines Institute for Global Health (GVGH) S.r.l., Siena, ItalyGSK Vaccines Institute for Global Health (GVGH) S.r.l., Siena, ItalyVisMederi S.r.l., Siena, ItalyVisMederi S.r.l., Siena, ItalyDepartment of Molecular and Developmental Medicine, University of Siena, Siena, ItalyGSK Vaccines Institute for Global Health (GVGH) S.r.l., Siena, ItalyVisMederi S.r.l., Siena, ItalyGSK Vaccines Institute for Global Health (GVGH) S.r.l., Siena, ItalyGSK Vaccines Institute for Global Health (GVGH) S.r.l., Siena, ItalyGSK Vaccines Institute for Global Health (GVGH) S.r.l., Siena, ItalyGSK Vaccines Institute for Global Health (GVGH) S.r.l., Siena, ItalyEffective vaccines against Salmonella Typhi, targeting the Vi capsular polysaccharide, have been developed and are being introduced into routine immunization in endemic countries. Vi conjugated vaccines are also being tested in new multi-component vaccine formulations. Simple, high-throughput and cost-effective assays to quantify Vi-specific IgG in clinical sera are needed. In this study we present the development and qualification of a new anti-Vi ELISA with continuous readout, which expresses results as ELISA Unit/mL (EU/mL). We have qualified the assay in terms of precision, linearity and specificity, demonstrating performance in line with a commercially available anti-Vi ELISA. We have also calibrated the assay against the 16/138 anti-Vi international standard and established conversion factor between EU/mL and international units/mL, to allow comparability of results across studies. In summary, this new assay met all the suitability criteria and is being used to evaluate anti-Vi responses in clinical studies.https://www.frontiersin.org/articles/10.3389/fimmu.2024.1466869/fullenzyme - linked immunosorbent assay (ELISA)Vihumanvaccineenteric fevertyphoid |
| spellingShingle | Martina Carducci Luisa Massai Elisa Lari Bianca Semplici Maria Grazia Aruta Daniele De Simone Pietro Piu Emanuele Montomoli Emanuele Montomoli Francesco Berlanda Scorza Silvia Grappi Miren Iturriza-Gómara Rocio Canals Simona Rondini Omar Rossi Qualification of an enzyme-linked immunosorbent assay for quantification of anti-Vi IgG in human sera Frontiers in Immunology enzyme - linked immunosorbent assay (ELISA) Vi human vaccine enteric fever typhoid |
| title | Qualification of an enzyme-linked immunosorbent assay for quantification of anti-Vi IgG in human sera |
| title_full | Qualification of an enzyme-linked immunosorbent assay for quantification of anti-Vi IgG in human sera |
| title_fullStr | Qualification of an enzyme-linked immunosorbent assay for quantification of anti-Vi IgG in human sera |
| title_full_unstemmed | Qualification of an enzyme-linked immunosorbent assay for quantification of anti-Vi IgG in human sera |
| title_short | Qualification of an enzyme-linked immunosorbent assay for quantification of anti-Vi IgG in human sera |
| title_sort | qualification of an enzyme linked immunosorbent assay for quantification of anti vi igg in human sera |
| topic | enzyme - linked immunosorbent assay (ELISA) Vi human vaccine enteric fever typhoid |
| url | https://www.frontiersin.org/articles/10.3389/fimmu.2024.1466869/full |
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