| Autor: |
Aruta MG; GSK Vaccines Institute for Global Health (GVGH) S.r.l., 53100 Siena, Italy., Lari E; VisMederi S.r.l., 53100 Siena, Italy., De Simone D; GSK Vaccines Institute for Global Health (GVGH) S.r.l., 53100 Siena, Italy., Semplici B; VisMederi S.r.l., 53100 Siena, Italy., Semplici C; VisMederi S.r.l., 53100 Siena, Italy., Dale H; Malawi Liverpool Wellcome Trust Programme, Blantyre 30096, Malawi.; Pathology Department, Kamuzu University of Health Sciences, Blantyre 312225, Malawi.; Institute of Infection, Veterinary and Ecological Sciences, University of Liverpool, Liverpool L69 3BX, UK., Chirwa E; Malawi Liverpool Wellcome Trust Programme, Blantyre 30096, Malawi.; Pathology Department, Kamuzu University of Health Sciences, Blantyre 312225, Malawi.; Institute of Infection, Veterinary and Ecological Sciences, University of Liverpool, Liverpool L69 3BX, UK., Kadwala I; Malawi Liverpool Wellcome Trust Programme, Blantyre 30096, Malawi.; Pathology Department, Kamuzu University of Health Sciences, Blantyre 312225, Malawi., Mbewe M; Malawi Liverpool Wellcome Trust Programme, Blantyre 30096, Malawi.; Pathology Department, Kamuzu University of Health Sciences, Blantyre 312225, Malawi., Banda H; Malawi Liverpool Wellcome Trust Programme, Blantyre 30096, Malawi.; Pathology Department, Kamuzu University of Health Sciences, Blantyre 312225, Malawi., Iturriza-Gomara M; GSK Vaccines Institute for Global Health (GVGH) S.r.l., 53100 Siena, Italy., Gordon M; Malawi Liverpool Wellcome Trust Programme, Blantyre 30096, Malawi.; Institute of Infection, Veterinary and Ecological Sciences, University of Liverpool, Liverpool L69 3BX, UK., Nyirenda T; Pathology Department, Kamuzu University of Health Sciences, Blantyre 312225, Malawi., Piu P; VisMederi S.r.l., 53100 Siena, Italy., Pizza M; GSK Vaccines Institute for Global Health (GVGH) S.r.l., 53100 Siena, Italy.; Imperial College South Kensington Campus, London SW7 2AZ, UK., Berlanda Scorza F; GSK Vaccines Institute for Global Health (GVGH) S.r.l., 53100 Siena, Italy., Grappi S; VisMederi S.r.l., 53100 Siena, Italy., Canals R; GSK Vaccines Institute for Global Health (GVGH) S.r.l., 53100 Siena, Italy., Rossi O; GSK Vaccines Institute for Global Health (GVGH) S.r.l., 53100 Siena, Italy., On Behalf Of The Vacc-iNTS Consortium Collaborators |
| Abstrakt: |
Nontyphoidal Salmonella (NTS) is a leading cause of morbidity and mortality caused by enteric pathogens worldwide in both children and adults, and vaccines are not yet available. The measurement of antigen-specific antibodies in the sera of vaccinated or convalescent individuals is crucial to understand the incidence of disease and the immunogenicity of vaccine candidates. A solid and standardized assay used to determine the level of specific anti-antigens IgG is therefore of paramount importance. In this work, we presented the characterization of a customized enzyme-linked immunosorbent assay (ELISA) with continuous readouts and a standardized definition of EU/mL. We assessed various performance parameters: standard curve accuracy, dilutional linearity, intermediate precision, specificity, limits of blanks, and quantification. The simplicity of the assay, its high sensitivity and specificity coupled with its low cost and the use of basic consumables and instruments without the need of high automation makes it suitable for transfer and application to different laboratories, including resource-limiting settings where the disease is endemic. This ELISA is, therefore, fit for purpose to be used for quantification of antibodies against Salmonella Typhimurium and Salmonella Enteritidis O-antigens in human samples, both for vaccine clinical trials and large sero-epidemiological studies. |
