medigraphic.com
ISSN 1025-0298 (Electronic)
ISSN 1025-028X (Print)

2015, Number 1

<< Back Next >>

VacciMonitor 2015; 24 (1)

Validation and application of an ELISA for the quantification of IgG antibodies against Salmonella Typhi Vi capsular polysaccharide

Espinosa-Viñals C, Soroa-Millán Y, Martin-García Y, Pérez-Baños A, Nicot-Valenciano M, Rodríguez-Noda L, Gómez-Amador A, Ramírez-González U, Soubal-Mora JP, García-Rivera D

Language: Spanish
References: 20
Page: 21-32
PDF size: 152.73 Kb.


ABSTRACT

An indirect ELISA for the quantification of IgG antibodies against the Vi polysaccharide of this bacteria was developed as a part of the stages of Research and Development of a conjugate vaccinal candidate against Salmonella Typhi. The results of the validation process are presented in this paper, in which the interval and linearity of the curve, the intra- and inter-assay precision, accuracy, specificity, limit of detection and robustness were determined. The calibration curve generated with an internal standard serum provided a good fit to a polynomial function and an interval between 1/100 and 1/3200 dilutions. The coefficients of variation in the precision and robustness tests and the percentages of recovery were in intervals established for each one (≤10%, ≤20% and 90-110%, respectively). The assay presented an optimal specificity, obtaining OD signals above 1.3 for positive sera against Vi and low for sera against unrelated antigens. The results support the use of this quantitative ELISA in immunogenicity assays for batch release of Vi conjugates. Likewise, they support their use for the immunogenicity evaluation of Vi polysaccharide formulations and Vi polysaccharide conjugates to proteins in phases of research and development.


REFERENCES

  1. WHO. Weekly epidemiological record Typhoid vaccines: WHO position paper. WHO 2008;6(83):49-60.

  2. WHO. The immunological basis of immunization series. Módulo 20. Salmonella enterica serovar Typhi (typhoid) vaccines. Geneva: WHO Document Production Services; 2011.

  3. Bhutta ZA, Capeding MR, Bavdekar A, Marchetti E, Ariff S, Soofi SB, et al. Immunogenicity and safety of the Vi-CRM197 conjugate vaccine against typhoid fever in adults, children, and infants in south and Southeast Asia: Results from two randomised, observer-blind, age de-escalation, phase 2 trials. Lancet Infect Dis 2014;14(2):119-29.

  4. Rondini S, Micoli F, Lanzilao L, Hale C, Saul AJ, Martin L. Evaluation of the immunogenicity and biological activity of the Citrobacter freudii Vi-CRM197 conjugate as a vaccine for Salmonella enterica serovar Typhi. Clin Vaccine Immunol 2011;8(3):460-8.

  5. Mandal S, Deb Mandal M, Pal NK. Changing Patterns of Antibiotic Resistances of Salmonella enterica Serovar Typhi in Kolkata, India. Advanced Bio Tech 2013;13(2):1-5.

  6. Lu YJ, Zhang F, Sayeed S, Thompson CM, Szu S, Anderson PW, et al. A bivalent vaccine to protect against Streptococcus pneumoniae and Salmonella typhi. Vaccine 2012;30(23):3405- 12.

  7. Simon R, Levine M. Glycoconjugate vaccine strategies for protection against invasive Salmonella infection. Human Vaccine & Immunotherapeutics 2012;8(4):1-5.

  8. World Health Organization (WHO). Guidelines on the quality, safety and efficacy of Typhoid conjugate vaccines. Geneva: WHO Press; 2013.

  9. An SJ, Yoon YK, Kothari S, Kim DK, Kim JA, Kothari N, et al. Immune suppression induced by Vi capsular polysaccharide is overcome by Vi-DT conjugate vaccine. Vaccine 2012;30(6):1023-8.

  10. Ali A, Jung AS, Cui C, Haque A, Carbis R. Preparation and evaluation of immunogenic conjugates of Salmonella enterica serovar Typhi O-specific polysaccharides with diphtheria toxoid. Human Vaccines & Immunotherapeutics 2012;8(2):189-93.

  11. Plikaytis BD, Carlone GM. Program ELISA for Windows User’s Manual, version 2. Centers for Desease Control and Prevention, Atlanta: CDC; 2005.

  12. Ochoa RF. Técnicas inmunoenzimáticas en el desarrollo clínico de vacunas. La Habana: Finlay Ediciones; 2013.

  13. Martínez JC, Ochoa RF, Estrada EA, Riverón L, González M, Ferriol XR, et al. Validación de un ELISA para la cuantificación de inmunoglobulinas séricas humanas anti polisacárido capsular de Salmonella typhi. VacciMonitor 1999;8(8):7-10.

  14. Szu SC, Hunt H, Xie G, Robbins JB, Schneerson R, Gupta RK. A human IgG anti-Vi reference for Salmonella typhi with weight-based antibody units assigned. Vaccine 2013;31(15):1970-4.

  15. Centro para el Control Estatal de la Calidad de los Medicamentos (CECMED). Anexo 1. De las Buenas Prácticas para Laboratorio de Control de Medicamentos. Validación de Métodos Analíticos. Regulación No. 37-2012. La Habana: CECMED; 2014.

  16. Olivares MN, Ochoa R, Martínez JC, Licea T, Ferriol X, García AM, et al. Validación de un ELISA para la cuantificación de IgG humana anti-polisacárido capsular de Neisseria meningitidis serogrupo C. Biotecnología Aplicada 1999;16(2):113-5.

  17. Leyva A, Sánchez JC, López L, Font M, González T, Pérez B, et al. Desarrollo, validación y aplicación de un nuevo ELISA para el control del proceso del antígeno de superficie del virus de la hepatitis B recombinante. Biotecnología Aplicada 2011;28(4):221-7.

  18. Paul L, Steinke K, Meyer HH. Development and validation of a sensitive enzyme immunoassay for surveillance of Cry1Ab toxin in bovine blood plasma of cows fed Bt-maize (MON810). Analytica Chimica Acta 2008;607(1):106-13.

  19. Mandiarote A, Gutiérrez N, Valmaseda T, Sosa R, Ontivero I, Talavera A. Estandarización de ensayos inmunoenzimáticos (ELISA) para la cuantificación de anticuerpos IgG inducidos por una vacuna de vesículas de membrana externa de los serogrupos A y W135 de Neisseria meningitidis. VacciMonitor 2012;21(2):16-23.

  20. Cuello M, Acosta Y, Martínez JC, Cabrera O, Ochoa R, Balboa JA, et al. Validación de un ELISA para la cuantificación de IgG antipolisacárido capsular de Neisseria meningitidis serogrupo C en sueros de ratones. VacciMonitor 2001:10(4):7-13.




2020     |     www.medigraphic.com