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Validation of a serologic test for the diagnosis for Helicobacter pylori infection by enzyme immunoassay ELISA in serum

Grant number: 14/25298-5
Support Opportunities:Regular Research Grants
Duration: April 01, 2015 - September 30, 2017
Field of knowledge:Health Sciences - Medicine - Maternal and Child Health
Principal Investigator:Elisabete Kawakami
Grantee:Elisabete Kawakami
Host Institution: Escola Paulista de Medicina (EPM). Universidade Federal de São Paulo (UNIFESP). Campus São Paulo. São Paulo , SP, Brazil
Associated researchers:Celso Francisco Hernandes Granato ; Silvio Kazuo Ogata ; Suely Carlos Ferreira Sampaio


The detection of IgG antibodies against Helicobacter pylori in serum by ELISA is practical, but its accuracy varies with the type of testing and the population assessed. Studies have shown lower performance of the tests produced in developed countries and marketed in populations of developing countries when compared to ELISA tests made with antigenic preparations strains of the local population. Purpose. Validating serological testing by ELISA method for detection and titration of IgG antibodies specific anti-H. pylori serum against whole cell antigens of bacteria isolated from fragments of biopsies of patients undergoing endoscopy for diagnostic purposes. Methods. Initial standardization of the ELISA test for the presence of immunoglobulin (Ig) class IgG anti-H. pylori in serum will be tested with control sera of 10 patients infected admittedly, and 10 uninfected, determined by gold standard (histology and rapid urease test positive and / or culture positive). Antigenic preparation: Sonication whole cell 20 samples (10 adults and 10 children) of isolated bacteria and selected from genotypic knowledge. Antigenic specificity is tested with 19 species of heterologous bacteria. Validation of the ELISA test: 78 adults and 95 children infected and uninfected symptomatic. (AU)

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Scientific publications
(References retrieved automatically from Web of Science and SciELO through information on FAPESP grants and their corresponding numbers as mentioned in the publications by the authors)
OGATA, SILVIO KAZUO; CAMORLINGA-PONCE, MARGARITA; HERNANDES GRANATO, CELSO FRANCISCO; DA SILVEIRA ROHR, MARIA RACHEL; NETO, RICARDO ARTIGIANI; KAWAKAMI, ELISABETE. Development and validation of a whole-cell ELISA for serologically diagnosing Helicobacter pylori infection in Brazilian children and adults: a diagnostic accuracy study. São Paulo Medical Journal, v. 136, n. 5, p. 442-448, . (14/25298-5)

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