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(Reference retrieved automatically from Web of Science through information on FAPESP grant and its corresponding number as mentioned in the publication by the authors.)

Development and validation of a whole-cell ELISA for serologically diagnosing Helicobacter pylori infection in Brazilian children and adults: a diagnostic accuracy study

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Author(s):
Ogata, Silvio Kazuo [1] ; Camorlinga-Ponce, Margarita [2, 3] ; Hernandes Granato, Celso Francisco [4] ; da Silveira Rohr, Maria Rachel [5, 6] ; Neto, Ricardo Artigiani [6] ; Kawakami, Elisabete [1]
Total Authors: 6
Affiliation:
[1] Univ Fed Sao Paulo EPM UNIFESP, Escola Paulista Med, Discipline Pediat Gastroenterol, Dept Pediat, Sao Paulo, SP - Brazil
[2] Univ Fed Sao Paulo EPM UNIFESP, Escola Paulista Med, Sao Paulo, SP - Brazil
[3] UMAE Hosp Pediat, Inst Mexicano Seguro Social, Infect Dis Res Unit, Mexico City, DF - Mexico
[4] Univ Fed Sao Paulo EPM UNIFESP, Escola Paulista Med, Dept Med, Discipline Parasit & Infect Dis, Sao Paulo, SP - Brazil
[5] Univ Fed Sao Paulo EPM UNIFESP, Escola Paulista Med, Dept Med, Discipline Gastroenterol, Sao Paulo, SP - Brazil
[6] Univ Fed Sao Paulo EPM UNIFESP, Escola Paulista Med, Dept Med, Discipline Clin Pathol, Sao Paulo, SP - Brazil
Total Affiliations: 6
Document type: Journal article
Source: São Paulo Medical Journal; v. 136, n. 5, p. 442-448, SEP-OCT 2018.
Web of Science Citations: 0
Abstract

ABSTRACT BACKGROUND: Serological tests are practical, with low cost, but no noninvasive tests are available for diagnosing Helicobacter pylori (H. pylori) infection in Brazil. The aim here was to develop and validate enzyme-linked immunosorbent assay (ELISA) serological tests to detect anti-H. pylori immunoglobulin G antibodies, based on cultured strains from Brazilian patients. DESIGN AND SETTING: Cross-sectional, diagnostic accuracy study comparing a locally developed and validated ELISA and invasive tests among dyspeptic patients at two public hospitals in São Paulo, Brazil. METHODS: An ELISA test was prepared using whole-cell antigen from 56 strains. After genotypic characterization, it was standardized and optical density (OD) cutoffs were determined based on the serum antibody response of 100 H. pylori-negative samples, compared with 82 H. pylori-positive samples. Validation was performed on 174 symptomatic patients. RESULTS: The optimal OD cutoffs established (for monoclonal and polyclonal tests, respectively) were 0.167 and 0.164; overall ELISA sensitivity: 84.3%, 78.9%; specificity: 88.6%, 90.6%; positive predictive value (PPV): 75.4%, 80%; negative predictive value (NPV): 93.1%, 81.8%; accuracy: 87.3%, 86.2%; child and adolescent ELISA sensitivity: 74.2%, 81.8%; specificity: 90.8%, 86.7%; PPV: 66.6%, 84.3%; NPV: 95.8%, 84.8%; accuracy: 88.5%, 84.6; adult ELISA sensitivity: 84.4%, 75%; specificity: 86.9%, 93%; PPV: 81.8%, 78.3%; NPV: 88.9%, 91.8%; accuracy: 85.9%, 88.5%. CONCLUSION: The polyclonal serological test developed using local strains presented better diagnostic performance among children and adolescents, while the monoclonal test was better among adults. The results from both tests suggest that these in-house serological tests could be used to detect anti-H. pylori antibodies in our population, for screening purposes. (AU)

FAPESP's process: 14/25298-5 - Validation of a serologic test for the diagnosis for Helicobacter pylori infection by enzyme immunoassay ELISA in serum
Grantee:Elisabete Kawakami
Support Opportunities: Regular Research Grants