Please use this identifier to cite or link to this item: https://www.arca.fiocruz.br/handle/icict/13242
Title: Evaluating HBsAg rapid test performance for different biological samples from low and high infection rate settings & populations
Authors: Cruz, Helena Medina
Scalioni, Letícia de Paula
Paula, Vanessa Salete de
Silva, Elisângela Ferreira da
Ó, Kycia Maria Rodrigues do
Milagres, Flavio Augusto Pádua
Cruz, Marcelo Santos
Bastos, Francisco Inácio Pinkusfeld Monteiro
Pollo-Flores, Priscila
Leal, Erotildes
Castro, Ana Rita Coimbra Motta
Pilotto, José Henrique
Lewis-Ximenez, Lia Laura
Lampe, Elisabeth
Villar, Livia Melo
Affilliation: Fundação Oswaldo Cruz. Instituto Oswaldo Cruz. Laboratório de Hepatites Virais. Rio de Janeiro, RJ, Brasil.
Fundação Oswaldo Cruz. Instituto Oswaldo Cruz. Laboratório de Hepatites Virais. Rio de Janeiro, RJ, Brasil.
Fundação Oswaldo Cruz. Instituto Oswaldo Cruz. Laboratório de Desenvolvimento Tecnológico em Virologia. Rio de Janeiro, RJ, Brasil.
Fundação Oswaldo Cruz. Instituto Oswaldo Cruz. Laboratório de Hepatites Virais. Rio de Janeiro, RJ, Brasil.
São Lucas Hospital. Petrópolis, Rio de Janeiro, RJ, Brasil.
Universidade Federal de Tocantins. Faculdade de Medicina. Palmas, TO, Brasil.
Universidade Federal do Rio de Janeiro. Instituto de Psiquiatria. Rio de Janeiro, RJ, Brasil.
Fundação Oswaldo Cruz. Instituto de Comunicação e Informação Científica e Tecnológica em Saúde. Rio de Janeiro, RJ, Brasil.
Universidade Federal Fluminense. Hospital Universitário Antonio Pedro. Niterói, RJ, Brasil.
Universidade Federal do Rio de Janeiro. Campus Macaé. Macaé, RJ, Brasil.
Universidade Federal de Mato Grosso do Sul. Campo Grande, MS, Brasil / Fundação Oswaldo Cruz-MS. Campo Grande, MS, Brasil.
Fundação Oswaldo Cruz. Instituto Oswaldo Cruz. Laboratório de AIDS e Imunologia Molecular. Rio de Janeiro, RJ, Brasil.
Fundação Oswaldo Cruz. Instituto Oswaldo Cruz. Laboratório de Hepatites Virais. Rio de Janeiro, RJ, Brasil.
Fundação Oswaldo Cruz. Instituto Oswaldo Cruz. Laboratório de Hepatites Virais. Rio de Janeiro, RJ, Brasil.
Fundação Oswaldo Cruz. Instituto Oswaldo Cruz. Laboratório de Hepatites Virais. Rio de Janeiro, RJ, Brasil.
Abstract: Background: Rapid tests (RTs) might have several advantages over standard laboratory procedures, increasing access to diagnosis, especially among vulnerable populations and/or those living in remote areas. The aim of this study was to evaluate the performance of RTs for the detection of hepatitis B virus surface antigen (HBsAg) in samples from different populations/settings. Methods: Three RTs for HBsAg detection (Vikia® HBsAg, HBsAg Teste Rápido®, and Imuno-Rápido HBsAg®) and different biological specimens (serum, whole blood, and saliva) were evaluated. Analyses comprised a reference panel and samples from field studies targeting suspected cases of hepatitis B virus (HBV) (G I), individuals living in deprived areas (G II), and highly vulnerable individuals (G III). Enzyme immunoassay (EIA) was defined as the gold standard in this study. Reproducibility, repeatability, and cross-reactivity with other infectious agents such as dengue, immunodeficiency (HIV), and hepatitis C (HCV) viruses and T. pallidum were determined. Results: For the reference panel, the sensitivity and specificity of all HBsAg RTs were higher than 93.00 %. G I presented the highest kappa values for all rapid assays using sera samples. When using serum, the sensitivity values were higher than 93.40 for G I, 60.00 % for G II and 66.77 % for G III, and the specificity values were higher than 99.50 for GI, 97.20 for G II and 99.10 % for G III for all tests. For whole blood samples & the Vikia® HBsAg assay, the best performance was achieved for GIII (k = 79.75 %). For saliva samples, the Imuno-Rápido HBsAg® assay showed the highest concordance values with EIA for G I (40.68 %) and G II (32.20 %). The reproducibility and repeatability of all RTs for serum and saliva were excellent, and the concordance between HBsAg EIAs and RTs using samples reactive with other infectious agents varied from 70.10 % to 100.00 %. Conclusions: The overall performance of RTs for HBsAg in serum was high/moderately high for all groups, thereby promoting increased access to HBV diagnosis among vulnerable populations as well as samples from individuals in emergency settings or remote areas. Rapid tests for HBsAg using whole blood could be used in prevalence studies, though these assays should not be used for saliva samples.
Keywords: Hepatitis B virus
Rapid tests
Performance of tests
Diagnostic procedures
keywords: Testes de desempenho
Vírus da hepatite B
Técnicas e Procedimentos Diagnósticos
Issue Date: 2015
Publisher: BioMed Central
Citation: CRUZ, Helena Medina; et al. Evaluating HBsAg rapid test performance for different biological samples from low and high infection rate settings & populations. BMC Infectious Disease, v.15:548, 10p, 2015.
DOI: 10.1186/s12879-015-1249-5
ISSN: 1471-2334
Copyright: open access
Appears in Collections:IOC - Artigos de Periódicos

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