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2051-01-01
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- ENSP - Artigos de Periódicos [2412]
- INI - Artigos de Periódicos [3646]
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DIAGNOSTIC PARAMETERS AND RELIABILITY OF FOUR RAPID IMMUNOCHROMATOGRAPHIC TESTS FOR DENGUE 4
Diagnosis
Immunochromatographic tests
Reproducibility of tests
Sensitivity and specificity
Author
Affilliation
Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Laboratório de Epidemiologia Clínica. Rio de Janeiro, RJ, Brasil.
Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Laboratório de Epidemiologia Clínica. Rio de Janeiro, RJ, Brasil.
Fundação Oswaldo Cruz. Escola Nacional de Saúde Pública Sergio Arouca. Rio de Janeiro, RJ, Brasil.
Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Laboratório de Epidemiologia Clínica. Rio de Janeiro, RJ, Brasil.
Universidade Estácio de Sá. Rio de Janeiro, RJ, Brasil.
Fundação Oswaldo Cruz. Instituto Oswaldo Cruz. Laboratório de Flavivírus. Rio de Janeiro, RJ, Brasil.
Universidade Estácio de Sá. Rio de Janeiro, RJ, Brasil.
Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Laboratório de Epidemiologia Clínica. Rio de Janeiro, RJ, Brasil.
Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Laboratório de Epidemiologia Clínica. Rio de Janeiro, RJ, Brasil.
Fundação Oswaldo Cruz. Escola Nacional de Saúde Pública Sergio Arouca. Rio de Janeiro, RJ, Brasil.
Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Laboratório de Epidemiologia Clínica. Rio de Janeiro, RJ, Brasil.
Universidade Estácio de Sá. Rio de Janeiro, RJ, Brasil.
Fundação Oswaldo Cruz. Instituto Oswaldo Cruz. Laboratório de Flavivírus. Rio de Janeiro, RJ, Brasil.
Universidade Estácio de Sá. Rio de Janeiro, RJ, Brasil.
Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Laboratório de Epidemiologia Clínica. Rio de Janeiro, RJ, Brasil.
Abstract
Background: Although performance of rapid immunochromatographic tests (RITs) for dengue virus (DENV) serotypes 1, 2 and 3 is relatively settled, evidence on accuracy of RITs for DENV-4 are based on studies with small sample sizes and with discrepant results. Objectives: To assess accuracy and inter-observer agreement of RITs targeting dengue nonstructural protein-1 (NS1) antigen - Dengue NS1-BioeasyTM, Dengue NS1 Ag Strip-Bio-RadTM, IVB Dengue Ag NS1-OrangelifeTM and Dengue NS1-K130-BioclinTM in DENV-4 samples. Methods: Study sample (n= 324) included adults presenting at an emergency unit in Rio de Janeiro, Brazil, with fever of ≤72h and two or more dengue symptoms. A serum sample from each patient was tested by each RIT. A positive reverse-transcription polymerase chain reaction was considered as the reference standard for dengue diagnosis. The diagnostic parameters analyzed for each RIT were sensitivity, specificity, positive and negative predictive values, and likelihood ratios. Each RIT was read by homogeneous (two junior nurses) or heterogeneous (one junior nurse and one senior biologist) pairs. Agreement was estimated by simple kappa with 95% confidence interval, positive (Ppos) and negative (Pneg) proportion concordance and prevalence and bias adjusted kappa, rated from poor (k < 0.0) to almost perfect (0.8 < k < 1.0), and perfect (k = 1). Results: NS1 RITs for DENV-4 diagnosis showed high specificity (95.9%–99.4%), but low sensitivity (14.7%–45.4%). BioeasyTM had the best performance, with a positive likelihood ratio of 26.0 (95% CI: 8.4;81.0). Inter-observer agreement was almost perfect for all evaluated RITs. Mismatches in confirmed dengue were more common for the BioclinTM (Ppos 88.3–90.0 %) and OrangelifeTM (Ppos 91.7–94.1 %) tests.
Keywords
DengueDiagnosis
Immunochromatographic tests
Reproducibility of tests
Sensitivity and specificity
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