Diagnostic parameters and reliability of four rapid immunochromatographic tests for dengue 4.

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Tytuł:: Diagnostic parameters and reliability of four rapid immunochromatographic tests for dengue 4.
Autorzy:: Mata VE; Oswaldo Cruz Foundation, Evandro Chagas National Institute of Infectious Diseases, Laboratory of Clinical Epidemiology, Rio de Janeiro, RJ, Brazil.
Passos SRL; Oswaldo Cruz Foundation, Evandro Chagas National Institute of Infectious Diseases, Laboratory of Clinical Epidemiology, Rio de Janeiro, RJ, Brazil. Electronic address: .
Santos MABD; Oswaldo Cruz Foundation, National School of Public Health (ENSP), Rio de Janeiro, RJ, Brazil.
Buonora SN; Oswaldo Cruz Foundation, Evandro Chagas National Institute of Infectious Diseases, Laboratory of Clinical Epidemiology, Rio de Janeiro, RJ, Brazil.
de Andrade CAF; Universidade Estácio de Sá, Rio de Janeiro, RJ, Brazil.
Lima MDRQ; Oswaldo Cruz Foundation, Oswaldo Cruz Institute, Laboratory of Flavivirus, Rio de Janeiro, RJ, Brazil.
Costa BM; Universidade Estácio de Sá, Rio de Janeiro, RJ, Brazil.
Hökerberg YHM; Oswaldo Cruz Foundation, Evandro Chagas National Institute of Infectious Diseases, Laboratory of Clinical Epidemiology, Rio de Janeiro, RJ, Brazil.
Źródło:: The Brazilian journal of infectious diseases : an official publication of the Brazilian Society of Infectious Diseases [Braz J Infect Dis] 2020 Jan - Feb; Vol. 24 (1), pp. 58-64. Date of Electronic Publication: 2020 Jan 16.
Typ publikacji:: Journal Article
Język:: English
Imprint Name(s):: Publication: 2010- : Rio de Janeiro : Elsevier Editora
Original Publication: Salvador, Bahia, Brazil : Contexto, c1997-
MeSH Terms:: Chromatography, Affinity/*standards
Dengue/*diagnosis
Dengue Virus/*isolation & purification
Adult ; Brazil ; Chromatography, Affinity/methods ; Cross-Sectional Studies ; Dengue/immunology ; Dengue/virology ; Enzyme-Linked Immunosorbent Assay ; Female ; Humans ; Male ; Middle Aged ; Observer Variation ; Prospective Studies ; Reference Standards ; Reproducibility of Results ; Reverse Transcriptase Polymerase Chain Reaction ; Sensitivity and Specificity ; Serogroup
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Contributed Indexing:: Keywords: Dengue; Diagnosis; Immunochromatographic tests; Reproducibility of tests; Sensitivity and specificity
Entry Date(s):: Date Created: 20200120 Date Completed: 20200410 Latest Revision: 20220824
Update Code:: 20240104
PubMed Central ID:: PMC9392029
DOI:: 10.1016/j.bjid.2019.12.004
PMID:: 31954721
: Czasopismo naukowe

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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-Bioeasy™, Dengue NS1 Ag Strip-Bio-Rad™, IVB Dengue Ag NS1-Orangelife™ and Dengue NS1-K130-Bioclin™ in DENV-4 samples.
Methods: Study sample (n = 324) included adults presenting at an emergency unit in Rio de Janeiro, Brazil, with fever of ≤72 h 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%). Bioeasy™ 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 Bioclin™ (Ppos 88.3-90.0 %) and Orangelife™ (Ppos 91.7-94.1 %) tests.
Conclusions: For DENV-4, the tested RITs had high specificity, but lower sensitivity compared to published results for other serotypes. They should not be used for screening purposes. Different brands may have very different performances. This should be considered upon deciding of using RITs in DENV-4 outbreaks.
(Copyright © 2020 Sociedade Brasileira de Infectologia. Published by Elsevier España, S.L.U. All rights reserved.)

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