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A prospective study to assess the diagnostic performance of the Sofia(®) Immunoassay for Influenza and RSV detection. [artículo]

Por: Gómez, Sara [Microbiología y Parasitología] | Prieto, Columbiana [Instituto de Investigación imas12] | Folgueira López, María Dolores [Microbiología y Parasitología].
Colaborador(es): Servicio de Microbiología y Parasitología.
Tipo de material: materialTypeLabelArtículoEditor: Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology, 2016Descripción: 77:1-4.Recursos en línea: Solicitar documento Resumen: Background: Respiratory viruses RSV and influenza A and B viruses are responsible for important disease outbreaks during the winter season in temperate climate regions. Rapid diagnostic tests (RDTs) are assays designed to yield a rapid diagnosis, which facilitates patient management. The Sofia Influenza A+B Fluorescence Immunoassay and Sofia RSV Fluorescence Immunoassay are RDTs for Influenza and RSV detection that employ a new technology to enhance their sensitivity. Objectives: Sensitivity, specificity and positive and negative predictive values of the assays were calculated compared with the reference diagnostic method: real-time RT-PCR. Study design: A prospective evaluation was carried out on 1065 respiratory samples for Sofia Influenza A+B FIA and on 261 samples for Sofia RSV FIA from November 2013 to April 2014. Results: The sensitivities of the Sofia Influenza A+B FIA for influenza A and influenza B detection were, respectively, 75.3% (244/324) and 50.0% (8/16). The sensitivity of the Sofia RSV FIA was 92.1% (128/139). There were no differences in Sofia FIA performance depending on the virus subtype. Conclusions: The results showed high sensitivity and specificity values for influenza A and RSV detection, but values were lower for influenza B. More information is needed regarding the performance for influenza B given the small number of positive samples assessed.
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Formato Vancouver:
Gomez S, Prieto C, Folgueira L. A prospective study to assess the diagnostic performance of the Sofia(®) Immunoassay for Influenza and RSV detection. J Clin Virol. 2016 Apr;77:1-4.

PMID: 26872325

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Background: Respiratory viruses RSV and influenza A and B viruses are responsible for important disease outbreaks during the winter season in temperate climate regions. Rapid diagnostic tests (RDTs) are assays designed to yield a rapid diagnosis, which facilitates patient management. The Sofia Influenza A+B Fluorescence Immunoassay and Sofia RSV Fluorescence Immunoassay are RDTs for Influenza and RSV detection that employ a new technology to enhance their sensitivity.
Objectives: Sensitivity, specificity and positive and negative predictive values of the assays were calculated compared with the reference diagnostic method: real-time RT-PCR.
Study design: A prospective evaluation was carried out on 1065 respiratory samples for Sofia Influenza A+B FIA and on 261 samples for Sofia RSV FIA from November 2013 to April 2014.
Results: The sensitivities of the Sofia Influenza A+B FIA for influenza A and influenza B detection were, respectively, 75.3% (244/324) and 50.0% (8/16). The sensitivity of the Sofia RSV FIA was 92.1% (128/139). There were no differences in Sofia FIA performance depending on the virus subtype.
Conclusions: The results showed high sensitivity and specificity values for influenza A and RSV detection, but values were lower for influenza B. More information is needed regarding the performance for influenza B given the small number of positive samples assessed.

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