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A prospective study to assess the diagnostic performance of the Sofia? Immunoassay for Influenza and RSV detection

tetano

Editor, Senior Moderator
J Clin Virol. 2016 Feb 4;77:1-4. doi: 10.1016/j.jcv.2016.01.018. [Epub ahead of print]
[h=1]A prospective study to assess the diagnostic performance of the Sofia? Immunoassay for Influenza and RSV detection.[/h] Gomez S[SUP]1[/SUP], Prieto C[SUP]2[/SUP], Folgueira L[SUP]2[/SUP].
[h=3]Author information[/h]

[h=3]Abstract[/h] [h=4]BACKGROUND:[/h] 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.
[h=4]OBJECTIVES:[/h] Sensitivity, specificity and positive and negative predictive values of the assays were calculated compared with the reference diagnostic method: real-time RT-PCR.
[h=4]STUDY DESIGN:[/h] 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.
[h=4]RESULTS:[/h] 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.
[h=4]CONCLUSIONS:[/h] 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.
Copyright ? 2016 Elsevier B.V. All rights reserved.


PMID: 26872325 [PubMed - as supplied by publisher]
 
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