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Diagnostic performance of the Sofia? influenza A + B fluorescent immunoassay in adult outpatients in Northern Taiwan

tetano

Editor, Senior Moderator
J Med Virol. 2018 Feb 9. doi: 10.1002/jmv.25043. [Epub ahead of print]
[h=1]Diagnostic performance of the Sofia? influenza A + B fluorescent immunoassay in adult outpatients in Northern Taiwan.[/h] Yang JH[SUP]1[/SUP], Huang PY[SUP]1[/SUP], Shie SS[SUP]1[/SUP], Yang S[SUP]2[/SUP], Tsao KC[SUP]2[/SUP], Wu TL[SUP]2[/SUP], Wu TS[SUP]1[/SUP], Huang CT[SUP]1[/SUP].
[h=3]Author information[/h]

[h=3]Abstract[/h] To evaluate the diagnostic performance of the Sofia influenza A + B fluorescent immunoassay (Sofia FIA), we performed a prospective study at the Chang Gung Memorial Hospital in Taiwan from January 2012 to December 2013. Patients who presented at out-patient clinics or the emergency department with influenza-like illness were included. Upper respiratory tract specimens were collected from oropharynx or nasopharynx. Performance of the Sofia FIA was compared to that of the Formosa One Sure Flu A/B Rapid Test. A real-time reverse transcriptase-polymerase chain reaction assay (RT-PCR) and/or virus culture were used as reference standards. Of the 109 enrolled patients, the sensitivity, specificity, positive, and negative predictive values of the Sofia FIA to detect influenza A virus were 82%, 89%, 77%, and 89%, respectively. These parameters were 100% when the samples were from nasopharynx. The positive predictive value for influenza B virus detection was 29%. The sensitivity of the Sofia FIA for detection of influenza A virus was 93% between days two and four after onset of symptoms. For specimens with low viral loads (RT-PCR cycle threshold between 30 and 34.9), the sensitivity of The Sofia FIA was 83% (10/12). The Sofia FIA performed effectively in detecting influenza A virus infection. With nasopharyngeal samples, the performance was comparable to RT-PCR. Although influenza viral load typically decreases with time, the Sofia FIA was sensitive enough to identify influenza infecting patients presenting after several days of illness. However, a high false positive rate limits the assay's usefulness to identify influenza B virus infection. This article is protected by copyright. All rights reserved.


[h=4]KEYWORDS:[/h] Influenza virus infection; diagnostic accuracy; influenza-like illness; point-of-care tests; sensitivity and specificity

PMID: 29424435 DOI: 10.1002/jmv.25043
 
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