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

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  • Diagnostic performance of the SofiaŽ influenza A + B fluorescent immunoassay in adult outpatients in Northern Taiwan

    J Med Virol. 2018 Feb 9. doi: 10.1002/jmv.25043. [Epub ahead of print]
    Diagnostic performance of the SofiaŽ influenza A + B fluorescent immunoassay in adult outpatients in Northern Taiwan.

    Yang JH1, Huang PY1, Shie SS1, Yang S2, Tsao KC2, Wu TL2, Wu TS1, Huang CT1.
    Author information

    Abstract

    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.


    KEYWORDS:

    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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