• Chang Kyu Lee, Chi Hyun Cho, Mi Kyung Woo, Agnes E Nyeck, Chae Seung Lim, and Woo Joo Kim.
• Department of Laboratory Medicine, Brain Korea 21 Graduate School of Medicine, College of Medicine, Korea University, Seoul, Republic of Korea. cklee@korea.ac.kr
• J. Clin. Virol. 2012 Nov 1; 55 (3): 239-43.

BackgroundThe influenza virus causes seasonal epidemics which are associated with high morbidity and mortality. Rapid diagnostics tests (RDT) are frequently used to make a quick influenza diagnosis to confirm the clinical suspicion, despite their low sensitivity.ObjectivesAssess the performance of the Sofia Influenza A+B Fluorescence Immunoassay (Quidel, San Diego, CA).Study DesignNasopharyngeal swabs, taken from 241 patients (influenza A (n=73)/B (n=72), negative samples (n=96)) were analyzed using the Sofia Influenza A+B Fluorescence Immunoassay, BinaxNOW Influenza A/B antigen kit (Alere Inc., USA), Directigen EZ Flu A and B (Becton Dickinson, USA), real-time RT-PCR and an influenza virus culture.ResultsThere was a significant difference between the performance of rapid antigen tests and the Sofia FIA, when compared to the RT-PCR, in the detection of influenza strain A and B. Indeed, the Sofia FIA displayed sensitivities of 82.2% and 77.8% for strains A and B respectively, whereas sensitivities of BinaxNOW Influenza A/B antigen kit, and Directigen Flu A and B were 54.8%, and 68.5% for influenza A, and 62.5%, and 52.8% for influenza B respectively. The average RT-PCR threshold cycle (C(t)) (±SD) for the Sofia Influenza A+B Fluorescence Immunoassay-positive specimens was higher than those of the BinaxNOW Influenza A/B antigen and the Directigen EZ Flu A and B kit positive specimens.ConclusionCompared to other RDTs, the Sofia Influenza A+B Fluorescence Immunoassay is a sensitive, and rapid method for the detection and discrimination between influenza A and B.Copyright © 2012 Elsevier B.V. All rights reserved.

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