GENEDIA Multi Influenza Ag Rapid Test for detection and H1, H3, and H5 subtyping of influenza viruses |
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| Institution: | 1. Division of Emergency Medicine, Nationwide Children''s Hospital, Columbus, OH, USA;2. The Medical College of Wisconsin, Milwaukee, WI, USA;3. Indiana University School of Medicine, Indianapolis, IN, USA;4. University of Iowa Hospital and Clinics, Iowa City, ID, USA;5. Ascension Sacred Heart Hospital, Pensacola, FL, USA;6. Cincinnati Children''s Hospital Medical Center, Cincinnati, OH, USA;7. Children''s Mercy Kansas City, Kansas City, MO, USA;8. University of Missouri-Kansas City School of Medicine, University of Kansas School of Medicine, Children''s Mercy Hospital, Kansas City, MO, USA;9. Geisinger, Diagnostic Medicine Institute, Danville, PA, USA;10. Department of Emergency Medicine, Washington University School of Medicine, St. Louis, MO, USA;11. American Family Care, No Resistance Consulting Group, LLC, Birmingham, AL, USA;12. Healthplex Family Clinic, Shreveport, LA, USA;13. Truman Medical Center, University of Missouri-Kansas City School of Medicine, Kansas City, MO, USA;14. Arkansas Children''s Hospital, Little Rock, AR, USA;15. Children''s Hospital of Minnesota, Minneapolis, MN, USA;p. West Virginia School of Medicine, Morgantown, WV, USA;q. Cepheid, Sunnyvale, CA, USA |
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| Abstract: | BackgroundRapid identification and subtype determination of influenza virus is important in managing infected patients. Rapid influenza diagnostic tests (RIDTs) are widely used in this manner, but most can only detect influenza A and B viruses without subtyping. A new RIDT, GENEDIA Multi Influenza Ag Rapid Test (GENEDIA), was developed for detection of influenza A and B viruses and also subtyping of influenza A to H1, H3, H5 which has not been possible with other RIDTs.ObjectivesAssess the performance of GENEDIA.Study designNasopharyngeal swabs were collected from 274 clinically suspected patients (influenza A/H1N1/2009 (n = 50), influenza A/H3 (n = 50), influenza B (n = 73) and influenza-negative (n = 101)) and analyzed with the real-time RT-PCR, GENEDIA, SD Bioline Influenza Ag, and Alere BinaxNow Influenza A&B Card. Also, 46 fecal specimens (H5N2 (n = 3), H5N3 (n = 3)) of spot-billed duck were analyzed with RT-PCR and GENEDIA.ResultsCompared to real-time RT-PCR, the sensitivities of GENEDIA, SD Bioline Influenza Ag, and Alere BinaxNow Influenza A&B Card were 73.0%, 57.0%, 58.0% for influenza A, respectively, and 68.5%, 65.8%, 57.5% for influenza B, respectively. Specifically, the sensitivity of GENEDIA was 70.0% for influenza A/H1N1/2009 and 76.0% for influenza A/H3. From the avian influenza samples, GENEDIA detected all six H5 subtype without any cross-reactions.ConclusionThe GENEDIA Multi Influenza Ag Rapid Test was sensitive in detecting influenza viruses compared with other commercial RIDTs and also useful for rapid subtype determination of influenza A. |
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| Keywords: | Rapid influenza diagnostic test (RIDT) Influenza Subtype H1N1 H3 H5 |
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