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Journal of Clinical Microbiology, May 2002, p. 1675-1680, Vol. 40, No. 5
0095-1137/02/$04.00+0     DOI: 10.1128/JCM.40.5.1675-1680.2002
Copyright © 2002, American Society for Microbiology. All Rights Reserved.

Evaluation of the Directigen FluA+B Test for Rapid Diagnosis of Influenza Virus Type A and B Infections

K. H. Chan,1 N. Maldeis,2 W. Pope,2 A. Yup,2 A. Ozinskas,2 J. Gill,2 W. H. Seto,1 K. F. Shortridge,1 and J. S. M. Peiris1*

Department of Microbiology, The University of Hong Kong and Queen Mary Hospital, Pokfulam, Hong Kong, Special Administrative Region,1 BD Diagnostic Systems, Sparks, Maryland2

Received 2 July 2001/ Returned for modification 19 January 2002/ Accepted 23 February 2002

Directigen FluA+B (BD Diagnostic Systems, Sparks, Md.), a new rapid test for the detection of influenza virus types A and B, was evaluated with nasopharyngeal aspirate specimens collected from 250 patients in comparison with culture and direct fluorescent antigen (DFA) detection tests. The patients studied were predominantly children, 80% being <=6 years old. Specimens negative by culture but positive by the Directigen FluA+B or DFA tests were analyzed by reverse transcription-PCR to resolve the discrepant results. The resolved sensitivity, specificity, and positive and negative predictive values of the Directigen FluA+B test for influenza virus type A were 96%, 99.6%, 96%, and 99.6%, respectively, and for influenza virus type B they were 87.5%, 96.8%, 80%, and 98%, respectively. Storage of nasopharyngeal aspirates in virus transport medium at 2 to 8°C for 48 h had little adverse effect on the detection of influenza virus type A, but diagnosis of influenza virus type B is best carried out with fresh specimens. The test detected a range of human and animal influenza virus A subtypes, including the H5N1 and H9N2 viruses that recently caused human disease in Hong Kong.

* Corresponding author. Mailing address: Department of Microbiology, University Pathology Building, Queen Mary Hospital, Pokfulam, Hong Kong, SAR. Phone: (852) 2855-4888. Fax: (852) 2855-1241. E-mail: malik{at}hkucc.hku.hk.

Journal of Clinical Microbiology, May 2002, p. 1675-1680, Vol. 40, No. 5
0095-1137/02/$04.00+0     DOI: 10.1128/JCM.40.5.1675-1680.2002
Copyright © 2002, American Society for Microbiology. All Rights Reserved.



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