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Journal of Clinical Microbiology, August 2003, p. 3487-3493, Vol. 41, No. 8
0095-1137/03/$08.00+0     DOI: 10.1128/JCM.41.8.3487-3493.2003
Copyright © 2003, American Society for Microbiology. All Rights Reserved.

Comparison of the Directigen Flu A+B Test, the QuickVue Influenza Test, and Clinical Case Definition to Viral Culture and Reverse Transcription-PCR for Rapid Diagnosis of Influenza Virus Infection

Annie Ruest, Sophie Michaud,* Sylvie Deslandes, and Eric H. Frost

Department of Microbiology and Infectious Diseases, Faculté de Médecine de l'Université de Sherbrooke, Sherbrooke, Québec, Canada

Received 23 October 2002/ Returned for modification 30 December 2002/ Accepted 12 May 2003

The diagnostic performances of the clinical case definition of influenza virus infection based on the combination of fever and cough and of two rapid influenza diagnostic tests, the Directigen Flu A+B test (Directigen; BD Diagnostic Systems, Sparks, Md.) and the QuickVue influenza test (QuickVue; Quidel, San Diego, Calif.), were compared to those of viral culture and an in-house reverse transcription (RT)-PCR during the 2000-2001 flu season. Two hundred consecutive nasopharyngeal aspirates were analyzed from 192 patients, including 122 adults and 70 children. Viral culture identified influenza virus A in 16 samples and influenza virus B in 55 samples, whereas RT-PCR identified influenza virus A in 21 samples and influenza virus B in 64 samples. When RT-PCR was used as the reference standard, the likelihood ratios for a positive test were 40.0 for Directigen, 8.6 for QuickVue, and 1.4 for the combination of fever and cough, whereas the likelihood ratios for a negative test were 0.22, 0.16, and 0.48, respectively. Our study suggests that (i) the poor specificity (35 to 58%) and the poor positive predictive value (41 to 60%) of the clinical case definition of influenza preclude its use for prediction of influenza virus infections during epidemics, especially when infection control decision making in the hospital setting is considered; (ii) Directigen has a higher diagnostic yield than QuickVue but is associated with a larger number of invalid results; (iii) the sensitivities of the rapid diagnostic tests are significantly lower with samples from adults than with samples from children, with the rates of false-negative results reaching up to 29%; and (iv) RT-PCR detects more cases of influenza than viral culture, and this greater accuracy makes it a more useful reference standard.

* Corresponding author. Mailing address: Department of Microbiology and Infectious Diseases, Faculté de Médecine de l'Université de Sherbrooke, 3001, 12e avenue Nord, Sherbrooke, Québec J1H 5N4, Canada. Phone: (819) 564-5321. Fax: (819) 564-5392. E-mail: Sophie.Michaud{at}USherbrooke.ca.

Journal of Clinical Microbiology, August 2003, p. 3487-3493, Vol. 41, No. 8
0095-1137/03/$08.00+0     DOI: 10.1128/JCM.41.8.3487-3493.2003
Copyright © 2003, American Society for Microbiology. All Rights Reserved.



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