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J Clin Microbiol. Field Performance of an Influenza Rapid Diagnostic Test in an Ambulatory Setting.

Giuseppe

Emeritus
J Clin Microbiol. 2009 Jul 8. [Epub ahead of print]

Field Performance of an Influenza Rapid Diagnostic Test in an Ambulatory Setting.


Rouleau I, Charest H, Douville-Fradet M, Skowronski DM, De Serres G. Unit? de recherche en sant? publique, Centre de recherche du CHUL, Universit? Laval, Qu?bec, Canada; Institut national de sant? publique du Qu?bec (INSPQ), Qu?bec, Canada; British Columbia Center for Disease Control, Vancouver, British Columbia, Canada.

Background:
Provided adequate test characteristics, point of care rapid antigen detection tests for influenza could improve the timeliness and appropriateness of clinical decisions. Our objective was to estimate the field sensitivity and specificity of the Quidel QuickVue Influenza A+B Test(TM) in an ambulatory setting.

Methods:
The sensitivity and specificity of the Quidel QuickVue was evaluated against reverse-transcriptase polymerase chain reaction (RT-PCR) on nasopharyngeal specimens collected over two consecutive influenza seasons from ambulatory patients consulting for influenza-like illness within 7 days of ILI onset.

Results:
A total of 491 patients (180 in 2006-2007 and 311 in 2007-2008) with ILI provided specimens tested both with PCR and the Quidel QuickVue. Among the 267 patients positive by PCR (55%), 52 were also positive by QuickVue for an overall sensitivity of 19.5% (CI 95% 14.7%-24.2%). Among the 221 PCR-negative patients, 2 were positive for Influenza B by the rapid test (< 1%), for an overall specificity of 99.1% (CI 95% 97.9-100%). The field sensitivity of the test varied little with the age or gender of the patient, immunization status, delay since onset of symptoms or with influenza season. The sensitivity was slightly but non-significantly higher for influenza B (23%) versus influenza A (18%).

Conclusion:
Despite its high specificity, the low sensitivity of the Quidel QuickVue Influenza A+B Test(TM) is too poor to direct clinical decisions among ambulatory patients with ILI. Negative results cannot rule out the diagnosis of influenza, and in that context, this test is of questionable utility for routine application in the clinical setting.

PMID: 19587306 [PubMed - as supplied by publisher]
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