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Clinical evaluation of rapid point-of-care testing for detection of novel influenza A (H1N1) virus in a population-based study in Spain

tetano

Editor, Senior Moderator
Clin Microbiol Infect. 2010 Sep;16(9):1358-61. doi: 10.1111/j.1469-0691.2010.03159.x. Epub 2010 Feb 16.
Clinical evaluation of rapid point-of-care testing for detection of novel influenza A (H1N1) virus in a population-based study in Spain.

Ortiz de la Tabla V, Antequera P, Masi? M, Ros P, Martin C, Gazquez G, Bu?uel F, S?nchez V, Robledano C, Guti?rrez F.

)  Microbiology Service, Hospital Universitario de San Juan ) Infectious Diseases Unit, Hospital General Universitario de Elche ) Department of Clinical Medicine, University Miguel Hern?ndez, Alicante, Spain.
Abstract

Clin Microbiol Infect 2010; 16: 1358-1361 ABSTRACT: Limited information exists on the performance of antigen-based rapid influenza diagnostic tests (RIDT) in diagnosing the novel influenza A pandemic (H1N1) 2009 virus. Large studies evaluating these tests in consecutive patients with a broad clinical spectrum of influenza-like illnesses are needed. We assessed the ClearView? Exact Influenza A & B test (Inverness Medical, Cologne, Germany) in comparison with real-time (r)RT-PCR for detection of the novel influenza A (H1N1) in a population-based prospective study of 1016 adults and children with suspected influenza in Spain. Three hundred and one (29.6%) patients had a positive sample with the rRT-PCR assay for influenza A and B viruses, with 297 (29.2%) confirmed cases of the novel influenza A pandemic (H1N1) 2009 virus. Fifty (16.8%) patients with confirmed A (H1N1) 2009 virus were admitted to hospital, with six of them to the intensive care unit. In comparison with rRT-PCR, the ClearView? Exact Influenza A & B test had a sensitivity of 19% (95% CI 14-23), a specificity of 100%, a positive predictive value of 100%, and a negative predictive value of 75% (95% CI 72-78). The sensitivity of the test remained low across all demographic and clinical strata. Although a positive RIDT performed well in predicting PCR-confirmed infection with pandemic H1N1 virus, the sensitivity was very low and a negative test result was a poor predictor of the absence of infection.
? 2010 The Authors. Journal Compilation ? 2010 European Society of Clinical Microbiology and Infectious Diseases.

PMID: 21382125 [PubMed - in process]

http://www.ncbi.nlm.nih.gov/pubmed/21382125
 
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