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

Clin Microbiol Infect. 2010 Sep;16(9):1358-61. doi: 10.1111/j.1469-0691.2010.03159.x. Epub 2010 Feb 16.


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.

Publication types

  • Comparative Study
  • Evaluation Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Antigens, Viral / blood*
  • Child
  • Child, Preschool
  • Clinical Laboratory Techniques / methods*
  • Female
  • Humans
  • Immunoassay
  • Infant
  • Influenza A Virus, H1N1 Subtype / isolation & purification*
  • Influenza, Human / diagnosis*
  • Influenza, Human / virology*
  • Male
  • Middle Aged
  • Point-of-Care Systems*
  • Sensitivity and Specificity
  • Spain
  • Virology / methods*
  • Young Adult


  • Antigens, Viral