Development and evaluation of a rapid influenza diagnostic test for the pandemic (H1N1) 2009 influenza virus

We evaluated a new rapid influenza diagnostic test for the pandemic (H1N1) 2009 influenza virus by using real-time reverse transcription-PCR (rRT-PCR) and viral culture. The sensitivities were 68.5 % and 64.5%, and the specificities were 98.4 % and 97.6%, respectively. This kit should be used with caution, and negative results should be verified by a confirmative test. In April 2009, a mixed-origin H1N1 influenza virus was recognized as a causative agent of influenza-like illnesses (ILI) in humans. Since its emergence, the virus has spread rapidly throughout the world, causing a pandemic. Most commercial rapid influenza diagnostic tests (RIDTs) can detect only the influenza virus or can distinguish influenza A and B but cannot distinguish the pandemic (H1N1) 2009 influenza virus from seasonal influenza. Recent studies have indicated that the poor performance of the RIDT approach and nonspecific detection of the pandemic (H1N1) 2009 virus were the main obstacles to their widespread use in privat