Evaluation of new hemagglutinin-based rapid antigen test for influenza A pandemic (H1N1) 2009

Background: A new rapid antigen test (RAT), based on hemagglutinin, was developed for the improvement of influenza A pandemic (H1N1) 2009 detection. Objective: To evaluate the performance of the new RAT for the diagnosis of influenza A pandemic (H1N1) 2009. Study design: The new RAT included 2009 H1N1 hemagglutinin-based band and influenza A and influenza B nucleoprotein-based bands. During the period from November 24, 2009 to December 14, 2009, 948 patients underwent the new RAT and real-time reverse transcriptase polymerase chain reaction (rRT-PCR) at the same time. The result of the new RAT was compared with that of rRT-PCR, and the results of hemagglutinin-based and nucleoprotein-based antigen tests were compared. Result: Among the 260 patients confirmed by rRT-PCR, 153 (58.8%) were positive in the nucleoprotein-based antigen test, and 182 (70.0%) were positive in the hemagglutinin-based antigen test. These results show that the new hemagglutinin-based antigen test was more sensitive than the nucleoprotein-based antigen test for the detection of influenza A pandemic (H1N1) 2009 (p< 0.001, the McNemar test). Conclusion: The new hemagglutinin-based antigen test improved the sensitivity of diagnosis for influenza A pandemic (H1N1) 2009 and it might be helpful for the diagnosis of influenza A pandemic (H1N1) 2009.