Performance Evaluation of a Novel Rapid Influenza Test

Influenza is an annually occurred infectious disease, causing severe infection and death among humans. Rapid influenza diagnostic tests (RIDTs) can facilitate appropriate prescription of antivirals for influenza treatment, reduce the need for unnecessary testing and allow the implementation of infection control measures. In this study, a novel Sofia influenza A+B fluorescent immunoassay (FIA) was evaluated for its detection ability for both influenza A and B viruses and compare with real-time RT-PCR assay. A total of 73 throat swab specimens were tested; the results showed that Sofia FIA exhibits detection sensitivity of 68.2% and 45.5% for influenza A and B viruses, respectively, comparing with real-time RT-PCR. If Cp (cycle of crossing point) value of real-time RT-PCR was set lower than 30, the sensitivity for influenza A and B viruses reached to 85% and 69% by Sofia kit. Moreover, the evaluated specificity of Sofia FIA was 100%. These results indicate that this novel RIDT has greater detection ability toward influenza A than influenza B viruses and the entire performance is better than traditional RIDTs, highlighting the future applications for clinical diagnosis and control of influenza.