Performance Evaluation of the Alere i Influenza A&B Rapid Diagnostic Test, 2016

Abstract

Influenza is an annually occurred infectious disease, causing severe infections and death among human cases. The use of rapid influenza diagnostic tests (RIDTs) facilitates antiviral prescription for influenza treatment, reduces the need for unnecessary antibacterial agents and allows the implementation of infection control measures. In this study, we evaluated a new RIDT, the Alere i Influenza A&B, for its detection ability against both influenza A and B viruses and compared to real-time RT-PCR assay. A total of 112 throat swab specimens were tested. Compared with the results of real-time RT-PCR assay, the Alere i assay exhibited a detection rate of 43.8% for influenza A viruses with cycle of crossing point (Cp) value ranged from 28-35, and 38.5% for B viruses at Cp value of 26-33, respectively. Detailed analysis showed that the assay had better detection ability of 88% toward influenza A viruses when Cp value was in the range of 28-29. In contrast, no significant difference was observed for the detection ability toward influenza B viruses when the Cp value was lower than 33. The evaluated specificity of Alere i Influenza A&B was 100%. These data indicate that this new RIDT provides fairly accurate results against influenza A viruses, highlighting the future applications for clinical diagnosis of influenza infections.