Performance of Fujifilm Dengue NS1 Antigen Rapid Diagnosis Kit Compared to Quantitative Real-Time Polymerase Chain Reaction

Dengue is a viral infection caused by the dengue virus (DENV), transmitted to humans through the bite of infected <i>Aedes</i> mosquitoes. About half of the world's population is now at risk of dengue, which represents a global public health concern, especially in tropical and subtropical countries. Early detection of the viral infection is crucial to manage the disease; hence, effective rapid diagnostic tests are essential. In this study, we evaluated the performance between the new Fujifilm Dengue non-structural antigen diagnosis kit (FF NS1 kit) and the SD Bioline NS1 antigen test kit (SD NS1 kit) against the quantitative real-time polymerase chain reaction (qRT-PCR) assays. The 140 acute serum samples collected from the Yangon General Hospital and Yangon Children's Hospital, Myanmar, from 2017 to 2019 were characterised by the three assays. With the qRT-PCR as the standard, the FF NS1 kit and the SD NS1 kit exhibited sensitivity of 94.3% and 88.6%, respectively, and specificity of 100% in both kits. Moreover, the positivity rates of the FF NS1 kit and the SD NS1 kit were 97.5% and 95% in primary infection and 90% and 80% in secondary infection, respectively. Our overall results suggest that the FF NS1 kit is reliable and accurate for detecting DENV infection.