PERFORMANCE VERIFICATION OF STANDARD™ F IgM/IgG DENGUE FIA KIT IN THE SEROLOGICAL DIAGNOSIS OF DENGUE FEVER

Tóm tắt

Serological testing plays a crucial role in the diagnosis of dengue fever. The STANDARD™ F IgM/IgG Dengue FIA kit, based on fluorescent immunoassay technology, simultaneously detects anti-Dengue IgM and IgG antibodies in serum or plasma with high performance and accuracy. This study was conducted to confirm the performance of the STANDARD™ F IgM/IgG Dengue FIA kit prior to its use in dengue diagnosis. We evaluated the main performance parameters, including sensitivity, specificity, and accuracy of the kit. Laboratory testing was performed on 200 serum samples collected from day 2 to day 10 after fever onset (50 IgM-positive, 50 IgM-negative; 50 IgG-positive, 50 IgG-negative). All samples were screened  by rapid test and confirmed ELISA assay. Compared with ELISA, our study results showed a sensitivity of 90% for IgM and 94% for IgG, and a specificity of 100% for both antibodies, with a positive predictive value (PPV) of 100% for FIA assay. The COI values of FIA showed a moderate positive correlation with ELISA OD in IgM samples (r = 0.44; p = 0.0012) and a weak correlation in IgG samples (r = 0.28; p = 0.049). The kit demonstrated high precision with CV ≤ 20% across different antibody concentration levels and 100% categorical agreement. The STANDARD™ F IgM/IgG Dengue FIA kit provides accurate, reliable, and stable results, making it suitable for serological diagnosis of dengue fever in healthcare facilities in Vietnam.