ESTABLISHMENT OF STANDARDIZED IgM AND IgG ANTIBODY REFERENCE PANELS FOR QUALITY EVALUATION OF SEROLOGICAL DENGUE IN VITRO DIAGNOSTIC DEVICES

Abstract

Dengue fever is a major infectious disease caused by the Dengue virus. Accurate diagnostic devices play a critical role in supporting the definitive diagnosis of Dengue patients for early and timely treatment. This study was conducted to establish Dengue virus-specific IgM and IgG antibody reference panels for the quality assessment of in vitro diagnostic (IVD) medical devices. The study utilized positive and negative IgM/IgG serum samples collected at Hanoi Medical University Hospital from April 2024 to May 2025. All samples were processed and strictly stored at -70°C. Sample characteristics were determined using three methods: ELISA (Diapro - Italy), rapid immunochromatography (SD Biosensor - South Korea), and fluorescence immunoassay (FIA) (SD Biosensor - South Korea). The study successfully established four reference panels: Dengue IgM positive/negative and Dengue IgG positive/negative panels, each consisting of 50 members. Characteristics were confirmed using ELISA as the reference method. Stability testing demonstrated that the panels, stored at -70°C, remained stable after six freeze-thaw cycles. The established reference panels meet the technical requirements for pre-market and post-market quality control of Dengue diagnostic devices.