Combined Analytical and Clinical Performance Evaluation of a Novel Dengue NS1 Rapid Test in a Real-World Endemic Setting.

ABSTRACT: Objectives: This study evaluated the analytical and clinical performance of a novel NS1 rapid diagnostic test in a dengue-endemic setting in Thailand. Methods: The K-Dengue NS1 Ag test (K.Bio Sciences, Pathumthani, Thailand) was developed. Analytical performance included determination of LOD, reproducibility, and evaluation against potentially cross-reactive pathogens and interfering substances. Unlike conventional assays employing 40 nm colloidal gold, this test incorporates 80 nm gold nanospheres to enhance detection sensitivity. The LOD was determined by serial dilution of recombinant NS1 proteins representing all four dengue virus serotypes. Clinical performance was assessed using 185 archived plasma samples collected between January 2024 and February 2025 from two tertia

SUBMITTER: Szekely J 

PROVIDER: S-EPMC12896629 | biostudies-literature | 2026 Jan

REPOSITORIES: biostudies-literature