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 Roche receives CE mark for novel automated high-throughput Elecsys Dengue Ag test to diagnose dengue
 Globenewswire· 2025-10-29 06:00
 Core Insights - Roche has received CE mark for its Elecsys® Dengue Ag test, which is a fully automated immunoassay aimed at diagnosing acute dengue virus infections, setting a new standard for efficiency and reliability in addressing dengue fever [1][3].   Industry Overview - Dengue fever is the most prevalent mosquito-borne viral illness globally, with over 14.6 million cases and more than 12,000 related deaths reported in 2024, marking a historic high [2][11]. - The disease's rapid spread has become a significant global health threat, with half of the world's population now living in areas at risk of infection [2][11].   Product Details - The Elecsys Dengue Ag test detects the NS1 antigen of the dengue virus in human serum and plasma, crucial for early diagnosis during the initial days of illness [4]. - The test has demonstrated 94.90% sensitivity and 99.96% specificity in clinical studies, effectively detecting all four dengue virus serotypes [5].   Key Benefits - The Elecsys Dengue Ag test provides reliable results in just 18 minutes, with a throughput of 120 to 300 tests per hour, enhancing patient management during outbreaks [6][8]. - The automated nature of the test improves laboratory efficiency and reduces the risk of human error, supporting healthcare systems in managing dengue cases [7][8].   Comprehensive Diagnostic Approach - The Elecsys Dengue Panel includes the Elecsys Dengue Ag test, along with IgM and IgG tests, providing a comprehensive diagnostic tool for clinicians to accurately diagnose dengue at various stages of the disease [9].