Dengue fever test kit LYOFIA®

for antigensclinicalserum

This device is intended to be used for the in vitro qualitative detection of dengue virus antigen in human whole blood, serum or plasma. And it is for professional use only, not for self-testing of untrained individuals, nor for near-patient testing. Summary Dengue is a flavivirus, transmitted by Aedesaegypti and Aedesalbopictus mosquitoes. It is widely distributed throughout the tropical and subtropical areas of the world, and causes up to 100 million infections annually. Classic Dengue infection is characterized by a sudden onset of fever, intense headache, myalgia, arthralgia and rash. NS1 is one of 7 Dengue Virus non-structural proteins which are thought to be involved in viral replication. NS1 exists as a monomer in its immature form but is rapidly processed in the endoplasmic reticulum to form a stable dimer. A small amount of NS1 remains associated with intracellular organelles where it is thought to be involved in viral replication. The rest of NS1 is found either associated with the plasma membrane or secreted as a soluble hexadimer. NS1 is essential for viral viability but its precise biological function is unknown. Antibodies raised in response to NS1 in viral infection can cross react with cell surface antigens on epithelial cells and platelets and this has been implicated in the development of Dengue Hemorrhagic fever. The current clinical methods for detecting Dengue include chemiluminescence, immunochromatography and so on. TEST INFORMATION Reference Negative ≤ 1 Positive > 1 Certificate CE