REF:

C3105 (Cassette)

INTENDED PURPOSE:

NOVA test® Dengue NS-1 Antigen Test is an immunoassay that uses double-antibody sandwich method for qualitative detection of dengue virus NS-1 antigen in human serum, plasma and whole blood specimens. It’s used as an aid in the diagnosis of dengue infection. This device is performed manually.

INTENDED USER:

Performance of the test is limited to laboratory professional use.

SUMMARY:

Dengue is a highly endemic infectious disease of the tropical countries. Dengue virus is transmitted within humans through female aedes, 99% of which are caused by just two species, Aedes aegypti and Aedes albopictus. Compared with 2015, dengue cases in the Southeast Asia Region increased by 46% by 2019, i.e. from 451, 442 cases in 2015 to 658, 301 cases in 2019.

DENV has four antigenically distinct serotypes, DENV-1 to DENV-4, with different genotypes and three structural proteins and seven non-structural proteins. Amount of NS-1 antigen is raised quickly during the acute phase of dengue infection, regardless of whether it is a primary or secondary infection. NOVAtest® Dengue NS-1 Antigen Test targets non-structural protein 1 (NS-1) detection and is the main tool used for diagnosis of dengue virus infection.