SOUTH SAN FRANCISCO (dpa-AFX) - Roche Holding AG (RO, ROG, RHHBY) on Wednesday announced that it has received CE mark for its Elecsys Dengue Ag test - a high-throughput, fully automated immunoassay to be used as an aid in the diagnosis of an acute dengue virus infection.
The Elecsys Dengue Ag is an in-vitro diagnostic immunoassay for the qualitative detection of the NS1 antigen of the dengue virus in human serum and plasma, a key marker of acute infection during the first days of illness.
It is intended for use on Roche's fully automated cobas e immunoassay analysers: cobas e 801 systems and cobas e 402 platforms - a widely used platform with an extensive installed base in laboratories worldwide.
The test has been shown to reliably detect NS1 antigen for all four dengue virus serotypes - DENV-1, DENV-2, DENV-3, and DENV-4.
In clinical studies, it demonstrated 94.90 percent sensitivity in PCR-confirmed positive samples and 99.96 percent relative specificity in a large cohort of healthy blood donors.
The Elecsys Dengue Ag test is expected to provide reliable and fast results, enhanced efficiency and traceability as well as a comprehensive response across the entire patient journey.
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