The symptoms of dengue aren't unique, so doctors often struggle to distinguish it from other fever-causing illnesses, such as chikungunya or yellow fever. This is why early and accurate diagnosis is critical so that patients can be managed in a timely manner to prevent severe complications.
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-4.4 In clinical studies, it demonstrated 94.90% (CI: 91.44–97.26%) sensitivity in PCR-confirmed positive samples and 99.96% (CI: 99.79–100%) relative specificity in a large cohort of healthy blood donors.
“Dengue’s rapid worldwide spread has elevated it to a serious global burden, placing a significant strain on healthcare resources,” said Matt Sause, CEO of Roche Diagnostics. “Roche is committed to supporting the global response to the rise of infectious diseases such as dengue. With our novel Elecsys Dengue antigen test, we enable healthcare systems to diagnose dengue more reliably and efficiently.”
Recognising the value of diagnostics, the World Health Organization (WHO) has developed an “Essential Diagnostics List” which includes in-vitro diagnostic solutions that should be accessible to all countries to increase timely and life-saving diagnoses. Dengue virus NS1 antigen, along with other biomarkers, is included in the WHO essential IVD list.
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