Roche secures CE mark for acute dengue virus infection diagnostic test

Studies showed that the assay demonstrated a 94.90% sensitivity in polymerase chain reaction-confirmed positive samples.

Roche has obtained CE mark approval for its fully automated immunoassay, Elecsys Dengue Ag test, intended for diagnosing acute infection.

The assay detects the virus’ non-structural protein 1 (NS1) antigen in human serum and plasma, a key indicator of acute infection in the initial days of illness.

According to Roche, the test identifies this antigen across all four serotypes of dengue virus, DENV-1, DENV-2, DENV-3 and DENV-4.

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