Roche’s test is part of Elecsys Dengue Panel. Credit: testing / Shutterstock.com.

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.

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

It is designed to work on the company’s fully automated cobas e 402 platforms and cobas e 801 systems.

Roche’s cobas and Elecsys instruments are said to enhance lab workflow, cut down on manual tasks and reduce the risk of human error.

Studies showed that the assay demonstrated a sensitivity of 94.90% in polymerase chain reaction (PCR)-confirmed positive samples and a relative specificity of 99.96% in a healthy blood donor cohort.

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The test is part of Elecsys Dengue Panel that includes Elecsys Dengue IgM and Elecsys Dengue IgG assays, due to be launched subsequently.

The panel combines NS1 detection for acute cases, IgM to indicate recent infection and IgG to show past exposure or immunity, enabling clinicians to assess dengue across its stages.

Roche Diagnostics CEO Matt Sause said: “Dengue’s rapid worldwide spread has elevated it to a serious global burden, placing a significant strain on healthcare resources.

“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.”

Earlier in the month, Roche and KlinRisk secured CE mark for an AI-based risk stratification tool for assessing the progression of kidney function decline.

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