Dublin-based HiberGene Diagnostics has successfully completed the CE marking of a new Covid-19 test. It follows a clinical evaluation study at the Mater Private Hospital in Dublin, that demonstrated the efficacy of the test.
The CE mark signifies that products sold in the European Economic Area have been assessed to meet high safety, health, and environmental protection requirements.
The new Covid-19 test uses HiberGene's proprietary molecular reagent format to accurately detect the virus in nose and throat swabs, with the company's small, portable HG Swift instrument to test four samples concurrently.
Positive results are returned within 30 minutes on average, enabling rapid diagnosis of the disease at the early and highly infectious