The first tests, from an Ireland-based company, will be shipped this week promising positive results within 30 minutes and cutting cost and export of tests for countries around the world.
HiberGene Diagnostics, based in Dublin, has received European Union approval for its COVID-19 test. The test has proven highly accurate, low-cost, and deliverable with 30-minutes. It also avoids sending samples to large specialized laboratories. It delivers results that are 96 to 97.5 percent accurate.
The test underwent evaluation at the Mater Private Hospital, in Dublin, and have no received the CE mark of approval from the European Union. The CE classification signifies that products sold in the European Economic Area have been assessed to meet high safety, health, and environmental protection requirements.
The new HiberGene Diagnostics coronavirus text uses the company's proprietary molecular reagent format to detect COVID-19 in nose and throat swabs, with the company's small, portable HG Swift instrument able to test four samples concurrently.
HiberGene Diagnostics' new text returns positive tests within an average of 30 minutes while negative results are returned within 60 minutes, allowing rapid diagnosis of the infectious coronavirus disease.
This project is supported by a grant of $1.02 million (€930k) from Horizon 2020, the European Union programme for research and development.
Speaking to RTE, Seamus Gorman, CEO of HiberGene, said: "HiberGene has responded to this global challenge by leveraging our proprietary technology to accelerate the development of an accurate and reliable test for Covid-19."
Gorman said this test is suitable for both decentralized facilities requiring rapid tests and centralised labs requiring additional tests for confirmation, or out of hours testing.
Julie Sinnamon, CEO of Enterprise Ireland said "It is exciting to see HiberGene, who are at the forefront of innovation in the delivery of molecular testing for human infectious diseases, use its technology to develop this diagnostic device, which will help address the urgent global demand for testing with fast results."
The Irish Times reports that Russia, who is currently struggling to cope with the COVID-19 pandemic, will be among the first to receive these tests. The first orders will be shipped this week.