A new test that can deliver positive results for Covid-19 in just 30 minutes has been approved for use by the European Union.
The test was developed by the Irish firm HiberGene Diagnostics, which is based in Dublin, and is now available for sale internationally.
The test was released for sale following the completion of a clinical evaluation study at the Mater Private Hospital in Dublin, which has demonstrated its effectiveness.
The new test accurately detects the COVID-19 virus in nose and throat swabs, using HiberGene’s small, portable HG Swift instrument to test four samples at the same time.
The test has excellent performance for samples with high to moderate viral loads. Positive results are returned within 30 minutes on average, enabling rapid diagnosis of the disease at the early and highly infectious stage of infection.
Negative results are returned within 60 minutes.
Further studies and collaborations to evaluate potential additional uses of the test, such as compatibility with new specimen types and patient cohorts, are planned including clinical evaluations at IRCCS Ospedale Policlinico San Martino in Genoa, Italy; Queens University in Belfast, Northern Ireland; and at laboratories in China.
The project is supported by a grant of €930,000 from Horizon 2020, the EU programme for research and innovation.
This new test complements HiberGene’s menu of current tests for respiratory disease such as Flu, RSV and Mycoplasma Pneumoniae.
Seamus Gorman, CEO of HiberGene, said: “The COVID-19 pandemic is the greatest challenge to humanity in our lifetimes. 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.
“The test is suitable for both decentralised facilities requiring rapid molecular tests for screening and centralised labs requiring additional tests for confirmation or out of hours testing. The support of the EU through the Horizon 2020 programme has been instrumental in delivering this project.”
Mariya Gabriel, Commissioner for Innovation, Research, Culture, Education and Youth, European Commission, said: “This is a great example of EU research in action. I am encouraged to see that these researchers have risen to the challenge, developed this new diagnostic system so fast, and delivered on one of the aims of our first emergency call. It’s crucial to diagnose coronavirus more quickly and more accurately, as it reduces the risk of further spread of the virus.”
- COVID-19 was assigned Global Pandemic Status by the WHO in March 2020
- Symptoms include fever, cough and shortness of breath, in more severe cases the infection can cause pneumonia, severe acute respiratory syndrome and death.
- WHO guidelines recommend Molecular Testing to determine an active infection
- Rapid detection can guide patient management, isolation, contact tracing and infection control
- Along with HG Flu A/B and RSV, our platform can distinguish between 3 common respiratory infections from 1 patient sample.
Meanwhile, the search for a vaccine against Covid-19 continues with hundreds of agencies around the world both competing and collaborating in an effort to find a solution.