The Company intends to launch the test throughout the European Union as well as other countries that recognise the CE Mark designation
Trinity Biotech has achieved a CE Mark for its 10-minute Covid-19 antigen test. (Credit: lukasmilan from Pixabay)
Trinity Biotech has achieved a CE Mark for its 10-minute Covid-19 antigen test. This CE mark allows for use by healthcare professionals and trained users. The Company intends to launch the test throughout the European Union as well as other countries that recognise the CE Mark designation.
In addition to its ease-of-use and impressive speed to result, in extensive clinical trails the test has demonstrated excellent 99% sensitivity and 99% specificity which are accuracy levels superior to many of the tests currently on the market.
The test uses an anterior nasal swab sample rather than the more invasive nasopharangeal swab, providing a more comfortable patient experience. The test also has several features that benefit the user including a convenient pre-filled extraction buffer and a run time of 10 minutes which is faster than many competitor products. This speed to result and pre-filled buffer allows a higher throughput of patients for healthcare professionals and trained users performing the test, while also providing a more comfortable patient experience without compromising on diagnostic performance.
In many instances, antigen tests have replaced PCR as the go-to method for Covid-19 testing and we expect antigen tests to be an important tool for the management of Covid-19 for many years to come.
The rapid Covid-19 antigen test has been developed by Trinity Biotech on the same lateral flow test platform as the recently World Health Organisation (WHO) approved Trinscreen HIV test and will be manufactured at the Company’s high volume automated lateral flow manufacturing site in Bray, Ireland.
The Company will continue to examine regulatory approval pathways in other countries in deciding what further regulatory approvals to seek for this product.
The Company intends to continue to expand its rapid test portfolio in infectious disease using the existing lateral flow test platform and high-volume automated manufacturing.
Source: Company Press Release