Consumers are being warned to check the packaging of new triple antigen tests to ensure they are safe and effective.
The Health Products Regulatory Authority has warned that manufacturers of the tests are responsible for making sure they function as advertised, as the HPRA has no role in certifying them.
The new version of the at-home tests allow people to test themselves for COVID-19, flu and HPV simultaneously with just one kit.
As they are intended by the manufacturer to be used as self-tests in a home environment, they require an additional assessment by a notified body on the suitability of the device design and the information included on the label and the instructions.
Customers are advised to check that any test they use is EU approved and has CE mark.
The HPRA says that the manufacturer needs to be carrying out ongoing tests to ensure they are working as advertised and conform with legislation.
As the HPRA has no role in certifying the devices for the EU market, it said that it "is unable to comment on the efficacy of the above mentioned device”.
“The HPRA strongly encourages members of the public and healthcare professionals to report any safety issues that they have experienced with a medical device to the HPRA", it said in a statement to Newstalk.
"Further information in relation to the reporting of safety issues can be found on the HPRA website."
Main image shows A positive COVID-19 result from an antigen test. Picture by: Michael Bihlmayer / Alamy Stock Photo