An antigen test manufacturer is investigating complaints made by Irish users of false positive results from its Covid-19 rapid tests.
Genrui Biotech is working closely with local agents in Ireland to “actively investigate” the product batches which were the subject of complaints here, according to The Irish Times.
The Irish medical devices regulator, the Health Products Regulatory Authority, says it has received a number of reports from medical professionals and members of the public over the performance of the test.
The Genrui brand is sold in supermarkets such as Dunnes Stores and Lidl. Large numbers of people have taken to social media in recent days to say their positive result using the Genrui test was not confirmed when they went for a PCR test.
A spokesman for the company based in Shenzen, China said: “We are also maintaining active communication with users who submit queries to us to ensure the proper handling of the related issues.”
Accuracy
The spokesman added that antigen self-test kits “can not be used alone for the diagnosis of SARS-CoV-2 infection” and should be combined with other information, such as a PCR test, to determine whether a user is infected.
The accuracy of test results depends on a variety of factors, including standardised sampling, the time of result interpretation, ambient temperature and operating procedures, he said.
“Users are advised to strictly follow the instructions to reduce the possibility of inaccurate results.”
Genrui’s kit was granted CE certification in the European Union last August, he said, and has been “filed” in most European countries. The product complies with all relevant quality standards and safety requirements, the spokesman added.
The HPRA does not approve antigen tests on sale in Ireland, but kits sold in the EU must conform with EU legislation and have been certified by an approved body in one of the member states.
The authority says it is following up with Genrui to investigate the matter and will also liaise with authorities in other EU states.
