Reports of false positives from Genrui antigen tests to be investigated by regulator

Reports of the Genrui false positives come as the Irish Pharmacy Union has warned that there will be a shortage of Covid-19 antigen tests in the country this week as further stocks are awaited.

An investigation has been launched following reports of false positive results from Genrui Covid antigen tests.

The Health Products Regulatory Agency (HPRA) has said it is following up with the manufacturer of the test to investigate the matter.

Cork paediatrician Dr Niamh Ni Loinsigh raised concerns about the Genrui antigen tests on Twitter, saying she had received hundreds of messages on social media from people about the tests.

"When PCR was available, there seemed to have been lots of false positives with these kits," said Dr Ni Loinsigh.

"This could have major implications for people now with no PCR available."

The test, produced by Genrui Biotech Inc, is CE certified and on the approved EU list.

In a statement, the HPRA said: "Rapid antigen tests, like all diagnostics, have the potential to provide false negative and false positive results.

"It is widely acknowledged that rapid antigen tests are less accurate than PCR tests and should be used in line with current public health guidance."

The association said the decision to follow up with Genrui Biotech Inc was made after it receive "a number of reports" from members of the public who said they had received a false positive when using the Genrui SARS-CoV-2 Rapid Antigen Test.

It said it will also liaise with other European authorities in relation to the issue.

The HPRA notes that individuals who receive a postive result from a rapid antigen test should follow the current public health advice available on the HSE website and seek advice from their GP if necessary.

Any person who has received a false positive or negative result is encouraged to report it to the HPRA at [e-mail] 

Reports of the Genrui false positives come as the Irish Pharmacy Union has warned that there will be a shortage of Covid-19 antigen tests in the country this week as further stocks are awaited.