The HPRA confirmed it has received a number of reports around false positive results from people using the Genrui antigen kits.
This follows reports online from members of the public that upon receiving a positive antigen test with the Genrui kits, they went for confirmatory PCR tests which showed a negative result.
The kits have been sold in many supermarkets across the country.
The issue appears to surround a faint line appearing on the T (test) line which makes the result appear as a positive.
Dr Niamh Ní Loinsigh first highlighted the issue a number of days ago and said she has received “hundreds” of messages about the Genrui kits.
“Received 100s of messages through my Insta about Genrui antigen tests.
"When PCR was available there seemed to have been lots of false positives with these kits. This could have major implications for people now with no PCR available,” Dr Ní Loinsigh said on Twitter.
The issue is not only confined to Ireland as in recent days the Hamburg Education Board also reported a similar issue around the Genrui rapid tests and advised people in the area using them to try another brand to confirm the positive result if they received a faint positive on the Genrui antigen test.
The HPRA said in a statement it is following up the reports with the manufacturer.
“The HPRA has received a number of reports from individuals, who have reported false positive results when using the Genrui SARS-CoV-2 Rapid Antigen Test.
"The HPRA is following up with the manufacturer of the test to investigate the matter and will also liaise with other European Competent Authorities in relation to this issue,” a spokesperson for the health authority 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.
“Individuals who have received a positive result following use of a rapid antigen test should follow the current public health advice on the HSE website and seek advice from their doctor if necessary,” the HPRA said.
The HPRA is requesting that any individuals who have experienced a false positive or negative result report the occurrence to the HPRA at devicesafety@HPRA.ie.