Removal of Genrui Covid antigen test from sale advised

The Health Products Regulatory Authority (HPRA) last night announced that it has advised retailers to remove the Genrui SARS-CoV-2 Rapid Antigen Self-Test from sale on a voluntary basis pending further investigation.

HPRA said this was a precautionary move following the receipt of over 550 reports in recent days from Irish consumers of false positive results associated with the use of this particular antigen self-test.

In a statement, HPRA said rapid antigen tests, like all diagnostic tests, have the potential to provide false negative or false positive results.

However, it added that "the rapid rise in the number of reports of false positive results relating to the Genrui self-test is significant" and that the precautionary removal from sale was warranted while the matter is further investigated by the manufacturer (Genrui Biotech, Shenzen, China) and its European representative.

The HPRA also advised against the online purchase of Genrui self-tests at this time while the matter remains under investigation.

It added that individuals who have received a positive result following use of any rapid antigen self-test, including this test, should follow the current public heath advice on the HSE website.

HPRA will continue to liaise with the manufacturer to investigate the matter further, and is also in contact with other European Competent Authorities in relation to this issue.

Individuals who have experienced a false positive or false negative result can report the occurrence via the HPRA website – www.hpra.ie

The HPRA said itg wished to acknowledge the cooperation and swift response of retailers in relation to this matter. Any retailers supplying this product who have not yet received communication in respect of this issue should contact devicesafety@hpra.ie.