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HPRA advises removal of Genrui antigen test from sale


Antigen test. Picture: Stock image

Antigen test. Picture: Stock image

Antigen test. Picture: Stock image

The Health Products Regulatory Authority (HPRA) has advised the removal of the Genrui Rapid Antigen Covid-19 test from sale.

In a statement issued this evening, the HPRA said this move would be on a voluntary basis pending further investigation.

This comes as the HPRA has received more than 550 reports in recent days from Irish consumers of false positive results associated with the use of this particular antigen test.

The HPRA said the rise in reports of false positive results associated with the Genrui antigen test is “significant”.

The statement added: “Rapid antigen tests, like all diagnostic tests, have the potential to provide false negative or false positive results.”

“However, the HPRA states that the rapid rise in the number of reports of false positive results relating to the Genrui self-test is significant and a precautionary removal from sale is 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 antigen tests at this time while the matter remains under investigation.

The statement said individuals who have received a positive result following use of any rapid antigen, including this test, should follow the current public heath advice on the HSE website.

The 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.

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The HPRA acknowledged the cooperation and swift response of retailers in relation to this matter.

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

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