Genrui antigen tests pulled from sale amid reports of false positives

The regulator received over 550 results from consumers in recent days that they had received false positive results from the Genrui SARS-CoV-2 Rapid Antigen Test. Picture: Gareth Chaney/Collins

The Health Products Regulatory Authority (HPRA) has advised the removal of the Genrui brand of antigen tests from shelves following widespread reports of false-positive results.

The regulator received over 550 complaints from consumers in recent days that they had received false-positive results from the Genrui SARS-CoV-2 Rapid Antigen Test.

The HPRA said retailers should remove the tests from sale on a voluntary basis pending further investigation.

While all diagnostic tests have the potential to provide both false-negative and false-positive results, the HPRA said the rapid rise in the number of reports of false positives relating to the Genrui test is "significant" and warrants the precautionary removal from sale and further investigation into the matter.

As the investigation is ongoing, the regulator also advises against people purchasing Genrui tests online.

The test, produced by Genrui Biotech Inc, is CE certified, meaning it is deemed to meet EU safety, health and environmental protection requirements.

The HPRA said it will liaise with other European authorities in relation to the false-positive trend.

It notes that individuals who receive a positive 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.

Individuals who receive a positive 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.

Cork paediatrician Dr Niamh Ní Loinsigh previously 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 Ní Loinsigh.

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

Meanwhile, it has been revealed that health authorities have sent out over 1.4m HSE-approved antigen tests to close contacts of Covid-19 cases since late October.

In total, 281,626 kits containing five tests have been dispatched since October 28, totalling 1,408,130 individual tests.

The current daily average number of test kits being issued is 9,971, or close to 50,000 individual tests per day.

As of December 22, all asymptomatic close contacts could avail of the service under new advice issued by the HSE.

During the first seven days of the programme, a daily average of 1,815 antigen test kits were dispatched to close contacts, steadily increasing week-on-week before reaching 3,920 per day between November 11 and 17.

Between December 9 and 13 alone, approximately 75,600 kits were dispatched to close contacts, an average of 15,120 per day.

A total of 98,301 antigen test results have been reported to the HSE so far; of these, 41,669 were negative, and 56,362 were positive.

Of this, 31,577 positive antigen test results were confirmed by PCR test, with a positivity rate of 77% in the past seven days.

The HSE has advised that “the majority of negative antigen results are not reported by users, whereas positive results are captured as part of the PCR online booking process”.