Regulator to investigate reports of false positives in widely-used antigen tests 4 months ago

Regulator to investigate reports of false positives in widely-used antigen tests

The Genrui antigen test is under the microscope.

A commonly-used antigen test kit will be examined following numerous reports of false positives generated as a result of using the test.

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The Health Products Regulatory Agency (HPRA) is set to investigate after receiving reports from both members of the public and medical professionals regarding the Genrui antigen test.

The Genrui model is widely available in a number of shops, supermarkets and pharmacies across Ireland, retailing at a notably inexpensive price in comparison to other test kits.

Many people have taken to social media in recent days to report false positives.

Cork-based doctor Niamh Lynch noted she had received hundreds of direct messages via Instagram in relation to usage of the Genrui antigen kits.

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"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," a HPRA spokesperson confirmed to JOE.

"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."

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An internal investigation will also be launched by Genrui Biotech, a Chinese pharmaceutical company first established in 2004.

"Rapid antigen tests, like all diagnostics, have the potential to provide false negative and false positive results," the HPRA spokesperson continued.

"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 heath advice on the HSE website and seek advice from their doctor if necessary."

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Anyone who has experienced a false positive or false negative result via antigen test use is encouraged to contact the HPRA at devicesafety@HPRA.ie.

Meanwhile, Tánaiste Leo Varadkar has proposed changes to self-isolation rules for boosted close contacts who aren't displaying symptoms of Covid-19.

Varadkar made the assertion when speaking to Virgin Media News on Tuesday afternoon (4 January).

The Tánaiste noted the distinction between those who have been boosted and those who have not, though underlined that Government will continue to follow the latest public health advice.

However, it is understood that Government will ask Chief Medical Officer Tony Holohan to consider easing the rules around the restriction of movement for boosted close contacts.

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Cabinet is set to meet on Wednesday, with the ongoing Covid situation a top priority in the face of escalating confirmed case numbers, a notable strain on the testing system, public service staff absences and the overall issue of schools.

As it stands, schools are set to reopen as planned on Thursday morning, having been given the green light by coalition leaders in light of the latest public health advice.