Spain has become the latest European country to remove COVID-19 antigen tests produced by Chinese pharmaceutical company Genrui Biotech over a spike in false positive results.
The Spanish Agency for Medicines and Health Products (AEMPS), which is currently investigating the product, has ordered the withdrawal of the tests "due to a possible increase in false positive results".
The tests are in circulation in Madrid, Barcelona, Seville, Getafe and Asturias after being distributed to five different companies.
On Friday, retailers in Ireland were asked to remove the tests made by the company following advice from the country’s Health Products Regulatory Authority (HPRA).
The request came after the HPRA said it received over 550 complaints from people claiming the Genrui testing kits have provided false positive results.
The AEMPS said it had been made aware of the removal of tests in Ireland by the HPRA.
Problems detected in December
In Germany, a decision was also made by the Hamburg Authority for Schools and Vocational Education and Training (BSB) last month to stop using the company’s tests after receiving similar complaints.
"The 'Genrui' brand rapid tests currently in use often report a corona infection that is not confirmed when checked with a PCR test,” the authority wrote on their website on December 17.
"This high number of false positive reports unsettles the school community and leads to a lot of feedback from schools and parents. The school authorities take this very seriously. That is why the authority has arranged for Hamburg to procure new corona tests for schools by the beginning of 2022".
In a statement, the HPRA said that all rapid antigen tests have the potential to provide false negative or false positive results, but went on to say “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".
The stress of false positives
The impact of a false positive can be disruptive. Cliodna Gillen, from Donegal in Ireland, was one of the people who sent a complaint to the HPRA.
A friend she had met in a beer garden in the days before Christmas had subsequently tested positive for COVID-19 so Gillen took an antigen test made by Genrui which showed a positive result.
Ireland’s testing system has been at overcapacity in recent weeks so she was unable to book a PCR test to confirm the result straight away and eventually had to travel to Northern Ireland to get one through the NHS which turned out to be negative.
“It really disrupted everyone’s Christmas in the house,” Gillen told Euronews Next.
“Our granny had come for Christmas to be with us so you feel really bad, she’s come up to spend Christmas with us and then you’ve brought COVID into the house”.
While relieved the PCR came back negative, Gillen was disappointed that the false positive from the antigen test had caused her and her family stress and cancelled plans. And that disappointment was compounded when reports of hundreds of similar complaints about the manufacturer became public.
The quality of EU antigen tests
Genrui antigen tests carry an EU CE mark, which certifies it as meeting EU standards.
However, research published in November last year by Paul Ehrlich Institute, on the sensitivity of 122 CE marked antigen tests found that “manufacturers can still self-certify COVID-19 tests as 'low-risk IVDs' and waive independent verification of the tests before marketing them”.
This is set to change - but not until May 2022 when manufacturers will require laboratory testing of the tests as well as independent verification of the data.
In the same peer-reviewed research, Genrui was one of 96 antigen test manufacturers that passed the sensitivity criteria of the study. Another 26 manufacturers who sell tests in Europe did not.
Ireland’s HPRA said it will continue to liaise with Genrui to investigate the matter further, and is also in contact with other European Competent Authorities in relation to the issue.
A spokesperson for Genrui told Euronews Next that the company is looking into the matter and is in close contact with the HPRA.