Spain has become the latest European country to withdraw COVID-19 antigen tests produced by Chinese pharmaceutical company Genrui Biotech following a spike in false positive results.
The Spanish Medicines and Health Products Agency (AEMPS), which is currently investigating the product, has ordered the testing to be withdrawn “due to a possible increase in false positive results”.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.
Irish retailers were urged on Friday to withdraw testing carried out by the company following advice from the country’s Health Products Regulatory Authority (HPRA).
The request came after the HPRA said it had received more than 550 complaints from people that the Genrui test kits had provided false positive results.
AEMPS said it had been made aware of the HPRA’s removal of testing in Ireland.
Problems detected in December
In Germany, the Hamburg Authority for Schools and Vocational Education and Training (BSB) also decided 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 verified with a PCR test,” the authority wrote on their website December 17th.
“This high number of false positives is confusing the school community and leads to a lot of comments from schools and parents. School authorities take this very seriously. This is why the authority has arranged for Hamburg to procure it. new corona tests for schools by early 2022 ”.
In one declaration, the HPRA said that all rapid antigenic tests have the potential to provide false negative or false positive results, but went on to say “that the rapid increase in the number of false positive results reports related to the Genrui self-test is material and a preventive withdrawal from the 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 met at a beer garden a few days before Christmas later tested positive for COVID-19, so Gillen performed an antigen test performed by Genrui which showed a positive result.
The Irish testing system had been overcapacity for the past few weeks, so she was unable to book a PCR test to confirm the result immediately and eventually had to travel to Northern Ireland to get one via the NHS, which turned turned out negative.
“It really disrupted Christmas for everyone back home,” Gillen told Euronews Next.
“Our grandmother came for Christmas to be with us so you feel really bad, she came to spend Christmas with us and then you brought COVID into the house.”
Although relieved that the PCR came back negative, Gillen was disappointed that the false positive of the antigen test had caused her and her family stress and canceled plans. And that disappointment was compounded when reports of hundreds of similar complaints about the manufacturer became public.
The quality of EU antigen testing
Genrui antigen tests carry an EU CE mark, which certifies it to comply with EU standards.
However, to research published in November last year by the 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 IVD’ and waive independent verification of the tests before they are marketed “.
That is set to change – but not until May 2022, when manufacturers demand lab testing of tests as well as independent data verification.
In the same peer-reviewed research, Genrui was one of 96 antigen test manufacturers who passed the study’s sensitivity criteria. 26 other manufacturers who sell tests in Europe have not.
Irish agency HPRA said it would continue to be in contact with Genrui to further investigate the matter and that it was also in contact with other relevant European authorities in the matter.
A spokesperson for Genrui told Euronews Next that the company is investigating the matter and is in close contact with the HPRA.