Retailers in Ireland are being asked to remove COVID-19 antigen tests made by the company Genrui Biotech following advice from the country’s Health Products Regulatory Authority (HPRA).
The request comes after the HPRA said it received over 550 complaints from people claiming the Genrui testing kits have provided false positive results.
It also follows a decision by the Hamburg Authority for Schools and Vocational Education and Training (BSB) to stop using the company’s tests after receiving similar complaints.
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.
