The Health Products Regulatory Agency (HPRA) of Ireland has ordered the preventive suspension of the sale of the Genrui brand antigen tests after receiving some 550 reports from users reporting false positives.
The keys to rapid antigen tests for self-diagnosis (for Christmas dinners)
"Rapid antigen tests, like all diagnostic tests, can report false positives or negatives. However, the agency has considered the rapid increase in reports of false positives for this brand of test to be significant," he said in an HPRA statement, which has therefore decided to preventively suspend the sale of these tests.
The Irish agency is investigating the reports sent and has contacted both the company that manufactures them and the European authorities to report on the data obtained.
These antigen tests, from the Chinese company Genrui Biotecth, are authorized in Spain for commercialization, as it appears in the list of the Spanish Agency for Medicines and Health Products (Aemps).