An antigen test that has been authorised for use in Spain has been withdrawn from sale in Germany and Ireland for giving false positives. The product, whcih is produced in China by Genrui Biotech is marketed under the same name Genrui, has been withdrawn following complaints about contradictory results.
HPRA (the Regulatory Authority for Health Products of Ireland) has ordered the withdrawal of the antigen tests following numerous complaints about the accuracy of the tests and the number of contradicting results given. The HPRA said they had no option but to withdraw the product whilst further investigations were being conducted.
Similarly the Department of Education of Hamburg (Germany) announced back in December that they had stopped using these same tests, after having received the same complaints about contradictory results and false positives.
At the time the department said: “Rapid tests of the ‘Genrui’ brand often report a coronavirus infection that is not confirmed when verified with a PCR test.”
The product is licenced for sale in Spain however it is understood that no complaints have been received about false positive from the antigen tests as yet.
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