EU EXPERTS WILL today discuss Genrui antigen test kits after a high number of reported false positives raised questions about the tests’ accuracy.
The Health Products Regulatory Authority (HPRA) last week advised that retailers in Ireland should remove the Genrui antigen tests from sale until further notice.
The HPRA issued the advice after receiving over 550 reports of false positives from people who used the test kits.
Similar issues have been reported in other countries. Authorities in Hamburg in Germany issued a warning about the Genrui tests in December – saying that if a faint line appears to detect the presence of Covid-19, the person should do a second antigen test from a different brand.
The Journal has confirmed that the European Commission’s Technical working group on Covid-19 diagnostic tests, which comes under the remit of the Health Security Committee, is set to discuss the tests today.
A spokesperson said the Commission “is in contact with the Irish colleagues” about the Genrui tests and the technical group will today “discuss the state of play”.
Experts from the 27 EU countries and Norway, as well as representatives from the Directorate-General for Health and Food Safety, the Joint Research Centre (JRC) and the European Centre for Disease Prevention and Control (ECDC) will attend today’s meeting.
Genrui’s antigen self-test kits were granted authorisation for use in Germany, France, Portugal, the Czech Republic and Austria on 10 April 2021, and the product was officially issued with European Union self-test CE certification on 2 August 2021.
CE marking indicates that a product has been assessed by the manufacturer and deemed to meet EU safety, health and environmental protection requirements.
The Commission’s spokesperson told The Journal: “This is a dynamic process and new emerging data is also considered by the experts.
“If a test is no longer considered as suitable, it will be removed from the list. The current table is the ninth update of the list.”
However, they added: “It must be stressed that it is not in the remit of the working group or the HSC to give the ‘CE’ mark,” a statement noted.
“The CE marking is not issued or granted by the Commission nor by a national authority, nor by a notified body or someone else, but it is affixed by the manufacturer after having successfully completed the prescribed conformity assessment procedure(s) and prepared the technical documentation in support of compliance of the product with the applicable legal requirements.”
Refunds
Meanwhile, a spokesperson for the Competition and Consumer Protection Commission (CCPC) said it is not yet clear if people who bought the Genrui tests are entitled to a refund but they encouraged consumers to keep receipts.
“As these investigations are ongoing, it isn’t possible to state at this time that the product was not in conformity and that consumers are entitled to a refund.
“Similarly, we cannot outline at this time any recourse options under consumer protection law which may be available to consumers who suffered detriment as a result of an inaccurate test.
“In the meantime, we would recommend that consumers retain their receipts and the products as proof of purchase.”
A spokesperson for Genrui, which is based in China, last week said that it will investigate the reports of false positives.
“We will conduct further internal investigations to understand the relevant facts,” a spokesperson for the company told The Journal.
The company will continue to work “with local agents and partners in Ireland and other countries to actively investigate related product batches complained by users and maintain active communication with users who send inquiries to properly handle the related issues”, they added.
In a statement issued last Wednesday, the HPRA said that while all antigen tests have the possibility to give false positives and negatives, the number of false positives being reported on Genrui antigen tests is “significant”.
“The HPRA states 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 by the manufacturer and its European representative,” said a spokesperson for the HPRA.
“The HPRA also advises against the online purchase of Genrui self-tests at this time while the matter remains under investigation.”
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