What’s this fuss I’m hearing about antigen tests?
It concerns one brand, made by Genrui Biotech in China. Over Christmas, users started noticing they were testing positive with this kit and then negative with the PCR test required to confirm the initial result. Other people said they were testing positive with the Genrui kit but negative with other antigen test brands.
The issue was first raised on social media, gathered steam through newspaper reports and resulted this week in the Health Products Regulatory Authority asking retailers to take the product off their shelves. By then, the HPRA had received more than 550 reports of false positives from Irish consumers.
So did this happen?
Yes, the HPRA says retailers are removing the Genrui test from sale on a voluntary basis “pending further investigation”.
A spokeswoman for Lidl, one of the supermarkets that sold this brand, told The Irish Times it had “very minor quantities” of these kits left as it had changed supplier before Christmas. However, any that might still be available were being removed.
What if I have a stash of these kits at home?
The Lidl spokeswoman said: “Our standard change-of-mind policy applies to these items – once they are unused, with seal intact, and customers have proof of purchase they can be returned for a full refund.”
What do the consumer experts say?
The Competition and Consumer Protection Commission says that because investigations are ongoing it can’t state at this time that the kits were “not in conformity” with the contract of sale 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.”
The commission recommends consumers retain their receipts and the products as proof of purchase.
Where someone buys a product and the conditions of sale are not met, the business that sold the product is responsible for addressing the issue.
Should I be worried about other antigen tests?
No test is perfect but there is no evidence of any specific issues in relation to other brands of antigen tests.
Generally speaking, antigen tests perform well for the periods when people are most infectious, but they may miss short periods when infectivity is nascent or very low. Even PCR tests, regarded as the gold-standard of testing, can return positive results long after a person has ceased to be infectious.
The unusual feature here was the problem involved false positives, rather than false negatives. Some users report getting a faint test line on the result but the Genrui instructions clearly say “any pink/purple here indicates a positive result”.
Who is monitoring the quality of the tests we use for Covid-19?
The issue around Genrui has highlighted shortcomings in the surveillance system for these self-administered tests. The HPRA does not approve antigen tests on sale in Ireland, though kits sold in the European Union must conform with EU legislation and have been certified by an approved body in one of the member states. In the case of Genrui, this work was done in Poland.
The rules around assessing the safety of medical devices, which include Covid-19 tests, are being tightened up in a new EU directive due to take effect next April.
What happens now?
The HPRA has advised consumers not to buy Genrui kits online while it is investigating the issues raised. The problems with these kits have been raised with regulatory bodies in other European countries.
Overall supplies of antigen kits remain tight, due to rising demand across Europe.