What am I hearing about antigen tests?
It belongs to a brand made in China by Genrui Biotech. Over Christmas, users started noticing that they were testing positive with this kit and then negative with a PCR test needed to confirm the initial result. Others said they were testing positive with the GenRui kit but negative with other antigen test brands.
The issue had previously been raised on social media, gathering steam through newspaper reports and this week the Health Products Regulatory Authority asking retailers to remove the product from their shelves. By then, the HPRA had received over 550 reports of false positives from Irish consumers.
So what happened?
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 sells the brand, told The Irish Times that it has “very small quantities” of these kits left because it switched suppliers before Christmas. However, those that could still be available were being removed.
What if I have a stock of these kits at home?
A Lidl spokesperson said: “Our standard change-of-mind policy applies to these items – once they’re unused, the seal remains intact, and customers have proof of purchase, they can get a full refund. can be returned.”
What do consumer experts say?
The Competition and Consumer Protection Commission says that because the investigation is ongoing, it cannot state at this time that the kits were not in accordance with the contract of sale and that consumers are entitled to a refund.
Similarly, we cannot at this time outline any substitute options under consumer protection law that may be available to consumers who have suffered as a result of an incorrect test.
The commission advises consumers to retain their receipts and products as proof of purchase.
Where someone buys a product and the terms of sale are not met, the business selling the product is responsible for resolving the problem.
Should I be concerned about other antigen tests?
No one test is perfect but there is no evidence of any specific issue with respect to other brands of antigen tests.
Generally, antigen tests perform well for the period when people are most infectious, but when infectivity is neonatal or very low, they may miss a shorter period. Even the PCR test, which is regarded as the gold-standard of testing, can return a positive result long after a person is infected.
The unusual feature here was that the problem was associated with 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 surrounding GenRui has exposed deficiencies in the monitoring system for these self-administered tests. The HPRA does not approve antigen tests on sale in Ireland, although kits sold in the EU must conform to EU law and be certified by an approved body in one of the Member States. In the case of Genrui, this work was done in Poland.
Rules for assessing the safety of medical devices, including those for COVID-19 tests, are being tightened in a new EU directive, due to take effect next April.
now what happened?
HPRA has advised consumers not to purchase GenRui kits online while it is investigating the issues raised. Problems with these kits have been raised with regulatory bodies in other European countries.
The overall supply of antigen kits remains tight due to increased demand across Europe.