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What’s this fuss I’m hearing about antigen tests?
It comes with one brand, produced by Genrui Biotech in China. Over Christmas, users began noticing they tested positive with this kit and then negative with the PCR test required to confirm the initial result. Other people said they tested positive with the Genrui kit but negative with other antigen test brands.
The issue was first raised on social media, gained traction through press reports and this week resulted in the Health Products Regulatory Authority asking retailers to take the product off their shelves. By that time, HPRA had received more than 550 reports of false positives from Irish consumers.
Did this happen?
Yes, 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 it had « very small quantities » of these kits as the supplier changed hands before Christmas. However, any that might still be available have been removed.
What if I have a stock of these kits at home?
A Lidl spokeswoman said, « Our standard change of mind policy applies to these items – once unused, sealed intact, and customers have proof of purchase, they can be returned for a full refund. »
What do consumer experts say?
The Competition and Consumer Commission says that because investigations are ongoing, it cannot at this time explain that the kits are « non-compliant » with the sales contract and that consumers are entitled to a refund.
« Likewise, we are currently unable to determine any recourse options under consumer law that may be available to consumers who have been affected by inaccurate testing. »
The committee recommends that consumers keep their receipts and products as proof of purchase.
When someone buys a product and the terms of sale are not met, the company that sold the product is responsible for addressing the problem.
Should I worry about other antigen tests?
No test is perfect but there is no evidence of any specific problems with other brands of antigen tests.
In general, antigen tests perform well in periods when people are most contagious, but they may miss short periods when infection is emerging or very low. Even PCR tests, considered the gold standard of testing, can give positive results long after a person has stopped having an infection.
The unusual feature here was that the problem included false positives, not false negatives. Some users have reported a faint test line appearing in the result but Genrui’s instructions clearly say « Any pink/purple here indicates a positive result ».
Who monitors the quality of the tests we use for Covid-19?
The Genrui case highlighted the shortcomings of the monitoring system for these self-administered tests. HPRA does not approve antigen tests for sale in Ireland, although kits sold in the EU must comply with EU legislation and have been approved by an authorized body in a Member State. In the case of Genrui, this work was carried out in Poland.
Rules regarding the safety assessment of medical devices, which include Covid-19 tests, have been tightened in a new European Union directive set to take effect next April.
What will happen now?
HPRA has advised consumers not to purchase Genrui kits online while the issues raised are investigated. The problems of these groups have been raised with regulatory agencies in other European countries.
The overall supply of antigen kits remains tight, due to increased demand across Europe.
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