The market for COVID-19 antibody tests is red-hot. It has ballooned in a matter of months as hundreds of products flood the world for people who want to find out whether they’ve already had the virus.
The problem is, some of them don’t work properly.
As a result, European authorities aim to tighten regulation of the new sector, to weed out tests that give consistently inaccurate results and crack down on companies that make false claims, three sources familiar with the plans told Reuters.
Much is on the line, even beyond the potential for fraud.
Governments and companies are relying on these tests to measure how widely the virus has spread as they rush to get their economies and employees back to work and avoid a second wave of infections, even if they do not prove immunity.
False results could undermine that effort.
Many people have also been using kits, also known as serological or blood tests, at home or for personal checks in clinics.
Since April the number of antibody kits carrying the region’s CE mark of quality doubled to more than 200, according to a list compiled by the EU Commission, the EU executive.
Some of these kits are unreliable, half a dozen national regulators and industry sources across Europe told Reuters. A dozen tests have been subject to regulators’ warnings for mis-selling, including in Spain and Sweden.
At least nine of them are no longer allowed to be sold in the United States, according to a Reuters analysis of public data from the Food and Drug Administration, which clamped down on the sector last month.
The EU Commission is now looking at changing the self-certification regime that allows test-makers to label their products with the CE mark themselves, an EU official and two European regulatory sources told Reuters, declining to be named as the plans have not been made public.
Among changes being examined, companies could be required to have tests reviewed by independent watchdogs before placing the CE mark on them, the sources said.
That would mark a significant toughening of the current regime, whereby makers merely self-certify compliance with EU safety rules and supervisors can subsequently penalise them if their claims turn out to be false.
Guidance setting out minimum performance criteria for tests could also be adopted, the two regulatory sources told Reuters. Under current rules, kits can carry a CE mark regardless of their accuracy.
When asked about the plans, a spokesman for the Commission, the EU executive, said it was “currently considering the best way forward”.
“We are assessing a number of different instruments available together with member states to see which action is the most appropriate,” he added.