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 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.
'SPENDING LOTS OF MONEY'
Scientists have not yet definitively proven whether or how long
COVID-19 survivors are immune to new infections, even if they
developed antibodies.
Nevertheless, many people are willing to pay for the tests - and
many don't come cheap, selling for anything from a few euros to more
than 150 euros in some private clinics in Europe.
It's a potentially lucrative business: testing about 450 million
people in the EU would cost billions of euros based on such prices.
"People might be spending lots of money for nothing," said Pauline
Constant of BEUC, a European consumer organisation.
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Severin Schwan, CEO of Swiss drug giant Roche <ROG.S> which has its own antibody
test, sounded an alarm in late April, when he said some tests on the market were
a "disaster". The World Health Organization also warned that tests on the market
were not sufficiently reliable and could not prove immunity.
Such comments were backed up by a study conducted by the Dutch regulator who
found in May that none of 16 reviewed tests were trustworthy.
"The test results are not reliable. The percentage of false positive and false
negative results is too high," the study concluded, without naming the
manufacturers.
"Those tests are quite meaningless," said a spokesman for the Dutch Health and
Youth Care Inspectorate, a part of the health ministry that supervises public
health.
Despite the poor results, clinics and labs in the Netherlands are still allowed
to offer these tests.
INDUSTRY BACKS RULE REVIEW
Introducing an independent review of products would bring forward an EU reform
that had been agreed before the coronavirus crisis but was not due to take
effect until 2022.
In the absence of an EU performance standard for tests, France has already set
its own thresholds. About 60 kits have met the country's requirement of at least
90% of correct positive results, a measure known as sensitivity, and 98% of
correct negative results, so-called specificity.
Under current EU rules, overseen and enforced by national watchdogs,
manufacturers must seek authorisation before using the CE mark only for
so-called home or self-tests, which are those who can be performed at home
without professional advice.
About a dozen antibody devices have been unlawfully marketed as CE-marked
self-tests without prior authorisation, according to the Spanish and Swedish
regulators.
Low performance is not in itself illegal and has been tolerated in Europe in the
initial phase of the COVID-19 crisis because tests were rare. But companies
cannot exaggerate the accuracy of their devices.
An official at the Swedish regulator said the body had yet to start performance
checks, while two pharmaceutical industry sources said such checks were rare in
Europe.
There is however a balance to be struck on regulation, according to industry
experts who worry that if new rules are too strict or onerous they could delay
the deployment of tests to conduct large-scale epidemiological surveys.
But greater scrutiny could help improve the tarnished reputation of the sector.
MedTechEurope, the trading body for medical technology firms including Abbott <ABT.N>,
Roche <ROG.S> and Siemens Healthineers <SHLG.DE>, backed plans to review
industry regulations.
"We support the intention of these plans, and would welcome the opportunity to
provide the industry's input into this debate on how to best ensure only
well-performing tests are on the market," it said.
(Reporting by Francesco Guarascio @fraguarascio; Additional reporting by Emma
Pinedo in Madrid, Caroline Humer in New York and Matthias Blamont in Paris;
Editing by Josephine Mason and Pravin Char)
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