EU support for Covid-19 testing

AuthorDumbrava, Costica
Lifting coronavirus restrictions
results88 from a Swedish study found that 7.3 % of Stockholm inhabitants had developed Covid-19
antibodies by the end of April. On 25 May, Italy started89 an antibody study on a sample of
150 000 people.
It has also been suggested that antibody tests can be used to assess immunity at individual level,
which may allow for the easing of restrictions for particular people. The idea behind an 'immunity
passport' is that individuals who test positive for SARS-CoV-2 antibodies could be allowed to move
freely (to access workplaces and public places) because they have proven immune to the virus and
therefore cannot spread the infection. However, there are a number of issues with this suggestion.90
First of all, little is known about immunity to SARS-CoV-2. An effective antibody test would need to
target the right type of antibodies that tackle SARS-CoV-2 (and not other coronaviruses), as well as
to assess the right level of antibodies (a sufficient enough level to provide protection). Antibodies
from other coronaviruses usually persist in the body and can provide protection for at least a year,91
but this is not known for SARS-CoV-2. The WHO warned in April that 'laboratory tests that detect
antibodies to SARS-CoV-2 in people, including rapid immunodiagnostic tests, need further
validation to determine their accuracy and reliability'.
5. EU support for Covid-19 testing
On 18 March 2020, the EU published recommendations for testing strategies, calling for timely and
accurate laboratory testing and
suggesting criteria for priority testing. On
15 April, the Commission published
guidelines on Covid-19 in vitro diagnostic
tests and their performance, designed to
support Member States in using testing
tools effectively in the context of their
national strategies and during the
different stages of the pandemic,
including when phasing out confinement
Directive 98/79/EC on in-vitro diagnostic
(IVD) medical devices lays down the
requirements applicable to diagnostic
tests. For example, test manufacturers
must prepare a technical file that
demonstrates that the test is safe and
performs as intended. However, as the
Commission's Joint Research Centre (JRC)
noted,92 'assessing the performance level
88 (Just 7.3 % of Stockholm had Covid-19 antibodies by end of April, study shows) see footnote 15 (above).
89 Ministry of Health, Seroprevalence survey in Italy, 26 May 2020.
90 WHO, "Immunity passports" in the context of COVID-19. Scientific Brief, 24 April 2020.
91 A. Joseph, Everything we know about coronavirus immunity and antibodies and plenty we still don’t,
, 20 April
92 JRC, Coronavirus: Commission issues guidelines on testing, 15 April 2020.
CE-mark for COVID-19 diagnostic devices
'According to IVD Directive 98/79/EC, to affix the CE-mark
to COVID-19 diagnostic devices to be used by health
professionals, the manufacturer has to specify device
performance characteristics and self-declare conformity
with the safety and performance requirements listed in
the Directive. In contrast, self-tests intended to be used by
patients themselves must also be assessed by a third-
party body (a notified body). The dedicated Commission
working group of Member States' competent authorities
for IVD serves as a forum for continuous exchange of
technical and regulatory information on IVDs including
COVID-19 rapid tests. While the majority of CE-marked
rapid tests are compliant with EU law, the group has
identified several devices with fraudulent documentation,
incomplete technical files or unsubstantiated claims.
Some of those were sold as alleged self-tests. Several
Member States have warned against the use of rapid self-
tests or even prohibited them.'
Source: ECDC, An overview of the rapid test situation for
COVID-19 diagnosis in the EU/EEA, 1 April 2020.

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