EU support for Covid-19 testing

• Author: Dumbrava, Costica
• Pages: 15-16

Lifting coronavirus restrictions

15

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

measures.

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,

STAT

, 20 April

2020.

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.