Coronavirus: Commission issues guidelines on testing

covid tests

(Credit: Unsplash)

This article is brought to you in association with the European Commission.


Today, as part of the European Roadmap towards lifting coronavirus containment measures, the Commission is presenting guidelines on coronavirus testing methodologies. The guidance aims to support Member States in effectively using testing tools in the context of their national strategies and during the different stages of the pandemic, including when phasing out confinement measures. The Commission also aims to ensure that high-quality tools are available to assess the performance of the tests.

Stella Kyriakides, Commissioner for Health and Food Safety, said: “The capacity to perform large-scale testing is key to detecting and slowing down the coronavirus pandemic and is a crucial pre-condition for a gradual return to our normal way of life. The main priority for us all is to fight the virus and protect our citizens from further exposure and infection, and to do so, we need to know where the virus is. In the absence of a vaccine, safe and reliable testing is our best bet to protect our health care workers, the most vulnerable of our citizens and our societies at large. This is a cornerstone of our roadmap towards lifting coronavirus containment measures.”

Mariya Gabriel, Commissioner for Innovation, Research, Culture, Education and Youth, responsible for the Joint Research Centre (JRC), said: “We have been working hard to analyse the information on the quality assurance of the coronavirus tests and devices that are currently being used. The results show that there is a mismatch between the existing quality and what could be expected to ensure good performance of the tests. The European Commission has therefore developed test performance criteria which aim to improve the overall performance of these tests. This will benefit all European citizens and is a key part for of the exit strategy from the current crises.”

The availability of reliable data over time is key to lifting containment measures. In order to achieve this, there needs to be sufficient monitoring of the progression of the coronavirus pandemic, including through large-scale testing.

In its guidelines, the Commission calls on manufacturers to produce “state of the art” testing kits. Although the science relating to testing is still evolving rapidly, this obligation is important as the information provided by these test kits is used for crucial public health decisions.

Given the importance of tests in the current situation and the rapid development of the pandemic, the Commission is also insisting on pooling resources for the validation of coronavirus tests at EU-level. It is important to centralise the validation and to share the results at EU and international level.

In order to ensure the highest possible testing quality, make sure that tests are correctly used and further align the evaluation and validation of test device performance, the Commission is proposing to launch the following actions in the coming weeks:

  • an assessment of common approaches in national strategies;
  • the sharing of information on the performance of tests;
  • the establishment of a network of coronavirus reference laboratories across the EU to facilitate the exchange of information, and the management and distribution of control samples;
  • the drafting of further guidance on performance evaluation and conformity assessment following additional dialogue with the industry and national competent authorities;
  • making available tools for assessment of performance, such as reference materials and common methods for the comparison of devices;
  • the fight against counterfeit devices through international cooperation and cooperation between Member States’ authorities;
  • the coordination of supply and demand by EU instruments such as the Clearing House, rescEU and joint procurement;
  • solidarity between Member States by ensuring a fair distribution of available stocks and laboratory equipment focussing on where they are most needed.

Background

Currently, EU legislation lays down a number of requirements for tests. The manufacturer of a test must prepare a technical file, which demonstrates that the test is safe and performs as intended.

There are currently two categories of tests:

  • tests detecting the virus;
  • tests detecting antibodies; these tests detect whether the patient has already been exposed to the virus and therefore produced antibodies.

Assessing the performance level of a test can be very challenging as the biological materials necessary for this assessment are not always available. Moreover, unified ways to compare tests do not always exist.

the sting Milestones

Featured Stings

Can we feed everyone without unleashing disaster? Read on

These campaigners want to give a quarter of the UK back to nature

How to build a more resilient and inclusive global system

Stopping antimicrobial resistance would cost just USD 2 per person a year

Syria’s groundbreaking constitutional talks: ‘a clear success of mediation’ says Guterres in Turkey

10 million Yemenis ‘one step away from famine’, UN food relief agency calls for ‘unhindered access’ to frontline regions

“911, What’s your emergency?”

Nearly a third of the globe is now on Facebook – chart of the day

Climate change is forcing 20 million people a year from their homes, Oxfam says

4 ways Africa can prepare its youth for the digital economy

Germany objects to EU Commission’s plan for a Eurozone bank deposits insurance scheme but Berlin could go along

Alcohol abuse kills three million people a year, most of them men – WHO report

2013, a Political Odyssey: What future for Italy?

This is why mental health should be a political priority

Commission welcomes European Parliament adoption of EU4Health programme

Commission welcomes agreement on the modernisation of EU export controls

7 ways to break the fast fashion habit – and save the planet

ECB again to subsidize euro area banks with more than one trillion euro

Thomas Cook bankruptcy: Better consumer and employee protection needed

MWC 2016 LIVE: Ingenu steps up efforts to build LPWA networks across the globe

Greener tourism: Greater collaboration needed to tackle rising emissions

How digital entrepreneurs will help shape the world after the COVID-19 pandemic

MEPs back plans to promote water reuse for agricultural irrigation

The ECB proposes a swift solution for SMEs’ financing

Working fewer hours makes you more efficient. Here’s the proof

COVID-19: A coordinated EU health strategy needed, say MEPs

‘BioSolar Leaves’ are better at cleaning the air than trees, say the technology’s developers

EU leaders agree to delay Brexit until 31 October

Yemen war ‘a test of our humanity’, and we’re ‘badly failing’ warns UN Children’s Fund chief

German Presidency outlines priorities to EP committees

The refugee crisis seen through the eyes of a young doctor from Turkey

EU, Latin America and the Caribbean: Partnering for prosperity, democracy, resilience and global governance

Collective action to enable sustainable growth will be critical to end tropical deforestation

Adoption of new rules to better protect children caught in cross-border parental disputes

Arrest of three Libyans wanted for grave crimes ‘would send strong and necessary message’ to victims, urges top Prosecutor

State aid: Commission approves around €36 million Romanian rescue aid to state-owned flag carrier TAROM

COVID-19: from the chaos of the pandemic to the difficulties in vaccination

Ecofin: ‘The Friday battle’ for the banking union

Haiti cholera outbreak ‘stopped in its tracks’

The UK option: An overarching alternative for the whole Brexit options

Security Council gravely concerned by Ebola outbreak in DR Congo, demands immediate end to violence hampering response

Here’s how to achieve growth in the Middle East and North Africa

Civil society groups matter for Cambodia’s sustainable development: UN expert

European Institute of Innovation and Technology: Commission welcomes political agreement on strategy for 2021-2027

The von der Leyen Commission: for a Union that strives for more

Number of MEPs to be reduced after EU elections in 2019

The challenge of palliative care in universal health coverage

The world needs carbon-neutral flying. Here’s how to bring it one step closer

Facts, not fear, will stop COVID-19 – so how should we talk about it?

Concorde is a reminder that the only way for innovation is up

Parlamentarians to “break up” with reality in the Google antitrust case

Implementation of tax transparency initiative delivering concrete and impressive results

The world has made spectacular progress in every measure of well-being. So why does almost no one know about it?

EU guidance on the handling of visa applications from residents of Ukraine’s Donetsk and Luhansk regions

MEPs to prioritise environment and climate action in next long-term budget

GDP growth slows in most G20 economies in third quarter of 2019

This is why retail is such a sore point in India-US trade relations

Khashoggi murder trials must public and meet international standards, UN expert urges

UN chief seeking ‘renewed commitment’ to global rules and values, as world leaders head to New York

Agriculture and Fisheries Council

A reality check on inclusive innovation

Austerity lovers to put a break on Renzi’s growth vision for Europe? the Sting reports live from World Economic Forum 2015 in Davos

This man is turning cities into giant sponges to save lives

4 key trends on how COVID has impacted women in business

More Stings?

Speak your Mind Here

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out /  Change )

Google photo

You are commenting using your Google account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

Connecting to %s