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

UN chief welcomes resolution to 27-year-old disagreement over renaming the former Yugoslav Republic of Macedonia

The US pipeline attack shows the energy sector must act now on cybersecurity. Here are 6 ways how

How trade-based money laundering works and its impact on world finances

Why is the World Health Organisation so much needed?

Remarks by Commissioner Lenarčič on the deployment of EU Medical Teams to Italy

The link between migration and technology is not what you think

UN space-based tool opens new horizons to track land-use on Earth’s surface

‘The clock is ticking’ on meeting the Sustainable Development Goals, says UN deputy chief

UN agencies call for more resettlement and end to detention of asylum seekers in Libya

NextGenerationEU: Commission gets ready to raise up to €800 billion to fund the recovery

Here are six bold ideas to accelerate sustainable energy innovation

Logo Mania: A call to action to our crisis of connection

Judges urge Security Council to serve interests of all UN Member States

Why financial services can kickstart Africa’s digital economy

Parliament approves seven-year EU budget 2021-2027

IMF: World cup and productivity

Connected Claims Europe on 18-19 September 2019, in association with The European Sting

A shocking new report reveals what we’ve done to the natural world

Bosnia and Herzegovina: EU allocates additional €3.5 million to support vulnerable refugees and migrants

Eurozone bank rescues ‘a la carte’ until 2015 then only bail-ins

EU’s tougher privacy rules: WhatsApp and Facebook set to be soon aligned with telcos

Nothing about us without us: how youth empowerment creates lasting change in the climate meltdown

It’s time for the circular economy to go global – and you can help

Dark spots on EU humanitarian aid spending

A reflection of health inequity in recent epidemics

Fuel crisis rapidly draining last ‘coping capacities’ of Palestinians in Gaza

MEPs hail minimum global corporate tax rate deal as historic

Closing VAT loopholes for sales through online platforms

COVID-19 Myths and Facts

A Sting Exclusive: EU Commission’s Vice President Šefčovič accentuates the importance of innovation to EU’s Energy Union

Brexit: €5 billion to help EU countries mitigate social and economic impact

Improvements to pension systems have made them better placed to deliver pensions

Easing ‘classroom crisis’ in Côte d’Ivoire, brick by (plastic) brick

State aid: Commission approves €1.1 billion Polish scheme to further support companies affected by coronavirus outbreak

ECB: The bastion of effective and equitable Europeanism keeps up quantitative easing

State aid: Commission approves German aid scheme to support airports affected by the coronavirus outbreak

Bertelsmann Stiftung @ European Business Summit 2014: Transatlantic Free Trade Agreement (TTIP) needs balanced approach

Green light for VAT overhaul to simplify system and cut fraud

What does strategy have to do with a platform approach?

This is the IMF’s latest take on the economy in 2020

EuroLat plenary in Panama: control of trade talks and fight against crime

Commission paralysed before the banking leviathan

Coronavirus: EU channels further support to Nepal and repatriates EU citizens

Vaccine hesitancy: a pregnancy related issue?

Impressions of China

Challenges in accessing Palliative Care from the perspective of Universal Health Coverage

4 innovative renewable energy projects powering Europe’s green future

South Korea once recycled 2% of its food waste. Now it recycles 95%

Is a deal over EU budget possible today?

EU agricultural production no more a self-sufficiency anchor

Partner countries get €3bn in loans to prop up economies affected by pandemic

Our food system is no longer fit for the 21st century. Here are three ways to fix it

IMF: The global economy keeps growing except Eurozone

The US banks drive the developing world to a catastrophe

Team Europe: Digital4Development Hub launched to help shape a fair digital future across the globe

UN chief pays tribute to Egypt’s role in avoiding ‘dramatic’ escalation in conflict across the Gaza-Israel border

3 ways to fight short-termism and relaunch Europe

More than speed: 5G could become the next big economic driver

Smart cities must pay more attention to the people who live in them

COVID-19 poses a dramatic threat to life in conflict zones

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