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Following the publication of the Data Note on the EU’s database of publicly available information on COVID-19 in vitro diagnostic medical devices, Mauro Petrillo discusses the use of research data to inform policy, and the benefits of collating and sharing publicly available information in an open resource when developing testing and diagnostic devices in the midst of a pandemic.

My name is Mauro Petrillo, and I come from Naples (Italy). Since 2012, I have been working at the European Commission’s Joint Research Centre (JRC) as Project Officer in the Knowledge for Health & Consumer Safety Unit of the JRC Directorate for Health, Consumers & Reference Materials.

The JRC is the European Commission’s science and knowledge service. The aim is to conduct research to provide independent scientific advice to support EU policies. My workplace is Ispra, a small town on the eastern coast of Lake Maggiore, in the province of Varese (Lombardy, northern Italy).

My background is in molecular biology, with many years’ experience in bioinformatics. I like to define myself as ‘a molecular biologist accidentally fallen into Informatics’, because my background is based on biology, but I was lucky enough to foster my knowledge in life sciences with basic principles of computer sciences. I developed my knowhow in dealing with large amounts of data, figures and software for specific data analyses, data integration, matters of both molecules and computers, before joining JRC; in Naples I worked at IGB-CNR, CEINGE, and the University of Naples Federico II.

Synthesising research for informing policy

As Project Officer in the Knowledge Management in Health and Consumer Safety Unit, my main role is to synthesise research for policy making (I am co-author of many JRC reports), participating in policymaking and understanding research implications of policy makers’ needs, managing knowledge communities, monitoring and evaluating the impact of research evidence on policymaking, engaging with citizens and stakeholders. My area of interest is bioinformatics applied to -omics data and mining. In my opinion, bioinformatics is (still?) an emerging field, that’s influence and presence nowadays cannot be ignored anymore in the ‘daily life of life science labs’.

To give an example, JRC was asked to provide support in understanding whether novel DNA sequencing technologies can be routinely used in establishing an efficient traceability framework for fish products, which is crucial for consumer protection, as well as fisheries management and conservation. For this reason, I took part in writing a JRC Technical Report, aimed to provide a state-of-the-art report on the use of novel DNA sequencing technologies for species identification of unknown fish samples or products, and for fish product traceability. At the same time, my colleagues and I developed and published ‘fish fraud-fighting methods’ based on the identification and use of nuclear DNA barcodes to check the true species of fish present in food samples (to distinguish flatfish species, and to identify cod in mildly-treated and processed food products). These studies have been presented as examples to encourage control and enforcement agencies to use DNA analysis techniques more routinely, as foreseen by Article 13 (‘new technologies’) of the EU Common Fisheries Policy Control Regulation.

Collating COVID-19 diagnostic devices and testing methods

The objective of the COVID-19 In Vitro Diagnostic Devices and Test Methods Database is to collect – in a single place – all publicly available information on performance of CE-marked in vitro diagnostic medical devices (IVDs) as well as in-house laboratory-developed devices and related test methods for COVID-19. Currently, the database is made of different sections:

• Section ‘COVID-19 in vitro diagnostic medical devices’ contains publicly available information on in vitro diagnostic medical devices for COVID-19 and it is being updated periodically.
• Section ‘Scientific literature on COVID-19 test methods and devices’ contains selected scientific articles reporting about the use and performances of devices and related test methods for COVID-19 diagnostics. A team of JRC experts regularly takes care of updating the scientific literature on COVID-19 test methods and devices section. A key feature in the database is the interconnection that links each scientific article to the corresponding devices assessed and, vice versa, the devices, and their features, to scientific articles that reported their use and performance. This allows a clear, transparent and fully open data source where users can look at and make the right choice in the selection of the device or method to use.
• Section ‘EUnetHTA publications repository’ points to the repository of the European network for Health Technology Assessment (EUnetHTA) publications on testing methods and devices for SARS-CoV-2, with information on publicly available results of validation studies and on publications by national health technology assessment (HTA) bodies and the EUnetHTA.
• Section ‘SARS-CoV-2 NAAT target regions’ is an inventory of nucleic acid amplification tests (NAAT) methods mostly used by laboratories (i.e., those listed in the WHO document  ‘Summary table of available protocols’) and in silico simulations of these assays on available high quality and full-length sequenced SARS-CoV-2 genomes (in collaboration with GISAID). The information is retrieved and updated periodically.
• Section ‘Explore the data’ allows surfing in and mining of data and analyses performed on SARS-CoV-2 sequences, like phylodynamics of hCoV-19 in EU countries, or pre-computed values corresponding to the extent of matchings of the primers and probes from the NAAT database methods against consensus sequences of SARS-CoV-2 main lineages.

The database aims to provide support to EU policies challenging the tremendous coronavirus disease 2019 (COVID-19), by making important data on COVID-19 In Vitro Diagnostic Devices and Test Methods easily available and searchable.

This is done in response to a specific need of the European Commission:

• On 15 April 2020, the Communication from the Commission ‘Guidelines on in vitro diagnostic tests and their performance’ for COVID-19 was adopted and published. In the document, it is stated: “The Commission, supported by the European Centre for Disease Prevention and Control (ECDC), health technology assessment experts and in vitro diagnostics competent authorities, will assist Member States with a centralised overview of available information on test performance and act as a single point of contact for management of this information”.
• On 16 April 2020, as an initial step in collecting information on performance of devices and in-house methods, the European Commission published the Working Document ‘Current performance of COVID-19 test methods and devices and proposed performance criteria’. This document had been produced by European Commission services (DG SANTE, DG JRC, DG RTD), by the ECDC and by several experts from in vitro diagnostics competent authorities and health technology assessment. We, as JRC, capitalised on its expertise in knowledge management to conduct the literature review as part of this work.

Following the publication of the Working Document, and as a follow-up action to the need identified in the Communication, the JRC has committed to make the information broadly accessible and to update the compilation as new data become available. The database has been developed by the JRC for this purpose. It represents one of the concrete actions initiated by the European Commission to fight COVID-19.

The benefits of sharing data as a Data Note

I see three main reasons for sharing data such as this as a Data Note:

1. To inform the scientific community that an ‘EU one-stop-shop collection’ of information about ‘COVID-19 kits and devices’ exists. It is open, fully transparent, and freely available to everyone: to researchers, partitioners, Member States’ national authorities, local healthcare authorities, hospital doctors, family doctors, students and citizens.
2. A scientific publication describing an open repository of information about these devices provides scientific robustness and solidness to policy making and decisions. The importance of science-based evidence for policy making is crucial and it is recognised by the EU decision makers.
3. By sharing data, it is possible to compare and assess methodologies and approaches not with the aim of selecting the best one, but with the aim of finding points of convergence in terms of harmonisation, standardisation, validation, etc. To give a concrete example, on 21 January 2021 EU Member States unanimously agreed on a Council Recommendation setting a common framework for the use of rapid antigen tests (RATs) and the mutual recognition of COVID-19 test results across the EU. It was agreed that EU Member States should agree on, maintain, and share a common and updated list of COVID-19 rapid antigen tests. On 17 February 2021, the Health Security Committee (HSC) published a document containing a first version of the common list of rapid antigen tests, which is regularly being reviewed by Member States in the context of Health Security Committee meetings, and, if necessary, is updated in line with new results from independent validation studies becoming available and new tests entering the market. The list is hosted in the COVID-19 In Vitro Diagnostic Medical Devices database, together with information on the related validation studies.

You can find out more about Data Notes with this blog post from Charlie Vickers, Senior Editorial Assistant at F1000Research >>

Final thoughts

I would also like to clarify that behind the database, there is a team of highly committed and motivated JRC colleagues, who daily put all their efforts in keeping the database up to date. We are used to defining the COVID-19 pandemic as a ‘moving target’: the COVID-19 In Vitro Diagnostic Devices and Test Methods Database is continuously updated and improved to give support to EU policy actions and to respond to the required urgent needs for tackling the pandemic.

Finally, I would like to add that I like very much working in a European institution environment like the JRC, where highly qualified scientists put their knowledge at service of the EU citizens, improving progress of knowledge and social well-being. I see this as an opportunity to do a job that is useful to the civil society. This feeling is probably linked to the fact that I was a boy-scout for more than 10 years and I learned that ‘serving the other’ is something providing great gratification, to yourself but most importantly to the community that you are part of.

You can read the full Data Note, ‘The EU one-stop-shop collection of publicly available information on COVID-19 in vitro diagnostic medical devices’ here >>

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