COVID-19 In Vitro Diagnostic Devices and Test Methods Database | COVID-19 In Vitro Diagnostic Devices and Test Methods Database

The objective of the JRC 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 laboratory-developed devices and related test methods for COVID-19. The database is manually curated and periodically updated.

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COVID-19 in vitro diagnostic medical devices

The database contains publicly available in vitro diagnostic medical devices for COVID-19 and it is being updated periodically. Please note that additional performance (as retrieved from manufacturers web pages) is provided only for devices commercially available with CE-IVD mark.
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This section of the database is based on publicly available information from manufacturers.
The conformity of the devices with applicable EU law has NOT been in any way assessed by the European Commission or Member State national authorities for the purposes of inclusion in the database. There is no central approval system for in vitro diagnostic medical devices in the EU and the database does NOT represent a list of authorised or approved devices in the European Union.
For rapid antigen tests, as part of the EU Health Security Committee (HSC), the Member States have agreed on a common list of these tests considered appropriate for use in the context of COVID-19 diagnosis, as well as a selection of these whose results should be mutually recognised.

For more information, please read “Aim of the website”.
Scientific literature on COVID-19 test methods and devices

The database contains performance of test methods and devices for COVID-19 diagnostics retrieved from selected scientific articles and it is being updated periodically.
SARS-CoV-2 NAAT target regions

The database provides pre-computed values corresponding to the extent of matchings of the primers and probes from NAAT database methods against high-quality, full length genomic sequences, which are made available by GISAID to enable this analysis.
EUnetHTA publications repository

EUnetHTA - European Network for Health Technology Assessment – developed a COVID-19-related repository of publications and outputs produced jointly or by individual HTA organisations on testing methods and devices for SARS-COV-2.
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This section allows surfing in and mining of data and analyses performed on SARS-CoV-2 sequences, like detectability of NAAT amplicons, and the phylodynamics of the pandemic in the European Union countries.

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Information for manufacturers

Submit / Update your device

Manufacturers are invited to submit information on new devices not yet listed or to provide performance data not available to the authors at the time of the last update. The submitted information, once verified against the source provider, will be taken into consideration for updating the database.
- Submit a NEW nucleic acid - PCR based device
- Submit a NEW immunoassay device
- Update a REGISTERED nucleic acid - PCR based device
- Update a REGISTERED immunoassay device
- Submit a NEW PCR-based molecular assay
Submit info for the EU common list on RAT

Manufacturers are invited to submit information and data on rapid antigen tests and lab-based antigenic assays for possible inclusion in the HSC common list/HSC mutually recognition list. The submitted information, once verified against the source provider, will be forwarded to the HSC Technical Working Group on COVID-19 diagnostic tests for evaluation and review.
- Submit/update info on a rapid antigen test
- Submit/update info on a lab-based antigenic assay

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