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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

Additional information for manufacturers

This page contains additional and important information for manufacturers.
Manufacturers are invited to visit this page regularly in order to be timely informed on relevant news and updates.

  • 26-01-2022 Omicron variant have been added

    During recent meetings, the Technical Working Group discussed the performance of rapid antigen tests in the context of the emerging Omicron variant of concern. In particular, concerns were raised about rapid antigen devices that are solely targeting the spike protein (thus not combined with the nucleocapsid protein) as well as the viral load measured at different time points and at different sites (e.g. throat and nose) after Omicron infection. The Technical Working Group will continue monitoring the situation including emerging evidence on the potential impact of the Omicron variant of concern on the performance of COVID-19 rapid antigen tests and, if necessary, amend the agreed criteria accordingly. For the time being, rapid antigen tests that target the S-protein or for which the target protein is unknown have been highlighted in the EU common list. Moreover, an additional column has been added where information is presented – either from published studies or data submitted by the manufacturer - on the performance of the device in relation to the detection of Omicron infection.

    This has been reflected in the database, where new fields to provide information related to Omicron variant have been added. Manufacturers are kindly requested to fill these additional fields.

    Also the forms of the surveys to submit applications for evaluation for possible inclusion in the Health Security Committee common list have been updated accordingly.

  • 10-11-2021 Rapid antigen tests that use a mix of different sampling materials

    As stated in the latest version of the document EU health preparedness: A common list ofCOVID-19 rapid antigen tests and a common standardised set of data to be included in COVID-19 test result certificates, Rapid antigen tests that are using a mix of different sampling materials (i.e. nasal, oropharyngeal and/or nasopharyngeal swabs as well as other specimen types such as saliva) can be included in the EU common list. However, the validation studies of such tests should present the results and data for each specimen type separately.

    Only the validation results based on nasal, oropharyngeal and/or nasopharyngeal swabs of such devices will be reviewed by the Technical Working Group and assessed against the specified criteria.

    Only test results based on nasal, oropharyngeal and/or nasopharyngeal specimens should be valid for the issuance of test certificates for the EU Digital COVID Certificate.

    Rapid antigen tests that are solely based on other sampling materials, such as saliva, sputum, blood and/or faeces, are not included in the EU common list of antigen tests, as well as rapid antigen self-tests.

  • 04-11-2021 Triton X-100

    Note concerning Triton X-100 in rapid test kits
    If Triton X-100 is contained in the rapid test kit this needs an authorisation under the REACH Regulation. The latest application date is 22 June 2022. If you intend to apply, please make a notification to the European Chemicals Agency (ECHA) here
    This will enable the Agency to give procedural advice to Manufacturers and be prepared to receive applications.