Ref. Ares(2022)552359 - 24/01/2022
From:
SANTE C3 HSC
Sent:
mercredi 26 mai 2021 13:50
To:
SANTE C3 HSC
Subject:
URGENT - Availability of RATs in JRC database
Dear members of the Health Security Committee,
Dear colleagues,
As discussed at the HSC meeting today, it is of great importance that
all the rapid antigen tests included
in the HSC agreed RAT common list are also available in the JRC COVID-19 In Vitro Diagnostic Devices
and Test Methods Database. As the information encoded in the JRC database will be linked to the
future EU Digital COVID-19 Certificate, it is key that relevant manufacturers provide the JRC with details
of their product. This will allow for the creation of the future digital COVID-19 test certificates to be
carried by travellers and that can be based on the results of rapid antigen tests included in the HSC
agreed list.
More specifically, there are currently
12 rapid antigen tests of which the HSC agreed that they should be
included in the RAT common list, but which are not in the JRC database. You will find the details below.
We would like to urge you, and in particular those countries that are using these RATs in practice, to
ensure that the companies will provide JRC with the necessary details so that their device can be
included and thus used for the creation of the future EU Digital COVID-19 test certificates.
Manufacturers can provide the necessary information here:
EUSurvey - Survey (europa.eu). To ensure the swift and timely continuation of the development of the EU Digital COVID-19 Certificate,
companies are required to submit the relevant data by 31 May the latest.
Kind regards,
HSC Secretariat
12 rapid antigen tests of the HSC agreed RAT list that are currently not included in the JRC database:
Manufacturer
Commercial name
Countries that are known to
be using the RAT in practice
1
AESKU.DIAGNOSTICS GmbH & Co, KG
AESKU.RAPID SARS-CoV-2
AT, DE, SI
2
Affimedix
TestNOW® - COVID-19 Antigen
DE
3
AXIOM Gesellschaft für Diagnostica und
COVID-19 Antigen Rapid Test
DE
Biochemica mbH
4
Core Technology Co., ltd
Canea Covid-19 Antigen Rapid Test
DE
5
Hangzhou Immuno BiotechCo., Ltd
SARS-CoV2 Antigen Rapid Test
AT, DE
6
Hangzhou Lysun Biotechnology Co., Ltd.
COVID-19 antigen Rapid Test Device (Colloidal
DE, CH
Gold)
7
Lumigenex (Suzhou) Co., Ltd
PocRoc SARS-Cov-2 Antigen Schnellnachweiskit
DE
(Gold kolloidal)
8
nal von minden GmbH
NADAL COVID -19 Ag +Influenza A/B Test
DE
9
PerGrande Biotech Development Co., Ltd.
SARS-CoV-2 Antigen Detection Kit (Colloidal Gold
AT, DE
Immunochromatographic assay)
10
Shenzhen Lvshiyuan Biotechnology Co.,
Green Spring SARS-CoV-2 Antigen-Rapid test-Set
DE
Ltd.
11
VivaChek Biotech (Hangzhou) Co., Ltd.
Vivadiag Pro SARS-CoV-2 Ag Rapid Test
AT
12
Wuhan EasyDiagnosis Biomedicine Co., Ltd. Antigen-Testkit for COVID-19 (SARS-Cov-2)
DE