Ref. Ares(2022)487558 - 21/01/2022
EUROPEAN COMMISSION
DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY
Public health, country knowledge, crisis management
Health Security
EU health preparedness:
A common list of COVID-19 rapid antigen tests and a
common standardised set of data to be included in
COVID-19 test result certificates
Agreed by the Health Security Committee
This document was agreed by the HSC on 17 February 2021
Annex I
Common list of COVID-19 rapid antigen tests
A first update was agreed by the HSC on 10 May 2021; A second update was agreed by the HSC on
16 June 2021; A third update was agreed by the HSC on 7 July 2021; A fourth update was agreed by
the HSC on 14 July 2021; A fifth update was agreed by the HSC on 23 July 2021.
IMPORTANT: A (interim) grace period of 8 weeks applies whenever updates are made to
Annex I, the common list of COVID-19 rapid antigen tests
Annex II
Common standardised data set to be included in COVID-19 test result certificates
An update to Annex II was agreed by the HSC on 19 March 2021
I.
Introduction
Robust testing strategies are an essential aspect of preparedness and response to the COVID-
19 pandemic, allowing for early detection of potentially infectious individuals and providing
visibility on infection rates and transmission within communities. Moreover, they are a
prerequisite to adequate contact tracing to limit the spread through prompt isolation. Also in
the context of the circulation of SARS-CoV-2 variants of concern, surge testing in addition to
existing testing deployment has proven to be key for controlling and suppressing further
spread of the virus.
While the reverse transcription real-time polymerase chain reaction (RT-PCR) assay, which is
a nucleic acid amplification test (NAAT), remains the ‘gold standard’ for COVID-19
diagnosis, rapid antigen tests, which detect the presence of viral proteins (antigens), are
increasingly being used by Member States as a way of further strengthening countries’ overall
testing capacity, particularly in case of limited NAAT capacities or where prolonged testing
turnaround times results in no clinical utility.
The Health Security Committee agreed on 17 September 2020 on Recommendations for a
common EU testing approach for COVID-191, setting out various actions for consideration by
countries when updating or adapting their testing strategies. The Recommendations included
Member States’ first experiences with rapid antigen tests and their deliberations concerning
the settings and situations in which these tests should be used. Since then, the Committee has
been discussing the use and application of rapid antigen tests in great depth, and has brought
together a wealth of (technical) information on the types of tests used in European countries
and the conditions applied.
On 21 January 2021, Member States unanimously agreed on a Council Recommendation
setting a common framework for the use of rapid antigen tests and the mutual recognition of
COVID-19 test results across the EU2. The Council Recommendation called on Member
States to agree on three concrete deliverables:
1.
A common list of COVID-19 rapid antigen tests that are considered appropriate for
use in the context of the situations described in the Council Recommendation, that are
in line with countries’ testing strategies and that:
a. carry CE marking;
b. meet the minimum performance requirements of ≥ 90% sensitivity and ≥ 97%
specificity; and
c. have been validated by at least one Member State as being appropriate for their
use in the context of COVID-19, providing details on the methodology and
results of such studies, such as the sample type used for validation, the setting
in which the use of the test was assessed, and whether any difficulties occurred
as regards the required sensitivity criteria or other performance elements.
1 https://ec.europa.eu/health/sites/health/files/preparedness_response/docs/common_testingapproach_covid-
19_en.pdf
2 https://data.consilium.europa.eu/doc/document/ST-5451-2021-INIT/en/pdf
2
2. A selection of rapid antigen tests of which Member States will
mutually recognise
the test results for public health measures.
3.
A common standardised set of data to be included in COVID-19 test result
certificates, further facilitating the mutual recognition of COVID-19 test results.
Based on the information collected by the Health Security Committee (HSC), and taking into
consideration the current epidemiological situation and the testing strategies and approaches
that have been put in place across the EU, this document sets out the deliverables as agreed by
Member States. Its content is prepared based on the criteria set out in the Council
Recommendation and further criteria agreed by Member States, and considers the relevant
recommendations published by the Commission3 as well as technical guidance issued the
European Centre for Disease Prevention and Control (ECDC)4 and the World Health
Organization (WHO)5.
II.
Annex I: Common list of rapid antigen tests
Point 11 of the Council Recommendation of 21 January 2021, calls on Member States to,
without prejudice to Directive 98/79/EC, agree on and maintain a common and updated list of
COVID-19 rapid antigen tests that are considered appropriate for use in the context of the
situations described under point 6 and are in line with countries’ testing strategies. Moreover,
the antigen tests included in the list should meet the three performance criteria as outlined in
section I of this document.
This list should be shared with ECDC and the Commission to prevent duplication of work and
to feed into ongoing initiatives, particularly the “COVID-19 In Vitro Diagnostic Devices and
Test Methods Database6, hosted by the Joint Research Centre (JRC).
Annex I to this
document sets out a common list of rapid antigen tests that meet the criteria as specified
by the Council. This list has been incorporated by the JRC in its COVID-19 In Vitro
Diagnostic Devices and Test Methods Database.
A first update to Annex I was agreed by the Health Security Committee on 10 May 2021, a
second update on 16 June 2021, a third update on 7 July 2021, a fourth update on 14 July
2021, and a fifth update on 23 July 2021.
The common list of rapid antigen tests is regularly being reviewed by Member States, and, if
necessary, be updated in line with new results from independent validation studies becoming
available and new tests entering the markets. These updates are also taking into account how
mutations of the SARS-CoV-2 virus may affect the efficacy of any particular rapid antigen
tests, allowing for the removal of tests no longer deemed effective. The effect of mutations of
3 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32020H1595 and https://eur-lex.europa.eu/legal-
content/EN/TXT/PDF/?uri=CELEX:32020H1743&from=EN
4 https://www.ecdc.europa.eu/en/publications-data/options-use-rapid-antigen-tests-covid-19-eueea-and-uk
5 https://www.who.int/publications/i/item/9789240017740
6 https://covid-19-diagnostics.jrc.ec.europa.eu/devices
3
the SARS-CoV-2 virus on the efficacy of NAAT, in particular RT-PCR assays, will also be
kept under review.
On 7 July 2021, the HSC agreed that a (interim) grace period of 8 weeks applies whenever
updates are made to Annex I, the common list of COVID-19 rapid antigen tests. The grace
period, which will be further discussed by the HSC during summer 2021 and for which a new
duration may be set in the future, applies to both the inclusion of new devices as well as the
removal of rapid antigen tests that are included in the list.
As stipulated in point 15 of the Council Recommendation of 21 January 2021, Member States
will agree on a selection of rapid antigen tests of which they will mutually recognise the test
results for public health measures. The Health Security Committee agrees that, considering
that
all of the rapid antigen tests included in the EU common list are eligible for a test
certificate issued as part of the EU Digital COVID Certificate7, the entire list is considered to
consist of rapid antigen tests of which Member States mutually recognise the test results for
public health measures.
III. HSC Technical Working Group on COVID-19 Diagnostic Tests
Based on the increasing political and commercial interest in the HSC agreed common list of
rapid antigen tests, particularly in the context of the EU Digital COVID Certificate8, there is a
need to put in place a more structured, coherent and swift procedure for updating the common
list of rapid antigen tests. As a first step, since 10 May 2021, it is now possible for
manufacturers to submit data and information concerning rapid antigen tests that they believe
should be considered for inclusion in the HSC agreed common list. This information will thus
be reviewed and considered alongside the proposals put forward by EU Member States.
Secondly, a HSC Technical Working Group on COVID-19 Diagnostic Tests was set up. This
Working Group, consisting of technical experts from EU and EEA Member States, will be
responsible for reviewing the information submitted by countries and manufacturers, taking
into account the latest result of independent validation studies and country practices and
experiences. Based on this, the technical working group will present proposals to the HSC for
further updates to the common list of rapid antigen tests. The HSC will thus remain the
platform where agreement between Member States is reached for updates to the list.
On 29 June 2021, the experts of the Technical Working Group agreed on (interim) definitions
and criteria that should be considered for independent validation studies assessing the clinical
performance of rapid antigen tests for COVID-19 diagnosis. There was a strong need to set
these further criteria in addition to the ones presented in Council Recommendation
2021/24/01 for the accurate assessment of proposals put forward. As of 29 June, the following
additional criteria have been taken into account by the Technical Working Group during their
review process, and will stay in place until further notice:
7 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32021R0953
8 https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32021R0953&from=EN.
4
Agreed (interim) definition of an independent validation study:
A study that may involve collaborations with or that may involve funding by private
entities, however, there is always a public body involved and the study is performed
objectively and in the public interest.
Agreed (interim) clinical performance criteria for independent validation studies:
In independent evaluations of unselected participants, assays should have a sensitivity
of 90% or greater for subjects with a Ct < 25, in symptomatic people (positive samples
from early infection within the first 7 days after symptom onset).
When this data is not yet available, for an interim period, a sensitivity of over 80%
when testing unselected symptomatic participants, where the diagnosis is confirmed
by PCR in independent field studies, will be accepted.
Target population considered in the context of an independent validation study should
be based on at least 100 positive samples and at least 100 negative samples.
In all cases: assays should have a specificity of at least 98%.
In all cases: samples should have been compared against PCR/NP swab (gold
standard).
As a wide range of different methodologies and protocols are being applied in countries,
discussions on further criteria and definitions will continue, with the overall goal to agree on
and develop an EU harmonised approach for validation studies assessing the clinical
performance of COVID-19 rapid antigen tests. This guidance is expected to be agreed in the
course of summer 2021, also taking into account the ongoing work by the In Vitro
Diagnostics Working Group of the Medical Device Coordination Group (MDCG IVD WG)
regarding guidance on the performance of COVID-19 tests in the context of CE-marking and
common specifications under Article 9 of Regulation (EU) 2017/7469.
Moreover, on 6 July 2021, the experts of the Technical Working Group agreed that:
At the moment, the HSC agreed that the common list of rapid antigen tests only
includes
rapid antigen tests for which their clinical performance was measured
based on samples collected from nasal, oropharyngeal or nasopharyngeal
specimens.
Rapid antigen tests that are based on other samples, such as saliva, sputum and/or
faeces, are not included.
The Technical Working Group will continue to monitor the development of these tests
and will, if deemed necessary, consider their inclusion once relevant evidence and data
has become available.
Similarly, at the moment, the HSC agreed that the common list of rapid antigen tests
only includes those tests that are
conducted by trained healthcare personnel or
9 The Medical Device Coordination Group is set up according to Art. 103 of Regulation (EU) 2017/745 and Art.
98 of Regulation (EU) 2017/746. This group is also responsible for overseeing the implementation of Directive
98/79/EC. See also Register of Commission Expert Groups and Other Similar Entities, code number X03565,
and its subgroups.
5
trained operators where appropriate (in line with Commission Recommendation
(EU) 2020/1743 of 18 November 2020).
Rapid antigen self-tests are not included.
The Technical Working Group will continue to monitor the development of rapid
antigen self-tests and will, if deemed necessary, consider their inclusion once relevant
evidence and data has become available.
Laboratory-based antigenic assays (e.g. enzyme immunoassays such as ELISA or
automated tests) should also be reviewed by the HSC technical working group on
COVID-19 diagnostic tests.
As of 8 July 2021, it is possible for manufacturers and countries to put forward
proposals for lab-based antigenic assays for review.
As of September 2021, the technical working group will start reviewing the proposals
and initiate discussions on these assays. The proposals will, in first instance, be
assessed against the same criteria as described by Council Recommendation
2021/24/01 and as agreed by the experts of the Technical Working Group on 29 June
2021. Further criteria for lab-based antigenic assays may be defined at a later stage.
IV. Annex II: Common standardised set of data for COVID-19 test certificates
In order to facilitate in practice the mutual recognition of results of rapid antigen tests as well
as NAAT, including RT-PCR assays, point 18 of Council Recommendation 2020/1475
defines that Member States should agree on a common standardised set of data to be included
in the form for test result certificates.
Based on information that was submitted by members of the Health Security Committee in
response to a survey on mutual recognition on COVID-19 test results and further discussions
that took place in the context of the Health Security Committee, Member States agree on
the
common standardised set of data for COVID-19 test result certificates as presented in
Annex II. Member States agree that COVID-19 test results should be made available in the
national language(s) of the country where the test was taken, as well as English.
An update to this Annex was agreed by the Health Security Committee on 19 March 2021,
addressing input received from the eHealth Network and in particular the Semantic Subgroup
and based on discussions that took place in the context of the EU Digital COVID Certificate.
The Health Security Committee will discuss, whenever relevant, possible updates to the
agreed common standardised set of data for COVID-19 test certificates, and publish, if
necessary, an updated agreed document.
6
ANNEX I: Common list of rapid antigen tests10
As agreed by Member States on 23 July 2021
Disclaimer: This list was agreed by the HSC based on a proposal by the Technical Working Group on COVID-19 Diagnostic Tests. Experts participating in the Technical
Working Group strongly recommend that use of rapid antigen tests is primarily intended for preliminary testing for SARS-CoV-2 infection in symptomatic patients, and note
that rapid antigen tests should in particular be used in the specific contexts and circumstances referred to by the Commission Recommendation (EU) 2020/1743 of 18
November 2020 and the technical guidance by ECDC on 19 November 2020. The content of the common list is based on the clinical performance data and information that is
available at this moment in time. The common list of rapid antigen tests does not include rapid antigen self-tests nor rapid antigen tests that are based on samples other than
those collected from nasal, oropharyngeal or nasopharyngeal specimens. Updates to the common list are based on the criteria as described in Council Recommendation
2021/C 24/01 as well as the additional criteria and definitions agreed by the Technical Working Group on 29 June 2021. Discussions on criteria and definitions will continue
during summer 2021, also taking into consideration the work carried out by the In Vitro Diagnostics Working Group of the Medical Device Coordination Group9 on
guidance on the performance of COVID-19 tests in the context of CE-marking and common specifications under Article 9 of Regulation (EU) 2017/746.
Clinical
Other
EU Member
Completed
Device ID #
Included in
CE
performance
Clinical performance
countries
MS currently
Manufacturer
RAT commercial name
FIND evaluation studies States using in
validation
in JRC
Common list
marking
Data by
Data used in MS
using in
validating
practice
studies
database11
of RATs as of:
manufacturer
practice
BE: 96.6% sensitivity, 100% specificity, NP
swab
COVID-VIRO® Rapid
96.6% sensitivity
FR
AAZ-LMB
Yes
FR: >95%% sensitivity, 100% specificity
BE, FR, SI
CH
1833
10 May 2021
antigen test COVID-19
100% specificity
CH
SI: 96.6% sensitivity, 100% specificity, NP
swab
BE[6]:
DE (10 Dec 2020)
Small-scale head-to-head comparison of 5
91.4% sensitivity
1108 samples, NP swab
RATs in Belgian hospital lab. Panbio overall
99.8% specificity
Clinical sensitivities:
AT, BE, BG, CY,
sensitivity (Ct range 14,6 – 35,5): 45/57
NP swab (Ct ≤ 33)
- Days < 7: 90.8%;
CZ, DE[2], DK,
samples (79%). Sensitivity for Ct≤25: 17/18
DE[2], ES, FI,
Abbott Rapid
Panbio™ COVID-19 Ag
- Ct < 33: 88.3%;
EE, EL, ES, FR[1], CH, ME, MK,
CY, ES, HR,
17 February
Yes
samples. Overall specificity 100%.
NL[5], PT
1232
Diagnostics
Rapid Test
98.1% sensitivity
- Ct < 25: 95.8%;
HR, IT, LT, LV,
NO, UK, UA
HU, IE, LU, SE
2021
CH, NO
99.8% specificity
Clinical specificity: 99.9% MT, NL[5], PL,
DE:
Nasal swab (Ct ≤
PT, RO, SE, SK
91.4% sensitivity 99.8% specificity, NP
33)
swab; 98.1% sensitivity, 99,8 specificity,
CH (10 Dec 2020)
Nasal swab
535 samples, NP swab
10 This is the list of rapid antigen tests as referred to in Article 3 of the Regulation (EU) 2021/953 of the European Parliament and of the Council of 14 June 2021 on a framework for the
issuance, verification and acceptance of interoperable COVID-19 vaccination, test and recovery certificates (EU Digital COVID Certificate) to facilitate free movement during the COVID-19
pandemic, OJ L 211, 15.6.2021, p. 1–22.
11 See
: https://covid-19-diagnostics.jrc.ec.europa.eu/.
Clinical
Other
EU Member
Completed
Device ID #
Included in
CE
performance
Clinical performance
countries
MS currently
Manufacturer
RAT commercial name
FIND evaluation studies States using in
validation
in JRC
Common list
marking
Data by
Data used in MS
using in
validating
practice
studies
database11
of RATs as of:
manufacturer
practice
Clinical sensitivities:
FI:
- Days < 7: 85.6%;
Validated in several laboratories (studies
- Ct < 33: 89.7%;
not published), meeting criteria.
- Ct < 25: 96.8%;
Clinical specificity: 100%
India (25 June 2021)
526 samples, NP swab
Clinical sensitivities:
- Days < 7: 61.3%-100%;
- Ct < 33: 74.2%-86.7%;
- Ct < 25: 91.9%-100%;
Clinical specificity: 100%
DE:
Acon Biotech
SARS-CoV-2 Antigen
96.9% sensitivity
Positive evaluation by Paul-Ehrlich-Institut
(Hangzhou) Co.,
Yes
DE[2], FR, PT
DE[2]
1457
14 July 2021
Rapid Test
Nasal swab
(sensitivity of 94,1% at <Ct25) +
Ltd
Manufacturer specificity: 99.54%xx%
BE:
CH (9 June 2021)
96.9% sensitivity, 99.5% specificity, NP
279 samples, nasal swab
swab
Clinical sensitivities:
ACON
Flowflex SARS-CoV-2
96.9% sensitivity
AT, BE, DE[2],
Yes
- Days < 7: 92.2%;
DE[2]
1468
10 May 2021
Laboratories, Inc. Antigen Rapid Test
Nasal swab
DE:
LT, LV, SI
Positive evaluation by Paul-Ehrlich-Institut - Ct < 33: 98.3%;
(sensitivity of 94,1% at <Ct25) +
- Ct < 25: 100%;
Manufacturer specificity: 98,7%
Clinical specificity: 99.5%
DE:
AESKU.DIAGNOS
96% sensitivity
96% sensitivity, 98% specificity
AESKU.RAPID SARS-CoV-
TICS GmbH & Co,
Yes
98% specificity
AT, DE[2], SI
DE[2]
2108
10 May 2021
2
SI:
KG
NP swab
96% sensitivity, 98% specificity, Nasal
swab
DE:
96.1% sensitivity
TestNOW® - COVID-19
Positive evaluation by Paul-Ehrlich-Institut
Affimedix Inc.
Yes
99.4% specificity
DE[2]
DE[2]
2130
10 May 2021
Antigen Test
(sensitivity of 100% at <Ct25) +
NP swab
Manufacturer specificity: 99,4%
BE: 97.3% sensitivity, 100% specificity, NP
97.3% sensitivity
swab
AMEDA
NP swab
AMP Rapid Test SARS-
AT, BG, DE[2]
DE[2]
17 February
Labordiagnostik
Yes
97.3% sensitivity
DE: Positive evaluation by Paul-Ehrlich-
CH, UA
HR
1304
CoV-2 Ag
HR, SI
CH
2021
GmbH
Nasal swab
Institut (sensitivity of 100% at <Ct25) +
100% specificity
Manufacturer specificity: 100%
8
Clinical
Other
EU Member
Completed
Device ID #
Included in
CE
performance
Clinical performance
countries
MS currently
Manufacturer
RAT commercial name
FIND evaluation studies States using in
validation
in JRC
Common list
marking
Data by
Data used in MS
using in
validating
practice
studies
database11
of RATs as of:
manufacturer
practice
SI:
97.3% sensitivity, 100% specificity, NP
swab
Anbio (Xiamen)
Rapid COVID-19
DE:
Biotechnology
Antigen-Test (colloidal
Yes
AT, DE[2]
DE[2]
1822
10 May 2021
99.27% sensitivity, 100% specificity
Co., Ltd
Gold)
Nasal swab: 96,4%
sensitivity, 99,8%
BE: 95% sensitivity, 99% specificity, NP/OP
specificity
Anhui Deep Blue
swab
COVID-19 (SARS-CoV-2)
NP swab: 95,7%
Medical
Antigen Test Kit
Yes
sensitivity, 99,3%
BE, DE[2]
UK
DE[2]
1736
10 May 2021
Technology Co.,
DE: Positive evaluation by Paul-Ehrlich-
(Colloidal Gold)
specificity
Ltd
Institut (sensitivity of 100% at <Ct25) +
OP swab: 96,4%
Manufacturer specificity: >99%
sensitivity, 99,8%
specificity
Anhui Deep Blue COVID-19 (SARS-CoV-2)
96.4 % sensitivity
Medical
Antigen Test Kit
Yes
99.8 % specificity
DE: 96,4 % sensitivity, 99,8 % specificity
DE[2]
DE[2]
1815
10 May 2021
Technology Co., (Colloidal Gold) – Nasal
Nasal swab
Ltd
swab
ArcDia
92% sensitivity
FI: Meets the minimum performance
mariPOC SARS-CoV-2
Yes
FI
FI
768
10 May 2021
International Ltd
100% specificity
requirements – see the report for details.
ArcDia
100 % sensitivity
FI:
International Oy mariPOC Respi+
Yes
100 % specificity
Validated in several laboratories (studies
FI, PT
FI
2078
14 July 2021
Ltd
NP swab
not published), meeting criteria.
ArcDia
100 % sensitivity
FI:
International Oy mariPOC Quick Flu+
Yes
100 % specificity
Validated in several laboratories (studies
FI, PT
FI
2079
14 July 2021
Ltd
NP swab
not published), meeting criteria.
96.67%
(Nasal)sensitivity
DE:
Artron
Artron COVID-19
91.67% (NP)
Positive evaluation by Paul-Ehrlich-Institut
Yes
DE[2]
DE[2]
1618
14 July 2021
Laboratories Inc. Antigen Test
sensitivity
(sensitivity of 100% at <Ct25) +
100 % specificity
Manufacturer specificity: 100%
Nasal/NP swab
Asan
Asan Easy Test COVID-
DE:
Pharmaceutical
Yes
DE[2]
DE[2]
1654
10 May 2021
19 Ag
94.67% sensitivity, 97.71% specificity
Co., Ltd
92.5 % sensitivity
DE:
Assure Tech.
ECOTEST COVID-19
99.2 % specificity
Positive evaluation by Paul-Ehrlich-Institut
(Hangzhou) Co., Antigen Rapid Test
Yes
DE[2]
DE[2]
770
14 July 2021
Nasal/NP/ OP
(sensitivity of 95% at <Ct25) +
Ltd.
Device
swab
Manufacturer specificity: 99.2%
9
Clinical
Other
EU Member
Completed
Device ID #
Included in
CE
performance
Clinical performance
countries
MS currently
Manufacturer
RAT commercial name
FIND evaluation studies States using in
validation
in JRC
Common list
marking
Data by
Data used in MS
using in
validating
practice
studies
database11
of RATs as of:
manufacturer
practice
DE:
Assure Tech.
ECOTEST COVID-19
Sensitivity: 97.7%, Positive evaluation by Paul-Ehrlich-Institut
(Hangzhou) Co., Antigen Rapid Test
Yes
Specificity: 99.1% (sensitivity of 95% at <Ct25) +
CZ, DE[2]
DE[2]
2350
23 July 2021
Ltd.
Device
NP and OP swab
Manufacturer specificity: 99.1%
NOVA Test ® SARS-CoV-
Atlas Link
2 Antigen Rapid Test Kit
98.5 % sensitivity
DE:
DE[2]
Technology Co.
(Colloidal Gold
Yes
99.4 % specificity
AT, DE[2], SI
CH
2010
10 May 2021
97.6% sensitivity, 99.2% specificity
CH
Ltd.
Immunochromatograph
Nasal/OP swab
y)
Clinical Sensitivity:
DE:
93.18 %
Ksmart® SARS-COV2
Positive evaluation by Paul-Ehrlich-Institut
Avalun
Yes
Clinical Specificity:
DE[2]
DE[2]
1800
7 July 2021
Antigen Rapid Test
(sensitivity of 94,1% at <Ct25) +
99.32 %
Manufacturer specificity: 99,32%
NP swab
AXIOM
98% sensitivity
Gesellschaft für
COVID-19 Antigen Rapid
DE:
Yes
100% specificity
DE[2]
DE[2]
2101
10 May 2021
Diagnostica und Test
98.1% sensitivity, 100% specificity
NP/Nasal swab
Biochemica mbH
95% sensitivity
Azure Biotech,
COVID-19 Antigen Rapid
DE:
Yes
99.2% specificity
DE[2]
DE[2]
1906
10 May 2021
Inc.
Test Device
94.3% sensitivity, 99.1% specificity
NP swab
NL:
Clinical Sensitivity: Independent field study in symptomatic
BD Veritor™ System for
91.1 %
individuals - sampling was Nasal mid-
Becton Dickinson Rapid Detection of SARS Yes
Clinical Specificity:
NL
NL
1065
7 July 2021
turbinate and OP swab. Sensitivity overall:
CoV 2
99.6 %
79.5% - Sensitivity Ct<30: 93.2% -
Nasal swab
Specificity overall: 99.8%
BE:
98.6% sensitivity, 100% specificity, NP
Swab
97.3% sensitivity, 99.2% specificity. OP
swab
Novel Coronavirus
Beijing Hotgen
97.1% sensitivity
DE:
AT, BE, DE[2],
2019-nCoV Antigen Test Yes
Ongoing
DE[2]
1870
10 May 2021
Biotech Co., Ltd
99.76% specificity Positive evaluation by Paul-Ehrlich-Institut
RO, SI
(Colloidal Gold)
(sensitivity of 100% at <Ct25) +
Manufacturer specificity: 99.76%
SI:
96.6% sensitivity, 99.8% specificity, NP
swab
10
Clinical
Other
EU Member
Completed
Device ID #
Included in
CE
performance
Clinical performance
countries
MS currently
Manufacturer
RAT commercial name
FIND evaluation studies States using in
validation
in JRC
Common list
marking
Data by
Data used in MS
using in
validating
practice
studies
database11
of RATs as of:
manufacturer
practice
Beijing Jinwofu
Novel Coronavirus
96.88 % sensitivity
DE:
Bioengineering
(SARS-CoV-2) Antigen
100 % specificity
Positive evaluation by Paul-Ehrlich-Institut
Yes
DE[2]
DE[2]
2072
14 July 2021
Technology
Rapid Test Kit
Nasal/ NP/ OP
(sensitivity of 100% at <Ct25) +
Co.,Ltd.
swab
Manufacturer specificity: 100%
BE:
Beijing Lepu
92% sensitivity, 99.3% specificity, Nasal
Medical
SARS-CoV-2 Antigen
92% sensitivity
AT, BE, DE[2],
17 February
Yes
UA
DE[2]
1331
Technology Co., Rapid Test Kit
Nasal swab
DE: 92.0% sensitivity, 99.26% specificity
SI, RO
2021
Ltd
SI: 92% sensitivity, 99.2% specificity, NP
Beijing Wantai
Biological
Wantai SARS-CoV-2 Ag
96.6% sensitivity,
DE:
17 February
Pharmacy
Yes
DE[2]
DE[2]
1484
Rapid Test (FIA)
Nasal swab
96.6% sensitivity, 96.9% specificity
2021
Enterprise Co.,
Ltd
Beijing Wantai
DE:
Biological
Wantai SARS-CoV-2 Ag
96.1 % sensitivity Positive evaluation by Paul-Ehrlich-Institut
Pharmacy
Rapid Test (colloidal
Yes
99% specificity
DE[2]
DE[2]
1485
14 July 2021
(sensitivity of 100% at <Ct25) +
Enterprise Co.,
gold)
Nasal swab
Manufacturer specificity: 99%
Ltd
HR:
Sensitivity: 96%,
300 NP samples (retrospective),
CoviGnost AG Test
BioGnost Ltd
Yes
Specificity: 99%
symptomatic (<7 dps): 200 PCR+ samples
HR
HR
2247
23 July 2021
Device 1x20
NP swab
(range Ct 16-30), Ct<30: sensitivity 96.5%
100 PCR- samples: specificity 100%
SARS-CoV-2 Antigen
DE:
BIOHIT
Rapid Test Kit
Sensitivity: 96.77% Positive evaluation by Paul-Ehrlich-Institut
Yes
HealthCcare
(Fluorescence
Yes
Specificity: 98.9%
DE[2]
DE[2]
23 July 2021
(sensitivity of 100% at <Ct25) +
(1286)
(Hefei) Co., Ltd.
Immunochromato-
NP/OP swab
Manufacturer specificity: 98.9%
graphy)
PL:
Sensitivity: 95%
SARS-CoV-2 Ag Rapid
Diagnostic sensitivity: 93.43% (95% CI:
Yes
BioMaxima SA
Yes
Specificity: 99%
PL
PL
23 July 2021
Test
91.61%~97.19%); diagnostic specificity:
(2035)
NP Swab
97.75%, manufacturer specificity: 99.1%
DE:
Biomerica COVID-19
Clinical Sensitivity: Positive evaluation by Paul-Ehrlich-Institut
Biomerica Inc.
Antigen Rapid Test
Yes
94.7 %
DE[2]
DE[2]
1599
7 July 2021
(sensitivity of 100% at <Ct25) +
(nasopharyngeal swab)
Nasal/NP swab
Manufacturer specificity: 99,7%
Brazil (20 April 2021)
Clinical Sensitivity:
DE:
400 samples, NP swab
NowCheck COVID-19 Ag
90.91 %
Positive evaluation by Paul-Ehrlich-Institut
BIONOTE
Yes
Clinical sensitivities:
DE[2]
DE[2]
1242
7 July 2021
Test
Clinical Specificity: (sensitivity of 100% at <Ct25) +
- Days < 7: 92.2%;
99.43 %
Manufacturer specificity: 98,6%
- Ct < 33: 91.4%;
11
Clinical
Other
EU Member
Completed
Device ID #
Included in
CE
performance
Clinical performance
countries
MS currently
Manufacturer
RAT commercial name
FIND evaluation studies States using in
validation
in JRC
Common list
marking
Data by
Data used in MS
using in
validating
practice
studies
database11
of RATs as of:
manufacturer
practice
- Ct < 25: 94.8%;
Clinical specificity: 97.3%
Brazil (30 March 2021)
218 samples, Nasal/NP
swab. Clinical sensitivities:
- Days < 7: 92.5% (N/NP);
- Ct < 33: 97.2% (N/NP);
- Ct < 25: 100% (N/NP);
Clinical specificity: 98.6%
Clinical Sensitivity:
ES:
98 % (NP Swab:
NP swab: sensitivity 98,3%; specificity
98,32% / Nasal
99,6% (119 positive samples, 746 negative
CORONAVIRUS AG
Swab: 97,25%)
BIO-RAD
Yes
samples)
ES
ES
2031
7 July 2021
RAPID TEST CASSETTE
Clinical Specificity: Nasal swab: sensitivity 97,2%; specificity
99 % (NP Swab:
100% (109 positive samples, 128 negative
99,6% / Nasal
samples)
Swab: 100%)
BE[6]:
Small-scale head-to-head comparison of 5
RATs in Belgian hospital lab. Biosynex
overall sensitivity (Ct range 14,6 – 35,5):
52/58 samples (89,7%). Sensitivity for
Ct≤25: 18/18 samples. Overall specificity
only 46,2%, but this is probably linked to
the use of transport medium instead of
96% sensitivity,
the swab included in the kit.
BIOSYNEX COVID-19 Ag
AT, BE, DE[2],
DE[2], NL[5],
17 February
BIOSYNEX S.A.
Yes
100% specificity,
CH
DK
1223
BSS
NP swab
DE:
DK,FR, NL[5], PT
CH
2021
Positive evaluation by Paul-Ehrlich-Institut
(sensitivity of 100% at <Ct25) +
Manufacturer specificity: 100%
NL:
Independent field study, mainly
symptomatic individuals, sensitivity Ct<30:
96.0%; specificity overall: 100%
FR:
BIOSYNEX COVID-19
Clinical Sensitivity: Validation study data: 125 positive and
BIOSYNEX SA
Yes
FR
FR
1494
7 July 2021
Ag+ BSS
97.5 %
118 negative samples; sensitivity 96%,
specificity: 99%
12
Clinical
Other
EU Member
Completed
Device ID #
Included in
CE
performance
Clinical performance
countries
MS currently
Manufacturer
RAT commercial name
FIND evaluation studies States using in
validation
in JRC
Common list
marking
Data by
Data used in MS
using in
validating
practice
studies
database11
of RATs as of:
manufacturer
practice
DE:
BIOTEKE
SARS-CoV-2 Antigen
96.49 % sensitivity Positive evaluation by Paul-Ehrlich-Institut
CORPORATION
Test Kit (colloidal gold
Yes
99.28 % specificity
DE[2]
DE[2]
2067
14 July 2021
(sensitivity of 95% at <Ct25) +
(WUXI) CO., LTD method)
OP/NP swab
Manufacturer specificity: 99.28%
BE:
Biotical Health
Sensitivity: 96%,
biotical SARS-CoV-2 Ag
Validation study 1: sensitivity 91.7% for
Yes
S.L.U.BIOTICAL
Yes
Specificity: 99%
BE
BE
23 July 2021
Card
Ct<25; Validation study 2: 94% for Ct<25.
(2013)
HEALTH S.L.U
NP swab
Manufacturer specificity: 99%
NL:
Independent field study in mild
Sensitivity: 91.7%,
Boditech Med
symptomatic (n= 427); overall sensitivity:
Yes
AFIAS COVID-19 Ag
Yes
Specificity: 98.7%
FR, NL
NL
23 July 2021
Inc
81.1% (106 PCR+), Ct <30: 96.4% (85
(1989)
NP swab
PCR+), PCR on NP+OP, Target antigen =
nucleoprotein
90.2% sensitivity
Rapid Response COVID-
100% specificity
DE:
BTNX Inc
Yes
AT, DE[2], ES, SI
DE[2]
1236
10 May 2021
19 Antigen Rapid Test
NP swab, NP swab, 94.55% sensitivity, 100% specificity
OP swab
ES:
92.9% sensitivity
CerTest SARS-CoV-2
Ct < 25, sensitivity: 94,0%; sensitivity for
17 February
CerTest Biotec
Yes
99.6% specificity
ES, PT, SI
DE[2], ES
1173
Card test
samples within the first 5 days after
2021
NP swab
symptom onset: 84,8%
98.1% sensitivity
Core Technology Coretests COVID-19 Ag
DE:
Yes
99.6% specificity
AT, DE[2], RO
DE[2]
1919
10 May 2021
Co., Ltd
Test
98.1% sensitivity, 99.6% specificity
NP swab
ES:
219 samples; Nasal swab - Clinical
sensitivity 86% (90%: Ct <30) Specificity:
Clinical Sensitivity: 100% (Method B)
92.3 %
OnSite COVID-19 Ag
CTK Biotech, Inc
Yes
Clinical Specificity:
To start
DK
DK, ES
1581
7 July 2021
Rapid Test
DK:
100 %
107 samples; Nasal swab - clinical
Nasal, NP swab
sensitivity 86%; (from asymptomatic and
mild symptomatic individuals), Clinical
specificity: 100%
Test Rapid Covid-19
98.77% sensitivity
RO:
RO
DDS DIAGNOSTIC Antigen (tampon
Yes
99.03% specificity Meets the minimum performance
RO
RO
1225
10 May 2021
China
nazofaringian)
Nasal swab
requirements.
BE:
DIAQUICK COVID -19 Ag
DIALAB GmbH
Yes
Z20401CE: 93.2% sensitivity, 100%
AT, BE, DE[2]
DE[2]
1375
10 May 2021
Cassette
specificity, NP swab
13
Clinical
Other
EU Member
Completed
Device ID #
Included in
CE
performance
Clinical performance
countries
MS currently
Manufacturer
RAT commercial name
FIND evaluation studies States using in
validation
in JRC
Common list
marking
Data by
Data used in MS
using in
validating
practice
studies
database11
of RATs as of:
manufacturer
practice
Z20601CE: 96.4% sensitivity, 99.2%
specificity, NP swab
DE: 97.3% sensitivity, 100% specificity
DE:
Sensitivity: 93.8%,
COVID-19 Antigen
Positive evaluation by Paul-Ehrlich-Institut
Yes
DNA Diagnostic
Yes
Specificity: 99.6%
DE[2]
DE[2]
23 July 2021
Detection Kit
(sensitivity of 100% at <Ct25) +
(2242)
Nasal swab
Manufacturer specificity: 99.56%
Peru (26 April 2021)
120 samples, NP swab
Edinburgh Genetics
DE:
Clinical sensitivities:
Edinburgh
ActivXpress+ COVID-19
Positive evaluation by Paul-Ehrlich-Institut
Yes
- Days < 7: 62%;
DE[2]
DE[2]
1243
14 July 2021
Genetics Limited Antigen Complete
(Sensitivity of 100% at <Ct25) +
- Ct < 33: 75%;
Testing Kit
Manufacturer Specificity: 99,24%
- Ct < 25: 100%;
Clinical specificity: 100%
DE:
Positive evaluation by Paul-Ehrlich-Institut
(sensitivity of 94,1% at <Ct25) +
Clinical Sensitivity: Manufacturer specificity: 99,1%
EBS SARS-CoV-2 Ag
Eurobio Scientific
Yes
95.7 %
DE[2], FR
DE[2], FR
1739
7 July 2021
Rapid Test
Nasal swab
FR:
Validation study data: 119 positive and
125 negative samples; sensitivity 93%,
specificity: 99%
DE (29 March 2021)
Clinical Sensitivity:
723 samples, NP swab
87.8 % ( (n=98,
DE:
Clinical sensitivities:
Ct<33))
Positive evaluation by Paul-Ehrlich-Institut
Fujirebio
ESPLINE SARS-CoV-2
Yes
- Days < 7: 88.5%;
DE[2]
DE[2]
2147
7 July 2021
Clinical Specificity: (sensitivity of 94,1% at <Ct25) +
- Ct < 33: 87.8%;
100 %
Manufacturer specificity: 99,13%
- Ct < 25: 92.4%;
NP swab
Clinical specificity: 100%
Sensitivity:
DE:
GA Generic
GA CoV-2 Antigen Rapid
97.059%,
Positive evaluation by Paul-Ehrlich-Institut
Yes
Yes
DE[2]
DE[2]
23 July 2021
Assays GmbH
Test
Specificity: 99.2% (sensitivity of 100% at <Ct25) +
(1855)
NP swab
Manufacturer specificity: 99.2%
90% sensitivity
Genbody COVID-19 Ag
17 February
GenBody Inc
Yes
98% specificity
DE: 90% sensitivity 98% specificity
Withdrawn
DE[2]
UA
DE[2]
1244
Test
2021
NP/OP swab
DE:
Sensitivity: 91.15%
Genrui Biotech
SARS-CoV-2 Antigen
Positive evaluation by Paul-Ehrlich-Institut
Yes
Specificity: 99.02%
DE[2]
DE[2]
2012
7 July 2021
Inc
Test Kit (Colloidal Gold)
(sensitivity of 94,1% at <Ct25) +
Nasal/NP/OP swab Manufacturer specificity: 99,02%
14
Clinical
Other
EU Member
Completed
Device ID #
Included in
CE
performance
Clinical performance
countries
MS currently
Manufacturer
RAT commercial name
FIND evaluation studies States using in
validation
in JRC
Common list
marking
Data by
Data used in MS
using in
validating
practice
studies
database11
of RATs as of:
manufacturer
practice
DE:
96.86% sensitivity,
GenSure Biotech GenSure COVID-19
Positive evaluation by Paul-Ehrlich-Institut
Yes
100% specificity
DE[2]
DE[2]
1253
10 May 2021
Inc
Antigen Rapid Test Kit
(sensitivity of 94,1% at <Ct25) +
Nasal swab
Manufacturer specificity: 100%
Getein Biotech,
SARS-CoV-2 Antigen
DE:
97.06% sensitivity
Inc
(Colloidal Gold)
Positive evaluation by Paul-Ehrlich-Institut
Yes
98.71% specificity
AT, DE[2]
DE[2]
1820
14 July 2021
(sensitivity of 100% at <Ct25) +
Nasal swab
Manufacturer specificity: 98.71%
DE:
One Step Test for SARS-
97.06% sensitivity
Getein Biotech,
Positive evaluation by Paul-Ehrlich-Institut
CoV-2 Antigen (Colloidal Yes
98.71% specificity
DE[2]
DE[2]
2183
16 June 2021
Inc.
(sensitivity of 90% at <Ct30 and 100% at
Gold)
Nasal swab
<Ct25)
Goldsite
SARS-CoV-2 Antigen Kit
DE:
BE, BG, CY, FR,
Diagnostic Inc.
(Colloidal Gold)
Yes
Positive evaluation by Paul-Ehrlich-Institut
UK
FR, DE[2], ES
1197
14 July 2021
RO, SI, ES
(sensitivity 100% at <Ct25)
100% sensitivity
BE:
Green Cross
GENEDIA W COVID-19
90.1% sensitivity
90.2% sensitivity, 100% specificity, NP
Medical Science
Yes
AT, BE, DE[2]
DE[2]
1144
10 May 2021
Ag
NP swab, Anterior swab
Corp.
nasal swab
DE: 90.1% sensitivity, 100% specificity
Guangdong
2019-nCoV Antigen Test
96.23% sensitivity
Hecin Scientific, Kit (colloidal gold
Yes
DE: 96.6% sensitivity, 99.07% specificity
AT, DE[2]
DE[2]
1747
10 May 2021
Nasal swab
Inc.
method)
Guangdong
COVID-2019-nCoV Ag
DE:
Longsee
Rapid TestDetection
99.72% specificity Positive evaluation by Paul-Ehrlich-Institut
Yes
DE[2]
DE[2]
1216
14 July 2021
Biomedical Co.,
Kit(Immuno-
NP/OP swab
(sensitivity of 100% at <Ct25) +
Ltd.
Chromatography)
Manufacturer specificity: 99.5%
DE:
Positive evaluation by Paul-Ehrlich-Institut
Guangdong
90% sensitivity
(sensitivity of 100% at <Ct25) +
17 February
Wesail Biotech
COVID-19 Ag Test Kit
Yes
98% specificity
Manufacturer specificity: 98%
DE[2], SI
DE[2]
1360
2021
Co. Ltd
Nasal swab
SI: 90% sensitivity, 98% specificity,
NP/Nasal swab
Guangzhou
V-CHEK, 2019-nCoV Ag
DE:
Clinical Sensitivity:
Decheng
Rapid Test Kit
Positive evaluation by Paul-Ehrlich-Institut
Yes
96.67 %
DE[2]
DE[2]
1324
7 July 2021
Biotechnology
(Immunochromatograp
(sensitivity of 94,1% at <Ct25) +
Nasal swab
CO., Ltd
hy)
Manufacturer specificity: 99,5%
BE:
CH (25 Feb 2020)
Guangzhou
Wondfo 2019-nCoV
96.2% sensitivity, 99.7% specificity, NP/OP 328 samples, NP swab
AT, BE, BG,
Wondfo Biotech Antigen Test (Lateral
Yes
swab
Clinical sensitivities:
CH
DE[2]
1437
10 May 2021
DE[2], FR
Co., Ltd
Flow Method)
- Days < 7: 85.7%;
DE: 96.18 % sensitivity, 99.72% specificity
15
Clinical
Other
EU Member
Completed
Device ID #
Included in
CE
performance
Clinical performance
countries
MS currently
Manufacturer
RAT commercial name
FIND evaluation studies States using in
validation
in JRC
Common list
marking
Data by
Data used in MS
using in
validating
practice
studies
database11
of RATs as of:
manufacturer
practice
- Ct < 33: 92.2%;
- Ct < 25: 100%;
Clinical specificity: 100%
DE:
Hangzhou Lysun COVID-19 Antigen Rapid
96.46% sensitivity Positive evaluation by Paul-Ehrlich-Institut
Biotechnology
Test Device (Colloidal
Yes
100% specificity
(sensitivity of 100% at <Ct25) +
DE[2]
CH
DE[2]
2139
10 May 2021
Co. Ltd
Gold)
Nasal swab
Manufacturer specificity: 100%
Hangzhou AllTest COVID-19 Antigen Rapid
AT, BE, BG, FR,
Yes
NP swab
DE: 93,40% sensitivity, 99,90% specificity
CH
DE[2]
AT
1257
10 May 2021
Biotech Co., Ltd Test
SI, RO
Clinical Sensitivity:
DE:
Hangzhou
91.4 %
COVID-19 Antigen Rapid
Positive evaluation by Paul-Ehrlich-Institut
Clongene
Yes
Clinical Specificity:
DE[2]
DE[2]
1610
7 July 2021
Test Casette
(sensitivity of 94,4% at <Ct25) +
Biotech Co., Ltd
100 %
Manufacturer specificity: 100%
NP swab
BE: 91.4% sensitivity, 100% specificity,
NP/OP swab
Hangzhou
98.5% (Ct<33)
Covid-19 Antigen Rapid
AT,BE, DE[2],
DE[2]
17 February
Clongene
Yes
sensitivity
DE: 91.4% sensitivity, 99.4% specificity
CH
HR
1363
Test Kit
FR, SI
CH
2021
Biotech Co., Ltd.
Nasal swab
SI: 91.4% sensitivity, 100% specificity,
NP/OP swab
Hangzhou
COVID-19/Influenza A+B
91% sensitivity
Clongene
Antigen Combo Rapid
Yes
100% specificity
DE: 97.7% sensitivity, 99.8% specificity
DE[2]
DE[2]
1365
10 May 2021
Biotech Co., Ltd. Test
NP swab
Immunobio SARS-CoV-2
Hangzhou
94% sensitivity
Antigen ANTERIOR
Immuno Biotech
Yes
100% specificity
DE: 94.39% sensitivity 97.67% specificity
DE[2]
DE[2]
1844
10 May 2021
NASAL Rapid Test Kit
Co., Ltd
Nasal swab, NP
(minimal invasive)
Clinical Sensitivity
Hangzhou
SARS-CoV2 Antigen
98 %
Immuno Biotech
Yes
DE: 95.6% sensitivity, 100% specificity
AT, DE[2]
DE[2]
2317
10 May 2021
Rapid Test
Clinical Specificity
Co., Ltd
100 %
Clinical Sensitivity:
LYHER Novel
DE:
95.07% %
Hangzhou Laihe Coronavirus (COVID-19)
Positive evaluation by Paul-Ehrlich-Institut
Yes
Clinical Specificity:
AT, DE[2]
CH
DE[2]
1215
10 May 2021
Biotech Co.
Antigen Test Kit
(sensitivity of 94,1% at <Ct25) +
99.74%
(Colloidal Gold)
Manufacturer specificity: 99,7%
Nasal swab
Hangzhou
92.1% sensitivity
Testsea
Covid-19 Antigen Test
Yes
98.1% specificity
DE: 97.6% sensitivity 98.4% specificity
DE[2]
DE[2]
1392
10 May 2021
Biotechnology
Cassette
Nasal swab
Co., Ltd.
16
Clinical
Other
EU Member
Completed
Device ID #
Included in
CE
performance
Clinical performance
countries
MS currently
Manufacturer
RAT commercial name
FIND evaluation studies States using in
validation
in JRC
Common list
marking
Data by
Data used in MS
using in
validating
practice
studies
database11
of RATs as of:
manufacturer
practice
DE: 97.25% sensitivity, 100% specificity
80.6 % sensitivity
Healgen
Coronavirus Ag Rapid
AT, DE[2], NL[5],
17 February
Yes
99.7% specificity
SI:
CH
DE[2], NL[5]
SE[3]
1767
Scientific
Test Cassette
SE, SI
2021
NP swab
96.7% sensitivity, 99.2% specificity,
NP/Nasal swab
DE:
Hubei Jinjian
SARS-CoV-2 Antigen
Sensitivity: 98.02%
Positive evaluation by Paul-Ehrlich-Institut
Yes
Yes
DE[2]
DE[2]
23 July 2021
Biology Co., Ltd
Test Kit
Nasal Swab
(sensitivity of 100% at <Ct25) +
(1759)
Manufacturer specificity: 99.3 %
BE:
95.5% sensitivity, 100% specificity, NP
swab
AT, BE, BG,
Humasis COVID-19 Ag
95.3% sensitivity
Humasis
Yes
DE[2], FR, HR,
DE[2]
HR, SE
1263
10 May 2021
Test
Nasal swab
DE: 95.5% sensitivity, 100% specificity
SE, SI
SI: 95.5% sensitivity, 100% specificity, NP
swab
Jiangsu
97.06 % sensitivity
DE:
Novel Corona Virus
Bioperfectus
99.15 % specificity Positive evaluation by Paul-Ehrlich-Institut
(SARS-CoV-2) Ag Rapid
Yes
DE[2]
DE[2]
2107
14 July 2021
Technologies
Nasal/NP/ OP
(sensitivity of 100% at <Ct25) +
Test Kit
Co., Ltd.
swab
Manufacturer specificity: 99.15%
Jiangsu
97.58 % sensitivity
DE:
COVID-19 Antigen Rapid
Diagnostics
100 % specificity
Positive evaluation by Paul-Ehrlich-Institut
Test Cassette (Colloidal Yes
DE[2]
DE[2]
1920
14 July 2021
Biotechnology
Nasal/NP/ OP
(sensitivity of 100% at <Ct25) +
Gold)
Co., Ltd
swab
Manufacturer specificity: 100%
Clinical Sensitivity:
Jiangsu
97.73 %
DE:
Medomics
SARS-CoV-2 antigen
Clinical Specificity: Positive evaluation by Paul-Ehrlich-Institut
medical
Yes
DE[2]
DE[2]
2006
7 July 2021
Test Kit (LFIA)
99.51 %
(sensitivity of 94,1% at <Ct25) +
technology
Anterior nasal
Manufacturer specificity: 99,51%
Co.,Ltd.
swab, NP swab
DE: 96.1% sensitivity, 98.1% specificity
Joinstar
96.1% sensitivity
Biomedical
COVID-19 Rapid Antigen
17 February
Yes
98.1% specificity
SI:
AT, DE[2], PT, SI
DE[2]
1333
Technology Co.
Test (Colloidal Gold)
2021
Nasal swab
96.1% sensitivity, 98.1% specificity, NP
Ltd
swab
CH (11 Feb 2021)
SARS-CoV-2 Antigen
265 samples, Nasal swab
JOYSBIO (Tianjin) Rapid Test Kit (Colloidal
CZ:
Clinical sensitivities:
98.13% sensitivity
CZ, DE[2]
Biotechnology
Gold
Yes
Meets the minimum performance
- Days < 7: 74.2%;
AT, CZ, SI
1764
10 May 2021
Nasal swab
CH
Co., Ltd.
immunochromatograph
requirements – se
e report for details.
- Ct < 33: 78.9%;
y)
- Ct < 25: 91.3%;
Clinical specificity: 99.1%
17
Clinical
Other
EU Member
Completed
Device ID #
Included in
CE
performance
Clinical performance
countries
MS currently
Manufacturer
RAT commercial name
FIND evaluation studies States using in
validation
in JRC
Common list
marking
Data by
Data used in MS
using in
validating
practice
studies
database11
of RATs as of:
manufacturer
practice
DE: 96.3% sensitivity, 97.3% specificity
Labnovation
SARS-CoV-2 Antigen
Yes
NP/OP swab
SI:
DE[2], IT, SI
DE[2]
1266
10 May 2021
Technologies Inc. Rapid Test Kit
96.3% sensitivity, 97.3% specificity, NP/OP
swab
DE:
PocRoc® SARS-CoV-2
93.33% sensitivity
Lumigenex
Positive evaluation by Paul-Ehrlich-Institut
Antigen Rapid Test Kit
Yes
99.16% specificity
DE[2]
DE[2]
2128
10 May 2021
(Suzhou) Co., Ltd
(sensitivity of 100% at <Ct25) +
(Colloidal Gold)
Nasal/NP/OP swab Manufacturer specificity: 99,16%
BE:
94% sensitivity, 99% specificity, NP swab
LumiQuick
QuickProfile™ COVID-19
DE: 93.7% sensitivity, 98.8% specificity
Yes
BE, DE[2] ,FR, SI,
DE[2]
1267
10 May 2021
Diagnostics Inc.
Antigen Test
SI:
93.7% sensitivity, 98.8% specificity, NP
swab
DE[2], ES,
DE:
SKUP –
93.8% sensitivity, 98.8% specificity
(Scandinavia
97.6% sensitivity
n evaluation
LumiraDx SARS-CoV-2
SI:
17 February
LumiraDX
Yes
96.6% specificity
To start
DE[2], ES, SI
CH
of laboratory
1268
Ag Test
97.6% sensitivity, 97.7% specificity,
2021
Nasal swab
NP/Nasal swab
equipment
for point of
SKUP/2021/124:
care testing)
90% sensitivity, 97,8% specificity, NP swab
CH
BE:
92.5% sensitivity
MEDsan SARS-CoV-2
92.5% sensitivity, 99.8% specificity,
DE[2]
17 February
MEDsan GmbH
Yes
99.8% specificity
AT, BE, DE[2]
CH
1180
Antigen Rapid Test
Nasal/OP swab
CH
2021
NP/OP swab
DE: 92.5% sensitivity, 99.8% specificity
Merlin
DE:
95.05% sensitivity
Biomedical
SARS-CoV-2 Antigen
Positive evaluation by Paul-Ehrlich-Institut
Yes
98.99% specificity
DE[2]
DE[2]
2029
16 June 2021
(Xiamen) Co.,
Rapid Test Cassette
(sensitivity of 90% at <Ct30 and 100% at
Nasal/NP swab
Ltd.
<Ct25)
DE:
Clinical Sensitivity:
MEXACARE
MEXACARE COVID-19
Positive evaluation by Paul-Ehrlich-Institut
Yes
96.17 %
DE[2]
DE[2]
1775
7 July 2021
GmbH
Antigen Rapid Test
(sensitivity of 100% at <Ct25) +
Nasal swab
Manufacturer specificity: 99,1%
mö-screen Corona
DE:
möLab
Yes
NP swab
DE[2], IE
DE[2], IE
1190
10 May 2021
Antigen Test
97.25% sensitivity , 99.99% specificity
18
Clinical
Other
EU Member
Completed
Device ID #
Included in
CE
performance
Clinical performance
countries
MS currently
Manufacturer
RAT commercial name
FIND evaluation studies States using in
validation
in JRC
Common list
marking
Data by
Data used in MS
using in
validating
practice
studies
database11
of RATs as of:
manufacturer
practice
96.17% sensitivity
BE:
99.16% specificity 96.4% sensitivity, 99% specificity, NP/OP
Rapid SARS-CoV-2
DE[2]
17 February
MP Biomedicals
Yes
Nasal swab,
swab
AT, BE, DE[2]
CH
1481
Antigen Test Card
CH
2021
Anterior nasal
DE:
swab
96.39 % sensitivity, 99.03% specificity
97% sensitivity
Nal von minden NADAL COVID -19 Ag
DE:
Yes
98% specificity
DE[2]
DE[2]
2104
10 May 2021
GmbH
+Influenza A/B Test
97.6% sensitivity, 99.9% specificity
NP swab
CH (26 April 2021)
BE: 97.6% sensitivity, 99.9% specificity,
462 samples, NP swab
97.6% sensitivity
NP/OP swab
Clinical sensitivities:
Nal von minden NADAL COVID -19 Ag
AT, BE, CY
DE[2], FR
17 February
Yes
99.9% specificity
DE:97.6% sensitivity, 99.9% specificity
- Days < 7: 88.5%;
HR, SKUP
1162
GmbH
Test
DE[2], FR, PT, SI
China
2021
Nasal swab
SI: 97.6% sensitivity, 99.9% specificity,
- Ct < 33: 92.4%;
NP/OP swab
- Ct < 25: 97.8%;
Clinical specificity: 99.2%
94.12% sensitivity
DE:
NanoEntek
FREND COVID-19 Ag
Yes
100% specificity
DE[2]
DE[2]
1420
10 May 2021
94.12% sensitivity , 100% specificity
NP swab
NanoRepro AG
NanoRepro SARS-CoV-2
DE:
97.2 % sensitivity
Antigen Rapid Test
Positive evaluation by Paul-Ehrlich-Institut
Yes
98.4% specificity
DE[2]
DE[2]
2200
14 July 2021
(sensitivity of 94,1% at <Ct25) +
Nasal/NP/OP swab Manufacturer specificity: 98.4%
Sensitivity:
ES:
MARESKIT COVID-19
NESAPOR
95.24%,
Independent validation study; Nasal test
Yes
ANTIGEN RAPID TEST
Yes
ES
ES
23 July 2021
EUROPA SL
Specificity: 100%
compared to nasal PCR. Sensitivity 95.24%,
(2241)
KIT
Nasal swab
Specificity 100%.
New Gene
DE:
(Hangzhou)
COVID-19 Antigen
98% sensitivity
Positive evaluation by Paul-Ehrlich-Institut
Yes
DE[2]
DE[2]
1501
16 June 2021
Bioengineering
Detection Kit
Nasal swab
(sensitivity of 92,5% at <Ct30 and 100% at
Co., Ltd.
<Ct25)
Novatech
SARS-CoV-2 Antigen
DE:
95 % sensitivity
Rapid Test
Positive evaluation by Paul-Ehrlich-Institut
Yes
100% specificity
DE[2]
DE[2]
1762
14 July 2021
(sensitivity of 94,1% at <Ct25) +
Nasal/ NP swab
Manufacturer specificity: 100%
DE:
Oncosem
93.75% sensitivity Positive evaluation by Paul-Ehrlich-Institut
Onkolojik
CAT
Yes
98.04% specificity (sensitivity of 94,1% at <Ct25) +
DE[2]
DE[2]
1199
10 May 2021
Sistemler San. ve
Nasal swab
Manufacturer specificity: 98,04%
Tic. A.S.
19
Clinical
Other
EU Member
Completed
Device ID #
Included in
CE
performance
Clinical performance
countries
MS currently
Manufacturer
RAT commercial name
FIND evaluation studies States using in
validation
in JRC
Common list
marking
Data by
Data used in MS
using in
validating
practice
studies
database11
of RATs as of:
manufacturer
practice
DE:
94,92 % sensitivity, 99,99 % specificity
PCL COVID19 Ag Rapid
PCL Inc.
Yes
FR, DE[2], RO, SI
DE[2]
308
10 May 2021
FIA
SI:
95.5% sensitivity, 98.6% specificity, NP/OP
swab, sputum
FR:
Validation study data: 120 positive and
PCL Inc.
PCL COVID19 Ag Gold
Yes
FR, PT
FR
2243
7 July 2021
200 negative samples; sensitivity 92%,
specificity: 100%
PerGrande Bio
SARS-CoV-2 Antigen
94.28% sensitivity
Tech
Detection Kit (Colloidal
DE:
Yes
99.11% specificity
AT, DE[2]
DE[2]
2116
10 May 2021
Development
Gold Immunochromato-
94.28% sensitivity, 99.11% specificity
NP/Nasal/OP swab
Co., Ltd.
graphic Assay)
DE:
93.9% sensitivity
Precision
93.88% sensitivity , 98% specificity
DE[2]
17 February
Exdia COVI-19 Ag
Yes
98% specificity
SI, DE[2]
CH
1271
Biosensor Inc.
CH
2021
NP swab
SI:93.9% sensitivity, 98% specificity, NP
swab
DE:
Clinical Sensitivity:
Prognosis
Rapid Test Ag 2019-
Positive evaluation by Paul-Ehrlich-Institut
Yes
95.56 %
CY, DE[2]
DE[2]
1495
7 July 2021
Biotech
nCov
(sensitivity of 94,1% at <Ct25) +
Nasal swab
Manufacturer specificity: 99,58%
SARS-CoV-2 Antigen
DE:
Qingdao Hightop Rapid Test
95% sensitivity
17 February
Yes
Positive evaluation by Paul-Ehrlich-Institut
AT, DE[2]
DE[2]
1341
Biotech Co. Ltd
(Immunochromatograp
Nasal swab
2021
(sensitivity of 100% at <Ct30 and 100% at
hy)
<Ct25)
BE:
96.7% sensitivity, 100% specificity,
NP/nasal swab
96.7% sensitivity
Quidel
DE:
AT, BE, DE[2],
DE[2], NL[5]
17 February
Sofia SARS Antigen FIA
Yes
100% specificity
CH
SI
1097
Corporation
96.7% sensitivity , 100% specificity
FI, NL[5], PT, SI
CH
2021
NP/Nasal swab
SI:
96.7% sensitivity, 100% specificity,
NP/Nasal swab
IT:
Sensitivity: 96.1%,
Rapid Pathogen LIAISON® Quick Detect
Independent validation study, 100 pos.
Yes
Yes
Specificity: 97%
IT
IT
23 July 2021
Screening, Inc
Covid Ag Assay
and 100 neg. samples; sensitivity: 92.7%
(2290)
NP and Nasal swab with Ct<25; specificity: 100%.
20
Clinical
Other
EU Member
Completed
Device ID #
Included in
CE
performance
Clinical performance
countries
MS currently
Manufacturer
RAT commercial name
FIND evaluation studies States using in
validation
in JRC
Common list
marking
Data by
Data used in MS
using in
validating
practice
studies
database11
of RATs as of:
manufacturer
practice
DE:
96.52% sensitivity, 99.68% specificity
96.52% sensitivity
Roche (SD
SARS-CoV-2 Rapid
AT, DE[2], MT,
Yes
99.2% specificity
CH, NO
DE[2], FI
1604
10 May 2021
BIOSENSOR)
Antigen Test
FI:
NL, RO
NP swab
Validated in several laboratories (studies
not published), meeting criteria.
DE (12 April 2021)
179 samples, nasal swab
Clinical sensitivities:
- Days < 7: 81.2%;
- Ct < 33: 87.5%;
Clinical Sensitivity:
- Ct < 25: 100%;
89.6 % ( (Ct ≤ 30)
DE:
Clinical specificity: 99.3%
Roche (SD
SARS-CoV-2 Rapid
93.1 % (Ct ≤ 27)
Yes
Positive evaluation by Paul-Ehrlich-Institut
DK, SK
CH, UK
DE[2]
2228
7 July 2021
BIOSENSOR)
Antigen Test Nasal
Clinical Specificity: (sensitivity of 89.6% at <Ct30)
Brazil (12 April 2021)
99.1 %
214 samples, nasal swab
Nasal swab
Clinical sensitivities:
- Days < 7: 81.2%;
- Ct < 33: 91.7%;
- Ct < 25: 100%;
Clinical specificity: 99.3%
Safecare Biotech COVID-19 Antigen Rapid
97.04% sensitivity
DE:
17 February
(Hangzhou) Co.
Yes
AT, DE[2], FR
CH
DE[2]
1489
Test Kit (Swab)
Nasal swab
97.27 % sensitivity , 99.42% specificity
2021
Ltd
Multi-Respiratory Virus
Safecare Biotech Antigen Test Kit (Swab)
97.04% sensitivity
DE:
(Hangzhou) Co.
Yes
DE[2]
DE[2]
1490
10 May 2021
(Influenza A+B/COVID-
Nasal swab
97.04% sensitivity , 99.44% specificity
Ltd
19)
DE:
96.6% sensitivity
ScheBo Biotech
ScheBo SARS CoV-2
Positive evaluation by Paul-Ehrlich-Institut
Yes
(Ct ≤ 30)
DE[2]
DE[2]
1201
16 June 2021
AG
Quick Antigen
(sensitivity of 95% at <Ct30 and 100% at
NP/ OP swab
<Ct25)
DE (12 April 2021)
FI:
179 samples, nasal swab
Validated in several laboratories (studies
Clinical Sensitivity:
Clinical sensitivities:
not published), meeting criteria.
97.12 %
- Days < 7: 81.2%;
STANDARD Q COVID-19
SD Biosensor Inc
Yes
Clinical Specificity:
- Ct < 33: 87.5%;
FI, PT, SK
DE[2], FI, FR
2052
7 July 2021
Ag Test Nasal
DE:
100 %
- Ct < 25: 100%;
Published study:
Nasal swab
Clinical specificity: 99.3%
https://www.medrxiv.org/content/10.110
1/2021.01.06.20249009v1
Brazil (12 April 2021)
21
Clinical
Other
EU Member
Completed
Device ID #
Included in
CE
performance
Clinical performance
countries
MS currently
Manufacturer
RAT commercial name
FIND evaluation studies States using in
validation
in JRC
Common list
marking
Data by
Data used in MS
using in
validating
practice
studies
database11
of RATs as of:
manufacturer
practice
214 samples, nasal swab
Clinical sensitivities:
- Days < 7: 81.2%;
- Ct < 33: 91.7%;
- Ct < 25: 100%;
Clinical specificity: 99.3%
DE (10 Dec 2020)
676 samples, NP swab
Clinical sensitivities:
- Days < 7: 81.2%;
- Ct < 33: 75%;
- Ct < 25: 100%;
Clinical specificity: 96.9%
Brazil (10 Dec 2020)
BE:
453 samples, NP swab
AT, BE, BG,
94,09% sensitivity 96.5% sensitivity, 99.7% specificity, NP
Clinical sensitivities:
DE[2], IT,
SD BIOSENSOR
STANDARD F COVID-19
DE[2], IT , LU,
17 February
Yes
98.52% specificity swab
- Days < 7: 80.2%;
CH
NL[5], DK
LU, PT
344
Inc.
Ag FIA
LV, NL[5], PT,
2021
NP swab
DE:
- Ct < 33: 80.9%;
CH, UK, BR
RO, SK
94% sensitivity 97% specificity
- Ct < 25: 87.9%;
Clinical specificity: 97.9%
India (25 June 2020)
417 samples, NP swab
Clinical sensitivities:
- Days < 7: 61.8%;
- Ct < 33: 53.6%;
- Ct < 25: 68.5%;
Clinical specificity: 99.5%
BE:
DE (10 Dec 2020)
96.5% sensitivity, 99.7% specificity, NP
1263 samples, NP swab
swab
Clinical sensitivities:
- Days < 7: 80%;
DE:
AT, BE, BG, CY,
- Ct < 33: 87.8%;
96.52% sensitivity, 99.68% specificity
DE[2], DK, EE,
DE[2], ES, IT,
96.52% sensitivity
- Ct < 25: 100%;
SD BIOSENSOR
STANDARD Q COVID-19
ES, FI, FR, HR,
NL[5], DK, PT HR, IE, LU, SI,
17 February
Yes
99.68% specificity
Clinical specificity: 99.3%
ME, NO, CH
345
Inc.
Ag Test
SI:
IT, LU, LV, MT,
CH, UA, UK,
SE
2021
NP swab
96.5% sensitivity, 99.7% specificity, NP
NL[5], PT, RO,
BR, NO
swab
Brazil (10 Dec 2020)
SE, SK, SI
400 samples, NP swab
FI:
Clinical sensitivities:
Validated in several laboratories (studies
- Days < 7: 90.7%;
not published), meeting criteria.
- Ct < 33: 91.9%;
22
Clinical
Other
EU Member
Completed
Device ID #
Included in
CE
performance
Clinical performance
countries
MS currently
Manufacturer
RAT commercial name
FIND evaluation studies States using in
validation
in JRC
Common list
marking
Data by
Data used in MS
using in
validating
practice
studies
database11
of RATs as of:
manufacturer
practice
- Ct < 25: 95.9%;
Clinical specificity: 97.6%
CH (10 Dec 2020)
529 samples, NP swab
Clinical sensitivities:
- Days < 7: 89.8%;
- Ct < 33: 91.8%;
- Ct < 25: 97.2%;
Clinical specificity: 99.7%
India (22 April 2021)
334 samples, NP swab
Clinical sensitivities:
- Days < 7: 58.3%;
- Ct < 33: 65.5%;
- Ct < 25: 89.4%;
Clinical specificity: 97.3%
Peru (22 April 2021)
335 samples, NP swab
Clinical sensitivities:
- Days < 7: 81.4%;
- Ct < 33: 83.3%;
- Ct < 25: 96.2%;
Clinical specificity: 99.6%
V-Chek SARS-CoV-2 Ag
96.6% sensitivity,
DE:
SGA Medikal
Rapid Test Kit (Colloidal Yes
DE[2]
DE[2]
1319
10 May 2021
Nasal swab
96.6% sensitivity, 99% specificity
Gold)
DE:
V-Chek SARS-CoV-2
Clinical Sensitivity: Positive evaluation by Paul-Ehrlich-Institut
SGA Medikal
Rapid Ag Test (colloidal Yes
96.60%
DE[2]
DE[2]
1357
7 July 2021
(sensitivity of 94,1% at <Ct25) +
gold)
Nasal swab
Manufacturer specificity: 99,5%
BE:
Clinical Sensitivity: 92% sensitivity, 100% specificity, NP swab
95.33 % (Nasal),
100% sensitivity, 100% specificity, OP
Shenzen Ultra-
SARS-CoV-2 Antigen
95.48(NP)
swab
Diagnostics
Yes
AT, BE, ES, SI
BE, SI
2017
10 May 2021
Test Kit
Clinical Specificity:
Biotec Co., Ltd
99.16 % (Nasal),
SI:
99.61 % (NP)
95.9% sensitivity, 99.9% specificity,
NP/OP/Nasal swab
23
Clinical
Other
EU Member
Completed
Device ID #
Included in
CE
performance
Clinical performance
countries
MS currently
Manufacturer
RAT commercial name
FIND evaluation studies States using in
validation
in JRC
Common list
marking
Data by
Data used in MS
using in
validating
practice
studies
database11
of RATs as of:
manufacturer
practice
Shenzhen
98% sensitivity
Lvshiyuan
Green Spring SARS-CoV- Yes
100% specificity
DE: 98% sensitivity , 100% specificity
DE[2]
DE[2]
2109
10 May 2021
Biotechnology
2 Antigen-Rapid test-Set
NP/OP/Nasal swab
Co., Ltd.
Clinical Sensitivity:
SARS-CoV-2 Antigen
DE:
Shenzhen
92.93 %
Test Kit (Colloidal Gold
Positive evaluation by Paul-Ehrlich-Institut
Microprofit
Yes
Clinical Specificity:
DE[2], ES
DE[2]
1967
7 July 2021
Chromatographic
(sensitivity of 100% at <Ct25) +
Biotech Co., Ltd
100 %
Immunoassay)
Manufacturer specificity: 100%
Nasal/NP/OP swab
SARS-CoV-2 Spike
DE:
Shenzhen
Protein Test Kit
Sensitivity: 86.3%, Positive evaluation by Paul-Ehrlich-Institut
Microprofit
(Colloidal Gold
Yes
Specificity: 100%
DE[2]
DE[2]
1178
23 July 2021
(sensitivity of 100% at <Ct25) +
Biotech Co., Ltd. Chromatographic
Nasal Swab
Immunoassay)
Manufacturer specificity: 100%
Shenzhen
SARS-CoV-2 Ag
95.15% Sensitivity
Watmind
Diagnostic Test Kit
Yes
DE: 95.15% sensitivity , 99.12% specificity
AT, DE[2], FR
DE[2]
1769
10 May 2021
Nasal swab
Medical Co., Ltd (Colloidal Gold)
Clinical Sensitivity:
DE:
Shenzhen
SARS-CoV-2 Ag
97.83 % (CT ≤ 33) Positive evaluation by Paul-Ehrlich-Institut
Watmind
Diagnostic Test Kit
Yes
Clinical Sensitivity:
DE[2]
DE[2]
1768
7 July 2021
(sensitivity of 100% at <Ct25) +
Medical Co., Ltd (Immuno-fluorescence)
90.08 % (Ct ≤ 36)
Manufacturer specificity: 99,13%
Nasal swab
Shenzhen
Zhenrui ®COVID-19
96% sensitivity
Zhenrui Biotech
Yes
DE: 96% sensitivity 97% specificity
DE[2]
DE[2]
1574
10 May 2021
Antigen Test Cassette
Nasal swab
Co., Ltd
BE:
98.32% sensitivity, 99.6% specificity, NP
98.32% sensitivity swab
(NP swab)
AT, BE, DE[2],
Siemens
CLINITEST Rapid COVID-
97.25% sensitivity, 100% specificity, Nasal
17 February
Yes
97.25% sensitivity
FR, HR, NL[5],
CH
DE[2], ES, NL[5] HR, PT, SE[3] 1218
Healthineers
19 Antigen Test
swab
2021
100% specificity
PT, SE, SI
(Nasal swab)
SI:
96.7% sensitivity, 99.2% specificity,
NP/Nasal swab
100% sensitivity
DE: Positive evaluation by Paul-Ehrlich-
Sugentech, Inc.
SGTi-flex COVID-19 Ag
Yes
100% specificity
Institut (sensitivity of 100% at <Ct30 and
AT, DE[2]
DE[2]
1114
10 May 2021
OP/NP swab
100% at <Ct25)
BE:
98.6% sensitivity
96.6% sensitivity, 100% specificity, NP/OP
TODA PHARMA
TODA CORONADIAG Ag Yes
BE, DE[2], SI
DE[2]
1466
10 May 2021
Nasal swab
swab
DE: 96.6% sensitivity, 100 specificity
24
Clinical
Other
EU Member
Completed
Device ID #
Included in
CE
performance
Clinical performance
countries
MS currently
Manufacturer
RAT commercial name
FIND evaluation studies States using in
validation
in JRC
Common list
marking
Data by
Data used in MS
using in
validating
practice
studies
database11
of RATs as of:
manufacturer
practice
SI: 96.6% sensitivity, 100% specificity,
NP/OP swab
Triplex
98.33% sensitivity
DE: Positive evaluation by Paul-Ehrlich-
International
SARS-CoV-2 Antigen
Yes
100% specificity
Institut (sensitivity of 92,5% at <Ct30 and
DE[2]
DE[2]
2074
16 June 2021
Biosciences Co., Rapid Test Kit
Nasal/OP/NP swab 100% at <Ct25)
Ltd
Triplex
SARS-CoV-2 Antigen
DE: Positive evaluation by Paul-Ehrlich-
International
Rapid Test Kit
98.51 % sensitivity
Yes
Institut (sensitivity of 100% at <Ct25) +
DE[2], FR, PT
DE[2]
1465
14 July 2021
Biosciences Co.,
Nasal swab
Manufacturer specificity: 100%
Ltd, China
DE:
Vitrosens
Positive evaluation by Paul-Ehrlich-Institut
RapidFor SARS-CoV-2
97.3% sensitivity
Biotechnology
Yes
(sensitivity of 100% at <Ct30 and 100% at
DE[2], SI
DE[2]
1443
10 May 2021
Rapid Ag Test
Nasal swab
Co., Ltd
<Ct25)
SI:
97.3% sensitivity, 99% specificity,
NP/OP/Nasal swab
VivaChek Biotech
97.04% sensitivity
AT:
VivaDiag Pro SARS-CoV-
(Hangzhou) Co.,
Yes
99.9% specificity
97,06% sensitivity, 100% specificity, all
AT, SI
AT, DE[2], SI
AT
2103
10 May 2021
2 Ag Rapid Test
Ltd.
Nasal/OP/NP swab specimen types, i.e. N&OP&NP swab
Wuhan
96.1% sensitivity
EasyDiagnosis
COVID-19 (SARS-CoV-2) Yes
100% specificity
DE: 96.15% sensitivity , 99.26% specificity
DE[2]
DE[2]
2098
10 May 2021
Biomedicine Co., Antigen-Test Kit
Nasal/OP/NP swab
Ltd.
Wuhan Life
SARS-CoV-2 Antigen
DE:
Origin Biotech
Assay Kit
92.67% sensitivity Positive evaluation by Paul-Ehrlich-Institut
Yes
DE[2]
DE[2]
1773
14 July 2021
Joint Stock Co.,
(Immunochromatograp
Nasal swab
(sensitivity of 100% at <Ct25) +
Ltd.
hy)
Manufacturer specificity: xx%
Clinical Sensitivity:
Wuhan
96.33 %
DE: Positive evaluation by Paul-Ehrlich-
UNscience
SARS-CoV-2 Antigen
Yes
Clinical Specificity: Institut (sensitivity of 100% at <Ct25) +
DE[2]
DE[2], FR
2090
7 July 2021
Biotechnology
Rapid Test Kit
99.57 %
Manufacturer specificity: 99,57%
Co., Ltd.
Nasal/NP/OP swab
Xiamen
DE: Positive evaluation by Paul-Ehrlich-
93.2% sensitivity
AmonMed
COVID-19 Antigen Rapid
Institut (sensitivity of 100% at <Ct25) +
Yes
99.55% specificity
DE[2]
DE[2]
1763
10 May 2021
Biotechnology
Test Kit (Colloidal Gold)
Manufacturer specificity: 99.55%
Nasal swab
Co., Ltd
BE: 93.8% sensitivity, 100% specificity, NP
Xiamen Boson
Rapid SARS-CoV-2
Not specified
AT, BE, BG, CY,
DE[2]
17 February
Yes
swab
CH
1278
Biotech Co. Ltd
Antigen Test Card
NP swab
DE[2], FR, RO
CH
2021
DE: 96.49% sensitivity, 99.03% specificity
25
Clinical
Other
EU Member
Completed
Device ID #
Included in
CE
performance
Clinical performance
countries
MS currently
Manufacturer
RAT commercial name
FIND evaluation studies States using in
validation
in JRC
Common list
marking
Data by
Data used in MS
using in
validating
practice
studies
database11
of RATs as of:
manufacturer
practice
Xiamen Wiz
SARS-CoV-2 Antigen
96.3% sensitivity,
Yes
DE: 96.3% sensitivity, 100% specificity
AT, DE[2]
DE[2]
1456
10 May 2021
Biotech Co., Ltd Rapid Test
Nasal swab
SARS-CoV-2 Antigen
95.91% sensitivity
Xiamen Wiz
Rapid Test (Colloidal
Yes
100% specificity
DE: 95.91% sensitivity , 100% specificity
AT, DE[2]
DE[2]
1884
10 May 2021
Biotech Co., Ltd Gold)
Nasal swab
Zhejiang Anji
AndLucky COVID-19
95.8% sensitivity,
Saianfu Biotech
Yes
DE: 97.5% sensitivity, 99.1% specificity
AT, DE[2]
DE[2]
1296
10 May 2021
Antigen Rapid Test
Nasal swab
Co.., Ltd
Zhejiang Anji
DE: Positive evaluation by Paul-Ehrlich-
reOpenTest COVID-19
95.8% sensitivity,
Saianfu Biotech
Yes
Institut (sensitivity of 94,1% at <Ct25) +
DE[2]
DE[2]
1295
10 May 2021
Antigen Rapid Test
Nasal swab
Co.., Ltd
Manufacturer specificity: 99%
BE: 98.32% sensitivity, 99.6% specificity,
Zhejiang Orient
98.32 % sensitivity
Coronavirus Ag Rapid
NP swab; 97.25% sensitivity, 100%
AT, BE, BG,
17 February
Gene Biotech
Yes
99.6 % specificity
CH, UK
DE[2]
SE[3]
1343
Test Cassette (Swab)
specificity, Nasal swab
DE[2], PT
2021
Co., Ltd
Nasal/NP swab
DE: 96.72% sensitivity, 99.22% specificity
96.12% sensitivity
Nasal swab
(CT<33)
Zhuhai Lituo
COVID-19 Antigen
DE: Positive evaluation by Paul-Ehrlich-
99.59% sensitivity
Biotechnology
Detection Kit (Colloidal Yes
Institut (sensitivity of 100% at <Ct25) +
CZ, DE[2], SI
DE[2]
1957
14 July 2021
NP swab
Co., Ltd.
Gold)
Manufacturer specificity: 100%
100% specificity
Nasal swab
(CT<33)
Notes:
[1] FR: Reference to validation study (not specifying which specific RAT is being recommended or was tested in practice
): https://www.has-sante.fr/upload/docs/application/pdf/2020-
10/synthese_tests_antigeniques_vd.pdf
[2] DE: Rapid antigen tests that have completed practical validation studies in Germany: See
: https://www.pei.de/SharedDocs/Downloads/DE/newsroom/dossiers/evaluierung-sensitivitaet-sars-
cov-2-antigentests-04-12-2020.pdf?__blob=publicationFile&v=43
[3] SE: Smaller evaluations ongoing in some of the regions.
[4] BE: In the clinical performance study performed in three different clinical laboratories during the ascendant phase of the epidemiological curve, we found an overall sensitivity and specificity
of 57.6 and 99.5%, respectively with an accuracy of 82.6%.
[5] NL: Collected validation data from accredited laboratories in the Netherlands. The report includes evaluations of various RAT that labs performed at their own initiative.
https://lci.rivm.nl/antigeensneltesten
[6] BE: Van Honacker E. et al., Comparison of five SARS-CoV-2 rapid antigen detection tests in a hospital setting and performance of one antigen assay in routine practice: a useful tool to guide
isolation precautions? J Hosp Infect. In press.
26
ANNEX II: Common standardised set of data to be included in COVID-19 test result
certificates, as agreed by Member States on 17 February 2021 and updated on 19 March 2021
Preferred Code
Section
Data element
Description
System
The legal name of the tested person.
Person name
Surname(s) and forename(s), in that order.
An identifier of the tested person, according to
Person identifier
the policies applicable in each country.
Person
identification
(optional)
Examples: citizen ID and/or document number
(ID-card/passport).
Person date of birth
Tested person’s date of birth.
Complete date, without
time, following the ISO
(optional)
Mandatory if no Person identifier is provided.
8601.
Disease or agent
Specification that it concerns the detection of
ICD-10, SNOMED CT
targeted
SARS-CoV-2 infection.
Description of the type of test that was
Type of test
LOINC, NPU
conducted, e.g. NAAT or rapid antigen test.
Test name
Commercial or brand name of the test.
(optional for NAAT)
Test Manufacturer
Legal manufacturer of the test.
(optional for NAAT)
Sample origin
The type of sample that was taken (e.g.
nasopharyngeal swab, oropharyngeal swab,
SNOMED CT
(optional)
nasal swab).
Complete date, with
Date and time of the
Date and time when the sample was collected.
time and time zone,
test sample collection
Test information
following ISO 8601
Date and time of the
Complete date, with
test result production
Date and time when the test result was
time and time zone,
produced.
(optional)
following ISO 8601
For example, negative, positive, inconclusive or
Result of the test
SNOMED CT
void.
Testing centre or
Name/code of testing centre, facility or a health
facility
authority responsible for the testing event.
(mandatory for NAAT)
Optional: address of the testing facility.
Health Professional
Name or health professional code responsible
identification
for conducting (and validating) the test.
(optional)
Surname(s) and forename(s), in that order.
Country where the test
ISO 3166 Country
The country in which the individual was tested.
was taken
Codes
Test result certificate
Entity that issued the COVID-19 test result
Test certificate
issuer
certificate (allowing to check the certificate).
metadata
Reference of the COVID-19 test result certificate
Certificate identifier
(unique identifier).