Covid-19 Rat Common-List en

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 Certificate 8, 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 1108 samples, NP swab
91.4% sensitivity
RATs in Belgian hospital lab. Panbio overall Clinical sensitivities:
99.8% specificity AT, BE, BG, CY,
sensitivity (Ct range 14,6 – 35,5): 45/57 - Days < 7: 90.8%;
NP swab (Ct ≤ 33) CZ, DE[2], DK,
samples (79%). Sensitivity for Ct≤25: 17/18 - Ct < 33: 88.3%; DE[2], ES, FI,
Abbott Rapid Panbio™ COVID-19 Ag EE, EL, ES, FR[1], CH, ME, MK, CY, ES, HR, 17 February
Yes samples. Overall specificity 100%. - Ct < 25: 95.8%; NL[5], PT 1232
Diagnostics Rapid Test 98.1% sensitivity HR, IT, LT, LV, NO, UK, UA HU, IE, LU, SE 2021
Clinical specificity: 99.9% [5] CH, NO
99.8% specificity MT, NL , PL,
DE:
Nasal swab (Ct ≤ PT, RO, SE, SK
91.4% sensitivity 99.8% specificity, NP
33) CH (10 Dec 2020)
swab; 98.1% sensitivity, 99,8 specificity,
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
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
- Days < 7: 61.3%-100%;
- Ct < 33: 74.2%-86.7%;
- Ct < 25: 91.9%-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 DE: - Days < 7: 92.2%; DE[2] 1468 10 May 2021
Laboratories, Inc. Antigen Rapid Test Nasal swab 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 SI: AT, DE[2], SI DE[2] 2108 10 May 2021
2
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%
97.3% sensitivity swab
AMEDA NP swab
AMP Rapid Test SARS- DE: Positive evaluation by Paul-Ehrlich- AT, BG, DE[2] DE[2] 17 February
Labordiagnostik Yes 97.3% sensitivity CH, UA HR 1304
CoV-2 Ag Institut (sensitivity of 100% at <Ct25) + HR, SI CH 2021
GmbH Nasal swab
100% specificity Manufacturer specificity: 100%
8
Clinical Other
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
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 %
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:
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:
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
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% 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
graphy)
PL:
Sensitivity: 95% Yes
SARS-CoV-2 Ag Rapid Diagnostic sensitivity: 93.43% (95% CI:
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:
Biomerica Inc. Antigen Rapid Test Yes 94.7 % DE[2] DE[2] 1599 7 July 2021
(nasopharyngeal swab) Nasal/NP swab
Brazil (20 April 2021)
Clinical Sensitivity: DE:
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
- 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);
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 100% specificity, AT, BE, DE[2], DE[2], NL[5], 17 February
BIOSYNEX S.A. Yes CH DK 1223
BSS NP swab DE: DK,FR, NL[5], PT CH 2021
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
DE:
BIOTEKE SARS-CoV-2 Antigen 96.49 % sensitivity
CORPORATION Test Kit (colloidal gold Yes 99.28 % specificity DE[2] DE[2] 2067 14 July 2021
(WUXI) CO., LTD method) OP/NP swab
BE:
Biotical Health Sensitivity: 96%, Validation study 1: sensitivity 91.7% for Yes
biotical SARS-CoV-2 Ag
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
NL:
Independent field study in mild
Sensitivity: 91.7%, Yes
Boditech Med symptomatic (n= 427); overall sensitivity:
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:
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
Z20601CE: 96.4% sensitivity, 99.2%
specificity, NP swab
DE: 97.3% sensitivity, 100% specificity
DE:
Sensitivity: 93.8%, Positive evaluation by Paul-Ehrlich-Institut Yes
COVID-19 Antigen
DNA Diagnostic Yes Specificity: 99.6% DE[2] DE[2] 23 July 2021
Detection Kit (sensitivity of 100% at <Ct25) + (2242)
Nasal swab
Peru (26 April 2021)
Edinburgh Genetics DE:
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%;
DE:
(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)
87.8 % ( (n=98, DE:
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
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
14
Clinical Other
DE:
96.86% sensitivity,
GenSure Biotech GenSure COVID-19 Positive evaluation by Paul-Ehrlich-Institut
Inc Antigen Rapid Test Kit (sensitivity of 94,1% at <Ct25) +
Nasal swab
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
Nasal swab
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:
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:
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
- Ct < 33: 92.2%;
- Ct < 25: 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
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 %
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 %
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
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:
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%
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: CZ, DE[2]
98.13% sensitivity
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 – see report for details. - Ct < 33: 78.9%;
y) - Ct < 25: 91.3%;
17
Clinical Other
Labnovation SARS-CoV-2 Antigen SI:
Yes NP/OP swab 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
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:
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 97.6% sensitivity, 97.7% specificity, To start DE[2], ES, SI CH of laboratory 1268
Ag Test 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 92.5% sensitivity, 99.8% specificity, DE[2]
MEDsan SARS-CoV-2 17 February
MEDsan GmbH Yes 99.8% specificity Nasal/OP swab AT, BE, DE[2] CH 1180
Antigen Rapid Test CH 2021
NP/OP swab
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:
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
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
96.17% sensitivity BE:

99.16% specificity 96.4% sensitivity, 99% specificity, NP/OP
Rapid SARS-CoV-2 swab DE[2] 17 February
MP Biomedicals Yes Nasal 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:
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%;
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
Nasal/NP/OP swab
Sensitivity: ES:
MARESKIT COVID-19 Yes
NESAPOR 95.24%, Independent validation study; Nasal test
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
Nasal/ NP swab
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
DE:
94,92 % sensitivity, 99,99 % specificity
PCL COVID19 Ag Rapid
PCL Inc. Yes SI: FR, DE[2], RO, SI DE[2] 308 10 May 2021
FIA
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 93.88% sensitivity , 98% specificity DE[2]
Precision 17 February
Exdia COVI-19 Ag Yes 98% specificity SI, DE[2] CH 1271
Biosensor Inc. SI:93.9% sensitivity, 98% specificity, NP CH 2021
NP swab
swab
DE:
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
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 DE[2], NL[5]
Quidel DE: AT, BE, DE[2], 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:
NP/Nasal swab
IT:
Sensitivity: 96.1%, Independent validation study, 100 pos. Yes
Rapid Pathogen LIAISON® Quick Detect
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
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
- Days < 7: 81.2%;
- Ct < 33: 87.5%;
- 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 %
Nasal swab
- Days < 7: 81.2%;
- Ct < 33: 91.7%;
- Ct < 25: 100%;
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:
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
- Days < 7: 81.2%;
- Ct < 33: 91.7%;
- Ct < 25: 100%;
DE (10 Dec 2020)
- Days < 7: 81.2%;
- Ct < 33: 75%;
- Ct < 25: 100%;
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%;
India (25 June 2020)

- Days < 7: 61.8%;
- Ct < 33: 53.6%;
- Ct < 25: 68.5%;
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%; DE[2], ES, IT,
96.52% sensitivity, 99.68% specificity DE[2], DK, EE,
96.52% sensitivity - Ct < 25: 100%; NL[5], DK, PT
SD BIOSENSOR STANDARD Q COVID-19 ES, FI, FR, HR, HR, IE, LU, SI, 17 February
Yes 99.68% specificity SI: Clinical specificity: 99.3% ME, NO, CH 345
Inc. Ag Test 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
FI: Clinical sensitivities:
Validated in several laboratories (studies - Days < 7: 90.7%;
not published), meeting criteria. - Ct < 33: 91.9%;
22
Clinical Other
- Ct < 25: 95.9%;
CH (10 Dec 2020)

- Days < 7: 89.8%;
- Ct < 33: 91.8%;
- Ct < 25: 97.2%;
India (22 April 2021)

- Days < 7: 58.3%;
- Ct < 33: 65.5%;
- Ct < 25: 89.4%;
Peru (22 April 2021)

- Days < 7: 81.4%;
- Ct < 33: 83.3%;
- Ct < 25: 96.2%;
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:
SGA Medikal Rapid Ag Test (colloidal Yes 96.60% DE[2] DE[2] 1357 7 July 2021
gold) Nasal swab
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
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.
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
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)
DE:
Shenzhen SARS-CoV-2 Ag 97.83 % (CT ≤ 33)
Watmind Diagnostic Test Kit Yes Clinical Sensitivity: DE[2] DE[2] 1768 7 July 2021
Medical Co., Ltd (Immuno-fluorescence) 90.08 % (Ct ≤ 36)
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 swab
(NP swab) 97.25% sensitivity, 100% specificity, Nasal AT, BE, DE[2],
Siemens CLINITEST Rapid COVID- 17 February
Yes 97.25% sensitivity swab FR, HR, NL[5], CH DE[2], ES, NL[5] HR, PT, SE[3] 1218
Healthineers 19 Antigen Test 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 swab BE, DE[2], SI DE[2] 1466 10 May 2021
Nasal swab
DE: 96.6% sensitivity, 100 specificity
24
Clinical Other
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
Ltd, China
DE:
Vitrosens Positive evaluation by Paul-Ehrlich-Institut

RapidFor SARS-CoV-2 97.3% sensitivity (sensitivity of 100% at <Ct30 and 100% at
Biotechnology Yes DE[2], SI DE[2] 1443 10 May 2021
Rapid Ag Test Nasal swab <Ct25)SI:
Co., Ltd
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%
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
Xiamen Boson Rapid SARS-CoV-2 Not specified swab AT, BE, BG, CY, DE[2] 17 February
Yes CH 1278
Biotech Co. Ltd Antigen Test Card NP swab DE[2], FR, RO CH 2021
25
Clinical Other
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 NP swab; 97.25% sensitivity, 100%
Coronavirus Ag Rapid AT, BE, BG, 17 February
Gene Biotech Yes 99.6 % specificity specificity, Nasal swab CH, UK DE[2] SE[3] 1343
Test Cassette (Swab) DE[2], PT 2021
Co., Ltd Nasal/NP swab
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).

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EUROPEAN COMMISSION

DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY

Public health, country knowledge, crisis management

Agreed by the Health Security Committee

An update to Annex II was agreed by the HSC on 19 March 2021

The Health Security Committee agreed on 17 September 2020 on Recommendations for a

On 21 January 2021, Member States unanimously agreed on a Council Recommendation

II. Annex I: Common list of rapid antigen tests

As stipulated in point 15 of the Council Recommendation of 21 January 2021, Member States

III. HSC Technical Working Group on COVID-19 Diagnostic Tests

Agreed (interim) clinical performance criteria for independent validation studies:

 Laboratory-based antigenic assays (e.g. enzyme immunoassays such as ELISA or

India (25 June 2021)

NOVA Test ® SARS-CoV-

Brazil (30 March 2021)

Hangzhou AllTest COVID-19 Antigen Rapid AT, BE, BG, FR,

LumiQuick QuickProfile™ COVID-19 DE: 93.7% sensitivity, 98.8% specificity

96.17% sensitivity BE:

Brazil (10 Dec 2020)

India (25 June 2020)

CH (10 Dec 2020)

India (22 April 2021)

Peru (22 April 2021)

SI: 96.6% sensitivity, 100% specificity,

Vitrosens Positive evaluation by Paul-Ehrlich-Institut

Xiamen Wiz SARS-CoV-2 Antigen 96.3% sensitivity,

Sample origin The type of sample that was taken (e.g.

For example, negative, positive, inconclusive or

Country where the test ISO 3166 Country

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