Ref. Ares(2022)547597 - 24/01/2022
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;
A common standardised set of data to be included in COVID-
19 test result certificates; and
A common list of COVID-19 laboratory based antigenic assays
Agreed by the Health Security Committee
Common list of COVID-19 rapid antigen tests (Annex I)
Agreed by the Health Security Committee on 17 February 2021.
First update: 10 May 2021; Second update: 16 June 2021; Third update: 7 July 2021; Fourth update:
14 July 2021; Fifth update: 23 July 2021; Sixth update: 20 October 2021; Seventh update: [TBC].
Common standardised data set to be included in COVID-19
test result certificates (Annex II)
Agreed by the Health Security Committee on 17 February 2021.
An update to Annex II was agreed by the HSC on 19 March 2021
Common list of COVID-19 laboratory based antigenic assays
(Annex III)
Agreed by the Health Security Committee on 20 October 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 (HSC) 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 HSC 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.
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 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.
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
This document is based on the content of 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.
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. This list has been incorporated by
the JRC in its COVID-19 In Vitro Diagnostic Devices and Test Methods Database.
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 rapid antigen tests, allowing
for the removal of tests no longer deemed effective. The effect of SARS-CoV-2 mutations on
the efficacy of NAAT, in particular RT-PCR assays, will also be kept under review.
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, a fifth update on 23 July 2021, a sixth update on 20 October 2021, and a seventh update
on [TBC].
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 HSC 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.
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
7 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32021R0953
3
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 was
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 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, is
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 presents proposals to the HSC for
further updates to the common list of rapid antigen tests. The HSC thus remains the platform
where agreement between Member States is reached for updates to the list.
Building on the interim definitions and criteria that were agreed by the experts on 29 June
2021, the Technical Working Group agreed on 21 September 2021 on further
definitions,
scope, considerations and criteria to be applied to independent validation studies assessing
the clinical performance of rapid antigen tests for COVID-19 diagnosis. These further
definitions, scope, considerations and criteria are used by the Technical Working Group in
addition to the ones presented in Council Recommendation 2021/24/01 when assessing the
proposals for new rapid antigen tests to be included in the EU common list. They have been
applied to all proposals received after 12 July 2021. Concerning the rapid antigen tests that
were included in the EU common list of rapid antigen tests before this date, the criteria will
apply as of May 2022.
Agreed scope of the EU common list of rapid antigen tests:
The EU common list includes rapid antigen tests that are used in practice in at
least one EU Member State and that have been validated by at least one EU
Member State.
The EU common list includes rapid antigen tests for which their clinical
performance was measured based on samples collected from nasal,
oropharyngeal or nasopharyngeal specimens and that meet the criteria as further
specified below.
Rapid antigen tests that are solely based on other sampling materials, such as
saliva, sputum, blood and/or faeces, are not included in the EU common list of
antigen tests. This is in line with current evidence and technical
recommendations provided by the European Centre for Disease Prevention and
Control (ECDC)9.
8 https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32021R0953&from=EN.
9 https://www.ecdc.europa.eu/sites/default/files/documents/covid-19-use-saliva-sample-material-testing.pdf
4
Rapid antigen tests that are using a mix of different sampling materials (i.e.
nasal, oropharyngeal and/or nasopharyngeal swabs as well as other specimen
types such as saliva) can be included in the EU common list. However, the
validation studies of such tests should present the results and data for each
specimen type separately. Only the validation results based on nasal,
oropharyngeal and/or nasopharyngeal swabs of such devices will be reviewed by
the Technical Working Group and assessed against the specified criteria.
Only test results based on nasal, oropharyngeal and/or nasopharyngeal
specimens should be valid for the issuance of test certificates for the EU Digital
COVID Certificate.
The EU common list of antigen tests does not include rapid antigen self-tests. It
only includes those rapid antigen tests that are conducted by trained healthcare
personnel or trained operators where appropriate (in line with Commission
Recommendation (EU) 20202/1743 of 18 November 2020).
The EU common list of antigen tests does not include pooled rapid antigen tests,
which involve mixing of multiple samples together in a batch or pooled sample
for testing.
Only rapid antigen tests that carry CE marking are included in the EU common
list of antigen tests.
The Technical Working Group will continue to monitor the developments in the
field of rapid antigen testing and will, if deemed necessary, reconsider the scope
of the EU common list of rapid antigen tests once relevant evidence and data has
become available. Particular attention will be paid to breakthrough infections
among vaccinated individuals and the possible impact of such cases on the
clinical performance of rapid antigen tests, as well as the performance of rapid
antigen tests in the context of emerging SARS-CoV-2 variants.
Agreed definition and considerations 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 from an EU
Member State.
Such study should be carried out in an EU Member State, and performed
objectively and in the public interest.
Such study should be performed by an independent laboratory, which is a
laboratory not owned nor operated by the manufacturer or sponsor of the test,
and which is not related to the operator by ownership, familial relationships, nor
contractual or other relationships that result in the laboratory being controlled by
or being under the common control of the operator.
Such study should preferably be based on a
prospective clinical field study
design, testing
unselected symptomatic and asymptomatic participants for
SARS-CoV-2 infection. Until May 2022, validation studies carried out based on
retrospective in vitro study designs, testing the clinical performance of rapid
5
antigen tests using SARS-CoV-2 reference panels, will be accepted too10.
“Unselected” means no prior knowledge of SARS-CoV-2 diagnosis (e.g.
determined by PCR); inclusion is allowed based on general possible COVID-like
symptoms (or close contact with COVID-19 cases); and exclusion is allowed of
children (e.g. <16 years) or for medical ethical permission reasons.
Agreed clinical performance criteria for independent validation studies:
Prospective clinical field studies:
A sensitivity over 80% when testing unselected symptomatic participants within
the first seven days after symptom onset or asymptomatic participants, where the
diagnosis is confirmed by RT-PCR in independent field studies, will be accepted.
OR
In independent evaluations of unselected participants, assays should have a
sensitivity of 90% or greater for subjects with a Ct < 25.
The study population shall be clearly defined stating the inclusion criteria of
participants (symptomatic individuals, close contacts or asymptomatic
individuals without known exposure). Ideally, the sensitivity for each group
should be discernible from the report. The RT-PCR protocol and the distribution
of Ct values should be described. Samples should represent naturally occurring
viral loads.
Target population considered in the context of an independent validation study
should be based on at least 100 RT-PCR positive samples and at least 300 RT-
PCR negative samples. Each specimen type should be evaluated separately.
In case of multiple smaller prospective clinical field studies that do not meet the
minimum number of positive and/or negative samples separately but that do
meet all the other criteria as agreed by the Technical Working Group, the
number of samples may be combined, provided that the different studies applied
the same or similar methodologies and that sufficient details are provided on
their study design.
Assays should have a specificity over 98%.
In line with the
MDCG Guidance on performance evaluation of SARS-CoV-2 in
vitro diagnostic medical devices11, preference is given to samples being
compared against RT-PCR results on nasopharyngeal swabs. However, in
independent validation studies, samples can also be compared against RT-PCR
results on oropharyngeal or nasal swabs if reasoning is provided (e.g. when
assessing the clinical performance of rapid antigen tests among children).
Retrospective in vitro studies:
A sensitivity over 80% when testing all specimen in the reference panel will be
10 After May 2022, only rapid antigen tests of which their clinical performance has been evaluated through independent
validation studies based on prospective clinical field study designs (in combination with retrospective in vitro studies) will be
accepted for inclusion in the EU common list of rapid antigen tests.
11 https://ec.europa.eu/health/sites/default/files/md_sector/docs/mdcg_2021-21_en.pdf
6
accepted;
OR
Assays should have a sensitivity of 90% or greater for subjects with a Ct < 25.
The composition of the reference panel should be as follows:
• A panel of at least 50 pooled clinical specimens that cover naturally
occurring viral loads with SARS-CoV-2 concentration ranging from
approximately 1.1 x 109 to 4.2 x 102 genome copies per mL of specimen
and Ct values between 17 and 36.
• The whole evaluation panel should be subdivided into three subgroups:
panel members, which are characterized by:
•
Very high viral load (Ct value 17-25; about 40% of the total
number of pooled clinical specimens);
•
High viral load (Ct value 25-30; about 40% of the total
number of pooled clinical specimens); and
•
Moderate viral load (Ct value 30-36; about 20% of the total
number of pooled clinical specimens).
• For each pool up to ten clinical respiratory specimens
(nasopharyngeal/oropharyngeal) obtained for routine diagnostics with
different virus loads may be used. The sample volume per panel
member should be sufficient to allow comparative evaluation with
different tests included in the evaluation.
• RT-PCR needs to be applied to determine the RNA load per pool.
• Ethical approval by an institutional review board is mandatory.
• For each rapid antigen test and panel member, a pre-defined aliquot
needs to be completely absorbed using the specimen collection device,
e.g. swab, provided with the respective test.
• Further steps needs to be strictly performed following the respective
instructions for use (IFU).
• The stability of the panel (antigen) must be considered throughout the
preparation of the panel and the workflow up to the test.
Assays should have a specificity over 98%, as measured through the retrospective
in vitro evaluation study or as specified by the manufacturer in the IFU.
In line with the
MDCG Guidance on performance evaluation of SARS-CoV-2 in
vitro diagnostic medical devices11, preference is given to samples being compared
against RT-PCR results on nasopharyngeal swabs. However, in independent
validation studies, samples can also be compared against RT-PCR results on
oropharyngeal or nasal swabs if reasoning is provided (e.g. when assessing the
clinical performance of rapid antigen tests among children).
As a wide range of different methodologies and protocols are being applied in countries,
discussions on testing approaches will continue, with the overall goal for the Technical
Working Group to develop and agree on an EU harmonised approach for validation studies
assessing the clinical performance of COVID-19 rapid antigen tests. This work will take into
account the ongoing work by the In Vitro Diagnostics Working Group of the Medical Device
7
Coordination Group regarding guidance on the performance of COVID-19 tests in the context
of CE-marking and common specifications under Article 9 of Regulation (EU) 2017/74612.
Grace period
Whenever updates are made to Annex I, a grace period of 8 weeks applies until the end of
2021. As of 1 January 2022, a grace period of 4 weeks will apply. The grace period applies to
both the inclusion of new devices as well as the removal or rapid antigen tests that are
included in the EU common list or rapid antigen tests.
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.
V.
Annex III: Common list of laboratory-based antigenic assays
In addition to COVID-19 rapid antigen tests, as of 8 July 2021, it is possible for
manufacturers and countries to put forward proposals for laboratory-based antigenic assays
(e.g. enzyme immunoassays such as ELISA or automated tests) for review by the Technical
Working Group. These proposals are reviewed by the experts against the same criteria used
for the review of rapid antigen tests. Annex III sets out those laboratory-based antigenic
assays that meet these criteria. Further criteria for lab-based antigenic assays may be defined
at a later stage.
The Technical Working Group on COVID-19 diagnostic devices does not, at the moment,
review proposals for inclusion of antibody tests in the EU common list.
12 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.
8
ANNEX I: Common list of rapid antigen tests13
As agreed by EU Member States on 20 October 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. Updates to the common list are based on the criteria as described in Council Recommendation 2021/C 24/01 as well as the further criteria
and definitions agreed by the Technical Working Group on 21 September 2021. The Medical Device Coordination Group Guidance on performance evaluation of SARS-CoV-
2 in vitro diagnostic medical devices14, envisaged to form the basis for common specifications to be adopted according to Article 9 of Regulation (EU) 2017/746, has been
taken into consideration in this regard.
Rapid antigen tests presented in boxes are so-called ‘twin tests’. These are rapid antigen tests that are identical in design and construction but, for example, branded or
distributed under a different name. The results of independent validation studies may be transferred between twin tests.
Clinical performance
Completed
SARS-CoV-2
Included in
Device
Clinical performance
Manufacturer
RAT commercial name
Data by
validation
Target
Specimen 16
EU common
ID # 15
As reported by independent validation studies
manufacturer
studies
protein
list since:
Prospective clinical field study
FR:
96.6% sensitivity
FR
Nasal swab,
Prospective study carried out in the “Centre Hospitalier
Nucleo-
AAZ-LMB
COVID-VIRO®
1833
Nasopharyngeal 10 May 2021
100% specificity
d’Orléans” on NP swabs simultaneously tested by RT PCR :
protein
CH
swab
sensitivity <7 days after onset of symptoms : 94,7% (72/76),
Nasal swab, NP swab
specificity : 100%.
13 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.
14 https://ec.europa.eu/health/sites/default/files/md_sector/docs/mdcg_2021-21_en.pdf
15 As registered in and used by the JRC database, see
: https://covid-19-diagnostics.jrc.ec.europa.eu/. 16 Only test results based on nasal, oropharyngeal and/or nasopharyngeal specimens should be valid for the issuance of test certificates for the EU Digital COVID Certificate. The information
included in this column is based on the information provided by the manufacturers to the JRC database.
Clinical performance
Completed
SARS-CoV-2
Included in
Device
Clinical performance
Manufacturer
RAT commercial name
Data by
validation
Target
Specimen 16
EU common
ID # 15
As reported by independent validation studies
manufacturer
studies
protein
list since:
Prospective clinical field studies
BE: Small-scale head-to-head comparison of 5 RATs in Belgian
hospital lab. Panbio overall sensitivity (Ct range 14,6 – 35,5):
45/57 samples (79%). Sensitivity for Ct≤25: 17/18 samples.
Overall specificity 100%.
NL: 1367 and 208 subjects were enrolled in Utrecht and Aruba,
respectively. Specificity of the Panbio™ COVID-19 Ag Rapid
Test was 100% (95%CI: 99.7–100%) in both settings. Test
sensitivity was 72.6% (95%CI: 64.5–79.9%) in the Netherlands
and 81.0% (95% CI: 69.0–89.8%) in Aruba. Restricting RT-
qPCR test positivity to Ct-values <32 yielded test sensitivities
of 95.2% (95%CI: 89.3–98.5%) in Utrecht and 98.0% (95%CI:
89.2–99.95%) in Aruba.
91.4% sensitivity
PT:
99.8% specificity
BE, DE[2], ES, FI,
83 samples from symptomatic individuals (27 PCR positive
NP swab (Ct ≤ 33)
NL[5], PT, SE
Nasal swab,
Abbott Rapid
Panbio™ COVID-19 Ag
and 56 negative by PCR) were tested. Sensitivity 63% (95%IC
Nucleo-
17 February
1232
Nasopharyngeal
Diagnostics
Rapid Test
42-81); specificity 100% (95%IC 94-100). LoD TCID50/ml 1,38
protein
2021
98.1% sensitivity
CH, India, NO,
swab
x 102 and CT<24.
99.8% specificity
UK
Nasal swab (Ct ≤ 33)
SE:
Karolinska hospital evaluation of Lot 41ADF061A. Patient
samples: 95 PCR positive, 150 negative. No detailed sample
description available. Sensitivity 59%, specificity 100%.
Sensitivity Ct<25 = 90.2%.
FIND evaluation studies
DE (10 Dec 2020)
1108 samples, NP swab. Clinical sensitivities: Days < 7: 90.8%;
Ct < 33: 88.3%; Ct < 25: 95.8%. Clinical specificity: 99.9%
CH (10 Dec 2020)
535 samples, NP swab. Clinical sensitivities: Days < 7: 85.6%;
Ct < 33: 89.7%; 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%
10
Clinical performance
Completed
SARS-CoV-2
Included in
Device
Clinical performance
Manufacturer
RAT commercial name
Data by
validation
Target
Specimen 16
EU common
ID # 15
As reported by independent validation studies
manufacturer
studies
protein
list since:
Retrospective in vitro studies
DE:
Positive evaluation by Paul-Ehrlich-Institut:
Sensitivity of 100% at Ct < 25; Manufacturer specificity of
99.8%
FI:
Validated in several laboratories (studies not published),
meeting criteria.
Retrospective in vitro study
Anterior nasal
swab, Nasal
DE:
swab,
Positive evaluation by Paul-Ehrlich-Institut:
Nucleo-
Sensitivity 98,7%,
Nasopharyngeal 20 October
ABIOTEQ
Cora Gentest-19
2374
Sensitivity of 100% at Ct < 25; Manufacturer specificity: 99.8%
DE[2]
capsid
Specificity 99,8%
swab,
2021
protein
Oropharyngeal
swab, Throat
swab
Retrospective in vitro study
Nucleo-
Accu-Tell SARS-CoV-2 Ag
DE:
Sensitivity: 95.7%
Nasopharyngeal 20 October
AccuBioTech Co.,Ltd
2579
DE[2]
capsid
Cassette
Positive evaluation by Paul-Ehrlich-Institut:
Specificity: 99.2%
swab
2021
protein
Sensitivity of 100% at Ct < 25; Manufacturer specificity: 99.2%
Prospective clinical field study
FIND evaluation
CH (9 June 2021)
Clinical Sensitivity
279 samples, nasal swab. Clinical sensitivities: Days < 7:
97.1 % (Nasal Swab)
92.2%; Ct < 33: 98.3%; Ct < 25: 100%. Clinical specificity:
Clinical Sensitivity
DE[2]
Nucleo-
Nasal swab,
Acon Biotech
Flowflex SARS-CoV-2
99.5%
97.6 % (NP Swab)
1457
capsid
Nasopharyngeal 14 July 2021
(Hangzhou) Co., Ltd
Antigen Rapid Test
Clinical Specificity
Retrospective in vitro study
protein
swab
99.5 % (Nasal Swab)
CH, UK
DE:
Clinical Specificity
Positive evaluation by Paul-Ehrlich-Institut:
99.4 % ( NP Swab)
Sensitivity of 94,1% at Ct < 25; Manufacturer specificity:
99.54%
Retrospective in vitro study
DE:
96.9% sensitivity
ACON Laboratories,
Flowflex SARS-CoV-2
Nucleo-
1468
Positive evaluation by Paul-Ehrlich-Institut:
98.7% specificity
DE[2]
Nasal swab
10 May 2021
Inc.
Antigen Rapid Test
protein
Sensitivity of 94,1% at Ct < 25; Manufacturer specificity:
Nasal swab
98,7%
AESKU.DIAGNOSTICS AESKU.RAPID SARS-CoV-2 2108
Retrospective in vitro study
96% sensitivity
DE[2]
Nucleo-
Nasal swab,
10 May 2021
11
Clinical performance
Completed
SARS-CoV-2
Included in
Device
Clinical performance
Manufacturer
RAT commercial name
Data by
validation
Target
Specimen 16
EU common
ID # 15
As reported by independent validation studies
manufacturer
studies
protein
list since:
GmbH & Co, KG
DE:
98% specificity
protein
Throat swab
Positive evaluation by Paul-Ehrlich-Institut:
NP swab
Sensitivity of 84% at Ct < 25; Manufacturer specificity: 98%
Retrospective in vitro study
95% sensitivity
99.2% specificity
DE:
Nasal swab,
TestNOW® - COVID-19
NP swab
Nucleo-
Affimedix Inc.
2130
Positive evaluation by Paul-Ehrlich-Institut:
DE[2]
Nasopharyngeal 10 May 2021
Antigen Test
98.1% sensitivity
protein
Sensitivity of 100% at Ct < 25; Manufacturer specificity: 99,2%
swab
100% specificity
Nasal swab
Retrospective in vitro study
97.3% sensitivity
NP swab
DE[2]
Nasal swab,
AMP Rapid Test SARS-
DE:
Nucleo-
17 February
e
1304
97.3% sensitivity
Nasopharyngeal
CoV-2 Ag
Positive evaluation by Paul-Ehrlich-Institut:
protein
2021
Nasal swab
CH, UK
swab
Sensitivity of 100% at Ct < 25; Manufacturer specificity: 100% 100% specificity
Retrospective in vitro study
Anbio (Xiamen)
99.27% sensitivity,
Rapid COVID-19 Antigen-
DE:
Nasal swab,
Biotechnology Co.,
1822
100% specificity
DE[2]
Unknown
10 May 2021
Test (colloidal Gold)
Positive evaluation by Paul-Ehrlich-Institut:
Throat swab
Ltd
Nasal swab
Sensitivity of 100% at Ct < 25; Manufacturer specificity: 100%
Retrospective in vitro study
Nasal/OP swab:
96,4% sensitivity,
COVID-19 (SARS-CoV-2)
DE[2]
Nasal swab,
DE:
99,8% specificity
Nucleo-
Antigen Test Kit (Colloidal 1736
10 May 2021
Positive evaluation by Paul-Ehrlich-Institut:
NP swab: 95,7%
protein
Gold)
UK
! Other
Sensitivity of 100% at Ct < 25; Manufacturer specificity: >99% sensitivity, 99,3%
Anhui Deep Blue
specificity
Medical Technology
Co., Ltd
Retrospective in vitro study
COVID-19 (SARS-CoV-2)
DE:
96.4 % sensitivity
DE[2]
Anterior nasal
Nucleo-
Antigen Test Kit (Colloidal 1815
Positive evaluation by Paul-Ehrlich-Institut:
99.8 % specificity
swab, Nasal
10 May 2021
protein
Gold) – Nasal swab
Sensitivity of 100% at Ct < 25; Manufacturer specificity: >99% Nasal swab
UK
swab
Retrospective in vitro study
Nasopharyngeal
Anhui Formaster
New Coronavirus (COVID-
DE:
sensitivity: 95.15%,
swab,
20 October
2089
DE[2]
Nucleo-
Biosci Co., Ltd.
19) Antigen Rapid Test
Positive evaluation by Paul-Ehrlich-Institut:
specificity: 98.5%
protein
Oropharyngeal
2021
Sensitivity of 100% at Ct < 25; Manufacturer specificity: 98.5%
swab
ArcDia International mariPOC SARS-CoV-2
768
Prospective clinical field study
92% sensitivity
FI
Unknown
Nasopharyngeal 10 May 2021
12
Clinical performance
Completed
SARS-CoV-2
Included in
Device
Clinical performance
Manufacturer
RAT commercial name
Data by
validation
Target
Specimen 16
EU common
ID # 15
As reported by independent validation studies
manufacturer
studies
protein
list since:
Ltd
FI:
100% specificity
swab
Clinical performance of the test was evaluated against qRT-
Nasopharyngeal
PCR with nasopharyngeal swab specimens collected from
swab
patients suspected of acute SARS-CoV-2 infection. Sensitivity
of the mariPOC test was 100.0% (13/13) directly from swab
specimens and 84.4% (38/45) from swab specimens in
undefined transport mediums. Specificity of the test was
100.0% (201/201).
Retrospective in vitro study
Nasopharyngeal
100 % sensitivity
ArcDia International
FI:
swab
mariPOC Respi+
2078
100 % specificity
FI
Unknown
14 July 2021
Oy Ltd
Validated in several laboratories (studies not published),
NP swab
meeting criteria.
! Wash aspirate
Retrospective in vitro study
Nasopharyngeal
100 % sensitivity
ArcDia International
FI:
swab
mariPOC Quick Flu+
2079
100 % specificity
FI
Unknown
14 July 2021
Oy Ltd
Validated in several laboratories (studies not published),
NP swab
meeting criteria.
! Wash aspirate
Retrospective in vitro study
96.67% sensitivity,
Nasal swab
Nasal swab,
Artron Laboratories
Artron COVID-19 Antigen
DE:
91.67% sensitivity,
Nucleo-
1618
DE[2]
Nasopharyngeal 14 July 2021
Inc.
Test
Positive evaluation by Paul-Ehrlich-Institut:
NP swab
protein
swab
Sensitivity of 100% at Ct < 25; Manufacturer specificity: 100%
100 % specificity
Nasal/NP swab
Retrospective in vitro study
94.67% sensitivity,
Asan Pharmaceutical Asan Easy Test COVID-19
DE:
1654
97.71% specificity
DE[2]
Unknown
Nasal swab
10 May 2021
Co., Ltd
Ag
Positive evaluation by Paul-Ehrlich-Institut:
Nasal swab
Sensitivity of 100% at Ct < 25; Manufacturer specificity:
97.71%
Retrospective in vitro study
Nasal swab,
92.5 % sensitivity
DE[2]
Nasopharyngeal
ECOTEST COVID-19
Nucleo-
770
DE:
99.2 % specificity
swab,
14 July 2021
Antigen Rapid Test Device
protein
Positive evaluation by Paul-Ehrlich-Institut:
Nasal/NP/OP swab
UK
Oropharyngeal
Sensitivity of 95% at Ct < 25; Manufacturer specificity: 99.2%
Assure Tech.
swab
(Hangzhou) Co., Ltd.
Retrospective in vitro study
Nasopharyngeal
Sensitivity: 97.7%,
DE[2]
ECOTEST COVID-19
Nucleo-
swab,
2350
DE:
Specificity: 99.1%
23 July 2021
Antigen Rapid Test Device
protein
Oropharyngeal
Positive evaluation by Paul-Ehrlich-Institut:
NP and OP swab
UK
Sensitivity of 95% at Ct < 25; Manufacturer specificity: 99.1%
swab
13
Clinical performance
Completed
SARS-CoV-2
Included in
Device
Clinical performance
Manufacturer
RAT commercial name
Data by
validation
Target
Specimen 16
EU common
ID # 15
As reported by independent validation studies
manufacturer
studies
protein
list since:
NOVA Test ® SARS-CoV-2
98.5 % sensitivity
DE[2]
Nasal swab,
Atlas Link Technology Antigen Rapid Test Kit
DE:
Nucleo-
2010
99.4 % specificity
Oropharyngeal
10 May 2021
Co. Ltd.
(Colloidal Gold
97.6% sensitivity, 99.2% specificity
protein
Nasal/OP swab
CH
swab
Immunochromatography)
Retrospective in vitro study
DE:
Sensitivity: 93.18%
Ksmart® SARS-COV2
Nasopharyngeal
Avalun
1800
Positive evaluation by Paul-Ehrlich-Institut:
Specificity: 99.32%
DE[2]
Unknown
7 July 2021
Antigen Rapid Test
swab
Sensitivity of 94,1% at Ct < 25; Manufacturer specificity:
NP swab
99,32%
Retrospective in vitro study
Nasal swab,
AXIOM Gesellschaft
98% sensitivity
COVID-19 Antigen Rapid
DE:
Nucleo-
Nasopharyngeal
für Diagnostica und
2101
100% specificity
DE[2]
10 May 2021
Test
Positive evaluation by Paul-Ehrlich-Institut:
protein
swab, Throat
Biochemica mbH
NP/Nasal swab
Sensitivity of 100% at Ct < 25; Manufacturer specificity: 100%
swab
Retrospective in vitro study
Nasal swab,
95% sensitivity
Nasopharyngeal
COVID-19 Antigen Rapid
Azure Biotech, Inc.
1906
DE:
99.2% specificity
DE[2]
Unknown
swab,
10 May 2021
Test Device
Positive evaluation by Paul-Ehrlich-Institut (NP swab):
NP swab
Oropharyngeal
Sensitivity of 86% at Ct < 25; Manufacturer specificity: 99.2%
swab
Prospective clinical field studies
ES:
Prospective study in four Spanish hospitals (n = 476); 108
positive samples, 368 negative samples. Sensitivity: 92%,
specificity: 98.6%.
NL:
Independent field study in symptomatic individuals (n=979,
PCR positive n=161) - sampling was Nasal mid-turbinate + OP Clinical Sensitivity:
BD Veritor™ System for
swab. Sensitivity overall: 79.5% - Sensitivity Ct<30: 93.2% -
91.1 %
Specificity overall: 99.8%
Nucleo-
Becton Dickinson
Rapid Detection of SARS
1065
Clinical Specificity:
DE[2], ES, NL, SE
Nasal swab
7 July 2021
protein
CoV 2
99.6 %
SE:
Nasal swab
Karolinska hospital evaluation of Lot 0255648. Patient
samples: 95 PCR positive, 150 negative. No detailed sample
description available. Sensitivity 45%, specificity 97%.
Sensitivity Ct<25 = 87.8%.
Retrospective in vitro study
DE:
Positive evaluation by Paul-Ehrlich-Institut:
Sensitivity of 83% at Ct < 25; Manufacturer specificity: 99.6%
14
Clinical performance
Completed
SARS-CoV-2
Included in
Device
Clinical performance
Manufacturer
RAT commercial name
Data by
validation
Target
Specimen 16
EU common
ID # 15
As reported by independent validation studies
manufacturer
studies
protein
list since:
Prospective clinical field studies
ES:
Prospective study in four Spanish hospitals (n = 476); 108
positive samples, 368 negative samples. Sensitivity: 92%,
Clinical Sensitivity:
specificity: 98.6%.
91.1 %
BD Kit for Rapid Detection
Nucleo-
Becton Dickinson
2282
Clinical Specificity:
ES, NL
Nasal swab
[TBC]
of SARS-CoV-2
protein
NL:
99.6 %
Independent field study in symptomatic individuals (n=979,
Nasal swab
PCR positive n=161) - sampling was Nasal mid-turbinate + OP
swab. Sensitivity overall: 79.5% - Sensitivity Ct<30: 93.2% -
Specificity overall: 99.8%
Prospective clinical field study
FIND evaluation
Brazil (15 September 2021)
453 samples, nasal swab. Clinical sensitivities: Days < 7:
90.1%; Ct < 33: 89.5%; Ct < 25: 95.5%. Clinical specificity:
100%
Nasal swabs,
Novel Coronavirus 2019-
Beijing Hotgen
UK (15 September 2021)
97.1% sensitivity
Nucleo-
Throat swabs,
nCoV Antigen Test
1870
DE[2]
10 May 2021
Biotech Co., Ltd
248 samples, NP swab. Clinical sensitivities: Days < 7: 84.4%; 99.76% specificity
protein
(Colloidal Gold)
Ct < 33: 80.6%; Ct < 25: 82.8%. Clinical specificity: 99.4%
! Saliva
Retrospective in vitro study
DE:
Positive evaluation by Paul-Ehrlich-Institut:
Sensitivity of 100% at Ct < 25; Manufacturer specificity:
99.76%
Retrospective in vitro study
Anterior nasal
swab, Nasal
swab,
Beijing Jinwofu
Novel Coronavirus (SARS-
DE:
96.88 % sensitivity
Nasopharyngeal
Nucleo-
Bioengineering
CoV-2) Antigen Rapid Test 2072
Positive evaluation by Paul-Ehrlich-Institut:
100 % specificity
DE[2]
swab,
14 July 2021
protein
Technology Co.,Ltd.
Kit
Sensitivity of 100% at Ct < 25 + Manufacturer specificity:
Nasal/ NP/ OP swab
Oropharyngeal
100%
swab
! Saliva
Retrospective in vitro study
DE:
92.00% sensitivity,
Nasal swab,
Beijing Lepu Medical SARS-CoV-2 Antigen
17 February
1331
Positive evaluation by Paul-Ehrlich-Institut:
99.26% specificity
DE[2]
Unknown
Nasopharyngeal
Technology Co., Ltd
Rapid Test Kit
2021
Sensitivity of 100% at Ct < 25; Manufacturer specificity:
Nasal swab
swab
99.26%
15
Clinical performance
Completed
SARS-CoV-2
Included in
Device
Clinical performance
Manufacturer
RAT commercial name
Data by
validation
Target
Specimen 16
EU common
ID # 15
As reported by independent validation studies
manufacturer
studies
protein
list since:
Retrospective in vitro study
DE:
Nucleo-
Nasal swab,
Beijing O&D Biotech COVID-19 Antigen Rapid
sensitivity: 92.17%,
20 October
2494
Positive evaluation by Paul-Ehrlich-Institut:
DE[2]
capsid
Oropharyngeal
Co., Ltd.
Test
specificity: 98.67 %
2021
Sensitivity of 100% at Ct < 25; Manufacturer specificity:
protein
swab
98.67%
96.6% sensitivity,
Beijing Wantai
Nasal swab
Nasal swab
Wantai SARS-CoV-2 Ag
Nucleo-
17 February
Biological Pharmacy
1484
No data available
93 % sensitivity
Rapid Test (FIA)
protein
202117
Enterprise Co., Ltd
97% specificity
! Other
NP, OP swabs
Prospective clinical field study
CZ:
Anterior nasal
Independent prospective study by Public Health Institute
swab, Nasal
Ostrava (CZ), including NP swabs from unselected
swab,
Beijing Wantai
symptomatic and asymptomatic participants. Sensitivity
93.2% sensitivity
Nasopharyngeal
Wantai SARS-CoV-2 Ag
Biological Pharmacy
1485
80.6%, specificity 98.5% on 155 pos. and 325 neg. samples (as 98.2% specificity
CZ, DE[2]
Unknown
swab,
14 July 2021
Rapid Test (colloidal gold)
Enterprise Co., Ltd
resulting by RT-PCR). Ct not reported. N total = 480
Nasal swab
Oropharyngeal
Retrospective in vitro study
swab
DE:
! Saliva
Positive evaluation by Paul-Ehrlich-Institut:
Sensitivity of 100% at Ct < 25; Manufacturer specificity: 98.2%
Retrospective in vitro study
HR:
Sensitivity: 96%,
CoviGnost AG Test Device
Nasopharyngeal
BioGnost Ltd
2247
300 NP samples (retrospective), symptomatic (<7 dps): 200
Specificity: 99%
HR
Unknown
23 July 2021
1x20
swab
PCR+ samples (range Ct 16-30), Ct<30: sensitivity 96.5%
NP swab
100 PCR- samples: specificity 100%
SARS-CoV-2 Antigen
Retrospective in vitro study
Rapid Test Kit
Sensitivity: 96.77%
Nucleo-
BIOHIT HealthCcare
Anterior nasal
(Fluorescence
1286
DE:
Specificity: 98.9%
DE[2]
capsid
23 July 2021
(Hefei) Co., Ltd.
Positive evaluation by Paul-Ehrlich-Institut:
swab
Immunochromato-
NP/OP swab
protein
graphy)
Sensitivity of 100% at Ct < 25; Manufacturer specificity: 98.9%
BioMaxima SA
SARS-CoV-2 Ag Rapid Test 2035
Prospective clinical field studies
Sensitivity: 95%
DE[2], FR, PL
Nucleo-
Nasopharyngeal 23 July 2021
17 This rapid antigen test, device ID 1484, was removed from the EU common list on 20 October 2021. The grace period will end on 15 Dec 2021, 23:59 CET
16
Clinical performance
Completed
SARS-CoV-2
Included in
Device
Clinical performance
Manufacturer
RAT commercial name
Data by
validation
Target
Specimen 16
EU common
ID # 15
As reported by independent validation studies
manufacturer
studies
protein
list since:
Specificity: 99%
protein
swab
FR:
NP Swab
NP swabs, Diagnostic sensitivity: 96,4% (80/83) (95% CI: 89,8-
99,2%); diagnostic specificity: 99,2%, (120/121)
PL:
Evaluation of the test was performed on 480 samples of
nasopharyngeal swabs taken from patients with symptoms of
COVID-19 and from people in contact with an infected person
but without symptoms of infection. Positive results of the
antigen test were obtained in 205 patients and in the
molecular test 213 people. On the other hand, negative
results of the antigen test were obtained in 275 people and in
the molecular test 267 people. The above results permitted
calculation of diagnostic sensitivity, which was 93.43% (95%
CI: 91.61%~97.19%) and diagnostic specificity, which was
97.75% (95% CI: 93.74%~98.92%)
Retrospective in vitro study
DE:
Positive evaluation by Paul-Ehrlich-Institut:
Sensitivity of 100% at Ct < 25; Manufacturer specificity: 99%
Retrospective in vitro study
Clinical Sensitivity:
Biomerica COVID-19
Nasal swab,
DE:
94.7%; Clinical
Nucleo-
Biomerica Inc.
Antigen Rapid Test
1599
DE[2]
Nasopharyngeal 7 July 2021
Positive evaluation by Paul-Ehrlich-Institut:
specificity: 99.7%
protein
(nasopharyngeal swab)
swab
Sensitivity of 100% at Ct < 25; Manufacturer specificity: 99,7%
Nasal/NP swab
Prospective clinical field study
FIND evaluation
Brazil (20 April 2021)
400 samples, NP swab. Clinical sensitivities: Days < 7: 92.2%;
Ct < 33: 91.4%; Ct < 25: 94.8%. Clinical specificity: 97.3%
Clinical Sensitivity:
Brazil (30 March 2021)
90.91 %
DE[2]
Nasal swab,
NowCheck COVID-19 Ag
218 samples, Nasal/NP swab. Clinical sensitivities: Days < 7:
BIONOTE
1242
Clinical Specificity:
Unknown
Nasopharyngeal 7 July 2021
Test
92.5% (N/NP); Ct < 33: 97.2% (N/NP); Ct < 25: 100% (N/NP);
99.43 %
Brazil
swab
Clinical specificity: 98.6%
Nasal swab, NP swab
Retrospective in vitro study
DE:
Positive evaluation by Paul-Ehrlich-Institut:
Sensitivity of 100% at Ct < 25; Manufacturer specificity: 98,6%
BIO-RAD
CORONAVIRUS AG RAPID 2031
Prospective clinical field studies
Clinical Sensitivity:
ES
Nucleo-
Nasal swab,
7 July 2021
17
Clinical performance
Completed
SARS-CoV-2
Included in
Device
Clinical performance
Manufacturer
RAT commercial name
Data by
validation
Target
Specimen 16
EU common
ID # 15
As reported by independent validation studies
manufacturer
studies
protein
list since:
TEST CASSETTE
98% (NP: 98,32% /
protein
Nasopharyngeal
ES7:
Nasal: 97,25%)
swab
[12 May 2021]: Prospective study; 96 positive samples and Clinical Specificity:
269 negative samples. Sensitivity 94%. Specificity 99.2%.
99% (NP: 99,6% /
No Ct distribution specified.
Nasal: 100%)
NP swab: sensitivity 98,3%; specificity 99,6% (119 positive
samples, 746 negative samples)
Nasal swab: sensitivity 97,2%; specificity 100% (109
positive samples, 128 negative samples)
Prospective clinical field studies
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 the swab
included in the kit.
FR:
NP swabs, prospective study (71/71) : sensitivity 100%
(45/45, specificity 100%
NL:
Independent field study, mainly symptomatic individuals
96% sensitivity, 100%
BE, DE[2], FR,
(n=568, PCR positive n=39), NP swab; sensitivity Ct<30:
Nucleo-
Nasal swab,
BIOSYNEX COVID-19 Ag
NL[5], SE
17 February
BIOSYNEX SWISS S.A.
1223
specificity, NP/Nasal
96.0%, sensitivity ≤25: 100%; specificity overall: 100%
capsid
Nasopharyngeal
BSS
swab
2021
protein
swab
NL:
CH
Independent field study, symptomatic individuals (n=270, PCR
positive n=17), NP+OP swab; sensitivity Ct≤30: 94.1%,
sensitivity Ct≤25: 100%; specificity overall: 100%
SE:
Karolinska hospital evaluation of Lot 20100103. Patient
samples; 95 PCR positive, 150 negative. No detailed sample
description available. Sensitivity 76%, specificity 96%.
Sensitivity Ct<25 = 100%.
Retrospective in vitro study
DE:
Positive evaluation by Paul-Ehrlich-Institut:
Sensitivity of 100% at Ct < 25; Manufacturer specificity: 100%
BIOSYNEX SA
BIOSYNEX COVID-19 Ag+ 1494
Prospective clinical field study
Clinical Sensitivity:
FR
Nucleo-
Nasal swab,
7 July 2021
18
Clinical performance
Completed
SARS-CoV-2
Included in
Device
Clinical performance
Manufacturer
RAT commercial name
Data by
validation
Target
Specimen 16
EU common
ID # 15
As reported by independent validation studies
manufacturer
studies
protein
list since:
BSS
97.5 %
capsid
Nasopharyngeal
FR:
Specificity: 99%
UK
protein
swab
Validation study data: 125 positive and 118 negative samples; Nasal swab, NP swab
sensitivity 96%, specificity: 99%
Retrospective in vitro study
Nasopharyngeal
BIOTEKE
SARS-CoV-2 Antigen Test
96.49 % sensitivity
DE:
Nucleo-
swab,
CORPORATION
Kit (colloidal gold
2067
99.28 % specificity
DE[2]
14 July 2021
Positive evaluation by Paul-Ehrlich-Institut:
protein
Oropharyngeal
(WUXI) CO., LTD
method)
OP/NP swab
Sensitivity of 95% at Ct < 25; Manufacturer specificity: 99.28%
swab
Retrospective in vitro study
Biotical Health
BE:
Sensitivity: 96%,
biotical SARS-CoV-2 Ag
Nucleo-
Nasopharyngeal
S.L.U.BIOTICAL
2013
Specificity: 99%
BE
23 July 2021
Card
Validation study 1: sensitivity 91.7% for Ct<25;
protein
swab
HEALTH S.L.U
NP swab
Validation study 2: 94% for Ct<25. Manufacturer specificity:
99%
Prospective clinical field study
NL:
Sensitivity: 91.7%,
Nucleo-
Nasopharyngeal
Boditech Med Inc
AFIAS COVID-19 Ag
1989
Independent field study in mild symptomatic (n= 427, PCR
Specificity: 98.7%
NL
23 July 2021
protein
swab
positive: 106); unknown swab, overall sensitivity: 81.1%,
NP swab
sensitivity Ct <30: 96.4%; specificity: 100%,
Retrospective in vitro study
Nasal swab,
90.2% sensitivity
Nasopharyngeal
Rapid Response COVID-19
DE:
100% specificity NP
Nucleo-
BTNX Inc
1236
DE[2]
swab,
10 May 2021
Antigen Rapid Test
Positive evaluation by Paul-Ehrlich-Institut (NP swab):
swab, NP swab, OP
protein
Oropharyngeal
Sensitivity of 100% at Ct < 25; Manufacturer specificity: 100%
swab
swab
Prospective clinical field study
ES:
92.9% sensitivity
CerTest SARS-CoV-2 Card
Nasopharyngeal 17 February
CerTest Biotec
1173
Ct < 25, sensitivity: 94,0%; sensitivity for samples within the
99.6% specificity
DE[2], ES
Unknown
test
swab
2021
first 5 days after symptom onset: 84,8%; 150 positive
NP swab
samples, 170 negative samples
Retrospective in vitro study
CHIL COVID-19 Antigen
Nasopharyngeal
Chil Tıbbi Malzeme
Rapid Test
DE:
Sensitivity 99.01%
Nucleo-
swab,
20 October
Sanayi ve Ticaret
(Nasopharyngeal /
1691
Positive evaluation by Paul-Ehrlich-Institut:
DE[2]
Specificity: 99.57%
protein
Oropharyngeal
2021
Limited Şirketi
Oropharyngeal Swab-
Sensitivity of 100% at Ct < 25; Manufacturer specificity:
swab
Casette)
99.57%
Chongqing M&D
2019-nCoV Antigen Test
2150
Retrospective in vitro study
sensitivity: 91.53%,
DE[2]
Nucleo-
Nasopharyngeal 20 October
19
Clinical performance
Completed
SARS-CoV-2
Included in
Device
Clinical performance
Manufacturer
RAT commercial name
Data by
validation
Target
Specimen 16
EU common
ID # 15
As reported by independent validation studies
manufacturer
studies
protein
list since:
Biotechnology Co.
Kit
specificity:100%
protein
swab
2021
Ltd
DE:
Positive evaluation by Paul-Ehrlich-Institut:
Sensitivity of 95% at Ct < 25; Manufacturer specificity: 100%
Retrospective in vitro study
98.1% sensitivity
Core Technology Co., Coretests COVID-19 Ag
DE:
Nucleo-
Nasopharyngeal
1919
99.6% specificity
DE[2]
10 May 2021
Ltd
Test
Positive evaluation by Paul-Ehrlich-Institut:
protein
swab
NP swab
Sensitivity of 88% at Ct < 25; Manufacturer specificity: 99.6%
Prospective clinical field study
Clinical Sensitivity:
DK:
92.3 %
Nasal swab,
OnSite COVID-19 Ag
Nucleo-
CTK Biotech, Inc
1581
107 samples; Nasal swab - clinical sensitivity 86%; (from
Clinical Specificity:
DK, ES
Nasopharyngeal 7 July 2021
Rapid Test
protein
asymptomatic and mild symptomatic individuals), Clinical
100 %
swab
specificity: 100%
Nasal, NP swab
Prospective clinical field study
RO:
Clinical study based on 228 COVID-19 positive samples and
Test Rapid Covid-19
597 COVID-19 negative samples. All the samples were
98.77% sensitivity
RO
Nasal swab
DDS DIAGNOSTIC
Antigen (tampon
1225
confirmed using PCR (Applied Biosystems™ 7500 and SLAN®- 99.03% specificity
Unknown
10 May 2021
nazofaringian)
96P) and clinical symptoms. The relative sensitivity of Rapid
Nasal swab
China
Test COVID-19 Antigen (Nasopharyngeal Swab) was 99.56%,
the relative specificity was 99.66%, and the accuracy was
99.64% compared to the qRT-PCR result.
BE:
DIAQUICK COVID -19 Ag
Nasopharyngeal
DIALAB GmbH
1375
Z20401CE: 93.2% sensitivity, 100% specificity, NP swab
NP swab
BE
Unknown
10 May 2021
Cassette
swab
Z20601CE: 96.4% sensitivity, 99.2% specificity, NP swab
Retrospective in vitro study
DE:
Sensitivity: 93.8%,
DE[2]
COVID-19 Antigen
Nucleo-
DNA Diagnostic
2242
Positive evaluation by Paul-Ehrlich-Institut:
Specificity: 99.6%
Nasal swab
23 July 2021
Detection Kit
protein
Sensitivity of 100% at Ct < 25; Manufacturer specificity:
Nasal swab
UK
99.56%
20
Clinical performance
Completed
SARS-CoV-2
Included in
Device
Clinical performance
Manufacturer
RAT commercial name
Data by
validation
Target
Specimen 16
EU common
ID # 15
As reported by independent validation studies
manufacturer
studies
protein
list since:
Prospective clinical field studies
DE:
Independent prospective study, mainly symptomatic <7 dps
(n=378, PCR positive = 70), self-collected nasal swab;
sensitivity overall: 88.6%, sensitivity Ct<26: 96.8%; specificity
overall: 99.7%
CH:
Sensitivity: 96.1% (Ct
DE[2]
Nucleo-
Dräger Safety AG &
Dräger Antigen Test SARS-
20 October
2273
Independent prospective study, mainly symptomatic ≤7 dps
values ≤25)
capsid
Nasal swab
Co. KGaA
CoV-2
(n=464, PCR positive = 57), self-collected nasal swab;
2021
Specificity: 99.6%
CH
protein
sensitivity Ct<30: 85.1%, sensitivity Ct<26: 90.0%; specificity
overall: 100%
Retrospective in vitro study
DE:
Positive evaluation by Paul-Ehrlich-Institut:
Sensitivity of 95% at Ct < 25; Manufacturer specificity: 99.6%
Retrospective in vitro study
Nasopharyngeal
Dynamiker
Nucleo-
Dynamiker SARS-CoV-2
DE:
sensitivity: 95.7%,
swab,
20 October
Biotechnolgy(Tianjin)
2533
DE[2]
capsid
Ag Rapid Test
Positive evaluation by Paul-Ehrlich-Institut:
specificity: 99.1%
Oropharyngeal
2021
Co., Ltd.
protein
Sensitivity of 100% at Ct < 25; Manufacturer Specificity: 99.1%
swab
Prospective clinical field study
FIND evaluation
Clinical Sensitivity
Peru (26 April 2021)
97.27% NP swab
120 samples, NP swab. Clinical sensitivities: Days < 7: 62%; Ct Clinical Specificity
Nasal swab,
Edinburgh Genetics
< 33: 75%; Ct < 25: 100%. Clinical specificity: 100%
99.62% NP swab
DE[2]
Nasopharyngeal
Edinburgh Genetics
ActivXpress+ COVID-19
Nucleo-
1243
swab,
14 July 2021
Limited
Antigen Complete Testing
Retrospective in vitro study
protein
Clinical Sensitivity
Peru
Oropharyngeal
Kit
95.63% OP swab
swab
DE:
Clinical Specificity
Positive evaluation by Paul-Ehrlich-Institut:
99.24% OP swab
Sensitivity of 100% at Ct < 25; Manufacturer Specificity:
99,24%
Prospective clinical field study
Clinical Sensitivity:
EBS SARS-CoV-2 Ag Rapid
FR:
Nucleo-
Eurobio Scientific
1739
95.7 %
DE[2], FR
Nasal swab
7 July 2021
Test
Validation study data: 119 positive and 125 negative samples;
protein
Nasal swab
sensitivity 93%, specificity: 99%
21
Clinical performance
Completed
SARS-CoV-2
Included in
Device
Clinical performance
Manufacturer
RAT commercial name
Data by
validation
Target
Specimen 16
EU common
ID # 15
As reported by independent validation studies
manufacturer
studies
protein
list since:
Retrospective in vitro study
DE:
Positive evaluation by Paul-Ehrlich-Institut:
Sensitivity of 94,1% at Ct < 25; Manufacturer specificity:
99,1%
Prospective clinical field study
FIND evaluation
DE (29 March 2021)
723 samples, NP swab. Clinical sensitivities: Days < 7: 88.5%;
Ct < 33: 87.8%; Ct < 25: 92.4%. Clinical specificity: 100%
Clinical Sensitivity:
South Africa (6 Oct 2021)
87.8 % ( (n=98,
494 samples, NP swab. Clinical sensitivities: Days < 7: 75%; Ct Ct<33))
Nucleo-
Nasopharyngeal
Fujirebio
ESPLINE SARS-CoV-2
2147
DE[2]
7 July 2021
< 33: 78.9%; Ct < 25: 90.1%. Clinical specificity: 99.7%
Clinical Specificity:
protein
swab
100 %
Retrospective in vitro study
NP swab
DE:
Positive evaluation by Paul-Ehrlich-Institut:
Sensitivity of 94,1% at Ct < 25; Manufacturer specificity:
99,13%
Retrospective in vitro study
Sensitivity: 97.059%,
GA Generic Assays
GA CoV-2 Antigen Rapid
Nucleo-
Nasopharyngeal
1855
DE:
Specificity: 99.2%
DE[2]
GmbH
Test
Positive evaluation by Paul-Ehrlich-Institut
protein
swab
23 July 2021
NP swab
Sensitivity of 100% at Ct < 25; Manufacturer specificity: 99.2%
90% sensitivity
Nasopharyngeal
98% specificity
swab,
Genbody COVID-19 Ag
NP/OP swab
Oropharyngeal
17 February
GenBody Inc
1244
No data available
Unknown
Test
89.05% sensitivity
swab
202118
99.19% specificity
NP/OP/Nasal swab
Retrospective in vitro study
Nasal swab,
DE:
Sensitivity: 91.15%
Nasopharyngeal
SARS-CoV-2 Antigen Test
Nucleo-
Genrui Biotech Inc
2012
Positive evaluation by Paul-Ehrlich-Institut:
Specificity: 99.02%
DE[2]
swab,
7 July 2021
Kit (Colloidal Gold)
protein
Sensitivity of 94,1% at Ct < 25; Manufacturer specificity:
Nasal/NP/OP swab
Oropharyngeal
99,02%
swab
18 This rapid antigen test, device ID 1244, was removed from the EU common list on 20 October 2021. The grace period will end on 15 Dec 2021, 23:59 CET.
22
Clinical performance
Completed
SARS-CoV-2
Included in
Device
Clinical performance
Manufacturer
RAT commercial name
Data by
validation
Target
Specimen 16
EU common
ID # 15
As reported by independent validation studies
manufacturer
studies
protein
list since:
Retrospective in vitro study
96.86% sensitivity
DE[2]
GenSure COVID-19
GenSure Biotech Inc
1253
DE:
100% specificity
Unknown
Nasal swab
10 May 2021
Antigen Rapid Test Kit
Positive evaluation by Paul-Ehrlich-Institut:
Nasal swab
UK
Sensitivity of 94,1% at Ct < 25; Manufacturer specificity: 100%
Retrospective in vitro study
DE:
97.06% sensitivity
Nasal swab
SARS-CoV-2 Antigen
Nucleo-
Getein Biotech, Inc
1820
Positive evaluation by Paul-Ehrlich-Institut:
98.71% specificity
DE[2]
14 July 2021
(Colloidal Gold)
protein
Sensitivity of 100% at Ct < 25; Manufacturer specificity:
Nasal swab
! Saliva
98.71%
Retrospective in vitro study
One Step Test for SARS-
DE:
97.06% sensitivity
DE[2]
Nasal swab
Nucleo-
Getein Biotech, Inc.
CoV-2 Antigen (Colloidal
2183
Positive evaluation by Paul-Ehrlich-Institut:
98.71% specificity
16 June 2021
protein
Gold)
Sensitivity of 90% at Ct < 30 and 100% at Ct < 25;
Nasal swab
UK
! Saliva
Manufacturer specificity: 98.71%
Retrospective in vitro study
93.04% sensitivity;
FR, DE[2], ES
Nasal swab
Goldsite Diagnostic
SARS-CoV-2 Antigen Kit
1197
DE:
100% specificity
Unknown
14 July 2021
Inc.
(Colloidal Gold)
Positive evaluation by Paul-Ehrlich-Institut:
Nasal swab
UK
! Other
Sensitivity of 100% at Ct < 25; Manufacturer specificity: 100%
Retrospective in vitro study
100% sensitivity
Anterior nasal
90.1% sensitivity
Green Cross Medical
DE:
Nucleo-
swab,
GENEDIA W COVID-19 Ag 1144
100% specificity
DE[2]
10 May 2021
Science Corp.
Positive evaluation by Paul-Ehrlich-Institut:
protein
Nasopharyngeal
NP swab, Anterior
Sensitivity of 83% at Ct < 25; Manufacturer specificity: 100%
swab
nasal swab
Retrospective in vitro study
2019-nCoV Antigen Test
96.23% sensitivity
Guangdong Hecin
DE:
Nucleo-
Kit (colloidal gold
1747
99.07% specificity
DE[2]
Nasopharyngeal 10 May 2021
Scientific, Inc.
Positive evaluation by Paul-Ehrlich-Institut:
protein
method)
Nasal swab
swab
Sensitivity of 82% at Ct < 25; Manufacturer specificity: 99.07%
Retrospective in vitro study
Nasopharyngeal
2019-nCoV Ag Rapid
99.72% sensitivity
Guangdong Longsee
DE:
swab,
Detection Kit(Immuno-
1216
99.5% specificity
DE[2]
Unknown
14 July 2021
Biomedical Co., Ltd.
Positive evaluation by Paul-Ehrlich-Institut:
Oropharyngeal
Chromatography)
NP/OP swab
Sensitivity of 100% at Ct < 25; Manufacturer specificity: 99.5%
swab
Retrospective in vitro study
90% sensitivity
Nasal swab,
Guangdong Wesail
DE:
Nucleo-
17 February
COVID-19 Ag Test Kit
1360
98% specificity
DE[2]
Nasopharyngeal
Biotech Co. Ltd
Positive evaluation by Paul-Ehrlich-Institut:
protein
2021
Nasal swab
swab
Sensitivity of 100% at Ct < 25; Manufacturer specificity: 98%
23
Clinical performance
Completed
SARS-CoV-2
Included in
Device
Clinical performance
Manufacturer
RAT commercial name
Data by
validation
Target
Specimen 16
EU common
ID # 15
As reported by independent validation studies
manufacturer
studies
protein
list since:
Retrospective in vitro study
Guangzhou Decheng V-CHEK, 2019-nCoV Ag
DE:
Clinical Sensitivity:
Nucleo-
Biotechnology CO.,
Rapid Test Kit (Immuno-
1324
Positive evaluation by Paul-Ehrlich-Institut:
96.67 %
DE[2]
Nasal swab
7 July 2021
protein
Ltd
chromatography)
Sensitivity of 94,1% at Ct < 25; Manufacturer specificity:
Nasal swab
99,5%
Prospective clinical field study
FIND evaluation
CH (25 Feb 2020)
328 samples, NP swab. Clinical sensitivities: Days < 7: 85.7%;
Ct < 33: 92.2%; Ct < 25: 100%. Clinical specificity: 100%
Wondfo 2019-nCoV
Brazil (10 Oct 2021)
DE[2]
Guangzhou Wondfo
Sensitivity: 87.12%
Nasopharyngeal
Antigen Test (Lateral Flow 1437
237 samples, NP swab. Clinical sensitivities: Days < 7: 90.4%;
Unknown
10 May 2021
Biotech Co., Ltd
Specificity: 99.74%
swab
Method)
Ct < 33: 89.3%; Ct < 25: 96.7%. Clinical specificity: 98.8%
CH, UK
Retrospective in vitro study
DE:
Positive evaluation by Paul-Ehrlich-Institut:
Sensitivity of 88% at Ct < 25; Manufacturer specificity: 99.74%
Retrospective in vitro study
Hangzhou Lysun
COVID-19 Antigen Rapid
96.46% sensitivity
DE:
Nucleo-
Biotechnology Co.
Test Device (Colloidal
2139
100% specificity
DE[2]
Nasal swab
10 May 2021
Positive evaluation by Paul-Ehrlich-Institut:
protein
Ltd
Gold)
Nasal swab
Sensitivity of 100% at Ct < 25; Manufacturer specificity: 100%
Prospective clinical field study
93,40% sensitivity,
Hangzhou AllTest
COVID-19 Antigen Rapid
Nasopharyngeal
1257
FR:
99,90% specificity
FR
Unknown
10 May 2021
Biotech Co., Ltd
Test
swab
Prospective study, sensitivity 96,4% (80/83), specificity 99,2% NP swab
(120/121)
Retrospective in vitro study
Clinical Sensitivity:
91.4 %
DE[2]
COVID-19 Antigen Rapid
Nucleo-
Nasopharyngeal
1610
DE:
Clinical Specificity:
7 July 2021
Test Casette
protein
swab
Positive evaluation by Paul-Ehrlich-Institut:
100 %
UK
Sensitivity of 94,4% at Ct < 25; Manufacturer specificity: 100%
NP swab
Hangzhou Clongene
Biotech Co., Ltd.
Retrospective in vitro study
98.5% (Ct<33)
DE[2]
Covid-19 Antigen Rapid
DE:
Nucleo-
17 February
1363
sensitivity
Nasal swab
Test Kit
Positive evaluation by Paul-Ehrlich-Institut:
protein
2021
Nasal swab
CH
Sensitivity of 94,4% at Ct < 25; Manufacturer specificity: 100%
24
Clinical performance
Completed
SARS-CoV-2
Included in
Device
Clinical performance
Manufacturer
RAT commercial name
Data by
validation
Target
Specimen 16
EU common
ID # 15
As reported by independent validation studies
manufacturer
studies
protein
list since:
Retrospective in vitro study
COVID-19/Influenza A+B
91% sensitivity
Nucleo-
Nasopharyngeal
Antigen Combo Rapid
1365
DE:
100% specificity
DE[2]
10 May 2021
protein
swab
Test
Positive evaluation by Paul-Ehrlich-Institut:
NP swab
Sensitivity of 94,4% at Ct < 25; Manufacturer specificity: 100%
Retrospective in vitro study
Immunobio SARS-CoV-2
94% sensitivity
Nasal swab,
Antigen ANTERIOR NASAL
Nucleo-
1844
DE:
100% specificity
DE[2]
Nasopharyngeal 10 May 2021
Rapid Test Kit (minimal
protein
Positive evaluation by Paul-Ehrlich-Institut:
Nasal swab, NP swab
swab
invasive)
Sensitivity of 88% at Ct < 25; Manufacturer specificity: 100%
Hangzhou Immuno
Retrospective in vitro study
Anterior nasal
Biotech Co., Ltd
Clinical Sensitivity
swab,
98 %
Nasopharyngeal
SARS-CoV2 Antigen Rapid
Clinical Specificity
Nucleo-
swab,
2317
DE:
DE[2]
10 May 2021
Test
100 %
protein
Oropharyngeal
Positive evaluation by Paul-Ehrlich-Institut:
Anterior nasal swab,
swab
Sensitivity of 88% at Ct < 25; Manufacturer specificity: 100%
NP swab, OP swab,
! Sputum
Retrospective in vitro study
Clinical Sensitivity:
LYHER Novel Coronavirus
DE:
95.07% %
DE[2]
Hangzhou Laihe
(COVID-19) Antigen Test
1215
Positive evaluation by Paul-Ehrlich-Institut:
Clinical Specificity:
Unknown
Nasal swab
10 May 2021
Biotech Co.
Kit (Colloidal Gold)
Sensitivity of 94,1% at Ct < 25; Manufacturer specificity:
99.74%
UK
99,7%
Nasal swab
Retrospective in vitro study
Hangzhou Testsea
92.1% sensitivity
Covid-19 Antigen Test
Nucleo-
Biotechnology Co.,
1392
DE:
98.1% specificity
DE[2]
Nasal swab
10 May 2021
Cassette
protein
Ltd.
Positive evaluation by Paul-Ehrlich-Institut (NP swab):
Nasal swab
Sensitivity of 100% at Ct < 25; Manufacturer specificity: 98.4%
25
Clinical performance
Completed
SARS-CoV-2
Included in
Device
Clinical performance
Manufacturer
RAT commercial name
Data by
validation
Target
Specimen 16
EU common
ID # 15
As reported by independent validation studies
manufacturer
studies
protein
list since:
Prospective clinical field studies
NL:
Independent clinical field study, symptomatic individuals
(n=417, PCR positive n=70), NP swab; sensitivity overall:
75.7%, sensitivity Ct≤30: 85.2%, sensitivity Ct≤25: 90.7%;
specificity overall: 100%
NL:
Independent clinical field study, symptomatic individuals
98.32 % sensitivity
(n=240, PCR positive n=21), NP+OP swab; sensitivity overall: 99.6% specificity
Nucleo-
Nasal swab,
Coronavirus Ag Rapid Test
85.7%, sensitivity Ct≤30: 89.5%, sensitivity Ct≤25: 100%;
(NP swab)
proteins,
17 February
Healgen Scientific
1767
DE[2], NL[5]
Nasopharyngeal
Cassette
specificity overall: 100%
97.25% sensitivity
S1, S1-RBD,
2021
swab
100% specificity
S2
NL:
(Nasal swab)
Independent clinical field study, symptomatic individuals
(n=94, PCR positive n=18), NP+OP swab in VTM; sensitivity
overall: 90.0%, sensitivity Ct≤30: 100%, sensitivity Ct≤25:
100%; specificity overall: 97.3%
Retrospective in vitro study
DE:
Positive evaluation by Paul-Ehrlich-Institut (NP swab):
Sensitivity of 100% at Ct < 25; Manufacturer specificity: 100%
Prospective clinical field studies
NL:
Independent clinical field study, symptomatic individuals
(n=417, PCR positive n=70), NP swab; sensitivity overall:
75.7%, sensitivity Ct≤30: 85.2%, sensitivity Ct≤25: 90.7%;
specificity overall: 100%
NL:
98.32% sensitivity
Independent clinical field study, symptomatic individuals
Nucleo-
(NP swab)
(n=240, PCR positive n=21), NP+OP swab; sensitivity overall:
proteins,
Nasal swab,
Siemens
CLINITEST Rapid COVID-
97.25% sensitivity
17 February
1218
85.7%, sensitivity Ct≤30: 89.5%, sensitivity Ct≤25: 100%;
DE[2], ES, NL[5]
S1, S1-RBD, Nasopharyngeal
Healthineers
19 Antigen Test
(Nasal swab)
2021
specificity overall: 100%
S2
swab
100% specificity
NL:
Independent clinical field study, symptomatic individuals
(n=94, PCR positive n=18), NP+OP swab in VTM; sensitivity
overall: 90.0%, sensitivity Ct≤30: 100%, sensitivity Ct≤25:
100%; specificity overall: 97.3%
SKUP:
Overall sensitivity 53% and 83% Ct<25, specificity 99.3%
26
Clinical performance
Completed
SARS-CoV-2
Included in
Device
Clinical performance
Manufacturer
RAT commercial name
Data by
validation
Target
Specimen 16
EU common
ID # 15
As reported by independent validation studies
manufacturer
studies
protein
list since:
Retrospective in vitro study
DE:
Positive evaluation by Paul-Ehrlich-Institut (NP swab):
Sensitivity of 100% at Ct < 25; Manufacturer specificity: 100%
Retrospective in vitro study
NP swab - Sensitivity:
Nasopharyngeal
Corona Virus (COVID-19)
96%, Specificity: 99%
Hoyotek Biomedical
swab,
20 October
Antigen Rapid Test
1929
DE:
DE[2]
Unknown
Co.,Ltd.
OP swab - Sensitivity:
Positive evaluation by Paul-Ehrlich-Institut:
Oropharyngeal
2021
(Colloidal Gold)
93%, Specificity:
Sensitivity of 90% at Ct < 25; Manufacturer specificity: 99%
swab
97.5%
Retrospective in vitro study
Hubei Jinjian Biology SARS-CoV-2 Antigen Test
DE:
Sensitivity: 98.02%
Nucleo-
Nasopharyngeal
1759
DE[2]
23 July 2021
Co., Ltd
Kit
Positive evaluation by Paul-Ehrlich-Institut:
Nasal Swab
protein
swab
Sensitivity of 100% at Ct < 25; Manufacturer specificity: 99.3%
Retrospective in vitro study
95.3% sensitivity
DE[2]
Humasis COVID-19 Ag
DE:
Humasis
1263
100% specificity
Unknown
Nasal swab
10 May 2021
Test
Positive evaluation by Paul-Ehrlich-Institut (NP swab):
Nasal swab
UK
Sensitivity of 88% at Ct < 25; Manufacturer specificity: 100%
Retrospective in vitro study
Sensitivity 94.0% : CI
95% (86.7%-98.0%) –
Innova SARS-CoV-2
calculated for viral
Nucleo-
Anterior nasal
Innova Medical
DE:
20 October
Antigen Rapid Qualitative 1801
loads x10^6 copies
DE[2]
capsid
swab, Nasal
Group.Inc
Positive evaluation by Paul-Ehrlich-Institut:
2021
Test
RNA /mL
protein
swab
Sensitivity of 100% at Ct < 25; Manufacturer specificity: 99%
Specificity: 99.6% -
CI:95%(99.4%-99.8%)
Retrospective in vitro study
Innovation
Coronavirus (SARS-Cov-2)
DE:
Sensitivity: 95.6%
Nucleo-
20 October
Biotech(Beijing)
Antigen Rapid Test
2278
DE[2]
Nasal swab
Positive evaluation by Paul-Ehrlich-Institut:
Specificity: 100%
protein
2021
Co.Ltd
Cassette (Nasal swab)
Sensitivity of 100% at Ct < 25; Manufacturer specificity: 99%
Retrospective in vitro study
Sensitivity 90.2%
Rapid SARS-CoV-2
(95% CI: 83.1% to
Nucleo-
InTec PRODUCTS,
Antigen Test
DE:
95.0%);
Nasopharyngeal 20 October
2419
DE[2]
capsid
INC.
(nasopharyngeal
Positive evaluation by Paul-Ehrlich-Institut:
Specificity 100.0%
swab
2021
protein
specimen)
Sensitivity of 100% at Ct < 25; Manufacturer specificity: 100%
(95% CI: 96.5% -
100.00%)
Retrospective in vitro study
Nasal swab,
Jiangsu Bioperfectus Novel Corona Virus
DE:
97.06 % sensitivity
DE[2]
Nasopharyngeal
Nucleo-
Technologies Co.,
(SARS-CoV-2) Ag Rapid
2107
Positive evaluation by Paul-Ehrlich-Institut:
99.15 % specificity
swab,
14 July 2021
protein
Ltd.
Test Kit
Sensitivity of 100% at Ct < 25; Manufacturer specificity:
Nasal/NP/ OP swab
UK
Oropharyngeal
99.15%
swab
27
Clinical performance
Completed
SARS-CoV-2
Included in
Device
Clinical performance
Manufacturer
RAT commercial name
Data by
validation
Target
Specimen 16
EU common
ID # 15
As reported by independent validation studies
manufacturer
studies
protein
list since:
! Other
Retrospective in vitro study
Nasal swab,
Nasopharyngeal
Jiangsu Diagnostics
COVID-19 Antigen Rapid
97.58 % sensitivity
DE:
Nucleo-
swab,
Biotechnology Co.,
Test Cassette (Colloidal
1920
100 % specificity
DE[2]
14 July 2021
Positive evaluation by Paul-Ehrlich-Institut:
protein
Oropharyngeal
Ltd
Gold)
Nasal/NP/ OP swab
Sensitivity of 100% at Ct < 25; Manufacturer specificity: 100%
swab, Throat
swab
Retrospective in vitro study
Anterior nasal
Sensitivity: 97.73%
Jiangsu Medomics
DE:
swab,
SARS-CoV-2 antigen Test
Specificity: 99.51%
Nucleo-
medical technology
2006
Positive evaluation by Paul-Ehrlich-Institut:
DE[2]
Nasopharyngeal 7 July 2021
Kit (LFIA)
Anterior nasal swab,
protein
Co.,Ltd.
Sensitivity of 94,1% at Ct < 25; Manufacturer specificity:
swab, Throat
NP swab
99,51%
swab
Retrospective in vitro study
Jiangsu Well Biotech COVID-19 Ag Rapid Test
DE:
sensitivity:94.74%,
Nucleo-
20 October
2144
DE[2]
Nasal swab
Co., Ltd.
Device
Positive evaluation by Paul-Ehrlich-Institut:
specificity:99%
protein
2021
Sensitivity of 100% at Ct < 25; Manufacturer specificity: 99%
Retrospective in vitro study
Nasal swab,
96.1% sensitivity
Nasopharyngeal
Joinstar Biomedical
COVID-19 Rapid Antigen
DE:
Nucleo-
17 February
1333
98.1% specificity
DE[2]
swab,
Technology Co. Ltd
Test (Colloidal Gold)
Positive evaluation by Paul-Ehrlich-Institut:
protein
2021
Nasal swab
Oropharyngeal
Sensitivity of 100% at Ct < 25; Manufacturer specificity: 98.1%
swab
Prospective clinical field studies
CZ
N=225 (90 RT-PCR positive), 60.3% symptomatic patients.
Test parameters for a subgroup of symptomatic patients
(estimates and 95% confidence intervals): sensitivity 92%
SARS-CoV-2 Antigen
(80.8–97.8), specificity 97.6% (91.5–99.7).
JOYSBIO (Tianjin)
CZ, DE[2]
Rapid Test Kit (Colloidal
Test parameters for a subgroup of asymptomatic patients
98.13% sensitivity
Biotechnology Co.,
1764
Unknown
Nasal swab
10 May 2021
Gold
(estimates and 95% confidence intervals): sensitivity 100%
Nasal swab
Ltd.
CH
immunochromatography)
100 (54.1–100), specificity 100% (95.5–100).
FIND Evaluation
CH (11 Feb 2021)
265 samples, Nasal swab. Clinical sensitivities: Days < 7:
74.2%; Ct < 33: 78.9%; Ct < 25: 91.3%; Clinical specificity:
99.1%
Labnovation
SARS-CoV-2 Antigen
1266
Retrospective in vitro study
96.3% sensitivity,
DE[2]
Nucleo-
Nasopharyngeal 10 May 2021
28
Clinical performance
Completed
SARS-CoV-2
Included in
Device
Clinical performance
Manufacturer
RAT commercial name
Data by
validation
Target
Specimen 16
EU common
ID # 15
As reported by independent validation studies
manufacturer
studies
protein
list since:
Technologies Inc.
Rapid Test Kit
DE:
97.3% specificity
protein
swab,
Positive evaluation by Paul-Ehrlich-Institut:
NP/OP swab
Oropharyngeal
Sensitivity of 94% at Ct < 25; Manufacturer specificity: 97.3%
swab
Retrospective in vitro study
Nasal swab,
PocRoc® SARS-CoV-2
DE:
93.33% sensitivity
Nasopharyngeal
Lumigenex (Suzhou)
Nucleo-
Antigen Rapid Test Kit
2128
Positive evaluation by Paul-Ehrlich-Institut:
99.16% specificity
DE[2]
swab,
10 May 2021
Co., Ltd
protein
(Colloidal Gold)
Sensitivity of 100% at Ct < 25; Manufacturer specificity:
Nasal/NP/OP swab
Oropharyngeal
99,16%
swab
Retrospective in vitro study
93.7% sensitivity,
LumiQuick
QuickProfile™ COVID-19
DE:
Nasopharyngeal
1267
98.8% specificity
DE[2]
Unknown
10 May 2021
Diagnostics Inc.
Antigen Test
Positive evaluation by Paul-Ehrlich-Institut:
swab
NP swab
Sensitivity of 100% at Ct < 25; Manufacturer specificity: 98.8%
Prospective clinical field study
SKUP/2021/124: 448 samples: 83 positive samples and 365 negative samples.
Nasal specimen: diagnostic sensitivity of 87% (79-92) and
diagnostic specificity of 99,5% (98,3-99,9). NP specimen:
diagnostic sensitivity of 90% (83-95) and diagnostic specificity
of 97,8% (96,0-98,8) (Scandinavian evaluation of laboratory
equipment for point of care testing)
DE[2], ES
FIND Evaluation
97.6% sensitivity
LumiraDx SARS-CoV-2 Ag
Nucleo-
17 February
LumiraDX
1268
DE (8 Oct 2021)
96.6% specificity
SKUP
Nasal swab
Test
protein
2021
761 samples, NP swab. Clinical sensitivities: Days < 7: 86.4%; Nasal swab
Ct < 33: 87.2%; Ct < 25: 92.6%; Clinical specificity: 99.3%
CH
Brazil (8 Oct 2021)
251 samples, NP swab. Clinical sensitivities: Days < 7: 85.7%;
Ct < 33: 87.7%; Ct < 25: 94.1%; Clinical specificity: 99%
Retrospective in vitro study
DE:
Positive evaluation by Paul-Ehrlich-Institut:
Sensitivity of 100% at Ct < 25; Manufacturer specificity: 98.8%
Retrospective in vitro study
Nasopharyngeal
92.5% sensitivity
DE[2]
MEDsan SARS-CoV-2
DE:
swab,
17 February
MEDsan GmbH
1180
99.8% specificity
Unknown
Antigen Rapid Test
Positive evaluation by Paul-Ehrlich-Institut:
Oropharyngeal
2021
NP/OP swab
CH
Sensitivity of 100% at Ct < 25; Manufacturer specificity: 99.8%
swab
Merlin Biomedical
SARS-CoV-2 Antigen
2029
Retrospective in vitro study
95.05% sensitivity
DE[2]
Nucleo-
Nasal swab,
16 June 2021
29
Clinical performance
Completed
SARS-CoV-2
Included in
Device
Clinical performance
Manufacturer
RAT commercial name
Data by
validation
Target
Specimen 16
EU common
ID # 15
As reported by independent validation studies
manufacturer
studies
protein
list since:
(Xiamen) Co., Ltd.
Rapid Test Cassette
98.99% specificity
protein
Nasopharyngeal
DE:
Nasal/NP swab
swab
Positive evaluation by Paul-Ehrlich-Institut:
Sensitivity of 90% at Ct < 30 and 100% at Ct < 25;
Manufacturer specificity: 98.99%
Retrospective in vitro study
Sensitivity: 96.17%
MEXACARE COVID-19
DE:
Nucleo-
Nasal swab
MEXACARE GmbH
1775
Specificity: 99,1%
DE[2]
7 July 2021
Antigen Rapid Test
Positive evaluation by Paul-Ehrlich-Institut:
protein
Nasal swab
Sensitivity of 100% at Ct < 25; Manufacturer specificity: 99,1%
Retrospective in vitro study
DE:
Sensitivity: 97.25%
mö-screen Corona
Nasopharyngeal
möLab
1190
Positive evaluation by Paul-Ehrlich-Institut:
Specificity: 99.99%
DE[2], IE
Unknown
10 May 2021
Antigen Test
swab
Sensitivity of 100% at Ct < 25; Manufacturer specificity:
NP swab
99,99%
Retrospective in vitro study
Anterior nasal
swab, Nasal
96.17% sensitivity
DE[2]
DE:
swab,
Rapid SARS-CoV-2
99.16% specificity
Nucleo-
17 February
MP Biomedicals
1481
Positive evaluation by Paul-Ehrlich-Institut:
Nasopharyngeal
Antigen Test Card
Nasal swab, Anterior
protein
2021
Sensitivity of 100% at Ct < 25; Manufacturer specificity:
CH
, UK
swab,
nasal swab
99.03%
Oropharyngeal
swab
Retrospective in vitro study
97% sensitivity
Nasopharyngeal
Nal von minden
NADAL COVID -19 Ag
DE:
Nucleo-
2104
98% specificity
DE[2]
swab
10 May 2021
GmbH
+Influenza A/B Test
Positive evaluation by Paul-Ehrlich-Institut:
protein
NP swab
Sensitivity of 83% at Ct < 25; Manufacturer specificity: 99.9%
Prospective clinical field study
FIND evaluation
CH (26 April 2021)
462 samples, NP swab. Clinical sensitivities: Days < 7: 88.5%;
Nasal swab
97.6% sensitivity
DE[2], FR
Nal von minden
Ct < 33: 92.4%; Ct < 25: 97.8%; Clinical specificity: 99.2%
Nucleo-
17 February
NADAL COVID -19 Ag Test 1162
99.9% specificity
GmbH
protein
! Serum, Whole
2021
Retrospective in vitro study
Nasal swab
China
blood
DE:
Positive evaluation by Paul-Ehrlich-Institut:
Sensitivity of 83% at Ct < 25; Manufacturer specificity: 99.9%
Nanjing Norman
Novel Coronavirus (2019- 2506
Retrospective in vitro study
Clinical sensitivity:
DE[2]
Nucleo-
Anterior nasal
[TBC]
30
Clinical performance
Completed
SARS-CoV-2
Included in
Device
Clinical performance
Manufacturer
RAT commercial name
Data by
validation
Target
Specimen 16
EU common
ID # 15
As reported by independent validation studies
manufacturer
studies
protein
list since:
Biological Technology nCoV) Antigen Testing Kit
- 91.13 % (Saliva)
capsid
swab,
Co., Ltd.
(Colloidal Gold)
- 93.02 % (Anterior
protein
Nasopharyngeal
Nasal swab)
swab,
- 93.21 % (NP swab)
Oropharyngeal
DE:
Clinical specificity:
swab
Positive evaluation by Paul-Ehrlich-Institut:
- 93.02 % (Anterior
Sensitivity of 94% at Ct < 25; Manufacturer specificity: 99.9%
Nasal swab)
! Saliva
- 99.23 % (Anterior
Nasal swab)
- 99.29 % (NP swab)
Retrospective in vitro study
94.12% sensitivity
DE:
Nucleo
-
Nasopharyngeal
NanoEntek
FREND COVID-19 Ag
1420
100% specificity
DE[2]
10 May 2021
Positive evaluation by Paul-Ehrlich-Institut:
protein
swab
NP swab
Sensitivity of 88% at Ct < 25; Manufacturer specificity: 100%
Retrospective in vitro study
Anterior nasal
swab,
DE:
97.2 % sensitivity
NanoRepro SARS-CoV-2
Nucleo
-
Nasopharyngeal
NanoRepro AG
2200
Positive evaluation by Paul-Ehrlich-Institut:
98.4% specificity
DE[2]
14 July 2021
Antigen Rapid Test
protein
swab,
Sensitivity of 94,1% at at Ct < 25; Manufacturer specificity:
Nasal/NP/OP swab
Oropharyngeal
98.4%
swab
Prospective clinical field study
Sensitivity: 95.24%,
MARESKIT COVID-19
Nucleo
-
NESAPOR EUROPA SL
2241
ES:
Specificity: 100%
ES
Nasal swab
23 July 2021
ANTIGEN RAPID TEST KIT
Independent validation study; Nasal test compared to nasal
protein
Nasal swab
PCR. Sensitivity 95.24% (Ct<30), Specificity 100%.
Retrospective in vitro study
Nasal swab,
Nasopharyngeal
New Gene
DE:
98% sensitivity
swab,
(Hangzhou)
COVID-19 Antigen
Nucleo
-
1501
Positive evaluation by Paul-Ehrlich-Institut:
99.2% specificity
DE[2]
Oropharyngeal
16 June 2021
Bioengineering Co.,
Detection Kit
protein
Sensitivity of 92,5% at Ct < 30 and 100% at Ct < 25;
Nasal swab
swab
Ltd.
Manufacturer specificity: 99.2%
! Saliva, Sputum
Prospective clinical field study
FR:
Clinical sensitivity:
Nasal swab,
Nucleo-
NG Biotech
Ninonasal
1880
Prospective validation study for NP and nasal swabs:
98%, Clinical
FR
Nasopharyngeal [TBC}
protein
NP sensitivity 89% (75/84) , specificity 99% (92/93)
specificity: 99%
swab
Nasal sensitivity 98% (125/128), specificity 99% (388/390)
Novatech
SARS-CoV-2 Antigen
1762
Retrospective in vitro study
95 % sensitivity
DE[2]
Nucleo-
Nasal swab,
14 July 2021
31
Clinical performance
Completed
SARS-CoV-2
Included in
Device
Clinical performance
Manufacturer
RAT commercial name
Data by
validation
Target
Specimen 16
EU common
ID # 15
As reported by independent validation studies
manufacturer
studies
protein
list since:
Rapid Test
DE:
100% specificity
protein
Nasopharyngeal
Positive evaluation by Paul-Ehrlich-Institut:
Nasal/ NP swab
swab
Sensitivity of 94,1% at Ct < 25; Manufacturer specificity: 100%
Retrospective in vitro study
Oncosem Onkolojik
DE:
93.75% sensitivity
Sistemler San. ve Tic. CAT
1199
Positive evaluation by Paul-Ehrlich-Institut:
98.04% specificity
DE[2]
Unknown
Nasal swab
10 May 2021
A.S.
Sensitivity of 94,1% at Ct < 25; Manufacturer specificity:
Nasal swab
98,04%
Prospective clinical field study
FR:
94,92% sensitivity,
Nasopharyngeal
PCL Inc.
PCL COVID19 Ag Rapid FIA 308
DE[2], FR
Unknown
10 May 2021
Validation study data: NP swabs, sensitivity 94.29% (33/35)
99,99% specificity
Swab
and specificity 100% (70/70)
Prospective clinical field study
Nasal swab,
Nasopharyngeal
FR:
Nucleo-
PCL Inc.
PCL COVID19 Ag Gold
2243
FR
swab
7 July 2021
Validation study data: 120 positive and 200 negative samples;
protein
sensitivity 92%, specificity: 100%
! Saliva
Retrospective in vitro study
Nasal swab,
SARS-CoV-2 Antigen
PerGrande Bio Tech
DE:
94.28% sensitivity
Nasopharyngeal
Detection Kit (Colloidal
Nucleo-
Development Co.,
2116
Positive evaluation by Paul-Ehrlich-Institut:
99.11% specificity
DE[2]
swab,
10 May 2021
Gold Immunochromato-
protein
Ltd.
Sensitivity of 100% at Ct < 25; Manufacturer specificity:
NP/Nasal/OP swab
Oropharyngeal
graphic Assay)
99.11%
swab
Retrospective in vitro study
93.9% sensitivity
DE[2]
Precision Biosensor
DE:
Nasopharyngeal 17 February
Exdia COVI-19 Ag
1271
98% specificity
Unknown
Inc.
Positive evaluation by Paul-Ehrlich-Institut:
swab
2021
NP swab
CH
Sensitivity of 100% at Ct < 25; Manufacturer specificity: 99.3%
Retrospective in vitro study
Clinical Sensitivity:
DE:
95.56 %
Nucleo-
Prognosis Biotech
Rapid Test Ag 2019-nCov 1495
Positive evaluation by Paul-Ehrlich-Institut:
DE[2]
Nasal swab
7 July 2021
Specificity: 99,58%
protein
Sensitivity of 94,1% at Ct < 25; Manufacturer specificity:
Nasal swab
99,58%
Qingdao Hightop
SARS-CoV-2 Antigen
1341
Retrospective in vitro study
95% sensitivity
DE[2]
Nucleo-
Anterior nasal
17 February
32
Clinical performance
Completed
SARS-CoV-2
Included in
Device
Clinical performance
Manufacturer
RAT commercial name
Data by
validation
Target
Specimen 16
EU common
ID # 15
As reported by independent validation studies
manufacturer
studies
protein
list since:
Biotech Co. Ltd
Rapid Test
99.75% specificity
protein
swab, Nasal
2021
DE:
(Immunochromatography
Nasal swab
swab
Positive evaluation by Paul-Ehrlich-Institut:
)
Sensitivity of 100% at Ct < 30 and 100% at Ct < 25;
Manufacturer specificity: 99.75%
Prospective clinical field studies
FR:
Validation study data: NP swabs sensitivity 84,44% (76/90),
specificity 99,19 (491/495)
NL:
Independent prospective clinical field study in symptomatic
(n=733, PCR positive 144); NP swab; sensitivity overall: 84.0%,
sensitivity Ct<30: 90.1%, sensitivity Ct<25: 92.5%; specificity
overall: 99.8%.
96.7% sensitivity
DE[2], NL[5], PT
Nasal swab,
Nucleo-
17 February
Quidel Corporation
Sofia SARS Antigen FIA
1097
100% specificity
Nasopharyngeal
PT:
protein
2021
NP/Nasal swab
CH
swab
80 samples from symptomatic individuals (27 PCR positive
and 53 negative by PCR) were tested. Sensitivity 70%
(95%IC50-86); specificity 100% (95%IC 93-100). TCID50/ml
0,68x 102 and CT<25.
Retrospective in vitro study
DE:
Positive evaluation by Paul-Ehrlich-Institut:
Sensitivity of 89% at Ct < 25; Manufacturer specificity: 100%
Retrospective in vitro study
Sensitivity: 96.1%,
Nasal swab,
Rapid Pathogen
LIAISON® Quick Detect
IT:
Nucleo-
2290
Specificity: 97%
IT
Nasopharyngeal 23 July 2021
Screening, Inc
Covid Ag Assay
Independent validation study, 100 pos. and 100 neg. samples;
protein
NP and Nasal swab
swab
sensitivity: 92.7% with Ct<25; specificity: 100%.
Roche (SD
SARS-CoV-2 Rapid
1604
Prospective clinical field study
96.52% sensitivity
DE[2], FI, NL, PT, Nucleo-
Nasopharyngeal 10 May 2021
33
Clinical performance
Completed
SARS-CoV-2
Included in
Device
Clinical performance
Manufacturer
RAT commercial name
Data by
validation
Target
Specimen 16
EU common
ID # 15
As reported by independent validation studies
manufacturer
studies
protein
list since:
BIOSENSOR)
Antigen Test
NL:
99.2% specificity
SE
protein
swab
Independent prospective clinical field study in symptomatic
NP swab
(n=970, PCR positive 186); NP swab; sensitivity overall: 84.9%,
UK
sensitivity Ct≤30: 94.3%, sensitivity Ct≤25: 99.1%; specificity
overall: 99.5%
SE:
Karolinska hospital evaluation of Lot QCO3020109. Patient
samples: 95 PCR positive, 150 negative. No detailed sample
description available. Sensitivity 43%, specificity 100%.
Sensitivity Ct<25 = 80.5%.
Retrospective in vitro studies
DE:
Positive evaluation by Paul-Ehrlich-Institut:
Sensitivity of 89% at Ct < 25; Manufacturer specificity: 99.68%
FI:
Validated in several laboratories (studies not published),
meeting criteria.
Prospective clinical field studies
FIND evaluation
DE (12 April 2021)
179 samples, nasal swab. Clinical sensitivities: Days < 7:
81.2%; Ct < 33: 87.5%; Ct < 25: 100%; Clinical specificity:
99.3%
Clinical Sensitivity:
Brazil (12 April 2021)
89.6 % ( (Ct ≤ 30)
DE[2]
Roche (SD
SARS-CoV-2 Rapid
214 samples, nasal swab. Clinical sensitivities: Days < 7:
93.1 % (Ct ≤ 27)
Nucleo-
2228
Nasal swab
7 July 2021
BIOSENSOR)
Antigen Test Nasal
81.2%; Ct < 33: 91.7%; Ct < 25: 100%; Clinical specificity:
Clinical Specificity:
protein
Brazil
, UK
99.3%
99.1 %
Nasal swab
Retrospective in vitro study
DE:
Positive evaluation by Paul-Ehrlich-Institut:
Sensitivity of 89.6% at Ct < 30; Manufacturer specificity:
99.1%
Safecare Biotech
COVID-19 Antigen Rapid
1489
Retrospective in vitro study
97.27% sensitivity
DE[2]
Nucleo-
Nasal swab
17 February
34
Clinical performance
Completed
SARS-CoV-2
Included in
Device
Clinical performance
Manufacturer
RAT commercial name
Data by
validation
Target
Specimen 16
EU common
ID # 15
As reported by independent validation studies
manufacturer
studies
protein
list since:
(Hangzhou) Co. Ltd
Test Kit (Swab)
99.42% specificity
protein
2021
DE:
Nasal swab
Positive evaluation by Paul-Ehrlich-Institut:
Sensitivity of 100% at Ct < 25; Manufacturer specificity:
99.42%
Retrospective in vitro study
Multi-Respiratory Virus
97.04% sensitivity
DE:
Nucleo-
Antigen Test Kit (Swab)
1490
99.44% specificity
DE[2]
Nasal swab
10 May 2021
Positive evaluation by Paul-Ehrlich-Institut:
protein
(Influenza A+B/COVID-19)
Nasal swab
Sensitivity of 100% at Ct < 25; Manufacturer specificity:
99.44%
Retrospective in vitro study
Nasopharyngeal
96.6% sensitivity (Ct
swab,
ScheBo SARS CoV-2 Quick
DE:
≤ 30)
Nucleo-
Oropharyngeal
ScheBo Biotech AG
1201
Positive evaluation by Paul-Ehrlich-Institut:
DE[2]
16 June 2021
Antigen
99.00% specificity
protein
swab
Sensitivity of 95% at Ct < 30 and 100% at Ct < 25;
NP/ OP swab
Manufacturer specificity: 99%
! Serum
Prospective clinical field studies
DE
146 symptomatic adults, 40 (27.4%) were RT-PCR-positive for
SARS-CoV-2. Sensitivity with 85.0% (34/40; 95% CI 70.9-92.9)
with professional testing. At high viral load (>7.0 log10 SARS-
CoV-2 RNA copies/ml), sensitivity was 96.6% (28/29; 95% CI
82.8-99.8) for professional testing.
FIND evaluation
DE (12 April 2021)
Clinical Sensitivity:
179 samples, nasal swab. Clinical sensitivities: Days < 7:
97.12 %
DE[2], FI, FR
STANDARD Q COVID-19
Nucleo-
SD Biosensor Inc
2052
81.2%; Ct < 33: 87.5%; Ct < 25: 100%; Clinical specificity:
Clinical Specificity:
Nasal swab
7 July 2021
Ag Test Nasal
protein
99.3%
100 %
Brazil
, UK
Nasal swab
Brazil (12 April 2021)
214 samples, nasal swab. Clinical sensitivities: Days < 7:
81.2%; Ct < 33: 91.7%; Ct < 25: 100%; Clinical specificity:
99.3%
Retrospective in vitro study
FI:
Validated in several laboratories (studies not published),
meeting criteria.
SD BIOSENSOR Inc.
STANDARD F COVID-19 Ag 344
Prospective clinical field studies
94,09% sensitivity
DE[2], IT, NL[5],
Nucleo-
Nasopharyngeal 17 February
35
Clinical performance
Completed
SARS-CoV-2
Included in
Device
Clinical performance
Manufacturer
RAT commercial name
Data by
validation
Target
Specimen 16
EU common
ID # 15
As reported by independent validation studies
manufacturer
studies
protein
list since:
FIA
98.52% specificity NP
DK
protein
swab
2021
NL
swab
Independent prospective clinical field study in symptomatic
(n=628, PCR positive 118); NP swab; sensitivity overall: 78.0%,
Brazil, CH,
sensitivity Ct<30: 84.4%, sensitivity Ct<25: 90.3%; specificity
India, UK
overall: 99.6%
FIND evaluation
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)
453 samples, NP swab. Clinical sensitivities: Days < 7: 80.2%;
- Ct < 33: 80.9%; 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%
Retrospective in vitro study
DE:
Positive evaluation by Paul-Ehrlich-Institut:
Sensitivity of 100% at Ct < 25; Manufacturer specificity:
98.52%
Prospective clinical field studies
PT
80 samples from symptomatic individuals (27 PCR positive
and 53 negative by PCR) were tested. Sensitivity 70%
(95%IC50-86); specificity 100% (95%IC 93-100). TCID50/ml
0,68x 102 and CT<25.
DE[2], ES, IT,
FIND evaluation
NL[5], DK, PT
DE (10 Dec 2020)
96.52% sensitivity
STANDARD Q COVID-19
1263 samples, NP swab. Clinical sensitivities: Days < 7: 80%;
Nasopharyngeal 17 February
SD BIOSENSOR Inc.
345
99.68% specificity
Unknown
Ag Test
- Ct < 33: 87.8%; Ct < 25: 100%; Clinical specificity: 99.3%
Brazil, CH,
swab
2021
NP swab
Brazil (10 Dec 2020)
India, NO, UA,
400 samples, NP swab. Clinical sensitivities: Days < 7: 90.7%;
UK
- Ct < 33: 91.9%; 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%;
36
Clinical performance
Completed
SARS-CoV-2
Included in
Device
Clinical performance
Manufacturer
RAT commercial name
Data by
validation
Target
Specimen 16
EU common
ID # 15
As reported by independent validation studies
manufacturer
studies
protein
list since:
- 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%
Retrospective in vitro studies
DE:
Positive evaluation by Paul-Ehrlich-Institut:
Sensitivity of 89% at Ct < 25; Manufacturer specificity: 99.68%
FI:
Validated in several laboratories (studies not published),
meeting criteria.
Retrospective in vitro study
V-Chek SARS-CoV-2 Ag
96.6% sensitivity,
DE:
Nucleo-
Rapid Test Kit (Colloidal
1319
99.5% specificity,
DE[2]
Nasal swab
10 May 2021
Positive evaluation by Paul-Ehrlich-Institut:
protein
Gold)
Nasal swab
Sensitivity of 94,1% at Ct < 25; Manufacturer specificity:
99,5%
SGA Medikal
Retrospective in vitro study
96.60% sensitivity:
V-Chek SARS-CoV-2 Rapid
DE:
Nucleo-
1357
99.5% specificity,
DE[2]
Nasal swab
7 July 2021
Ag Test (colloidal gold)
Positive evaluation by Paul-Ehrlich-Institut:
protein
Nasal swab
Sensitivity of 94,1% at Ct < 25; Manufacturer specificity:
99,5%
Prospective clinical field study
Clinical Sensitivity:
Nasal swab,
SI:
95.33 % (Nasal),
Shenzen Ultra-
Nasopharyngeal
SARS-CoV-2 Antigen Test
Sensitivity in unselected symptomatic population: 86.4% (172 95.48(NP)
Nucleo-
Diagnostics Biotec
2017
BE, SI
swab
10 May 2021
Kit
RAT pos. / 199 RT-PCR pos.), sensitivity of 97.8% at Ct≤25.
Clinical Specificity:
protein
Co., Ltd
Specificity: 99.1% (1972 RAT neg. / 1990 RT-PCR neg.), NP
99.16 % (Nasal),
! Saliva
swab
99.61 % (NP)
Retrospective in vitro study
Shenzhen Dymind
DE:
Nasal swab,
SARS-CoV-2 Antigen Test
Sensitivity: 96.58%,
Nucleo-
20 October
Biotechnology Co.,
2415
Positive evaluation by Paul-Ehrlich-Institut:
DE[2]
Nasopharyngeal
Kit (Colloidal Gold)
Specificity: 98.37%
protein
2021
Ltd
Sensitivity of 100% at Ct < 25; Manufacturer specificity:
swab
96.58%
37
Clinical performance
Completed
SARS-CoV-2
Included in
Device
Clinical performance
Manufacturer
RAT commercial name
Data by
validation
Target
Specimen 16
EU common
ID # 15
As reported by independent validation studies
manufacturer
studies
protein
list since:
Retrospective in vitro study
NP/OP swab:
Sensitivity: 95.0%,
Shenzhen Huian
Specificity: 99.1%
Nucleo-
Nasal swab,
SARS-CoV-2 Antigen Test
DE:
20 October
Biosci Technology
2414
DE[2]
capsid
Nasopharyngeal
Kit (Colloidal Gold)
Positive evaluation by Paul-Ehrlich-Institut:
2021
Co., Ltd.
Nasal swab:
protein
swab
Sensitivity of 100% at Ct < 25; Manufacturer specificity: 99.1%
Sensitivity: 94.6%,
Specificity: 99.1%
Retrospective in vitro study
NP swabs:
Sensitivity: 99.49%,
Anterior nasal
Specificity: 99.24%.
Shenzhen Kisshealth
Nucleo-
swab, Nasal
SARS-CoV-2 Antigen Test
DE:
20 October
Biotechnology Co.,
1813
DE[2]
capsid
swab,
Kit (GICA)
Positive evaluation by Paul-Ehrlich-Institut:
Nasal (Anterior)
2021
Ltd
protein
Nasopharyngeal
swabs:
Sensitivity of 100% at Ct < 25; Manufacturer specificity: 99.2%
swab
Sensitivity: 99.43%,
Specificity: 99.23%.
Retrospective in vitro study
Anterior nasal
swab, Nasal
swab,
Shenzhen Lvshiyuan
96.77% sensitivity
Nasopharyngeal
Green Spring SARS-CoV-2
DE:
Nucleo-
Biotechnology Co.,
2109
100% specificity
DE[2]
swab,
10 May 2021
Antigen-Rapid test-Set
Positive evaluation by Paul-Ehrlich-Institut:
protein
Ltd.
NP/OP/Nasal swab
Oropharyngeal
Sensitivity of 100% at Ct < 25; Manufacturer specificity: 100%
swab
! Saliva
Nasal swab,
SARS-CoV-2 Antigen Test
Retrospective in vitro study
Sensitivity: 92.93%
Shenzhen
Nasopharyngeal
Kit (Colloidal Gold
DE:
Clinical Specificity:
Nucleo-
Microprofit Biotech
1967
DE[2]
swab,
7 July 2021
Chromatographic
Positive evaluation by Paul-Ehrlich-Institut:
100 %
protein
Co., Ltd
Oropharyngeal
Immunoassay)
Sensitivity of 100% at Ct < 25; Manufacturer specificity: 100%
Nasal/NP/OP swab
swab
Retrospective in vitro study
Nasal swab,
SARS-CoV-2 Spike Protein
Shenzhen
Sensitivity: 86.3%,
Nasopharyngeal
Test Kit (Colloidal Gold
Spike
Microprofit Biotech
1178
DE:
Specificity: 100%
DE[2]
swab,
23 July 2021
Chromatographic
Positive evaluation by Paul-Ehrlich-Institut:
protein
Co., Ltd.
Nasal Swab
Oropharyngeal
Immunoassay)
Sensitivity of 100% at Ct < 25; Manufacturer specificity: 100%
swab
Retrospective in vitro study
Nasopharyngeal
Shenzhen Reagent
SARS-CoV-2 antigen IVD
Sensitivity: 95.2 %,
Nucleo-
swab,
20 October
2026
DE:
DE[2]
Technology Co.,Ltd.
kit SWAB
specificity: 98.1 %
protein
Oropharyngeal
2021
Positive evaluation by Paul-Ehrlich-Institut:
Sensitivity of 100% at Ct < 25; Manufacturer specificity: 98.1%
swab
Shenzhen Watmind
SARS-CoV-2 Ag Diagnostic 1769
Retrospective in vitro study
Sensitivity: 95.15%
DE[2]
Nucleo-
Nasal swab,
10 May 2021
38
Clinical performance
Completed
SARS-CoV-2
Included in
Device
Clinical performance
Manufacturer
RAT commercial name
Data by
validation
Target
Specimen 16
EU common
ID # 15
As reported by independent validation studies
manufacturer
studies
protein
list since:
Medical Co., Ltd
Test Kit (Colloidal Gold)
(for symptom onset
capsid
Nasopharyngeal
DE:
within 7 days)
protein
swab,
Positive evaluation by Paul-Ehrlich-Institut:
Specificity: 99.12%
Oropharyngeal
Sensitivity of 100% at Ct < 25; Manufacturer specificity:
Nasal swab
swab
99.12%
Retrospective in vitro study
Clinical Sensitivity:
97.83 % (CT ≤ 33)
SARS-CoV-2 Ag Diagnostic
Shenzhen Watmind
DE:
Clinical Sensitivity:
Nucleo-
Test Kit (Immuno-
1768
Positive evaluation by Paul-Ehrlich-Institut:
DE[2]
Nasal swab
7 July 2021
Medical Co., Ltd
90.08 % (Ct ≤ 36)
protein
fluorescence)
Sensitivity of 100% at Ct < 25; Manufacturer specificity:
Specificity: 99,13%
99,13%
Nasal swab
Retrospective in vitro study
96% sensitivity
Nasal swab
Shenzhen Zhenrui
Zhenrui ®COVID-19
DE:
Nucleo-
1574
97% specificity
DE[2]
10 May 2021
Biotech Co., Ltd
Antigen Test Cassette
Positive evaluation by Paul-Ehrlich-Institut:
protein
Nasal swab
! Saliva
Sensitivity of 82% at Ct < 25; Manufacturer specificity: 97%
Retrospective in vitro study
Nasopharyngeal
DE:
100% sensitivity
swab,
Sugentech, Inc.
SGTi-flex COVID-19 Ag
1114
Positive evaluation by Paul-Ehrlich-Institut:
100% specificity
DE[2]
Unknown
10 May 2021
Oropharyngeal
Sensitivity of 100% at Ct < 30 and 100% at Ct < 25;
OP/NP swab
swab
Manufacturer specificity: 99.0%
Retrospective in vitro study
DE[2]
Anterior nasal
SureScreen
SARS-CoV-2 Rapid
DE:
Sensitivity: 96.1%,
Nucleo-
swab
20 October
2297
Diagnostics
Antigen Test Cassette
Positive evaluation by Paul-Ehrlich-Institut:
Specificity: 99%
protein
2021
UK
Sensitivity of 100% at Ct < 25; Manufacturer specificity: 99%
! Other
Prospective clinical field study
FR:
Validation data: NP swabs, sensitivity : 96,1-100%, specificity
99,2-100%
Nasal swab,
98.6% sensitivity
Nucleo-
TODA PHARMA
TODA CORONADIAG Ag
1466
DE[2], FR
Nasopharyngeal 10 May 2021
Retrospective in vitro study
Nasal swab
protein
swab
DE:
Positive evaluation by Paul-Ehrlich-Institut:
Sensitivity of 100% at Ct < 25; Manufacturer specificity: 100%
Triplex International SARS-CoV-2 Antigen
2074
Retrospective in vitro study
98.51% sensitivity
DE[2]
Nucleo-
Nasal swab,
16 June 2021
39
Clinical performance
Completed
SARS-CoV-2
Included in
Device
Clinical performance
Manufacturer
RAT commercial name
Data by
validation
Target
Specimen 16
EU common
ID # 15
As reported by independent validation studies
manufacturer
studies
protein
list since:
Biosciences Co., Ltd
Rapid Test Kit
99.91% specificity
capsid
Nasopharyngeal
DE:
Nasal/OP/NP swab
protein
swab,
Positive evaluation by Paul-Ehrlich-Institut:
Oropharyngeal
Sensitivity of 92,5% at Ct < 30 and 100% at Ct < 25;
swab
Manufacturer specificity: 99.91%
! Saliva
Triplex International SARS-CoV-2 Antigen
Retrospective in vitro study
Biosciences Co., Ltd, Rapid Test Kit
98.51 % sensitivity
DE:
Nucleo-
China
1465
100% specificity
DE[2]
Nasal swab
14 July 2021
Positive evaluation by Paul-Ehrlich-Institut:
protein
Nasal swab
Sensitivity of 100% at Ct < 25; Manufacturer specificity: 100%
Retrospective in vitro study
Anterior nasal
swab, Nasal
swab,
Vitrosens
DE:
97.30% sensitivity
RapidFor SARS-CoV-2
Nucleo-
Nasopharyngeal
Biotechnology Co.,
1443
Positive evaluation by Paul-Ehrlich-Institut:
99.05% specificity
DE[2]
10 May 2021
Rapid Ag Test
protein
swab,
Ltd
Sensitivity of 100% at Ct < 30 and 100% at Ct < 25;
NP swab
Oropharyngeal
Manufacturer specificity: 99.05%
swab, Throat
swab
Nasal swab,
AT:
97.04% sensitivity
Nasopharyngeal
VivaChek Biotech
VivaDiag Pro SARS-CoV-2
10 May
2103
97,06% sensitivity, 100% specificity, all specimen types, i.e.
99.9% specificity
AT, DE[2], SI
Unknown
swab,
(Hangzhou) Co., Ltd. Ag Rapid Test
202119
N&OP&NP swab
Nasal/OP/NP swab
Oropharyngeal
swab
Retrospective in vitro study
Nasal swab,
Wuhan
DE:
96.1% sensitivity
DE[2]
Nasopharyngeal
COVID-19 (SARS-CoV-2)
Nucleo-
EasyDiagnosis
2098
Positive evaluation by Paul-Ehrlich-Institut:
100% specificity
swab,
10 May 2021
Antigen-Test Kit
protein
Biomedicine Co., Ltd.
Sensitivity of 100% at Ct < 25; Manufacturer specificity:
Nasal/OP/NP swab
UK
Oropharyngeal
99.26%
swab
Retrospective in vitro study
Wuhan Life Origin
SARS-CoV-2 Antigen
DE:
92.67% sensitivity
Biotech Joint Stock
Assay Kit (Immuno-
1773
DE[2]
Unknown
Nasal swab
14 July 2021
Positive evaluation by Paul-Ehrlich-Institut:
Nasal swab
Co., Ltd.
chromatography)
Sensitivity of 100% at Ct < 25; Manufacturer specificity: %
Wuhan UNscience
SARS-CoV-2 Antigen
2090
Retrospective in vitro study
Sensitivity: 96.33%
DE[2], FR
Nucleo-
Mid-turbinates
7 July 2021
19 This rapid antigen test, device ID 2103, was removed from the EU common list on [TBC]. The grace period will end on [TBC], 23:59 CET
40
Clinical performance
Completed
SARS-CoV-2
Included in
Device
Clinical performance
Manufacturer
RAT commercial name
Data by
validation
Target
Specimen 16
EU common
ID # 15
As reported by independent validation studies
manufacturer
studies
protein
list since:
Biotechnology Co.,
Rapid Test Kit
Specificity: 99.57%
protein
swab, Nasal
Ltd.
DE:
Nasal/NP/OP swab
swab,
Positive evaluation by Paul-Ehrlich-Institut:
Nasopharyngeal
Sensitivity of 100% at Ct < 25; Manufacturer specificity:
swab,
99,57%
Oropharyngeal
swab
Retrospective in vitro study
Nasopharyngeal
Wuxi Biohermes Bio SARS-CoV-2 Antigen Test
DE:
Sensitivity: 95.31 %,
Nucleo-
swab,
20 October
& Medical
2143
Positive evaluation by Paul-Ehrlich-Institut:
DE[2]
Kit (Lateral Flow Assay)
Specificity: 98.02 %
protein
Oropharyngeal
2021
Technology Co., Ltd.
Sensitivity of 100% at Ct < 25; Manufacturer specificity:
swab
98.02%
Retrospective in vitro study
Xiamen AmonMed
DE:
93.2% sensitivity
COVID-19 Antigen Rapid
Nucleo-
Biotechnology Co.,
1763
Positive evaluation by Paul-Ehrlich-Institut:
99.55% specificity
DE[2]
Nasal swab
10 May 2021
Test Kit (Colloidal Gold)
protein
Ltd
Sensitivity of 100% at Ct < 25; Manufacturer specificity:
Nasal swab
99.55%
Retrospective in vitro study
96.49% sensitivity
DE[2]
Xiamen Boson
Rapid SARS-CoV-2
DE:
Nasopharyngeal 17 February
1278
99.03% specificity NP
Unknown
Biotech Co. Ltd
Antigen Test Card
Positive evaluation by Paul-Ehrlich-Institut:
swab
2021
swab
CH
, UK
Sensitivity of 100% at Ct < 25; Manufacturer specificity:
99.03%
Retrospective in vitro study
96.3% sensitivity,
Nasal swab
SARS-CoV-2 Antigen
Nucleo-
1456
DE:
100% specificity
DE[2]
10 May 2021
Rapid Test
protein
Positive evaluation by Paul-Ehrlich-Institut:
Nasal swab
! Other
Sensitivity of 88% at Ct < 25; Manufacturer specificity: 100%
Xiamen Wiz Biotech
Co., Ltd
Retrospective in vitro study
Nucleo-
SARS-CoV-2 Antigen
95.91% sensitivity
protein
Anterior nasal
Rapid Test (Colloidal
1884
DE:
100% specificity
DE[2]
(nucleo-
10 May 2021
swab
Gold)
Positive evaluation by Paul-Ehrlich-Institut:
Nasal swab
capside
Sensitivity of 88% at Ct < 25; Manufacturer specificity: 100%
protein)
Retrospective in vitro study
Nasal swab,
95.8% sensitivity,
Nasopharyngeal
Zhejiang Anji Saianfu AndLucky COVID-19
DE:
Nucleo-
1296
99% specificity,
DE[2]
swab,
10 May 2021
Biotech Co.., Ltd
Antigen Rapid Test
Positive evaluation by Paul-Ehrlich-Institut:
protein
Nasal swab
Oropharyngeal
Sensitivity of 94,1% at Ct < 25; Manufacturer specificity: 99%
swab
Zhejiang Anji Saianfu reOpenTest COVID-19
1295
Retrospective in vitro study
95.8% sensitivity,
DE[2]
Nucleo-
Nasal swab,
10 May 2021
41
Clinical performance
Completed
SARS-CoV-2
Included in
Device
Clinical performance
Manufacturer
RAT commercial name
Data by
validation
Target
Specimen 16
EU common
ID # 15
As reported by independent validation studies
manufacturer
studies
protein
list since:
Biotech Co.., Ltd
Antigen Rapid Test
DE:
99% specificity,
protein
Nasopharyngeal
Positive evaluation by Paul-Ehrlich-Institut:
Nasal swab
swab
Sensitivity of 94,1% at Ct < 25; Manufacturer specificity: 99%
Retrospective in vitro study
DE:
98.32 % sensitivity
DE[2]
Nasal swab,
Zhejiang Orient Gene Coronavirus Ag Rapid Test
Nucleo-
17 February
1343
Positive evaluation by Paul-Ehrlich-Institut:
99.6 % specificity
Nasopharyngeal
Biotech Co., Ltd
Cassette (Swab)
protein
2021
Sensitivity of 100% at Ct < 25; Manufacturer specificity:
Nasal/NP swab
UK
swab
99.22%
Retrospective in vitro study
Throat swab/Nasal
Swab: Sensitivity
96.49%, Specificity
Anterior nasal
Zhuhai Encode
DE[2]
Nucleo-
ENCODE SARS-COV-2
DE:
100%
swab, Nasal
20 October
Medical Engineering
1902
capsid
Antigen Rapid Test Device
Positive evaluation by Paul-Ehrlich-Institut:
swab, Throat
2021
Co.,Ltd
protein
Sensitivity of 95% at Ct < 25; Manufacturer specificity: 100%
Anterior Swab:
UK
swab
Sensitivity 94.74%,
Specificity: 100%
Retrospective in vitro study
96.12% sensitivity
Nasal swab (CT<33);
Zhuhai Lituo
COVID-19 Antigen
Nasal swab,
DE:
99.59% sensitivity
Nucleo-
Biotechnology Co.,
Detection Kit (Colloidal
1957
DE[2]
Nasopharyngeal 14 July 2021
Positive evaluation by Paul-Ehrlich-Institut:
NP swab; 100%
protein
Ltd.
Gold)
swab
Sensitivity of 100% at Ct < 25; Manufacturer specificity: 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.
42
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
Person identifier
the policies applicable in each country.
identification
(optional)
Examples: citizen ID and/or document number
(ID-card/passport).
Complete date, without
Person date of birth
Tested person’s date of birth.
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)
The type of sample that was taken (e.g.
Sample origin
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 information test sample collection
following ISO 8601
Date and time of the
Complete date, with
Date and time when the test result was
test result production
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).
ANNEX III: Common list of COVID-19 laboratory based antigenic assays
As agreed by Member States on 20 October 2021
EU Member
Completed
SARS-CoV-2 Included in EU
Device
Clinical performance
Clinical performance
Other countries
Manufacturer
RAT commercial name
States using in
validation
Target
common list
ID # 20
As reported by independent validation studies
Data by manufacturer
using in practice
practice
studies
protein
since:
Prospective clinical field studies
BE:
Independent prospective study (random selection),
Nasal Swab:
symptomatic and asymptomatic (n=414, PCR positive = 204,
Sensitivity: 99/101
PCR negative = 210), NP swab; sensitivity Ct<35: 73.4%,
(98.0%, 95% CI: 93.1 –
sensitivity Ct<25: 96.4%; specificity: 100%
99.5%).
Specificity: 210/211
FR:
(99.5%, 95% CI: 97.4 –
Independent prospective study, symptomatic and
99.9%).
Nucleo-
LIAISON SARS-CoV-2 Ag
asymptomatic (n=378, PCR positive = 46), NP swab; overall
BE, CZ, FR, IT,
20 October
DIASORIN
1960
BE, FR, IT, NL
capside
assay
sensitivity: 84.8%, sensitivity Ct=<25 100%; specificity: 99.4%
NL
2021
NP Swabs:
protein
IT:
Sensitivity: 108/109
Independent prospective study, asymptomatic (n=1075, PCR
(99.1%, 95% CI: 95.0 –
positive = 23), NP swab; sensitivity Ct=<30 90.5%; specificity:
99.8%).
99.8%
Specificity: 295/299
(98.7%, 95% CI: 96.6 –
NL :
99.5%).
Independent field study, mainly symptomatic individuals
(n=980, PCR positive n=98), NP+OP swab; sensitivity overall
82.7%, sensitivity Ct<30: 91.9%; specificity overall: 99.1%.
Prospective clinical field study
Sensitivity:
NP/OP: 94.5 % (95%
DE:
CI: 90.4-97.2);
Nucleo-
Roche Diagnostics
Elecsys® SARS-CoV-2
Total N: 3139 (2747 negative, 392 positive) Germany
20 October
2156
Nasal swabs: 96.8%
DE[2], EE, PL
DE[2]
capsid
GmbH
Antigen
participated in the validation. Roche coordinated and
2021
(95% CI: 88.8-99.6%)
protein
performed partially the data analysis. Relative specificity overall Specificity: 99.9%
99.9%; relative sensitivity (n=390) overall 92.5% (CT<26).
(95 % CI: 99.6‑100%)
20 As registered in and used by the JRC database, see
: https://covid-19-diagnostics.jrc.ec.europa.eu/.
Document Outline