Ref. Ares(2022)549989 - 24/01/2022
ANNEX I: Common list of rapid antigen tests1
As agreed by Member States on […]
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 additional
criteria and definitions agreed by the Technical Working Group on 14 September 2021 (tbc). The Medical Device Coordination Group Guidance on performance evaluation
of SARS-CoV-2 in vitro diagnostic medical devices2, 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.
Questions to TWG:
Please review the entries below. In particular, for those tests where the study design is listed as ‘unknown’, please assess these cases, collect more
information and evaluate if and how these evaluation studies and their results should be listed.
In case any new data or results are known from evaluation studies (matching the criteria and definition) not yet listed, please provide these details.
Which tests included in the list are ‘twin tests’?
1 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.
2 https://ec.europa.eu/health/sites/default/files/md_sector/docs/mdcg_2021-21_en.pdf
EU
Clinical
Other
Complete
Member
MS
Included in
Device
Clinical performance as reported by independent validation
performance
countries
d
Manufacturer
RAT commercial name
States
currently EU common
ID # 3
studies
Data by
using in
validation
using in
validating
list since:
manufacturer
practice
studies
practice
Study design unknown
COVID-VIRO® Rapid
BE: 96.6% sensitivity, 100% specificity, NP swab
96.6% sensitivity
FR
AAZ-LMB
1833
BE, FR, SI
CH
10 May 2021
antigen test COVID-19
100% specificity
CH
FR: >95%% sensitivity, 100% specificity
SI: 96.6% sensitivity, 100% specificity, NP swab
Prospective clinical field study
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%;
91.4% sensitivity
AT, BE, BG,
- Ct < 33: 89.7%;
99.8% specificity
CY, CZ,
- Ct < 25: 96.8%;
NP swab (Ct ≤ 33) DE[2], DK,
DE[2], ES,
CY, ES,
Abbott Rapid
Panbio™ COVID-19 Ag
Clinical specificity: 100%
EE, EL, ES,
CH, ME, MK,
17 February
1232
FI, NL[5], PT HR, HU,
Diagnostics
Rapid Test
98.1% sensitivity
FR[1], HR, IT, NO, UK, UA
2021
CH, NO
IE, LU, SE
India (25 June 2021)
99.8% specificity
LT, LV, MT,
526 samples, NP swab
Nasal swab (Ct ≤
NL[5], PL, PT,
Clinical sensitivities:
33)
RO, SE, SK
- Days < 7: 61.3%-100%;
- Ct < 33: 74.2%-86.7%;
- Ct < 25: 91.9%-100%;
Clinical specificity: 100%
Retrospective in vitro studies
FI:
Validated in several laboratories (studies not published), meeting
criteria.
Study design unknown
DE:
91.4% sensitivity 99.8% specificity, NP swab; 98.1% sensitivity,
3 As registered in and used by the JRC database, see
: https://covid-19-diagnostics.jrc.ec.europa.eu/.
EU
Clinical
Other
Complete
Member
MS
Included in
Device
Clinical performance as reported by independent validation
performance
countries
d
Manufacturer
RAT commercial name
States
currently EU common
ID # 3
studies
Data by
using in
validation
using in
validating
list since:
manufacturer
practice
studies
practice
99,8 specificity, Nasal swab
BE[6]:
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%.
Retrospective in vitro studies
DE:
Acon Biotech
SARS-CoV-2 Antigen Rapid
96.9% sensitivity
1457
Positive evaluation by Paul-Ehrlich-Institut (sensitivity of 94,1% at
DE[2], FR, PT
DE[2]
14 July 2021
(Hangzhou) Co., Ltd Test
Nasal swab
<Ct25) + Manufacturer specificity: 99.54%
Prospective clinical field study
FIND evaluation
CH (9 June 2021)
279 samples, nasal swab
Clinical sensitivities:
- Days < 7: 92.2%;
- Ct < 33: 98.3%;
AT, BE,
ACON Laboratories, Flowflex SARS-CoV-2
- Ct < 25: 100%;
96.9% sensitivity
1468
DE[2], LT, LV,
DE[2]
10 May 2021
Inc.
Antigen Rapid Test
Clinical specificity: 99.5%
Nasal swab
SI
Retrospective in vitro studies
DE:
Positive evaluation by Paul-Ehrlich-Institut (sensitivity of 94,1% at
<Ct25) + Manufacturer specificity: 98,7%
Study design unknown
BE: 96.9% sensitivity, 99.5% specificity, NP swab
Study design unknown
96% sensitivity
AESKU.DIAGNOSTICS AESKU.RAPID SARS-CoV-2 2108
DE: 96% sensitivity, 98% specificity
98% specificity
AT, DE[2], SI
DE[2]
10 May 2021
GmbH & Co, KG
NP swab
SI: 96% sensitivity, 98% specificity, Nasal swab
Retrospective in vitro studies
96.1% sensitivity
TestNOW® - COVID-19
Affimedix Inc.
2130
DE:
99.4% specificity
DE[2]
DE[2]
10 May 2021
Antigen Test
Positive evaluation by Paul-Ehrlich-Institut (sensitivity of 100% at
NP swab
<Ct25) + Manufacturer specificity: 99,4%
AMEDA
AMP Rapid Test SARS-
1304
Retrospective in vitro studies
97.3% sensitivity
AT, BG,
CH, UA
DE[2]
HR
17 February
EU
Clinical
Other
Complete
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MS
Included in
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Clinical performance as reported by independent validation
performance
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d
Manufacturer
RAT commercial name
States
currently EU common
ID # 3
studies
Data by
using in
validation
using in
validating
list since:
manufacturer
practice
studies
practice
Labordiagnostik
CoV-2 Ag
DE: Positive evaluation by Paul-Ehrlich-Institut (sensitivity of 100% NP swab
DE[2] HR, SI
CH
2021
GmbH
at <Ct25) + Manufacturer specificity: 100%
97.3% sensitivity
Nasal swab
Study design unknown
100% specificity
BE: 97.3% sensitivity, 100% specificity, NP swab
SI: 97.3% sensitivity, 100% specificity, NP swab
Anbio (Xiamen)
Study design unknown
Rapid COVID-19 Antigen-
Biotechnology Co.,
1822
AT, DE[2]
DE[2]
10 May 2021
Test (colloidal Gold)
DE: 99.27% sensitivity, 100% specificity
Ltd
Retrospective in vitro studies
Nasal swab: 96,4%
sensitivity, 99,8%
DE: Positive evaluation by Paul-Ehrlich-Institut (sensitivity of 100% specificity
at <Ct25) + Manufacturer specificity: >99%
Anhui Deep Blue
COVID-19 (SARS-CoV-2)
NP swab: 95,7%
Medical Technology Antigen Test Kit (Colloidal 1736
Study design unknown
sensitivity, 99,3% BE, DE[2]
UK
DE[2]
10 May 2021
Co., Ltd
Gold)
BE: 95% sensitivity, 99% specificity, NP/OP swab
specificity
OP swab: 96,4%
sensitivity, 99,8%
specificity
Anhui Deep Blue
COVID-19 (SARS-CoV-2)
Study design unknown
96.4 % sensitivity
Medical Technology Antigen Test Kit (Colloidal 1815
99.8 % specificity
DE[2]
DE[2]
10 May 2021
Co., Ltd
Gold) – Nasal swab
DE: 96,4 % sensitivity, 99,8 % specificity
Nasal swab
Study design unknown
ArcDia International
92% sensitivity
mariPOC SARS-CoV-2
768
FI: Meets the minimum performance requirements – see the
FI
FI
10 May 2021
Ltd
100% specificity
report for details.
Retrospective in vitro studies
100 % sensitivity
ArcDia International mariPOC Respi+
2078
FI: Validated in several laboratories (studies not published),
100 % specificity
FI, PT
FI
14 July 2021
Oy Ltd
meeting criteria.
NP swab
Retrospective in vitro studies
100 % sensitivity
ArcDia International mariPOC Quick Flu+
2079
FI: Validated in several laboratories (studies not published),
100 % specificity
FI, PT
FI
14 July 2021
Oy Ltd
meeting criteria.
NP swab
Retrospective in vitro studies
96.67%
(Nasal)sensitivity
Artron Laboratories Artron COVID-19 Antigen
DE:
91.67% (NP)
1618
DE[2]
DE[2]
14 July 2021
Inc.
Test
Positive evaluation by Paul-Ehrlich-Institut (sensitivity of 100% at
sensitivity
<Ct25) + Manufacturer specificity: 100%
100 % specificity
Nasal/NP swab
Asan Pharmaceutical Asan Easy Test COVID-19 1654
Study design unknown
DE[2]
DE[2]
10 May 2021
EU
Clinical
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Manufacturer
RAT commercial name
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currently EU common
ID # 3
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using in
validation
using in
validating
list since:
manufacturer
practice
studies
practice
Co., Ltd
Ag
DE:
94.67% sensitivity, 97.71% specificity
Retrospective in vitro studies
92.5 % sensitivity
Assure Tech.
ECOTEST COVID-19
DE:
99.2 % specificity
770
DE[2]
DE[2]
14 July 2021
(Hangzhou) Co., Ltd. Antigen Rapid Test Device
Positive evaluation by Paul-Ehrlich-Institut (sensitivity of 95% at
Nasal/NP/ OP
<Ct25) + Manufacturer specificity: 99.2%
swab
Retrospective in vitro studies
Sensitivity: 97.7%,
Assure Tech.
ECOTEST COVID-19
2350
DE:
Specificity: 99.1% CZ, DE[2]
DE[2]
23 July 2021
(Hangzhou) Co., Ltd. Antigen Rapid Test Device
Positive evaluation by Paul-Ehrlich-Institut (sensitivity of 95% at
NP and OP swab
<Ct25) + Manufacturer specificity: 99.1%
NOVA Test ® SARS-CoV-2
Study design unknown
98.5 % sensitivity
Atlas Link
Antigen Rapid Test Kit
DE[2]
2010
DE:
99.4 % specificity
AT, DE[2], SI CH
10 May 2021
Technology Co. Ltd. (Colloidal Gold
CH
97.6% sensitivity, 99.2% specificity
Nasal/OP swab
Immunochromatography)
Retrospective in vitro studies
Clinical Sensitivity:
93.18 %
Ksmart® SARS-COV2
Avalun
1800
DE:
Clinical Specificity: DE[2]
DE[2]
7 July 2021
Antigen Rapid Test
Positive evaluation by Paul-Ehrlich-Institut (sensitivity of 94,1% at 99.32 %
<Ct25) + Manufacturer specificity: 99,32%
NP swab
Study design unknown
AXIOM Gesellschaft
98% sensitivity
COVID-19 Antigen Rapid
für Diagnostica und
2101
DE:
100% specificity
DE[2]
DE[2]
10 May 2021
Test
Biochemica mbH
98.1% sensitivity, 100% specificity
NP/Nasal swab
Study design unknown
95% sensitivity
COVID-19 Antigen Rapid
Azure Biotech, Inc.
1906
DE:
99.2% specificity
DE[2]
DE[2]
10 May 2021
Test Device
94.3% sensitivity, 99.1% specificity
NP swab
Prospective clinical field study
Clinical Sensitivity:
BD Veritor™ System for
NL:
91.1 %
Becton Dickinson
Rapid Detection of SARS
1065
Independent field study in symptomatic individuals - sampling was Clinical Specificity: NL
NL
7 July 2021
CoV 2
Nasal mid-turbinate and OP swab. Sensitivity overall: 79.5% -
99.6 %
Sensitivity Ct<30: 93.2% - Specificity overall: 99.8%
Nasal swab
Beijing Hotgen
Novel Coronavirus 2019-
1870
Retrospective in vitro studies
97.1% sensitivity
AT, BE,
DE[2]
10 May 2021
EU
Clinical
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Manufacturer
RAT commercial name
States
currently EU common
ID # 3
studies
Data by
using in
validation
using in
validating
list since:
manufacturer
practice
studies
practice
Biotech Co., Ltd
nCoV Antigen Test
DE:
99.76% specificity DE[2], RO, SI
(Colloidal Gold)
Positive evaluation by Paul-Ehrlich-Institut (sensitivity of 100% at
<Ct25) + Manufacturer specificity: 99.76%
Study design unknown
BE:
98.6% sensitivity, 100% specificity, NP Swab
97.3% sensitivity, 99.2% specificity. OP swab
SI:
96.6% sensitivity, 99.8% specificity, NP swab
Beijing Jinwofu
Novel Coronavirus (SARS-
Retrospective in vitro studies
96.88 % sensitivity
Bioengineering
CoV-2) Antigen Rapid Test
DE:
100 % specificity
Technology Co.,Ltd. Kit
2072
DE[2]
DE[2]
14 July 2021
Positive evaluation by Paul-Ehrlich-Institut (sensitivity of 100% at
Nasal/ NP/ OP
<Ct25) + Manufacturer specificity: 100%
swab
Study design unknown
BE: 92% sensitivity, 99.3% specificity, Nasal
Beijing Lepu Medical SARS-CoV-2 Antigen Rapid
92% sensitivity
AT, BE,
17 February
1331
UA
DE[2]
Technology Co., Ltd Test Kit
DE: 92.0% sensitivity, 99.26% specificity
Nasal swab
DE[2], SI, RO
2021
SI: 92% sensitivity, 99.2% specificity, NP
Study design unknown
Beijing Wantai
Wantai SARS-CoV-2 Ag
DE:
96.6% sensitivity,
17 February
Biological Pharmacy
1484
DE[2]
DE[2]
Rapid Test (FIA)
96.6% sensitivity, 96.9% specificity
Nasal swab
2021
Enterprise Co., Ltd
Retrospective in vitro studies
Beijing Wantai
96.1 % sensitivity
Wantai SARS-CoV-2 Ag
Biological Pharmacy
1485
DE:
99% specificity
DE[2]
DE[2]
14 July 2021
Rapid Test (colloidal gold)
Enterprise Co., Ltd
Positive evaluation by Paul-Ehrlich-Institut (sensitivity of 100% at
Nasal swab
<Ct25) + Manufacturer specificity: 99%
Retrospective in vitro studies
HR:
Sensitivity: 96%,
CoviGnost AG Test Device
BioGnost Ltd
2247
300 NP samples (retrospective), symptomatic (<7 dps): 200 PCR+
Specificity: 99%
HR
HR
23 July 2021
1x20
samples (range Ct 16-30), Ct<30: sensitivity 96.5%
NP swab
100 PCR- samples: specificity 100%
SARS-CoV-2 Antigen Rapid
Retrospective in vitro studies
Sensitivity: 96.77%
BIOHIT HealthCcare Test Kit (Fluorescence
Yes
DE:
Specificity: 98.9% DE[2]
DE[2]
23 July 2021
(Hefei) Co., Ltd.
Immunochromato-
(1286) Positive evaluation by Paul-Ehrlich-Institut (sensitivity of 100% at
NP/OP swab
graphy)
<Ct25) + Manufacturer specificity: 98.9%
BioMaxima SA
SARS-CoV-2 Ag Rapid Test Yes
Study design unknown
Sensitivity: 95%
PL
PL
23 July 2021
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using in
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manufacturer
practice
studies
practice
(2035)
PL:
Specificity: 99%
Diagnostic sensitivity: 93.43% (95% CI: 91.61%~97.19%); diagnostic NP Swab
specificity: 97.75%, manufacturer specificity: 99.1%
Retrospective in vitro studies
Biomerica COVID-19
Clinical Sensitivity:
Biomerica Inc.
Antigen Rapid Test
1599
DE:
94.7 %
DE[2]
DE[2]
7 July 2021
(nasopharyngeal swab)
Positive evaluation by Paul-Ehrlich-Institut (sensitivity of 100% at
Nasal/NP swab
<Ct25) + Manufacturer specificity: 99,7%
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:
NowCheck COVID-19 Ag
90.91 %
BIONOTE
1242
DE[2]
DE[2]
7 July 2021
Test
Brazil (30 March 2021)
Clinical Specificity:
218 samples, Nasal/NP swab. Clinical sensitivities:
99.43 %
- Days < 7: 92.5% (N/NP);
- Ct < 33: 97.2% (N/NP);
- Ct < 25: 100% (N/NP);
Clinical specificity: 98.6%
Retrospective in vitro studies
DE:
Positive evaluation by Paul-Ehrlich-Institut (sensitivity of 100% at
<Ct25) + Manufacturer specificity: 98,6%
Study design unknown
Clinical Sensitivity:
ES:
98 % (NP: 98,32% /
CORONAVIRUS AG RAPID
NP swab: sensitivity 98,3%; specificity 99,6% (119 positive
Nasal: 97,25%)
BIO-RAD
2031
ES
ES
7 July 2021
TEST CASSETTE
samples, 746 negative samples)
Clinical Specificity:
Nasal swab: sensitivity 97,2%; specificity 100% (109 positive
99 % (NP: 99,6% /
samples, 128 negative samples)
Nasal: 100%)
Prospective clinical field study
96% sensitivity,
AT, BE,
NL:
BIOSYNEX COVID-19 Ag
DE[2],
DE[2], NL[5],
17 February
BIOSYNEX S.A.
1223
100% specificity,
Independent field study, mainly symptomatic individuals,
CH
DK
BSS
NP swab
DK,FR, NL[5],
CH
2021
sensitivity Ct<30: 96.0%; specificity overall: 100%
PT
Retrospective in vitro studies
EU
Clinical
Other
Complete
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Included in
Device
Clinical performance as reported by independent validation
performance
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Manufacturer
RAT commercial name
States
currently EU common
ID # 3
studies
Data by
using in
validation
using in
validating
list since:
manufacturer
practice
studies
practice
DE:
Positive evaluation by Paul-Ehrlich-Institut (sensitivity of 100% at
<Ct25) + Manufacturer specificity: 100%
Study design unknown
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.
Prospective clinical field study
BIOSYNEX COVID-19 Ag+
FR:
Clinical Sensitivity:
BIOSYNEX SA
1494
FR
FR
7 July 2021
BSS
Validation study data: 125 positive and 118 negative samples;
97.5 %
sensitivity 96%, specificity: 99%
Retrospective in vitro studies
BIOTEKE
96.49 % sensitivity
SARS-CoV-2 Antigen Test
CORPORATION
2067
DE:
99.28 % specificity DE[2]
DE[2]
14 July 2021
Kit (colloidal gold method)
(WUXI) CO., LTD
Positive evaluation by Paul-Ehrlich-Institut (sensitivity of 95% at
OP/NP swab
<Ct25) + Manufacturer specificity: 99.28%
Retrospective in vitro studies
Biotical Health
Sensitivity: 96%,
biotical SARS-CoV-2 Ag
Yes
BE:
S.L.U.BIOTICAL
Specificity: 99%
BE
BE
23 July 2021
Card
(2013)
HEALTH S.L.U
Validation study 1: sensitivity 91.7% for Ct<25; Validation study 2: NP swab
94% for Ct<25. Manufacturer specificity: 99%
Prospective clinical field study
Yes
NL:
Sensitivity: 91.7%,
Boditech Med Inc
AFIAS COVID-19 Ag
Independent field study in mild symptomatic (n= 427); overall
Specificity: 98.7% FR, NL
NL
23 July 2021
(1989) sensitivity: 81.1% (106 PCR+), Ct <30: 96.4% (85 PCR+), PCR on
NP swab
NP+OP, Target antigen = nucleoprotein
Study design unknown
90.2% sensitivity
Rapid Response COVID-19
100% specificity
AT, DE[2],
BTNX Inc
1236
DE:
DE[2]
10 May 2021
Antigen Rapid Test
NP swab, NP swab, ES, SI
94.55% sensitivity, 100% specificity
OP swab
Prospective clinical field study
92.9% sensitivity
CerTest SARS-CoV-2 Card
ES:
17 February
CerTest Biotec
1173
99.6% specificity
ES, PT, SI
DE[2], ES
test
Ct < 25, sensitivity: 94,0%; sensitivity for samples within the first 5
2021
NP swab
days after symptom onset: 84,8%
Core Technology
Coretests COVID-19 Ag
1919
Study design unknown
98.1% sensitivity
AT, DE[2],
DE[2]
10 May 2021
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currently EU common
ID # 3
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using in
validation
using in
validating
list since:
manufacturer
practice
studies
practice
Co., Ltd
Test
DE:
99.6% specificity
RO
98.1% sensitivity, 99.6% specificity
NP swab
Prospective clinical field study
DK:
107 samples; Nasal swab - clinical sensitivity 86%; (from
Clinical Sensitivity:
asymptomatic and mild symptomatic individuals), Clinical
92.3 %
OnSite COVID-19 Ag Rapid
specificity: 100%
CTK Biotech, Inc
1581
Clinical Specificity: DK
DK, ES
7 July 2021
Test
Study design unknown
100 %
ES:
Nasal, NP swab
219 samples; Nasal swab - Clinical sensitivity 86% (90%: Ct <30)
Specificity: 100% (Method B)
Test Rapid Covid-19
Study design unknown
98.77% sensitivity
RO
DDS DIAGNOSTIC
Antigen (tampon
1225
RO:
99.03% specificity RO
RO
10 May 2021
China
nazofaringian)
Meets the minimum performance requirements.
Nasal swab
Study design unknown
BE:
DIAQUICK COVID -19 Ag
DIALAB GmbH
1375
Z20401CE: 93.2% sensitivity, 100% specificity, NP swab
AT, BE, DE[2]
DE[2]
10 May 2021
Cassette
Z20601CE: 96.4% sensitivity, 99.2% specificity, NP swab
DE: 97.3% sensitivity, 100% specificity
Retrospective in vitro studies
Sensitivity: 93.8%,
COVID-19 Antigen
Yes
DE:
DNA Diagnostic
Specificity: 99.6% DE[2]
DE[2]
23 July 2021
Detection Kit
(2242) Positive evaluation by Paul-Ehrlich-Institut (sensitivity of 100% at
Nasal swab
<Ct25) + Manufacturer specificity: 99.56%
Prospective clinical field study
FIND evaluation
Peru (26 April 2021)
Edinburgh Genetics
120 samples, NP swab
Edinburgh Genetics ActivXpress+ COVID-19
Clinical sensitivities:
1243
DE[2]
DE[2]
14 July 2021
Limited
Antigen Complete Testing
- Days < 7: 62%;
Kit
- Ct < 33: 75%;
- Ct < 25: 100%;
Clinical specificity: 100%
Retrospective in vitro studies
EU
Clinical
Other
Complete
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Included in
Device
Clinical performance as reported by independent validation
performance
countries
d
Manufacturer
RAT commercial name
States
currently EU common
ID # 3
studies
Data by
using in
validation
using in
validating
list since:
manufacturer
practice
studies
practice
DE:
Positive evaluation by Paul-Ehrlich-Institut
(Sensitivity of 100% at <Ct25) + Manufacturer Specificity: 99,24%
Prospective clinical field study
FR:
Validation study data: 119 positive and 125 negative samples;
Clinical Sensitivity:
EBS SARS-CoV-2 Ag Rapid
sensitivity 93%, specificity: 99%
Eurobio Scientific
1739
95.7 %
DE[2], FR
DE[2], FR
7 July 2021
Test
Retrospective in vitro studies
Nasal swab
DE:
Positive evaluation by Paul-Ehrlich-Institut (sensitivity of 94,1% at
<Ct25) + Manufacturer specificity: 99,1%
Prospective clinical field study
FIND evaluation
DE (29 March 2021)
723 samples, NP swab
Clinical sensitivities:
Clinical Sensitivity:
- Days < 7: 88.5%;
87.8 % ( (n=98,
- Ct < 33: 87.8%;
Ct<33))
Fujirebio
ESPLINE SARS-CoV-2
2147
DE[2]
DE[2]
7 July 2021
- Ct < 25: 92.4%;
Clinical Specificity:
Clinical specificity: 100%
100 %
NP swab
Retrospective in vitro studies
DE:
Positive evaluation by Paul-Ehrlich-Institut (sensitivity of 94,1% at
<Ct25) + Manufacturer specificity: 99,13%
Retrospective in vitro studies
Sensitivity:
GA Generic Assays
GA CoV-2 Antigen Rapid
Yes
DE:
97.059%,
DE[2]
DE[2]
23 July 2021
GmbH
Test
(1855) Positive evaluation by Paul-Ehrlich-Institut (sensitivity of 100% at
Specificity: 99.2%
<Ct25) + Manufacturer specificity: 99.2%
NP swab
Study design unknown
90% sensitivity
Genbody COVID-19 Ag
17 February
GenBody Inc
1244
DE: 90% sensitivity 98% specificity
98% specificity
DE[2]
UA
DE[2]
Test
2021
NP/OP swab
Retrospective in vitro studies
Sensitivity: 91.15%
SARS-CoV-2 Antigen Test
Genrui Biotech Inc
2012
DE:
Specificity: 99.02% DE[2]
DE[2]
7 July 2021
Kit (Colloidal Gold)
Positive evaluation by Paul-Ehrlich-Institut (sensitivity of 94,1% at Nasal/NP/OP swab
<Ct25) + Manufacturer specificity: 99,02%
GenSure Biotech Inc GenSure COVID-19
1253
Retrospective in vitro studies
96.86% sensitivity, DE[2]
DE[2]
10 May 2021
EU
Clinical
Other
Complete
Member
MS
Included in
Device
Clinical performance as reported by independent validation
performance
countries
d
Manufacturer
RAT commercial name
States
currently EU common
ID # 3
studies
Data by
using in
validation
using in
validating
list since:
manufacturer
practice
studies
practice
Antigen Rapid Test Kit
DE:
100% specificity
Positive evaluation by Paul-Ehrlich-Institut (sensitivity of 94,1% at Nasal swab
<Ct25) + Manufacturer specificity: 100%
Getein Biotech, Inc
SARS-CoV-2 Antigen
Retrospective in vitro studies
(Colloidal Gold)
97.06% sensitivity
1820
DE:
98.71% specificity AT, DE[2]
DE[2]
14 July 2021
Positive evaluation by Paul-Ehrlich-Institut (sensitivity of 100% at
Nasal swab
<Ct25) + Manufacturer specificity: 98.71%
Retrospective in vitro studies
One Step Test for SARS-
97.06% sensitivity
Getein Biotech, Inc. CoV-2 Antigen (Colloidal
2183
DE:
98.71% specificity DE[2]
DE[2]
16 June 2021
Gold)
Positive evaluation by Paul-Ehrlich-Institut (sensitivity of 90% at
Nasal swab
<Ct30 and 100% at <Ct25)
Goldsite Diagnostic SARS-CoV-2 Antigen Kit
Retrospective in vitro studies
Inc.
(Colloidal Gold)
BE, BG, CY,
FR, DE[2],
1197
DE:
FR, RO, SI,
UK
14 July 2021
Positive evaluation by Paul-Ehrlich-Institut
ES
ES
(sensitivity 100% at <Ct25)
Study design unknown
100% sensitivity
Green Cross Medical
90.1% sensitivity
GENEDIA W COVID-19 Ag 1144
BE: 90.2% sensitivity, 100% specificity, NP swab
AT, BE, DE[2]
DE[2]
10 May 2021
Science Corp.
NP swab, Anterior
DE: 90.1% sensitivity, 100% specificity
nasal swab
Guangdong Hecin
2019-nCoV Antigen Test
Study design unknown
96.23% sensitivity
1747
AT, DE[2]
DE[2]
10 May 2021
Scientific, Inc.
Kit (colloidal gold method)
DE: 96.6% sensitivity, 99.07% specificity
Nasal swab
COVID-2019-nCoV Ag
Retrospective in vitro studies
Guangdong Longsee Rapid TestDetection
DE:
99.72% specificity
1216
DE[2]
DE[2]
14 July 2021
Biomedical Co., Ltd. Kit(Immuno-
Positive evaluation by Paul-Ehrlich-Institut (sensitivity of 100% at
NP/OP swab
Chromatography)
<Ct25) + Manufacturer specificity: 99.5%
Retrospective in vitro studies
DE:
Positive evaluation by Paul-Ehrlich-Institut (sensitivity of 100% at
90% sensitivity
Guangdong Wesail
17 February
COVID-19 Ag Test Kit
1360
<Ct25) + Manufacturer specificity: 98%
98% specificity
DE[2], SI
DE[2]
Biotech Co. Ltd
2021
Study design unknown
Nasal swab
SI: 90% sensitivity, 98% specificity, NP/Nasal swab
V-CHEK, 2019-nCoV Ag
Retrospective in vitro studies
Guangzhou Decheng
Clinical Sensitivity:
Rapid Test Kit
Biotechnology CO.,
1324
DE:
96.67 %
DE[2]
DE[2]
7 July 2021
(Immunochromatography
Ltd
Positive evaluation by Paul-Ehrlich-Institut (sensitivity of 94,1% at Nasal swab
)
<Ct25) + Manufacturer specificity: 99,5%
Guangzhou Wondfo Wondfo 2019-nCoV
1437
Prospective clinical field study
AT, BE, BG, CH
DE[2]
10 May 2021
EU
Clinical
Other
Complete
Member
MS
Included in
Device
Clinical performance as reported by independent validation
performance
countries
d
Manufacturer
RAT commercial name
States
currently EU common
ID # 3
studies
Data by
using in
validation
using in
validating
list since:
manufacturer
practice
studies
practice
Biotech Co., Ltd
Antigen Test (Lateral Flow
FIND evaluation
DE[2], FR
Method)
CH (25 Feb 2020)
328 samples, NP swab
Clinical sensitivities:
- Days < 7: 85.7%;
- Ct < 33: 92.2%;
- Ct < 25: 100%;
Clinical specificity: 100%
Study design unknown
BE: 96.2% sensitivity, 99.7% specificity, NP/OP swab
DE: 96.18 % sensitivity, 99.72% specificity
Retrospective in vitro studies
Hangzhou Lysun
COVID-19 Antigen Rapid
96.46% sensitivity
Biotechnology Co.
Test Device (Colloidal
2139
DE:
100% specificity
DE[2]
CH
DE[2]
10 May 2021
Ltd
Gold)
Positive evaluation by Paul-Ehrlich-Institut (sensitivity of 100% at
Nasal swab
<Ct25) + Manufacturer specificity: 100%
Study design unknown
Hangzhou AllTest
COVID-19 Antigen Rapid
AT, BE, BG,
1257
NP swab
CH
DE[2]
AT
10 May 2021
Biotech Co., Ltd
Test
DE: 93,40% sensitivity, 99,90% specificity
FR, SI, RO
Retrospective in vitro studies
Clinical Sensitivity:
91.4 %
Hangzhou Clongene COVID-19 Antigen Rapid
1610
DE:
Clinical Specificity: DE[2]
DE[2]
7 July 2021
Biotech Co., Ltd
Test Casette
Positive evaluation by Paul-Ehrlich-Institut (sensitivity of 94,4% at 100 %
<Ct25) + Manufacturer specificity: 100%
NP swab
Study design unknown
98.5% (Ct<33)
Hangzhou Clongene Covid-19 Antigen Rapid
BE: 91.4% sensitivity, 100% specificity, NP/OP swab
AT,BE, DE[2],
DE[2]
17 February
1363
sensitivity
CH
HR
Biotech Co., Ltd.
Test Kit
DE: 91.4% sensitivity, 99.4% specificity
FR, SI
CH
2021
Nasal swab
SI: 91.4% sensitivity, 100% specificity, NP/OP swab
Study design unknown
91% sensitivity
Hangzhou Clongene COVID-19/Influenza A+B
1365
100% specificity
DE[2]
DE[2]
10 May 2021
Biotech Co., Ltd.
Antigen Combo Rapid Test
DE: 97.7% sensitivity, 99.8% specificity
NP swab
Immunobio SARS-CoV-2
Study design unknown
94% sensitivity
Hangzhou Immuno
Antigen ANTERIOR NASAL 1844
100% specificity
DE[2]
DE[2]
10 May 2021
Biotech Co., Ltd
Rapid Test Kit (minimal
DE: 94.39% sensitivity 97.67% specificity
Nasal swab, NP
invasive)
Hangzhou Immuno
SARS-CoV2 Antigen Rapid 2317
Study design unknown
Clinical Sensitivity AT, DE[2]
DE[2]
10 May 2021
EU
Clinical
Other
Complete
Member
MS
Included in
Device
Clinical performance as reported by independent validation
performance
countries
d
Manufacturer
RAT commercial name
States
currently EU common
ID # 3
studies
Data by
using in
validation
using in
validating
list since:
manufacturer
practice
studies
practice
Biotech Co., Ltd
Test
98 %
DE: 95.6% sensitivity, 100% specificity
Clinical Specificity
100 %
Retrospective in vitro studies
Clinical Sensitivity:
LYHER Novel Coronavirus
95.07% %
Hangzhou Laihe
(COVID-19) Antigen Test
1215
DE:
Clinical Specificity: AT, DE[2]
CH
DE[2]
10 May 2021
Biotech Co.
Kit (Colloidal Gold)
Positive evaluation by Paul-Ehrlich-Institut (sensitivity of 94,1% at 99.74%
<Ct25) + Manufacturer specificity: 99,7%
Nasal swab
Hangzhou Testsea
Study design unknown
92.1% sensitivity
Covid-19 Antigen Test
Biotechnology Co.,
1392
98.1% specificity
DE[2]
DE[2]
10 May 2021
Cassette
Ltd.
DE: 97.6% sensitivity 98.4% specificity
Nasal swab
Study design unknown
80.6 % sensitivity
Coronavirus Ag Rapid Test
AT, DE[2],
17 February
Healgen Scientific
1767
DE: 97.25% sensitivity, 100% specificity
99.7% specificity
CH
DE[2], NL[5] SE[3]
Cassette
NL[5], SE, SI
2021
NP swab
SI:96.7% sensitivity, 99.2% specificity, NP/Nasal swab
Retrospective in vitro studies
Hubei Jinjian Biology SARS-CoV-2 Antigen Test Yes
DE:
Sensitivity: 98.02%
DE[2]
DE[2]
23 July 2021
Co., Ltd
Kit
(1759) Positive evaluation by Paul-Ehrlich-Institut (sensitivity of 100% at
Nasal Swab
<Ct25) + Manufacturer specificity: 99.3 %
Study design unknown
AT, BE, BG,
Humasis COVID-19 Ag
BE: 95.5% sensitivity, 100% specificity, NP swab
95.3% sensitivity
Humasis
1263
DE[2], FR,
DE[2]
HR, SE
10 May 2021
Test
DE: 95.5% sensitivity, 100% specificity
Nasal swab
HR, SE, SI
SI: 95.5% sensitivity, 100% specificity, NP swab
Retrospective in vitro studies
97.06 % sensitivity
Jiangsu Bioperfectus Novel Corona Virus (SARS-
DE:
99.15 % specificity
Technologies Co.,
2107
DE[2]
DE[2]
14 July 2021
CoV-2) Ag Rapid Test Kit
Positive evaluation by Paul-Ehrlich-Institut (sensitivity of 100% at
Nasal/NP/ OP
Ltd.
<Ct25) + Manufacturer specificity: 99.15%
swab
Retrospective in vitro studies
97.58 % sensitivity
Jiangsu Diagnostics
COVID-19 Antigen Rapid
DE:
100 % specificity
Biotechnology Co.,
Test Cassette (Colloidal
1920
DE[2]
DE[2]
14 July 2021
Positive evaluation by Paul-Ehrlich-Institut (sensitivity of 100% at
Nasal/NP/ OP
Ltd
Gold)
<Ct25) + Manufacturer specificity: 100%
swab
Retrospective in vitro studies
Clinical Sensitivity:
97.73 %
Jiangsu Medomics
SARS-CoV-2 antigen Test
DE:
Clinical Specificity:
medical technology
2006
DE[2]
DE[2]
7 July 2021
Kit (LFIA)
Positive evaluation by Paul-Ehrlich-Institut (sensitivity of 94,1% at 99.51 %
Co.,Ltd.
<Ct25) + Manufacturer specificity: 99,51%
Anterior nasal
swab, NP swab
Joinstar Biomedical COVID-19 Rapid Antigen
1333
Study design unknown
96.1% sensitivity
AT, DE[2],
DE[2]
17 February
EU
Clinical
Other
Complete
Member
MS
Included in
Device
Clinical performance as reported by independent validation
performance
countries
d
Manufacturer
RAT commercial name
States
currently EU common
ID # 3
studies
Data by
using in
validation
using in
validating
list since:
manufacturer
practice
studies
practice
Technology Co. Ltd
Test (Colloidal Gold)
DE: 96.1% sensitivity, 98.1% specificity
98.1% specificity
PT, SI
2021
SI:96.1% sensitivity, 98.1% specificity, NP swab
Nasal swab
Prospective clinical field study
FIND Evaluation
CH (11 Feb 2021)
265 samples, Nasal swab
Clinical sensitivities:
JOYSBIO (Tianjin)
SARS-CoV-2 Antigen Rapid
- Days < 7: 74.2%;
98.13% sensitivity
CZ, DE[2]
Biotechnology Co.,
Test Kit (Colloidal Gold
1764
- Ct < 33: 78.9%;
AT, CZ, SI
10 May 2021
Nasal swab
CH
Ltd.
immunochromatography)
- Ct < 25: 91.3%;
Clinical specificity: 99.1%
Study design unknown
CZ: Meets the minimum performance requirements – se
e report for
details.
Study design unknown
Labnovation
SARS-CoV-2 Antigen Rapid 1266
DE: 96.3% sensitivity, 97.3% specificity
NP/OP swab
DE[2], IT, SI
DE[2]
10 May 2021
Technologies Inc.
Test Kit
SI: 96.3% sensitivity, 97.3% specificity, NP/OP swab
Retrospective in vitro studies
PocRoc® SARS-CoV-2
93.33% sensitivity
Lumigenex (Suzhou) Antigen Rapid Test Kit
2128
DE:
99.16% specificity DE[2]
DE[2]
10 May 2021
Co., Ltd
(Colloidal Gold)
Positive evaluation by Paul-Ehrlich-Institut (sensitivity of 100% at
Nasal/NP/OP swab
<Ct25) + Manufacturer specificity: 99,16%
Study design unknown
LumiQuick
QuickProfile™ COVID-19
BE: 94% sensitivity, 99% specificity, NP swab
BE, DE[2]
1267
DE[2]
10 May 2021
Diagnostics Inc.
Antigen Test
DE: 93.7% sensitivity, 98.8% specificity
,FR, SI,
SI: 93.7% sensitivity, 98.8% specificity, NP swab
Study design unknown
DE:93.8% sensitivity, 98.8% specificity
97.6% sensitivity
DE[2], ES,
LumiraDx SARS-CoV-2 Ag
SI: 97.6% sensitivity, 97.7% specificity, NP/Nasal swab
17 February
LumiraDX
1268
96.6% specificity
DE[2], ES, SI CH
SKUP
Test
2021
SKUP/2021/124: 90% sensitivity, 97,8% specificity, NP swab
Nasal swab
CH
(Scandinavian evaluation of laboratory equipment for point of care
testing))
MEDsan GmbH
MEDsan SARS-CoV-2
1180
Study design unknown
92.5% sensitivity
AT, BE, DE[2] CH
DE[2]
17 February
EU
Clinical
Other
Complete
Member
MS
Included in
Device
Clinical performance as reported by independent validation
performance
countries
d
Manufacturer
RAT commercial name
States
currently EU common
ID # 3
studies
Data by
using in
validation
using in
validating
list since:
manufacturer
practice
studies
practice
Antigen Rapid Test
BE: 92.5% sensitivity, 99.8% specificity, Nasal/OP swab
99.8% specificity
CH
2021
NP/OP swab
DE: 92.5% sensitivity, 99.8% specificity
Retrospective in vitro studies
95.05% sensitivity
Merlin Biomedical
SARS-CoV-2 Antigen Rapid 2029
DE:
98.99% specificity DE[2]
DE[2]
16 June 2021
(Xiamen) Co., Ltd.
Test Cassette
Positive evaluation by Paul-Ehrlich-Institut (sensitivity of 90% at
Nasal/NP swab
<Ct30 and 100% at <Ct25)
Retrospective in vitro studies
Clinical Sensitivity:
MEXACARE COVID-19
MEXACARE GmbH
1775
DE:
96.17 %
DE[2]
DE[2]
7 July 2021
Antigen Rapid Test
Positive evaluation by Paul-Ehrlich-Institut (sensitivity of 100% at
Nasal swab
<Ct25) + Manufacturer specificity: 99,1%
Study design unknown
mö-screen Corona
möLab
1190
DE:
NP swab
DE[2], IE
DE[2], IE
10 May 2021
Antigen Test
97.25% sensitivity , 99.99% specificity
Study design unknown
96.17% sensitivity
99.16% specificity
Rapid SARS-CoV-2 Antigen
DE[2]
17 February
MP Biomedicals
1481
BE: 96.4% sensitivity, 99% specificity, NP/OP swab
Nasal swab,
AT, BE, DE[2] CH
Test Card
CH
2021
Anterior nasal
DE: 96.39 % sensitivity, 99.03% specificity
swab
Study design unknown
97% sensitivity
Nal von minden
NADAL COVID -19 Ag
2104
DE:
98% specificity
DE[2]
DE[2]
10 May 2021
GmbH
+Influenza A/B Test
97.6% sensitivity, 99.9% specificity
NP swab
Prospective clinical field study
FIND evaluation
CH (26 April 2021)
462 samples, NP swab
Clinical sensitivities:
- Days < 7: 88.5%;
- Ct < 33: 92.4%;
97.6% sensitivity
AT, BE, CY
Nal von minden
DE[2], FR
17 February
NADAL COVID -19 Ag Test 1162
- Ct < 25: 97.8%;
99.9% specificity
DE[2], FR,
HR, SKUP
GmbH
China
2021
Clinical specificity: 99.2%
Nasal swab
PT, SI
Study design unknown
BE: 97.6% sensitivity, 99.9% specificity, NP/OP swab
DE:97.6% sensitivity, 99.9% specificity
SI: 97.6% sensitivity, 99.9% specificity, NP/OP swab
NanoEntek
FREND COVID-19 Ag
1420
Study design unknown
94.12% sensitivity DE[2]
DE[2]
10 May 2021
EU
Clinical
Other
Complete
Member
MS
Included in
Device
Clinical performance as reported by independent validation
performance
countries
d
Manufacturer
RAT commercial name
States
currently EU common
ID # 3
studies
Data by
using in
validation
using in
validating
list since:
manufacturer
practice
studies
practice
100% specificity
DE:
NP swab
94.12% sensitivity , 100% specificity
NanoRepro AG
NanoRepro SARS-CoV-2
Retrospective in vitro studies
Antigen Rapid Test
97.2 % sensitivity
2200
DE:
98.4% specificity
DE[2]
DE[2]
14 July 2021
Positive evaluation by Paul-Ehrlich-Institut (sensitivity of 94,1% at Nasal/NP/OP swab
<Ct25) + Manufacturer specificity: 98.4%
Study design unknown
Sensitivity:
NESAPOR EUROPA
MARESKIT COVID-19
Yes
ES:
95.24%,
ES
ES
23 July 2021
SL
ANTIGEN RAPID TEST KIT (2241) Independent validation study; Nasal test compared to nasal PCR.
Specificity: 100%
Sensitivity 95.24%, Specificity 100%.
Nasal swab
New Gene
Retrospective in vitro studies
(Hangzhou)
COVID-19 Antigen
DE:
98% sensitivity
1501
DE[2]
DE[2]
16 June 2021
Bioengineering Co., Detection Kit
Positive evaluation by Paul-Ehrlich-Institut (sensitivity of 92,5% at Nasal swab
Ltd.
<Ct30 and 100% at <Ct25)
Novatech
SARS-CoV-2 Antigen Rapid
Retrospective in vitro studies
Test
95 % sensitivity
1762
DE:
100% specificity
DE[2]
DE[2]
14 July 2021
Positive evaluation by Paul-Ehrlich-Institut (sensitivity of 94,1% at Nasal/ NP swab
<Ct25) + Manufacturer specificity: 100%
Retrospective in vitro studies
Oncosem Onkolojik
93.75% sensitivity
Sistemler San. ve Tic. CAT
1199
DE:
98.04% specificity DE[2]
DE[2]
10 May 2021
A.S.
Positive evaluation by Paul-Ehrlich-Institut (sensitivity of 94,1% at Nasal swab
<Ct25) + Manufacturer specificity: 98,04%
Study design unknown
FR, DE[2],
PCL Inc.
PCL COVID19 Ag Rapid FIA 308
DE: 94,92 % sensitivity, 99,99 % specificity
DE[2]
10 May 2021
RO, SI
SI: 95.5% sensitivity, 98.6% specificity, NP/OP swab
Prospective clinical field study
PCL Inc.
PCL COVID19 Ag Gold
2243
FR:
FR, PT
FR
7 July 2021
Validation study data: 120 positive and 200 negative samples;
sensitivity 92%, specificity: 100%
SARS-CoV-2 Antigen
Study design unknown
PerGrande Bio Tech
94.28% sensitivity
Detection Kit (Colloidal
Development Co.,
2116
DE:
99.11% specificity AT, DE[2]
DE[2]
10 May 2021
Gold Immunochromato-
Ltd.
94.28% sensitivity, 99.11% specificity
NP/Nasal/OP swab
graphic Assay)
Precision Biosensor Exdia COVI-19 Ag
1271
Study design unknown
93.9% sensitivity
SI, DE[2]
CH
DE[2]
17 February
EU
Clinical
Other
Complete
Member
MS
Included in
Device
Clinical performance as reported by independent validation
performance
countries
d
Manufacturer
RAT commercial name
States
currently EU common
ID # 3
studies
Data by
using in
validation
using in
validating
list since:
manufacturer
practice
studies
practice
Inc.
DE: 93.88% sensitivity , 98% specificity
98% specificity
CH
2021
NP swab
SI:93.9% sensitivity, 98% specificity, NP swab
Retrospective in vitro studies
Clinical Sensitivity:
Prognosis Biotech
Rapid Test Ag 2019-nCov 1495
DE:
95.56 %
CY, DE[2]
DE[2]
7 July 2021
Positive evaluation by Paul-Ehrlich-Institut (sensitivity of 94,1% at Nasal swab
<Ct25) + Manufacturer specificity: 99,58%
SARS-CoV-2 Antigen Rapid
Retrospective in vitro studies
Qingdao Hightop
Test
DE:
95% sensitivity
17 February
1341
AT, DE[2]
DE[2]
Biotech Co. Ltd
(Immunochromatography
Positive evaluation by Paul-Ehrlich-Institut (sensitivity of 100% at
Nasal swab
2021
)
<Ct30 and 100% at <Ct25)
Study design unknown
96.7% sensitivity
AT, BE,
BE: 96.7% sensitivity, 100% specificity, NP/nasal swab
DE[2], NL[5]
17 February
Quidel Corporation Sofia SARS Antigen FIA
1097
100% specificity
DE[2], FI,
CH
SI
DE: 96.7% sensitivity , 100% specificity
CH
2021
NP/Nasal swab
NL[5], PT, SI
SI: 96.7% sensitivity, 100% specificity, NP/Nasal swab
Study design unknown
Sensitivity: 96.1%,
Rapid Pathogen
LIAISON® Quick Detect
Yes
IT: Independent validation study, 100 pos. and 100 neg. samples;
Specificity: 97%
IT
IT
23 July 2021
Screening, Inc
Covid Ag Assay
(2290) sensitivity: 92.7% with Ct<25; specificity: 100%.
NP and Nasal swab
Retrospective in vitro studies
FI: Validated in several laboratories (studies not published),
96.52% sensitivity
Roche (SD
SARS-CoV-2 Rapid Antigen
meeting criteria.
AT, DE[2],
1604
99.2% specificity
CH, NO
DE[2], FI
10 May 2021
BIOSENSOR)
Test
Study design unknown
MT, NL, RO
NP swab
DE: 96.52% sensitivity, 99.68% specificity
Prospective clinical field study
FIND evaluation
DE (12 April 2021)
179 samples, nasal swab
Clinical Sensitivity:
Clinical sensitivities:
89.6 % ( (Ct ≤ 30)
- Days < 7: 81.2%;
Roche (SD
SARS-CoV-2 Rapid Antigen
93.1 % (Ct ≤ 27)
2228
- Ct < 33: 87.5%;
DK, SK
CH, UK
DE[2]
7 July 2021
BIOSENSOR)
Test Nasal
Clinical Specificity:
- Ct < 25: 100%;
99.1 %
Clinical specificity: 99.3%
Nasal swab
Brazil (12 April 2021)
214 samples, nasal swab
Clinical sensitivities:
- Days < 7: 81.2%;
EU
Clinical
Other
Complete
Member
MS
Included in
Device
Clinical performance as reported by independent validation
performance
countries
d
Manufacturer
RAT commercial name
States
currently EU common
ID # 3
studies
Data by
using in
validation
using in
validating
list since:
manufacturer
practice
studies
practice
- Ct < 33: 91.7%;
- Ct < 25: 100%;
Clinical specificity: 99.3%
Retrospective in vitro studies
DE:
Positive evaluation by Paul-Ehrlich-Institut (sensitivity of 89.6% at
<Ct30)
Study design unknown
Safecare Biotech
COVID-19 Antigen Rapid
97.04% sensitivity
17 February
1489
DE:
AT, DE[2], FR CH
DE[2]
(Hangzhou) Co. Ltd
Test Kit (Swab)
Nasal swab
2021
97.27 % sensitivity , 99.42% specificity
Study design unknown
Multi-Respiratory Virus
Safecare Biotech
97.04% sensitivity
Antigen Test Kit (Swab)
1490
DE:
DE[2]
DE[2]
10 May 2021
(Hangzhou) Co. Ltd
Nasal swab
(Influenza A+B/COVID-19)
97.04% sensitivity , 99.44% specificity
Retrospective in vitro studies
96.6% sensitivity
ScheBo SARS CoV-2 Quick
ScheBo Biotech AG
1201
DE:
(Ct ≤ 30)
DE[2]
DE[2]
16 June 2021
Antigen
Positive evaluation by Paul-Ehrlich-Institut (sensitivity of 95% at
NP/ OP swab
<Ct30 and 100% at <Ct25)
Prospective clinical field study
FIND evaluation
DE (12 April 2021)
179 samples, nasal swab
Clinical sensitivities:
- Days < 7: 81.2%;
- Ct < 33: 87.5%;
Clinical Sensitivity:
- Ct < 25: 100%;
97.12 %
STANDARD Q COVID-19
Clinical specificity: 99.3%
SD Biosensor Inc
2052
Clinical Specificity: FI, PT, SK
DE[2], FI, FR
7 July 2021
Ag Test Nasal
100 %
Brazil (12 April 2021)
Nasal swab
214 samples, nasal swab
Clinical sensitivities:
- Days < 7: 81.2%;
- Ct < 33: 91.7%;
- Ct < 25: 100%;
Clinical specificity: 99.3%
Retrospective in vitro studies
EU
Clinical
Other
Complete
Member
MS
Included in
Device
Clinical performance as reported by independent validation
performance
countries
d
Manufacturer
RAT commercial name
States
currently EU common
ID # 3
studies
Data by
using in
validation
using in
validating
list since:
manufacturer
practice
studies
practice
FI: Validated in several laboratories (studies not published),
meeting criteria.
Study design unknown
DE: Published study:
https://www.medrxiv.org/content/10.1101/2021.01.06.20249009
v1
Prospective clinical field study
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:
AT, BE, BG,
- Days < 7: 80.2%;
94,09% sensitivity DE[2], IT ,
DE[2], IT,
STANDARD F COVID-19 Ag
- Ct < 33: 80.9%;
17 February
SD BIOSENSOR Inc.
344
98.52% specificity LU, LV,
CH
NL[5], DK
LU, PT
FIA
- Ct < 25: 87.9%;
2021
NP swab
NL[5], PT,
CH, UK, BR
Clinical specificity: 97.9%
RO, SK
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%
Study design unknown
BE: 96.5% sensitivity, 99.7% specificity, NP swab
DE: 94% sensitivity 97% specificity
SD BIOSENSOR Inc.
STANDARD Q COVID-19
345
Prospective clinical field study
96.52% sensitivity AT, BE, BG, ME, NO, CH
DE[2], ES,
HR, IE, LU, 17 February
EU
Clinical
Other
Complete
Member
MS
Included in
Device
Clinical performance as reported by independent validation
performance
countries
d
Manufacturer
RAT commercial name
States
currently EU common
ID # 3
studies
Data by
using in
validation
using in
validating
list since:
manufacturer
practice
studies
practice
Ag Test
FIND evaluation
99.68% specificity CY, DE[2],
IT, NL[5],
SI, SE
2021
DE (10 Dec 2020)
NP swab
DK, EE, ES,
DK, PT
1263 samples, NP swab
FI, FR, HR,
CH, UA,
Clinical sensitivities:
IT, LU, LV,
UK, BR, NO
- Days < 7: 80%;
MT, NL[5],
- Ct < 33: 87.8%;
PT, RO, SE,
- Ct < 25: 100%;
SK, SI
Clinical specificity: 99.3%
Brazil (10 Dec 2020)
400 samples, NP swab
Clinical sensitivities:
- Days < 7: 90.7%;
- 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%;
- 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
EU
Clinical
Other
Complete
Member
MS
Included in
Device
Clinical performance as reported by independent validation
performance
countries
d
Manufacturer
RAT commercial name
States
currently EU common
ID # 3
studies
Data by
using in
validation
using in
validating
list since:
manufacturer
practice
studies
practice
FI:
Validated in several laboratories (studies not published), meeting
criteria.
Study design unknown
BE: 96.5% sensitivity, 99.7% specificity, NP swab
DE: 96.52% sensitivity, 99.68% specificity
SI: 96.5% sensitivity, 99.7% specificity, NP swab
V-Chek SARS-CoV-2 Ag
Study design unknown
96.6% sensitivity,
SGA Medikal
Rapid Test Kit (Colloidal
1319
DE[2]
DE[2]
10 May 2021
DE:
Nasal swab
Gold)
96.6% sensitivity, 99% specificity
Retrospective in vitro studies
Clinical Sensitivity:
V-Chek SARS-CoV-2 Rapid
SGA Medikal
1357
DE:
96.60%
DE[2]
DE[2]
7 July 2021
Ag Test (colloidal gold)
Positive evaluation by Paul-Ehrlich-Institut (sensitivity of 94,1% at Nasal swab
<Ct25) + Manufacturer specificity: 99,5%
Study design unknown
Clinical Sensitivity:
95.33 % (Nasal),
Shenzen Ultra-
BE:
SARS-CoV-2 Antigen Test
95.48(NP)
AT, BE, ES,
Diagnostics Biotec
2017
92% sensitivity, 100% specificity, NP swab
BE, SI
10 May 2021
Kit
Clinical Specificity: SI
Co., Ltd
100% sensitivity, 100% specificity, OP swab
99.16 % (Nasal),
SI: 95.9% sensitivity, 99.9% specificity, NP/OP/Nasal swab
99.61 % (NP)
Shenzhen Lvshiyuan
Study design unknown
98% sensitivity
Green Spring SARS-CoV-2
Biotechnology Co.,
2109
100% specificity
DE[2]
DE[2]
10 May 2021
Antigen-Rapid test-Set
Ltd.
DE: 98% sensitivity , 100% specificity
NP/OP/Nasal swab
Retrospective in vitro studies
Clinical Sensitivity:
SARS-CoV-2 Antigen Test
Shenzhen
92.93 %
Kit (Colloidal Gold
Microprofit Biotech
1967
DE:
Clinical Specificity: DE[2], ES
DE[2]
7 July 2021
Chromatographic
Co., Ltd
Positive evaluation by Paul-Ehrlich-Institut (sensitivity of 100% at
100 %
Immunoassay)
<Ct25) + Manufacturer specificity: 100%
Nasal/NP/OP swab
SARS-CoV-2 Spike Protein
Retrospective in vitro studies
Shenzhen
Sensitivity: 86.3%,
Test Kit (Colloidal Gold
DE:
Microprofit Biotech
1178
Specificity: 100%
DE
[2]
DE[2]
23 July 2021
Chromatographic
Positive evaluation by Paul-Ehrlich-Institut (sensitivity of 100% at
Co., Ltd.
Nasal Swab
Immunoassay)
<Ct25) + Manufacturer specificity: 100%
Study design unknown
Shenzhen Watmind SARS-CoV-2 Ag Diagnostic
95.15% Sensitivity
1769
AT, DE[2], FR
DE[2]
10 May 2021
Medical Co., Ltd
Test Kit (Colloidal Gold)
DE: 95.15% sensitivity , 99.12% specificity
Nasal swab
Shenzhen Watmind SARS-CoV-2 Ag Diagnostic 1768
Retrospective in vitro studies
Clinical Sensitivity: DE[2]
DE[2]
7 July 2021
EU
Clinical
Other
Complete
Member
MS
Included in
Device
Clinical performance as reported by independent validation
performance
countries
d
Manufacturer
RAT commercial name
States
currently EU common
ID # 3
studies
Data by
using in
validation
using in
validating
list since:
manufacturer
practice
studies
practice
Medical Co., Ltd
Test Kit (Immuno-
97.83 % (CT ≤ 33)
DE:
fluorescence)
Clinical Sensitivity:
Positive evaluation by Paul-Ehrlich-Institut (sensitivity of 100% at
90.08 % (Ct ≤ 36)
<Ct25) + Manufacturer specificity: 99,13%
Nasal swab
Study design unknown
Shenzhen Zhenrui
Zhenrui ®COVID-19
96% sensitivity
1574
DE[2]
DE[2]
10 May 2021
Biotech Co., Ltd
Antigen Test Cassette
DE: 96% sensitivity 97% specificity
Nasal swab
Study design unknown
98.32% sensitivity AT, BE,
BE:
(NP swab)
Siemens
CLINITEST Rapid COVID-19
DE[2], FR,
DE[2], ES,
HR, PT,
17 February
1218
98.32% sensitivity, 99.6% specificity, NP swab
97.25% sensitivity
CH
Healthineers
Antigen Test
HR, NL[5],
NL[5]
SE[3]
2021
97.25% sensitivity, 100% specificity, Nasal swab
100% specificity
PT, SE, SI
(Nasal swab)
SI: 96.7% sensitivity, 99.2% specificity, NP/Nasal swab
Retrospective in vitro studies
100% sensitivity
Sugentech, Inc.
SGTi-flex COVID-19 Ag
1114
DE: Positive evaluation by Paul-Ehrlich-Institut (sensitivity of 100% 100% specificity
AT, DE[2]
DE[2]
10 May 2021
at <Ct30 and 100% at <Ct25)
OP/NP swab
Study design unknown
BE: 96.6% sensitivity, 100% specificity, NP/OP swab
98.6% sensitivity
TODA PHARMA
TODA CORONADIAG Ag
1466
BE, DE[2], SI
DE[2]
10 May 2021
DE: 96.6% sensitivity, 100 specificity
Nasal swab
SI: 96.6% sensitivity, 100% specificity, NP/OP swab
Retrospective in vitro studies
98.33% sensitivity
Triplex International SARS-CoV-2 Antigen Rapid 2074
DE: Positive evaluation by Paul-Ehrlich-Institut (sensitivity of
100% specificity
DE[2]
DE[2]
16 June 2021
Biosciences Co., Ltd Test Kit
92,5% at <Ct30 and 100% at <Ct25)
Nasal/OP/NP swab
Triplex International SARS-CoV-2 Antigen Rapid
Retrospective in vitro studies
Biosciences Co., Ltd, Test Kit
98.51 % sensitivity
China
1465
DE: Positive evaluation by Paul-Ehrlich-Institut (sensitivity of 100%
DE[2], FR, PT
DE[2]
14 July 2021
Nasal swab
at <Ct25) + Manufacturer specificity: 100%
Retrospective in vitro studies
DE:
Positive evaluation by Paul-Ehrlich-Institut (sensitivity of 100% at
Vitrosens
RapidFor SARS-CoV-2
<Ct30 and 100% at <Ct25)
97.3% sensitivity
Biotechnology Co.,
1443
DE[2], SI
DE[2]
10 May 2021
Rapid Ag Test
Study design unknown
Nasal swab
Ltd
SI:
97.3% sensitivity, 99% specificity, NP/OP/Nasal swab
EU
Clinical
Other
Complete
Member
MS
Included in
Device
Clinical performance as reported by independent validation
performance
countries
d
Manufacturer
RAT commercial name
States
currently EU common
ID # 3
studies
Data by
using in
validation
using in
validating
list since:
manufacturer
practice
studies
practice
Study design unknown
97.04% sensitivity
VivaChek Biotech
VivaDiag Pro SARS-CoV-2 2103
AT:
99.9% specificity
AT, SI
AT, DE[2], SI AT
10 May 2021
(Hangzhou) Co., Ltd. Ag Rapid Test
97,06% sensitivity, 100% specificity, all specimen types, i.e.
Nasal/OP/NP swab
N&OP&NP swab
Wuhan
Study design unknown
96.1% sensitivity
EasyDiagnosis
COVID-19 (SARS-CoV-2)
2098
100% specificity
DE[2]
DE[2]
10 May 2021
Biomedicine Co.,
Antigen-Test Kit
DE: 96.15% sensitivity , 99.26% specificity
Nasal/OP/NP swab
Ltd.
Wuhan Life Origin
SARS-CoV-2 Antigen Assay
Retrospective in vitro studies
Biotech Joint Stock
Kit
DE:
92.67% sensitivity
Co., Ltd.
(Immunochromatography 1773
DE[2]
DE[2]
14 July 2021
Positive evaluation by Paul-Ehrlich-Institut (sensitivity of 100% at
Nasal swab
)
<Ct25) + Manufacturer specificity: xx%
Retrospective in vitro studies
Wuhan UNscience
Sensitivity: 96.33%
SARS-CoV-2 Antigen Rapid
Biotechnology Co.,
2090
DE:
Specificity: 99.57% DE[2]
DE[2], FR
7 July 2021
Test Kit
Ltd.
Positive evaluation by Paul-Ehrlich-Institut (sensitivity of 100% at
Nasal/NP/OP swab
<Ct25) + Manufacturer specificity: 99,57%
Retrospective in vitro studies
Xiamen AmonMed
93.2% sensitivity
COVID-19 Antigen Rapid
Biotechnology Co.,
1763
DE:
99.55% specificity DE[2]
DE[2]
10 May 2021
Test Kit (Colloidal Gold)
Ltd
Positive evaluation by Paul-Ehrlich-Institut (sensitivity of 100% at
Nasal swab
<Ct25) + Manufacturer specificity: 99.55%
Study design unknown
AT, BE, BG,
Xiamen Boson
Rapid SARS-CoV-2 Antigen
Not specified
DE[2]
17 February
1278
BE: 93.8% sensitivity, 100% specificity, NP swab
CY, DE[2],
CH
Biotech Co. Ltd
Test Card
NP swab
CH
2021
FR, RO
DE: 96.49% sensitivity, 99.03% specificity
Study design unknown
Xiamen Wiz Biotech SARS-CoV-2 Antigen Rapid
96.3% sensitivity,
1456
AT, DE[2]
DE[2]
10 May 2021
Co., Ltd
Test
DE: 96.3% sensitivity, 100% specificity
Nasal swab
Study design unknown
95.91% sensitivity
Xiamen Wiz Biotech SARS-CoV-2 Antigen Rapid 1884
100% specificity
AT, DE[2]
DE[2]
10 May 2021
Co., Ltd
Test (Colloidal Gold)
DE: 95.91% sensitivity , 100% specificity
Nasal swab
Study design unknown
Zhejiang Anji Saianfu AndLucky COVID-19
95.8% sensitivity,
1296
AT, DE[2]
DE[2]
10 May 2021
Biotech Co.., Ltd
Antigen Rapid Test
DE: 97.5% sensitivity, 99.1% specificity
Nasal swab
Retrospective in vitro studies
Zhejiang Anji Saianfu reOpenTest COVID-19
95.8% sensitivity,
1295
DE: Positive evaluation by Paul-Ehrlich-Institut (sensitivity of
DE[2]
DE[2]
10 May 2021
Biotech Co.., Ltd
Antigen Rapid Test
Nasal swab
94,1% at <Ct25) + Manufacturer specificity: 99%
EU
Clinical
Other
Complete
Member
MS
Included in
Device
Clinical performance as reported by independent validation
performance
countries
d
Manufacturer
RAT commercial name
States
currently EU common
ID # 3
studies
Data by
using in
validation
using in
validating
list since:
manufacturer
practice
studies
practice
Study design unknown
Zhejiang Orient
98.32 % sensitivity
Coronavirus Ag Rapid Test
BE: 98.32% sensitivity, 99.6% specificity, NP swab; 97.25%
AT, BE, BG,
17 February
Gene Biotech Co.,
1343
99.6 % specificity
CH, UK
DE[2]
SE[3]
Cassette (Swab)
sensitivity, 100% specificity, Nasal swab
DE[2], PT
2021
Ltd
Nasal/NP swab
DE: 96.72% sensitivity, 99.22% specificity
Retrospective in vitro studies
96.12% sensitivity
Nasal swab
Zhuhai Lituo
COVID-19 Antigen
(CT<33); 99.59%
Biotechnology Co.,
Detection Kit (Colloidal
1957
DE: Positive evaluation by Paul-Ehrlich-Institut (sensitivity of 100% sensitivity
CZ, DE[2], SI
DE[2]
14 July 2021
Ltd.
Gold)
at <Ct25) + Manufacturer specificity: 100%
NP swab; 100%
specificity Nasal
swab (CT<33)