Verbraucher
Schutzstelle |
Niedersachsen |

| |
Das Paul-Ehrlich-Institut (PEI) hat eine vergleichende Evaluierung bei in
Deutschland zugelassenen Coronaschnelltests vom 12.01.2022 zur Sensivität der
Tests veröffentlicht.
Die vergleichende Evaluierung einer großen Anzahl von SARS-CoV-2
Antigenschnelltests verschiedener Designs und verschiedener Hersteller mit einem
einheitlichen Probenset ermöglicht einen Überblick über den derzeitigen Stand
der Technik hinsichtlich ihrer Sensitivität.
Der derzeitige Stand der Technik wurde einer Mindestsensitivität von 75 % für
die Pools mit einem Cq =25 gleichgesetzt. Die Ergebnisse lassen keine
Rückschlüsse auf die Spezifität der Tests zu.
Die beiden „Testsieger“, wenn man das so sagen kann, mit Gesamtsensitivität
100,0% waren:
Longsee 2019-nCoV Ag Rapid Detection Kit (Immuno-Chromatography)
Guangdong Longsee Biomedical Co.,Inc.
AT-Nr. / AT-No.: AT731/21
Ref-Nr./ ID-No.: LS-C-T-009
Zielantigen / target antigen: N
Cq <25 : 100 %
Cq 25-30: 100 %
Cq >30 : 100 %
Gesamt-Sensitvität: 100 %
COVID-19 Rapid Test Cassette Antigen Test Kit
Lifecosm Biotech Limited
AT-Nr. / AT-No.: AT1054/21
Ref-Nr./ ID-No.: n.a.
Zielantigen / target antigen: N
Cq <25 : 100 %
Cq 25-30: 100 %
Cq >30 : 100 %
Gesamt-Sensitvität: 100 %
Die Testsieger sind Tests für die Anwendung mit geschultem Personal.
Hierbei ist aber zu beachten, dass z.B. der zuerst genannte Longsee 2019-nCoV Ag Rapid Detection Kit
(Immuno-Chromatography), auch Testen mit einer Eindringtiefe in die Nase von nur
2,5 cm ermöglicht. Nach unserer Auffassung also problemlos auch für Laien
durchführbar.
In der Testreihe, die alle in Deutschland zugelassenen Corona-Schnelltests
umfasst, sind aber auch offiziell als Selbsttests ausgewiesene Tests
aufgeführt. Hier hat der "beste" Test mit 90 % Gesamtsensivität
abgeschnitten:
Sienna COVID-19 Antigen-Schnelltestkassette (Nasenabstrich)
Hangzhou Biotest Biotech Co., Ltd
AT-Nr. AT568/21
AT-Nr. Selbsttest AT1331/21
Ref-Nr. 302281
Zielantigen / target antigen: N
Cq <25 : 100 %
Cq 25-30: 95 %
Cq >30 : 60 %
Gesamt-Sensitvität: 90 %
Gesamtliste der
zugelassenen Corona-Schnelltests, Consumer und Professionell (Reihenfolge
nach Gesamtsensivität) |
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Mindestanforderung
ist eine Rate von 75 % bei Quantifizierungscyclus Cq <25 |
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Gesamt-Sensitvität |
|
Zielantigen |
Quantifizierungscyclus
Cq <25 |
Quantifizierungscyclus
Cq 25-30 |
Quantifizierungscyclus
Cq >30 |
|
Testname |
Hersteller |
|
AT-Nr. |
AT-Nr.
Selbsttest |
Ref-Nr. |
100,0% |
|
N |
100,0% |
100,0% |
100,0% |
|
Longsee
2019-nCoV Ag Rapid Detection Kit (Immuno-Chromatography) |
Guangdong
Longsee Biomedical Co.,Inc. |
|
AT731/21 |
|
LS-C-T-009 |
100,0% |
|
N |
100,0% |
100,0% |
100,0% |
|
COVID-19
Rapid Test Cassette Antigen Test Kit |
Lifecosm
Biotech Limited |
|
AT1054/21 |
|
n.a. |
98,0% |
|
N |
100,0% |
100,0% |
90,0% |
|
COVID-19
Antigen Rapid Test (Oral Fluid) |
CITEST
Diagnostics Inc. |
|
AT889/21 |
|
n.a. |
96,0% |
|
N |
100,0% |
100,0% |
80,0% |
|
SARS-CoV-2
Antigen Rapid Detection Kit (LFA) |
Acro
Diagnostics Co., Ltd |
|
AT1024/21 |
|
n.a. |
96,0% |
|
N |
100,0% |
100,0% |
80,0% |
|
SARS-CoV-2
Ag Schnelltestkit |
Hangzhou
Jucheng Medical Products Co., Ltd |
|
AT961/21 |
|
n.a. |
96,0% |
|
N |
100,0% |
100,0% |
80,0% |
|
INNOVA
SARS-CoV-2 Selbsttest (Qualitativer-Antigen-Schnelltest) |
Innova
Medical Group,Inc. |
|
AT637/21 |
|
BT1389 |
96,0% |
|
N |
100,0% |
100,0% |
80,0% |
|
InstantSure
Covid-19 Ag CARD |
Suzhou
Soochow University Saier Immuno Biotech Co., Ltd. |
|
AT830/21 |
|
n.a. |
94,0% |
|
N |
100,0% |
100,0% |
70,0% |
|
INVBIO
One Step Diagnostic Rapid Test Cassette |
Innovation
Biotech (Beijing) Co. LTD |
|
AT1073/21 |
|
n.a. |
94,0% |
|
N |
100,0% |
100,0% |
70,0% |
|
SARS-Cov-2
Antigen Rapid Detection Kit |
Shenzhen
CAS-Envision Medical Technology Co., Ltd. |
|
AT928/21 |
|
CG201A |
92,0% |
|
N |
100,0% |
100,0% |
60,0% |
|
Novel
Coronavirus(2019-nCoV) Antigen Rapid Test |
Bioscience
(Tianjin) Diagnostic Technology Co., Ltd |
|
AT805/21 |
|
n.a. |
92,0% |
|
N |
100,0% |
100,0% |
60,0% |
|
Dynamiker
SARS-CoV-2 AG Rapid Test |
Dynamiker
Biotechnology (Tianjin) Co., Ltd. |
|
AT342/21 |
|
DNK-1425-1 |
92,0% |
|
N |
100,0% |
100,0% |
60,0% |
|
Novel
Corona Virus (2019-nCoV) Ag Rapid Test Kit |
Glallergen
CO., LTD. |
|
AT755/21 |
|
600008 |
90,0% |
|
N |
100,0% |
95,0% |
60,0% |
|
Sienna
COVID-19 Antigen-Schnelltestkassette (Nasenabstrich) |
Hangzhou
Biotest Biotech Co., Ltd |
|
AT568/21 |
AT1331/21 |
302281 |
90,0% |
|
N |
100,0% |
95,0% |
60,0% |
|
COVID-19
antigen Schnelltest (Kolloidales Gold) / Novel Coronavirus(SARS-CoV-2)
Antigen Rapid Detection Kit |
Jiangxi
Province JinHuan Medical Instrument Co.,LTD. |
|
AT770/21 |
|
n.a. |
90,0% |
|
N |
100,0% |
100,0% |
50,0% |
|
SARS-CoV-2
Antigen Rapid Test |
Nantong
Egens Biotechnology |
|
AT425/21 |
|
n.a. |
90,0% |
|
N |
100,0% |
95,0% |
60,0% |
|
COVID-19
Antigen Detection Kit (Quantum Dots-Based Immunofluorescence
Chromatography) |
Shenzhen
Kingfocus Biomedical Engineering Co., Ltd. |
|
AT1019/21 |
|
150129 |
88,0% |
|
N |
100,0% |
100,0% |
40,0% |
|
Amper
COVID-19 Antigen Rapid Testing Kit (Colloidal Gold) |
Amper,lnc. |
|
AT412/21 |
|
MU00325 |
86,0% |
|
N |
100,0% |
95,0% |
40,0% |
|
Virusee®
SARS-CoV-2 Antigen Rapid Test (Colloidal Gold) (Saliva/Swab) |
Genobio
Pharmaceutical Co., Ltd. |
|
AT1100/21 |
|
CoVSLFA-20 |
86,0% |
|
N |
100,0% |
95,0% |
40,0% |
|
COVID-19
Schnelltestgerät |
Jiangsu
Well Biotech Co., Ltd. |
|
AT883/21 |
|
CO-05 |
86,0% |
|
N |
100,0% |
95,7% |
40,0% |
|
Green
Spring SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) |
Shenzhen
Lvshiyuan Biotechnology Co., Ltd. |
|
AT417/20 |
|
n.a. |
86,0% |
|
N |
100,0% |
95,0% |
40,0% |
|
SARS-CoV-2
Antigen Assay Kit by Latex Immunochromatography method |
Sichuan
Xincheng Biological Co., Ltd. |
|
AT941/21 |
|
T3701W,
T3702W, T3706W |
86,0% |
|
N |
100,0% |
95,7% |
40,0% |
|
Toda
Coronadiag Ag |
Toda
Pharma |
|
AT379/20 |
|
2276-20 |
84,0% |
|
N |
100,0% |
95,0% |
30,0% |
|
Rapid
SARS-CoV-2 Antigen Test Colloidal Gold (Nasopharyngeal/Nasal specimen) |
InTec
Products, Inc. |
|
AT981/21
(AT574/21) |
|
ITP16010-TC25 |
82,0% |
|
N |
100,0% |
95,0% |
20,0% |
|
COVID-19
Antigentest |
Artron
Laboratories Inc. |
|
AT518/20 |
|
A03-50-422 |
82,0% |
|
N |
100,0% |
95,0% |
20,0% |
|
SARS-CoV-2
Antigen Rapid Test (Colloidal Gold Method) |
Biohit
Healthcare (Hefei) Co., Ltd. |
|
AT879/21 |
|
209.01.25.01 |
82,0% |
|
N |
100,0% |
95,7% |
20,0% |
|
SARS-CoV-2
Ag Diagnostic Test Kit (Colloidal Gold) |
Shenzhen
Watmind Medical Co., Ltd. |
|
AT108/20 |
|
LFA0401-25N |
82,0% |
|
N |
100,0% |
95,7% |
20,0% |
|
COVID-19
Antigen Speicheltest (Immunochromatographie) |
ulti
med Products (Deutschland) GmbH |
|
AT075/21 |
|
012G521 |
80,0% |
|
N |
100,0% |
87,0% |
30,0% |
|
Tigsun
COVID-19 Saliva Antigen Rapid Test |
Beijing
Tigsun Diagnostics Co.;Ltd. |
|
AT122/21 |
|
TG1417 |
80,0% |
|
N |
100,0% |
91,3% |
20,0% |
|
Quick
Profile Covid-19 Antigen Test Card |
LumiQuick
Diagnostics, Inc. |
|
AT151/20 |
|
71110 |
80,0% |
|
N |
100,0% |
87,0% |
30,0% |
|
COVID-19
Antigen Rapid Test Kit (Colloidal Gold) |
Xiamen
AmonMed Biotechnology Co., Ltd. |
|
AT246/21 |
AT1279/21 |
CG01Ag-25 |
78,0% |
|
N |
100,0% |
87,0% |
20,0% |
|
Covid-19-Antigen-Testkit |
New
Gene (Hangzhou) Bioengineering Co., Ltd. |
|
AT331/21 |
AT1210/21 |
COVID-19-NG08 |
78,0% |
|
N |
100,0% |
91,3% |
10,0% |
|
ScheBo
SARS-CoV-2 Quick Antigen |
ScheBo
Biotech AG |
|
AT069/20 |
|
34 |
78,0% |
|
N |
100,0% |
90,0% |
10,0% |
|
SARS-CoV-2
Antigen Saliva Rapid Test Kit |
Shenzhen
Huaree Technology Co., Ltd. |
|
AT458/21 |
|
HRK-6820 |
78,0% |
|
N |
100,0% |
87,0% |
20,0% |
|
SARS-CoV-2
Antigen Rapid Test Kit |
Triplex
International Biosciences (China) Co., Ltd. |
|
AT044/21 |
|
C011906 |
76,0% |
|
N |
100,0% |
90,0% |
0,0% |
|
KaiBiLi
COVID-19 Antigen Pro |
Hangzhou
Genesis Biodetection & Biocontrol Co., Ltd. |
|
AT818/21 |
|
P211138 |
76,0% |
|
N |
100,0% |
87,0% |
0,0% |
|
CLINITEST®
Rapid COVID-19 Antigen Test |
Healgen
Scientific Limited Liability Company (Siemens Healthineers) |
|
AT001/20 |
AT1208/21 |
GCCOV-502a-H5 |
76,0% |
|
N |
100,0% |
90,0% |
0,0% |
|
SARS-CoV-2
Antigen Rapid Test Kit (Colloidal Gold) SPUCKTEST |
JOYSBIO
(Tianjin) Biotechnology Co., Ltd. |
|
AT527/20 |
|
COV-AG-20
/ G10313 |
76,0% |
|
N |
100,0% |
85,0% |
10,0% |
|
KISSH
SARS-CoV-2 Antigen Test Kit (GICA) |
Shenzhen
Kisshealth Biotechnology Co., Ltd. |
|
AT420/21 |
|
K602-20 |
76,0% |
|
S |
100,0% |
85,0% |
10,0% |
|
SARS-CoV-2
Spike Protein Test Kit (Fluorescence Immunoassay) |
Shenzhen
Microprofit Biotech Co., Ltd. |
|
AT071/20 |
|
MF-63 |
76,0% |
|
N |
100,0% |
70,0% |
40,0% |
|
Novel
Coronavirus (COVID-19) Antigen Detection Kit (Latex Immunochromatography) |
Zhejiang
Gene Science Co., Ltd. |
|
AT516/21 |
|
n.a. |
76,0% |
|
N |
100,0% |
87,0% |
0,0% |
|
Coronavirus
Ag Rapid Test Cassette (Swab) |
Zhejiang
Orient Gene Biotech Co.,Ltd |
|
AT039/20 |
|
GCCOV-502a |
74,0% |
|
N |
100,0% |
78,3% |
11,1% |
|
BIOSYNEX
COVID-19 Ag BSS |
BIOSYNEX
SWISS SA |
|
AT025/20 |
|
SW4000605 |
74,0% |
|
N |
100,0% |
70,0% |
30,0% |
|
Konsung
COVID-19 Antigen Rapid Test Kit |
Jiangsu
Konsung Bio-Medical Science And Technology Co., Ltd |
|
AT231/20 |
|
n.a. |
74,0% |
|
N |
100,0% |
85,0% |
0,0% |
|
LionRun™
SARS-CoV-2 Antigen Rapid Test Kit (Lateral Flow Immunoassay) |
Shanghai
Liangrun Biomedicine Technology Co., Ltd. |
|
AT748/21 |
|
n.a. |
72,0% |
|
N |
100,0% |
75,0% |
10,0% |
|
Covid-19
Antigen Rapid Test (Colloidal Gold) |
Beijing
O&D Biotech Co., Ltd. |
|
AT820/21 |
|
00013C |
72,0% |
|
N |
100,0% |
78,3% |
0,0% |
|
Wantai
SARS-CoV-2 Ag Rapid Test (FIA) |
Beijing
Wantai Biological Pharmacy Enterprise Co., Ltd. |
|
AT022/21 |
|
WJ-2850 |
72,0% |
|
N |
100,0% |
82,6% |
0,0% |
|
One
Step Test for SARS-CoV-2 Antigen (Colloidal Gold) |
Getein
Biotech, Inc. |
|
AT166/20 |
AT1257/21 |
CG2061 |
72,0% |
|
N |
100,0% |
82,6% |
0,0% |
|
SARS-CoV-2
Antigen Rapid Test Cassette |
Merlin
Biomedical (Xiamen) Co., Ltd. |
|
AT214/20 |
|
CP01810011 |
72,0% |
|
N |
100,0% |
75,0% |
10,0% |
|
COVID
19 Antigen Test Kit (Colloidal Gold Method) |
Neo-nostics
(Suzhou) Bioengeneering Co., Ltd. |
|
AT722/21 |
|
SVRAG |
72,0% |
|
N |
95,0% |
80,0% |
10,0% |
|
TBG
SARS-CoV-2 Antigen Rapid Test |
TBG
Biotechnology Xiamen Inc. |
|
AT848/21 |
|
04A024 |
72,0% |
|
N |
100,0% |
80,0% |
0,0% |
|
COVID-19
Antigen Detection Kit (Colloidal Gold) |
Zhuhai
Lituo Biotechnology Co., Ltd. |
|
AT542/21 |
AT1290/21 |
n.a. |
70,0% |
|
N |
100,0% |
75,0% |
0,0% |
|
Accu-Tell
Rapid In-vitro Diagnostiktest |
AccuBioTech
Co.,Ltd. |
|
AT084/21 |
|
ABT-IDTB367 |
70,0% |
|
N |
100,0% |
78,3% |
0,0% |
|
AMP
Rapid Test SARS-CoV-2 Ag |
Ameda
Labordiagnostik GmbH |
|
AT033/20 |
|
RT2952 |
70,0% |
|
N |
100,0% |
78,3% |
0,0% |
|
Covid
19 Antigen Schnelltest |
BioRepair
GmbH |
|
AT219/20 |
|
COV-201 |
70,0% |
|
N |
100,0% |
75,0% |
0,0% |
|
SARS-CoV-2-Antigen-Schnelltestgerät |
Hangzhou
Funworld Biotech. Co., Ltd |
|
AT415/21 |
|
n.a. |
70,0% |
|
N |
100,0% |
78,3% |
0,0% |
|
Lysun
COVID-19 Antigen Rapid Test Device (Colloidal Gold) |
Hangzhou
Lysun Biotechnology Co., Ltd. |
|
AT060/20 |
|
COV-201 |
70,0% |
|
N |
100,0% |
75,0% |
0,0% |
|
Novel
Coronavirus (SARS-CoV-2) Ag Rapid Test Kit |
Jiangsu
Bioperfectus Technologies Co., Ltd. |
|
AT849/21 |
|
n.a. |
70,0% |
|
N |
95,0% |
80,0% |
0,0% |
|
StrongStep®
SARS-COV2 Antigen Rapid Test |
Nanjing
Liming Bio-Products Co., Ltd. |
|
AT593/21 |
|
500200 |
70,0% |
|
N |
100,0% |
70,0% |
10,0% |
|
Neuartiges
Coronavirus (2019-nCoV) Antigendetektions-reagenz (immunochromatographischer
Assay) |
Zhongxiu
Science and Technology Co., Ltd |
|
AT839/21 |
|
n.a. |
68,0% |
|
N |
100,0% |
78,3% |
0,0% |
|
COVID-19
Antigen Rapid Test Cassette (Colloidal Gold) |
Jiangsu
Diagnostics Biotechnology Co., Ltd |
|
AT418/20 |
|
n.a. |
68,0% |
|
N |
100,0% |
73,9% |
0,0% |
|
SGTi-flex
COVID-19 Ag |
Sugentech,
Inc. |
|
AT010/20 |
|
CAGT025E0 |
68,0% |
|
N |
100,0% |
73,9% |
0,0% |
|
COVID-19
(SARS-CoV-2) Antigen Test Kit |
Wuhan
EasyDiagnosis Biomedicine Co., Ltd. |
|
AT430/20 |
|
W-Ag03-20 |
66,0% |
|
N |
100,0% |
69,6% |
0,0% |
|
Asan
Easy Test COVID-19 Ag |
ASAN
PHARM.CO.,LTD. |
|
AT431/20 |
|
AM3474-K |
66,0% |
|
N |
100,0% |
65,2% |
0,0% |
|
NowCheck®
COVID-19 Ag Test |
BIONOTE |
|
AT014/20 |
|
RG1901DG |
66,0% |
|
N |
100,0% |
65,0% |
0,0% |
|
SARS-CoV-2
Antigen Test Kit (Colloidal Gold Method) |
Hubei
Jinjian Biology Co.,Ltd. |
|
AT1076/21 |
|
n.a. |
66,0% |
|
N |
100,0% |
65,0% |
0,0% |
|
SARS-CoV-2
Antigen Test Cassette |
Jiangsu
Mole Bioscience Co., Ltd |
|
AT1082/21 |
|
R220T001B0C0 |
66,0% |
|
N |
100,0% |
65,2% |
0,0% |
|
STANDARD
F COVID-19 Ag FIA |
SD
Biosensor, Inc. |
|
AT022/20 |
|
F-NCOV-01G |
64,0% |
|
N |
100,0% |
60,9% |
0,0% |
|
Panbio™
COVID-19 Ag Rapid Test Device (NASOPHARYNGEAL) |
Abbott
Rapid Diagnostics Jena GmbH |
|
AT005/20 |
|
41FK10 |
64,0% |
|
N |
100,0% |
60,0% |
0,0% |
|
SARS-CoV-2
Ag Rapid Test |
BioMaxima
S.A. |
|
AT172/21 |
|
1-367-K020 |
64,0% |
|
N |
95,0% |
65,0% |
0,0% |
|
Tebsun
2019-nCoV Antigen Test Kit |
Guangzhou
Tebsun Bio-Tech Development Co., Ltd. |
|
AT582/21 |
|
n.a. |
64,0% |
|
N |
100,0% |
60,9% |
0,0% |
|
COVID-19
Antigen Schnelltest (Colloidal Gold) |
Joinstar
Biomedical Technology Co., Ltd (CIV care impuls Vertrieb) |
|
AT236/20 |
AT1276/21 |
n.a. |
64,0% |
|
N |
100,0% |
65,2% |
0,0% |
|
PocRoc
SARS-CoV-2, Antigen Schnelltest Set (Kolloidales Gold) |
Lumigenex
(Suzhou) Co., Ltd. |
|
AT455/20 |
|
PR210101 |
64,0% |
|
N |
100,0% |
60,9% |
0,0% |
|
Exdia
COVID-19-Ag-Test |
Precision
Biosensor Inc. (Axon Lab AG) |
|
AT078/20 |
|
PR-FC13 |
64,0% |
|
N |
94,1% |
65,2% |
10,0% |
|
Rapid
Test Ag 2019-nCoV |
ProGnosis
Biotech |
|
AT376/20 |
|
V1330 |
64,0% |
|
N |
100,0% |
60,0% |
0,0% |
|
SARS-CoV-2Antigen
Test Kit (Colloidal Gold) |
Shenzhen
Huian Biosci Technology Co., Ltd. |
|
AT472/21 |
|
203-020 |
64,0% |
|
N |
100,0% |
60,0% |
0,0% |
|
SARS-CoV-2
Antigen Test Kit (Lateral Flow Assay) |
Wuxi
Biohermes Bio & Medical Technology Co., Ltd. |
|
AT847/21 |
|
COV-S31 |
62,0% |
|
N |
100,0% |
50,0% |
10,0% |
|
New
Coronavirus (COVID-19) Antigen Rapid Test |
Anhui
Formaster Biosci Co., Ltd |
|
AT785/21 |
|
FCB-103 |
62,0% |
|
N |
100,0% |
60,9% |
0,0% |
|
Nova
Test SARS-CoV-2 Antigen Rapid Test Kit |
Atlas
Link Technology Co.,Ltd. |
|
AT132/20 |
|
nCOV-500 |
62,0% |
|
N |
100,0% |
60,9% |
0,0% |
|
COVID-19
Antigen Schnell Test (Nasopharyngeal / Oropharyngeal Tupfer Kassette) |
Chil
Tibbi Mal. San. Tic. Ltd. Şti |
|
AT337/20 |
|
CCOV-201 |
62,0% |
|
N |
100,0% |
52,2% |
11,1% |
|
COVID-19
Ag Test Kit |
Guangdong
Wesail Biotech Co., Ltd. |
|
AT086/20 |
AT1158/21 |
BE0040 |
62,0% |
|
N |
100,0% |
55,0% |
0,0% |
|
Covid-19
Antigen Rapid Test (Oral fluid) |
Hangzhou
AllTest Biotech Co., Ltd. |
|
AT276/21 |
AT1117/21 |
ICOV-802 |
62,0% |
|
N |
100,0% |
55,0% |
0,0% |
|
SARS-Cov-2
Nucleocapsid(N) Antigen Rapid Test Cassette |
Hangzhou
Zheda Dixun Biological Gene Engineering Co., Ltd. |
|
AT821/21 |
|
IFC-SCoV2-AG |
62,0% |
|
N |
100,0% |
55,0% |
0,0% |
|
SARS-CoV-2
Antigen Rapid Test Cassette |
Merlin
Biomedical (Xiamen) Co., Ltd. |
|
AT790/21 |
|
CP02150011 |
62,0% |
|
N |
100,0% |
60,9% |
0,0% |
|
Safecare
COVID-19 Ag Rapid Test Kit (Swab) |
Safecare
Biotech Hangzhou Co., Ltd. |
|
AT199/20 |
|
COV
Ag-6012 |
62,0% |
|
N |
100,0% |
60,9% |
0,0% |
|
SARS-CoV-2
Ag Diagnostic Test Kit (Immunofluorescence) |
Shenzhen
Watmind Medical Co., Ltd. |
|
AT385/20 |
|
LFB0401-25N |
60,0% |
|
N |
100,0% |
50,0% |
0,0% |
|
Jinwofu
Novel Coronavirus (SARS-COV-2) Antigen Rapid Test Kit |
Beijing
Jinwofu Bioengineering Technology Co.,Ltd. |
|
AT205/20 |
|
C3042 |
60,0% |
|
N |
100,0% |
45,0% |
10,0% |
|
Check
Up SARS-CoV-2 Nasal Antigen Rapid Test |
Cesna
Biyoteknoloji Arastirma Gelistirme Laboratuvar Sist. |
|
AT924/21 |
|
C2104N01 |
60,0% |
|
N |
100,0% |
50,0% |
0,0% |
|
OnSite
COVID-19 Ag Rapid Test |
CTK
Biotech, Inc. |
|
AT390/21 |
|
R0182C |
60,0% |
|
N |
100,0% |
50,0% |
0,0% |
|
SARS-CoV-2
Antigen Schnelltestkassette |
Hangzhou
Sejoy Electronics & Instruments Co.,Ltd. |
|
AT628/21 |
AT1269/21 |
COVG-602 |
60,0% |
|
N |
100,0% |
52,2% |
0,0% |
|
LumiraDx
SARS-CoV-2 Ag Test |
LumiraDX |
|
AT075/20 |
|
SPEC-32312
R2 ART-00571 R4 |
60,0% |
|
N |
100,0% |
56,5% |
0,0% |
|
COVID-19
Antigen Saliva Test Kit (Colloidal Gold) |
Nantong
Diagnos Biotechnology Co., Ltd. |
|
AT517/20 |
|
17252668 |
60,0% |
|
N+S |
100,0% |
50,0% |
0,0% |
|
SARS-CoV-2
Antigen IVD kit SWAB |
Shenzhen
Reagent Technology Co., Ltd. |
|
AT844/21 |
|
RNS92048B |
60,0% |
|
n.a. |
100,0% |
56,5% |
0,0% |
|
SARS-CoV-2
Antigen Assay Kit (Immunochromatography) |
Wuhan
Life Origin Biotech Joint Stock Co., Ltd. |
|
AT172/20 |
|
SF24025 |
58,0% |
|
N |
100,0% |
45,0% |
0,0% |
|
Cora
Gentest-19 |
Abioteq |
|
AT018/21 |
|
n.a. |
58,0% |
|
N |
100,0% |
47,8% |
0,0% |
|
TestNOW®
COVID-19-Antigen-Test |
Affimedix |
|
AT181/21 |
|
1166-25 |
58,0% |
|
N |
100,0% |
52,2% |
0,0% |
|
Rapid
Covid-19 Antigen Test (Colloidal Gold ) |
Anbio
(Xiamen) Biotechnology Co., Ltd |
|
AT147/20 |
AT1332/21
/ AT1333/21 |
A6061202 |
58,0% |
|
N |
95,0% |
50,0% |
0,0% |
|
ECOTEST
COVID-19 Antigen Rapid Test Device |
Assure
Tech (Hangzhou) Co.,Ltd |
|
AT286/20 |
|
NL-CA002-2020-52777 |
58,0% |
|
N |
100,0% |
52,2% |
0,0% |
|
Axiom
Diagnostics COVID-19 Ag Schnelltest |
AXIOM
Gesellschaft für Diagnostica und Biochemica mbH |
|
AT374/20 |
|
88
99 19 |
58,0% |
|
N |
94,1% |
56,5% |
0,0% |
|
Genrui
SARS-CoV-2 Antigen Test Kit (Colloidal Gold) |
Genrui
Biotech Inc. |
|
AT111/20 |
AT1200/21 |
52026075 |
58,0% |
|
N |
100,0% |
47,8% |
0,0% |
|
MEDsan®
SARS-CoV-2 Antigen Rapid Test |
MEDsan
GmbH |
|
AT012/20 |
|
76748 |
58,0% |
|
N |
100,0% |
47,8% |
0,0% |
|
mö-screen
Corona Antigen Test |
Mölab
GmbH |
|
AT047/20 |
|
0230005SP |
58,0% |
|
N |
100,0% |
52,2% |
0,0% |
|
PCL
COVID19 Ag Gold Saliva |
PCL,
Inc. |
|
AT538/20 |
|
COV04S |
58,0% |
|
N |
100,0% |
45,0% |
0,0% |
|
SARS-CoV-2
Antigen Rapid Test Kit (Immunochromatography) |
Shenzhen
Huaree Technology Co.,Ltd. |
|
AT424/21 |
|
HRK-6620 |
58,0% |
|
S |
100,0% |
47,8% |
10,0% |
|
fluorecare
COVID-19 SARS-CoV-2 Spike Protein Test Kit (Colloidal Gold Chromatographic
Immunoassay) |
Shenzhen
Microprofit Biotech Co., Ltd. |
|
AT070/20 |
|
MF-60 |
56,0% |
|
N |
100,0% |
47,8% |
0,0% |
|
Novel
Coronavirus 2019-nCoV Antigen Test (Colloidal gold) |
Beijing
Hotgen Biotech Co., Ltd. |
|
AT120/20 |
AT1236/21 |
n.a. |
56,0% |
|
N |
100,0% |
35,0% |
10,0% |
|
Convergys®
COVID-19 Rapid Antigen Test |
Convergent
Technologies |
|
AT498/20 |
|
1100-5330 |
56,0% |
|
N |
100,0% |
47,8% |
0,0% |
|
Testsealabs®
Rapid Test Kit COVID-19 Antigen Test Cassette |
Hangzhou
Testsea Biotechnology Co., Ltd |
|
AT082/20 |
|
n.a. |
56,0% |
|
N |
100,0% |
40,0% |
0,0% |
|
COVID-19
Antigen Test Kit |
Surge
Medical Inc. |
|
AT765/21 |
|
n.a. |
54,0% |
|
N |
100,0% |
35,0% |
0,0% |
|
COVID-19
Antigen Test Kit |
Beijing
Homa Biological Engineering Co., Ltd. |
|
AT967/21 |
|
P2311 |
54,0% |
|
N |
100,0% |
35,0% |
0,0% |
|
Novel
Coronavirus(COVID-19) Antigen Test Kit (Colloidal Gold) |
Changzhou
Biowin Pharmaceutical Co.,Ltd. |
|
AT1010/21 |
|
n.a. |
54,0% |
|
N |
100,0% |
39,1% |
10,0% |
|
Covid-19
Antigen Detection Kit |
DNA
Diagnostic A/S. |
|
AT085/21 |
|
CV19IC |
54,0% |
|
N |
100,0% |
35,0% |
0,0% |
|
Goldsite
COVID-19 SARS-CoV-2 Antigen Kit (Colloidal Gold) |
Goldsite
Diagnostics Inc. |
|
AT533/21 |
AT1295/21 |
CG123005 |
54,0% |
|
N |
100,0% |
35,0% |
0,0% |
|
SARS-CoV-2
Antigen Rapid Detection Kit (Colloidal Gold Method) |
Jinan
Babio Biotechnology Co., Ltd. |
|
AT559/21 |
|
n.a. |
54,0% |
|
N |
100,0% |
35,0% |
0,0% |
|
Joysbio
SARS-CoV-2 Antigen rapid test kit -PRO (Colloidal Gold) |
JOYSBIO
(Tianjin) Biotechnology Co.,Ltd. |
|
AT692/21 |
|
G10322 |
54,0% |
|
N |
100,0% |
43,5% |
0,0% |
|
Rapid
SARS-CoV-2 Antigen Test Card |
MP
Biomedicals Germany GmbH |
|
AT198/20 |
|
07AG6020B |
54,0% |
|
N |
100,0% |
35,0% |
0,0% |
|
Synthgene
Neues Coronavirus (SARS-CoV-2) Antigen-Schnellerkennungskit (Collate
Gold-Methode) |
Nanjing
Synthgene Medical Technology Co., Ltd. |
|
AT678/21 |
|
RQ005 |
54,0% |
|
N |
100,0% |
35,0% |
0,0% |
|
Saliva
SARS-CoV-2(2019-nCoV) Antigen Test Kit (Nanocarbon Assay) |
Ningbo
Beautiful Life Medical Biotechnology |
|
AT989/21 |
|
NBMLRS-XG-S2 |
54,0% |
|
N |
100,0% |
43,5% |
0,0% |
|
Hightop
SARS-CoV-2 (Covid-19) Antigen Rapid Test |
Qingdao
Hightop Biotech Co., Ltd. |
|
AT320/20 |
AT1224/21 |
H100G |
54,0% |
|
N |
100,0% |
43,5% |
0,0% |
|
SARS-CoV-2
Antigen Schnelltest |
Xiamen
Boson Biotech Co., Ltd. |
|
AT116/20 |
AT1165/21 |
07AG6020B |
52,0% |
|
N |
100,0% |
39,1% |
0,0% |
|
COVID-19
(SARS CoV-2) Antigen Test Kit (Colloidal Gold) |
Anhui
Deepblue Medical Technology Co. , Ltd. |
|
AT031/20 |
AT1190/21
/ AT1288/21 |
n.a. |
52,0% |
|
N |
100,0% |
30,0% |
0,0% |
|
SARS-CoV-2
Antigen Test Kit (Colloidal Gold) |
Shenzhen
Dymind Biotechnology Co., Ltd. |
|
AT260/21 |
|
n.a. |
52,0% |
|
N |
100,0% |
30,0% |
0,0% |
|
SARS-CoV-2
Antigen Test Kit (Colloidal Gold) |
Shenzhen
Dymind Biotechnology Co., Ltd. |
|
AT829/21 |
|
n.a. |
50,0% |
|
N |
100,0% |
25,0% |
0,0% |
|
Wantai
SARS-CoV-2 Ag Schnelltest (Kolloidales Gold) |
Beijing
Wantai Biological Pharmacy Enterprise Co., Ltd. |
|
AT496/20 |
AT1265/21 |
WJ-2910 |
50,0% |
|
N |
100,0% |
34,8% |
0,0% |
|
Edinburgh
Genetics ActivXpress+ COVID-19 Antigen Complete Testing Kit |
Edinburgh
Genetics Limited |
|
AT032/20 |
|
EGCV0101B |
50,0% |
|
N |
94,4% |
34,8% |
0,0% |
|
Clungene
COVID-19 Antigen Rapid Test |
Hangzhou
Clongene Biotech Co., Ltd. |
|
AT079/20 |
|
2020110090 |
50,0% |
|
N |
100,0% |
25,0% |
0,0% |
|
Bisdeal
SARS-CoV-2 Antigen-Schnelltest |
Hangzhou
Zheda Dixun Biological Gene Engineering Co., Ltd. |
|
AT934/21 |
|
G-C-0104 |
50,0% |
|
N |
100,0% |
25,0% |
0,0% |
|
SARS-CoV-2
Rapid Antigen Test (Colloidal Gold Method) |
Sansure
Biotech Inc. |
|
AT506/21 |
|
S3109E |
48,0% |
|
N |
100,0% |
30,4% |
0,0% |
|
COVID-19-Antigen-Schnelltest
(Nasopharyngeal-Abstrich) |
BIOMERICA
Inc. |
|
AT007/21 |
|
1509A-I |
48,0% |
|
N |
95,0% |
25,0% |
0,0% |
|
2019-nCoV
Antigen Test Kit |
Chongqing
M&D Biotechnology Co. Ltd. |
|
AT595/21 |
|
n.a. |
48,0% |
|
N |
100,0% |
20,0% |
0,0% |
|
Whole
Power One Step 2019-Novel Coronavirus(2019-nCoV) Antigen Test |
Co-Innovation
Biotech Co. Ltd |
|
AT409/20 |
|
7200331 |
48,0% |
|
N |
94,1% |
34,8% |
0,0% |
|
EBS
SARS-CoV-2 Ag Rapid Test |
Eurobio
Scientific |
|
AT491/20 |
|
EBS
1020 |
48,0% |
|
N |
100,0% |
20,0% |
0,0% |
|
Fosun
Covid-19 Ag Card |
Fosun
Diagnostics (Shanghai) Co., Ltd (ehemals Shanghai Fosun Long March Medical
Science Co., Ltd.) |
|
AT767/21 |
|
PCSYHN02 |
48,0% |
|
N |
95,0% |
25,0% |
0,0% |
|
INVBIO
Antigen Rapid Test Device (Saliva) |
Innovation
Biotech (Beijing) Co.,Ltd |
|
AT247/21 |
|
n.a. |
48,0% |
|
N |
100,0% |
20,0% |
0,0% |
|
MSP
SARS-CoV-2 Antigen-Schnelltest |
MSP
bodmann GmbH |
|
AT823/21 |
AT1281/21 |
0000000168 |
48,0% |
|
N |
100,0% |
20,0% |
0,0% |
|
Novel
Coronavirus (COVID-19) Antigen Rapid Test Kit |
Qingdao
AIBO Diagnostic CO., Ltd. |
|
AT935/21 |
|
n.a. |
48,0% |
|
N |
90,0% |
30,0% |
0,0% |
|
GLINE-2019-nCoV
Ag |
Shenzhen
YHLO Biotech Co., Ltd. |
|
AT409/21 |
|
G86247 |
48,0% |
|
N |
100,0% |
20,0% |
0,0% |
|
COVID-19
Antigen Rapid Test Cassette (Nasal Swab) |
SureScreen
Diagnostics Ltd. |
|
AT789/21 |
|
COVID19AGVCG |
48,0% |
|
N |
100,0% |
30,4% |
0,0% |
|
RapidFor
SARS-CoV-2 Rapid Antigen Test Colloidal Gold |
Vitrosens
Biyoteknoloji Ltd. Sti |
|
AT507/20 |
|
VSCD02 |
46,0% |
|
N |
100,0% |
26,1% |
0,0% |
|
SARS-CoV-2
Antigen Rapid Test Kit |
Beijing
Lepu Medical Technology Co., Ltd |
|
AT216/20
(AT052/20) |
|
n.a. |
46,0% |
|
N |
100,0% |
21,7% |
0,0% |
|
ESPLINE®
SARS-CoV-2 |
Fujirebio
Inc. (Mast Diagnostica GmbH) |
|
AT029/20 |
|
231906 |
46,0% |
|
N |
94,4% |
26,1% |
0,0% |
|
GenBody
COVID-19 Ag |
GenBody
Inc. |
|
AT019/20 |
|
COVAG025 |
46,0% |
|
N |
94,1% |
30,4% |
0,0% |
|
CAT
Antigen Covid Rapid Test |
Oncosem
Onkolojik Sistemler San. Ve Tic.A.S. |
|
AT117/20 |
|
CAT-01 |
46,0% |
|
N |
88,9% |
30,4% |
0,0% |
|
STANDARD
Q COVID-19 Ag Test (SARS-CoV-2 Rapid Antigen Test) |
SD
Biosensor, Inc. (Roche Diagnostics GmbH) |
|
AT023/20
(AT004/20) |
AT1154/21 |
Q-NCOV-01G
(9901-NCOV-01G) |
46,0% |
|
N |
94,1% |
30,4% |
0,0% |
|
reOpenTest
COVID-19 Antigen Rapid Test (Colloidal Gold) |
Zhejiang
Anji Saianfu Biotech Co.,Ltd. |
|
AT102/20 |
|
COVG10S |
44,0% |
|
N |
95,0% |
15,0% |
0,0% |
|
SARS-Cov-2-Antigen-Schnelltest-Karte |
BioDetect
(Xiamen) Biotechnology Co., Ltd |
|
AT787/21 |
|
GMT102 |
44,0% |
|
N |
90,0% |
20,0% |
0,0% |
|
AllTest
SARS-CoV-2 Antigen Rapid Test (Nasal Swab) |
Hangzhou
AllTest Biotech Co.,Ltd. |
|
AT766/21 |
AT1172/21 |
INCP-502-N |
44,0% |
|
N |
94,1% |
26,1% |
0,0% |
|
Novel
Coronavirus (2019-nCOV) Antigen Testing Kit (Colloidal Gold) |
Nanjing
Norman Biological Technology Co., Ltd |
|
AT462/20 |
|
n.a. |
44,0% |
|
N |
100,0% |
17,4% |
0,0% |
|
RIDA®QUICK
SARS-CoV-2 Antigen |
R-Biopharm
AG |
|
AT008/20 |
|
N6803 |
44,0% |
|
N |
94,1% |
26,1% |
0,0% |
|
V-Chek
SARS-CoV-2 Rapid Ag Test Kit (Colloidal Gold) |
SGA
Mühendislik DAN. EG. Icve DIS.Ltd.STI |
|
AT918/21 |
AT1291/21
/ AT1338/21 |
SCVC02 |
44,0% |
|
N |
95,0% |
15,0% |
0,0% |
|
ENCODE
SARS-COV-2 Antigen Rapid Test Device |
Zhuhai
Encode Medical Engineering Co., Ltd. |
|
AT583/21 |
|
RDC-802 |
42,0% |
|
N |
95,0% |
10,0% |
0,0% |
|
Tell
Me Fast Rapid Diagnostic Test |
Biocan
Diagnostics Inc. |
|
AT284/21 |
|
B255C |
42,0% |
|
N |
95,0% |
10,0% |
0,0% |
|
SARS-CoV-2
Antigen Test Kit (Colloidal Gold Method) |
BioTeke
Corporation (Wuxi) Co.,Ltd. |
|
AT349/21 |
|
400-678-8982 |
42,0% |
|
N |
90,0% |
15,0% |
0,0% |
|
ISIA
SARS-CoV-2 Antigen Rapid Test Kit |
Chongqing
ISIA BIO-Technology Co.,Ltd |
|
AT635/21 |
|
n.a. |
42,0% |
|
N |
88,2% |
26,1% |
0,0% |
|
Canea
COVID-19 Antigen Schnelltest |
Core
Technology Co., Ltd. |
|
AT267/20 |
|
n.a. |
42,0% |
|
N |
95,0% |
10,0% |
0,0% |
|
Dräger
Antigen Test SARS-CoV-2 |
Dräger
Safety AG & Co. KGaA |
|
AT1173/21 |
AT1189/21 |
3715270 |
42,0% |
|
N |
94,4% |
17,4% |
0,0% |
|
Lyher
Novel Coronavirus (COVID-19) Antigen Test Kit (Colloidal Gold) |
Hangzhou
Laihe Biotech Co., Ltd. (Lissner Qi GmbH) |
|
AT011/20 |
AT1228/21 |
n.a. |
42,0% |
|
N |
94,1% |
21,7% |
0,0% |
|
SARS-CoV-2-Antigen-Testkit
(LFIA) |
Jiangsu
Medomics Medical Technology Co., Ltd |
|
AT244/20 |
AT1298/21 |
1031-02 |
42,0% |
|
N |
85,0% |
15,0% |
10,0% |
|
Saliva
SARS-CoV-2 (2019-nCoV) Antigen Test Kit (Nanocarbon Assay) |
Jiaxing
Wisetest Bio-Tech Co., Ltd. |
|
AT882/21 |
|
n.a. |
42,0% |
|
N |
94,1% |
21,7% |
0,0% |
|
novacheck®-Ag
SARS-CoV-2 Covid-19 Antigen Rapid Test |
Novatech
Tibbi Cihaz Ürünleri San. Ve Tic.A.S. |
|
AT036/21 |
|
MY28 |
42,0% |
|
N+S |
100,0% |
17,4% |
0,0% |
|
SARS-CoV-2
Antigen Detection Kit (Colloidal Gold Immunochromatographic Assay) |
PerGrande
BioTech Development Co., Ltd. |
|
AT209/20 |
|
n.a. |
42,0% |
|
N |
95,0% |
10,0% |
0,0% |
|
GreenLight
SARS-CoV-2 Antigen-Test |
Senova
Gesellschaft für Biowissenschaft und Technik mbH |
|
AT1064/21 |
|
2.13.1.587 |
42,0% |
|
N |
95,0% |
10,0% |
0,0% |
|
SARS-CoV-2
Antigen Rapid Test (Lateral Flow Assay) |
Shenzhen
Kang Sheng Bao Bio- Technology Co., Ltd. |
|
AT1065/21 |
|
808151-1 |
42,0% |
|
N |
90,0% |
15,0% |
0,0% |
|
fluorecare
SARS-CoV-2 Antigen Test Kit |
Shenzhen
Microprofit Biotech Co., Ltd. |
|
AT544/21 |
AT1308/21 |
MF-68 |
40,0% |
|
N |
94,1% |
13,0% |
10,0% |
|
Rapid
Response COVID-19 Rapid Test Device |
BTNX,
Inc. |
|
AT373/20 |
|
COV-19C25 |
40,0% |
|
N |
90,0% |
10,0% |
0,0% |
|
Corona
Virus (COVID-19) Antigen Rapid Test (Colloidal Gold) |
Hoyotek
Biomedical Co., Ltd. |
|
AT563/21 |
|
HYT-G01 |
40,0% |
|
N+S |
88,2% |
21,7% |
0,0% |
|
Humasis
COVID-19 Ag Test |
Humasis
Co., Ltd. |
|
AT083/20 |
|
ACOVA-7025 |
40,0% |
|
N |
94,1% |
17,4% |
0,0% |
|
Labnovation
SARS-CoV-2 Antigen Rapid Test Kit (Immunochromatography) |
Labnovation
Technologies, Inc. |
|
AT127/20 |
AT1284/21
/ AT1155/21 |
B63000 |
40,0% |
|
N |
90,0% |
10,0% |
0,0% |
|
Rapidan
Tester COVID-19 Ag Test |
Türklab
Tibbi Malzemeleri San. Ve Tic. A.S |
|
AT492/20 |
AT1222/21 |
RTCV03 |
40,0% |
|
N |
82,4% |
21,7% |
10,0% |
|
softec
SARS COV-2 (Covid-19) Antigen Test Kit |
Zet
Medikal Tekstil Dis Ticaret Ltd. STI. |
|
AT167/20 |
|
n.a. |
38,0% |
|
N |
94,1% |
13,0% |
0,0% |
|
Ksmart®
SARS-COV2 Antigen Rapid Test |
Avalun |
|
AT441/20 |
|
8004664 |
38,0% |
|
N |
95,0% |
0,0% |
0,0% |
|
COVID-19
Antigen Rapid Test Kit |
Beijing
Kewei Clinical Diagnostic Reagent Inc. |
|
AT313/20 |
|
601460 |
38,0% |
|
N |
85,0% |
10,0% |
0,0% |
|
FUJIFILM
COVID-19 Ag Test |
FUJIFILM
Corporation |
|
AT587/21 |
|
16696722 |
38,0% |
|
N |
94,1% |
13,0% |
0,0% |
|
DIA-COVID®
COVID-19 Ag Rapid Test Kit |
GenSure
Biotech Inc. |
|
AT161/20 |
|
P2004 |
38,0% |
|
N |
90,0% |
5,0% |
0,0% |
|
GENEDIAN
COVID-19 Antigen Test Cassette |
Hangzhou
DIAN Biotechnology Co., Ltd. |
|
AT816/21 |
|
n.a. |
38,0% |
|
N |
90,0% |
5,0% |
0,0% |
|
Kanzone
COVID-19 Antigen Rapid Test |
Weihai
Kangzhou Biotechnology Engineering Co., Ltd. |
|
AT711/21 |
|
n.a. |
38,0% |
|
N |
88,2% |
17,4% |
0,0% |
|
SARS-CoV-2
Antigen Rapid Test Kit |
Wuhan
UNscience Biotechnology Co., Ltd. |
|
AT429/20 |
|
CoV2Ag-25 |
38,0% |
|
N |
90,0% |
5,0% |
0,0% |
|
ZandCell
COVID-19 Saliva Antigen-Test |
ZandCell
AB |
|
AT311/21 |
|
n.a. |
36,0% |
|
N |
82,4% |
17,4% |
0,0% |
|
Aesku
Rapid SARS-CoV-2 Rapid Test |
Aesku
Diagnostics GmbH |
|
AT363/20 |
|
840001 |
36,0% |
|
N |
85,0% |
5,0% |
0,0% |
|
AS-check
COVID-19 Antigen Schnelltest |
Asterion
Otel Insaat Bilisim Medikal Maden Tic.Ltd.Sti. |
|
AT791/21 |
|
MY28 |
36,0% |
|
N |
76,5% |
13,0% |
20,0% |
|
Dia
Sure Covid-19 Antigen Rapid Test Device (Nasopharyngeal/Oropharyngeal Swab) |
Azure
Biotech Inc. |
|
AT061/20 |
|
B62000 |
36,0% |
|
N |
88,2% |
13,0% |
0,0% |
|
IMMUNOBIO
SARS-CoV-2 Antigen-Schnelltest (COVID-19 Ag) |
Hangzhou
Immuno Biotech Co.,Ltd. |
|
AT228/20 |
|
YMC050G |
36,0% |
|
N |
85,0% |
5,0% |
0,0% |
|
2019-nCoV
Ag Test (Latex Chromatography Assay) |
Innovita
(Tangshan) Biological Technology Co.; LTD. |
|
AT199/21 |
|
n.a. |
36,0% |
|
N |
83,3% |
13,0% |
0,0% |
|
NADAL®
COVID-19 Ag Schnelltest |
nal
von minden gmbh |
|
AT021/20 |
AT1293/21 |
243103N-20 |
36,0% |
|
N+S |
85,0% |
5,0% |
0,0% |
|
Vazyme
SARS-CoV-2 Antigen Detection Kit (Colloidal Gold-Based) |
Nanjing
Vazyme Medical Technology Co., Ltd. |
|
AT255/20 |
|
C8602C |
36,0% |
|
N |
80,0% |
10,0% |
0,0% |
|
Zijian
SARS-CoV-2 (COVID-19) Antigen Rapid Detection Kit (Lateral Flow Method) |
Shen
Zhen Zi Jian Biotechnology Co., Ltd. |
|
AT857/21 |
|
n.a. |
36,0% |
|
N |
90,0% |
0,0% |
0,0% |
|
SARS-CoV-2
Antigen Test Kit (Colloidal Gold) |
Wuhan
HealthCare Biotechnology Co., Ltd. |
|
AT997/21 |
|
FP-318 |
36,0% |
|
N |
88,2% |
13,0% |
0,0% |
|
Wizbiotech
SARS-CoV-2 Antigen Rapid Test |
Xiamen
WIZ Biotech Co., Ltd. |
|
AT109/20 |
AT1297/21 |
51232012 |
34,0% |
|
N |
94,1% |
4,3% |
0,0% |
|
Flowflex
SARS-CoV-2-Antigenschnelltest |
ACON
Biotech (Hangzhou) Co., Ltd |
|
AT155/20 |
AT1217/21 |
L031-11815 |
34,0% |
|
N |
83,3% |
8,7% |
0,0% |
|
BD
Veritor™ System for Rapid Detection of SARS-CoV-2 |
Becton
Dickinson |
|
AT200/20 |
|
256082 |
34,0% |
|
N |
83,3% |
8,7% |
0,0% |
|
Genedia
W Covid-19 Ag |
Green
Cross Medical Science Corp. (Weko Pharma GmbH) |
|
AT018/20 |
|
n.a. |
34,0% |
|
N |
82,4% |
13,0% |
0,0% |
|
2019-nCoV
Antigen Test Kit (colloidal gold method) |
Guangdong
Hecin Scientific,Inc. |
|
AT542/20 |
|
n.a. |
34,0% |
|
N |
88,2% |
8,7% |
0,0% |
|
FREND™
COVID-19 Ag |
NanoEntek
Inc |
|
AT090/20 |
|
FRCOG
020P |
34,0% |
|
N |
80,0% |
5,0% |
0,0% |
|
Pro-med
COVID-19 Antigen Rapid Detection Kit |
Pro-med
(Beijing) Technology Co.,Ltd. |
|
AT863/21 |
|
n.a. |
34,0% |
|
N |
82,4% |
13,0% |
0,0% |
|
salocor
SARS-CoV-2 Antigen Rapid Test Cassette (Nasopharyngeal swab) |
Salofa
OY |
|
AT106/20 |
|
COV-06-S |
34,0% |
|
N |
82,4% |
13,0% |
0,0% |
|
Zhenrui
COVID-19 (SARS-COV-2) Antigen Test Kits |
Shenzhen
Zhenrui Biotech Co., Ltd. |
|
AT211/20 |
|
n.a. |
30,0% |
|
N |
76,5% |
8,7% |
0,0% |
|
CoroVisio
Covid-19 Ag Versieglungsröhrchen Teststreifen (Kolloidales Gold) |
Amazing
Biotech (Shanghai) Co., Ltd |
|
AT303/20 |
|
RICOV2 |
30,0% |
|
N |
88,2% |
0,0% |
0,0% |
|
Wondfo
SARS-CoV-2 Antigen Test (Lateral Flow Method) |
Guangzhou
Wondfo Biotech Co. Ltd |
|
AT125/20 |
|
W196 |
30,0% |
|
N |
75,0% |
0,0% |
0,0% |
|
SARS-CoV-2-Antigen-Schnelltest |
Hangzhou
Careomedic Tech Co., Ltd. |
|
AT825/21 |
|
n.a. |
28,0% |
|
N |
77,8% |
0,0% |
0,0% |
|
Covid-19
Antigen Schnelltest |
Beijing
Beier Bioengineering Co., Ltd. |
|
AT074/20 |
|
n.a. |
Liste der ausgewiesenen
Consumer Selbsttests (Reihenfolge nach Gesamtsensivität) |
|
|
|
|
|
Mindestanforderung
ist eine Rate von 75 % bei Quantifizierungscyclus Cq <25 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gesamt-Sensitvität |
|
Zielantigen |
Quantifizierungscyclus
Cq <25 |
Quantifizierungscyclus
Cq 25-30 |
Quantifizierungscyclus
Cq >30 |
|
Testname |
Hersteller |
|
AT-Nr. |
AT-Nr.
Selbsttest |
Ref-Nr. |
|
|
|
|
|
|
|
|
|
|
|
|
|
90,0% |
|
N |
100,0% |
95,0% |
60,0% |
|
Sienna
COVID-19 Antigen-Schnelltestkassette (Nasenabstrich) |
Hangzhou
Biotest Biotech Co., Ltd |
|
AT568/21 |
AT1331/21 |
302281 |
80,0% |
|
N |
100,0% |
87,0% |
30,0% |
|
COVID-19
Antigen Rapid Test Kit (Colloidal Gold) |
Xiamen
AmonMed Biotechnology Co., Ltd. |
|
AT246/21 |
AT1279/21 |
CG01Ag-25 |
78,0% |
|
N |
100,0% |
87,0% |
20,0% |
|
Covid-19-Antigen-Testkit |
New
Gene (Hangzhou) Bioengineering Co., Ltd. |
|
AT331/21 |
AT1210/21 |
COVID-19-NG08 |
76,0% |
|
N |
100,0% |
87,0% |
0,0% |
|
CLINITEST®
Rapid COVID-19 Antigen Test |
Healgen
Scientific Limited Liability Company (Siemens Healthineers) |
|
AT001/20 |
AT1208/21 |
GCCOV-502a-H5 |
72,0% |
|
N |
100,0% |
82,6% |
0,0% |
|
One
Step Test for SARS-CoV-2 Antigen (Colloidal Gold) |
Getein
Biotech, Inc. |
|
AT166/20 |
AT1257/21 |
CG2061 |
72,0% |
|
N |
100,0% |
80,0% |
0,0% |
|
COVID-19
Antigen Detection Kit (Colloidal Gold) |
Zhuhai
Lituo Biotechnology Co., Ltd. |
|
AT542/21 |
AT1290/21 |
n.a. |
64,0% |
|
N |
100,0% |
60,9% |
0,0% |
|
COVID-19
Antigen Schnelltest (Colloidal Gold) |
Joinstar
Biomedical Technology Co., Ltd (CIV care impuls Vertrieb) |
|
AT236/20 |
AT1276/21 |
n.a. |
62,0% |
|
N |
100,0% |
55,0% |
0,0% |
|
Covid-19
Antigen Rapid Test (Oral fluid) |
Hangzhou
AllTest Biotech Co., Ltd. |
|
AT276/21 |
AT1117/21 |
ICOV-802 |
62,0% |
|
N |
100,0% |
52,2% |
11,1% |
|
COVID-19
Ag Test Kit |
Guangdong
Wesail Biotech Co., Ltd. |
|
AT086/20 |
AT1158/21 |
BE0040 |
60,0% |
|
N |
100,0% |
50,0% |
0,0% |
|
SARS-CoV-2
Antigen Schnelltestkassette |
Hangzhou
Sejoy Electronics & Instruments Co.,Ltd. |
|
AT628/21 |
AT1269/21 |
COVG-602 |
58,0% |
|
N |
94,1% |
56,5% |
0,0% |
|
Genrui
SARS-CoV-2 Antigen Test Kit (Colloidal Gold) |
Genrui
Biotech Inc. |
|
AT111/20 |
AT1200/21 |
52026075 |
58,0% |
|
N |
100,0% |
52,2% |
0,0% |
|
Rapid
Covid-19 Antigen Test (Colloidal Gold ) |
Anbio
(Xiamen) Biotechnology Co., Ltd |
|
AT147/20 |
AT1332/21
/ AT1333/21 |
A6061202 |
56,0% |
|
N |
100,0% |
47,8% |
0,0% |
|
Novel
Coronavirus 2019-nCoV Antigen Test (Colloidal gold) |
Beijing
Hotgen Biotech Co., Ltd. |
|
AT120/20 |
AT1236/21 |
n.a. |
54,0% |
|
N |
100,0% |
43,5% |
0,0% |
|
SARS-CoV-2
Antigen Schnelltest |
Xiamen
Boson Biotech Co., Ltd. |
|
AT116/20 |
AT1165/21 |
07AG6020B |
54,0% |
|
N |
100,0% |
43,5% |
0,0% |
|
Hightop
SARS-CoV-2 (Covid-19) Antigen Rapid Test |
Qingdao
Hightop Biotech Co., Ltd. |
|
AT320/20 |
AT1224/21 |
H100G |
54,0% |
|
N |
100,0% |
35,0% |
0,0% |
|
Goldsite
COVID-19 SARS-CoV-2 Antigen Kit (Colloidal Gold) |
Goldsite
Diagnostics Inc. |
|
AT533/21 |
AT1295/21 |
CG123005 |
52,0% |
|
N |
100,0% |
39,1% |
0,0% |
|
COVID-19
(SARS CoV-2) Antigen Test Kit (Colloidal Gold) |
Anhui
Deepblue Medical Technology Co. , Ltd. |
|
AT031/20 |
AT1190/21
/ AT1288/21 |
n.a. |
50,0% |
|
N |
100,0% |
25,0% |
0,0% |
|
Wantai
SARS-CoV-2 Ag Schnelltest (Kolloidales Gold) |
Beijing
Wantai Biological Pharmacy Enterprise Co., Ltd. |
|
AT496/20 |
AT1265/21 |
WJ-2910 |
48,0% |
|
N |
100,0% |
20,0% |
0,0% |
|
MSP
SARS-CoV-2 Antigen-Schnelltest |
MSP
bodmann GmbH |
|
AT823/21 |
AT1281/21 |
0000000168 |
46,0% |
|
N |
88,9% |
30,4% |
0,0% |
|
STANDARD
Q COVID-19 Ag Test (SARS-CoV-2 Rapid Antigen Test) |
SD
Biosensor, Inc. (Roche Diagnostics GmbH) |
|
AT023/20
(AT004/20) |
AT1154/21 |
Q-NCOV-01G
(9901-NCOV-01G) |
44,0% |
|
N |
90,0% |
20,0% |
0,0% |
|
AllTest
SARS-CoV-2 Antigen Rapid Test (Nasal Swab) |
Hangzhou
AllTest Biotech Co.,Ltd. |
|
AT766/21 |
AT1172/21 |
INCP-502-N |
44,0% |
|
N |
94,1% |
26,1% |
0,0% |
|
V-Chek
SARS-CoV-2 Rapid Ag Test Kit (Colloidal Gold) |
SGA
Mühendislik DAN. EG. Icve DIS.Ltd.STI |
|
AT918/21 |
AT1291/21
/ AT1338/21 |
SCVC02 |
42,0% |
|
N |
95,0% |
10,0% |
0,0% |
|
Dräger
Antigen Test SARS-CoV-2 |
Dräger
Safety AG & Co. KGaA |
|
AT1173/21 |
AT1189/21 |
3715270 |
42,0% |
|
N |
94,4% |
17,4% |
0,0% |
|
Lyher
Novel Coronavirus (COVID-19) Antigen Test Kit (Colloidal Gold) |
Hangzhou
Laihe Biotech Co., Ltd. (Lissner Qi GmbH) |
|
AT011/20 |
AT1228/21 |
n.a. |
42,0% |
|
N |
94,1% |
21,7% |
0,0% |
|
SARS-CoV-2-Antigen-Testkit
(LFIA) |
Jiangsu
Medomics Medical Technology Co., Ltd |
|
AT244/20 |
AT1298/21 |
1031-02 |
42,0% |
|
N |
90,0% |
15,0% |
0,0% |
|
fluorecare
SARS-CoV-2 Antigen Test Kit |
Shenzhen
Microprofit Biotech Co., Ltd. |
|
AT544/21 |
AT1308/21 |
MF-68 |
40,0% |
|
N |
90,0% |
10,0% |
0,0% |
|
Rapidan
Tester COVID-19 Ag Test |
Türklab
Tibbi Malzemeleri San. Ve Tic. A.S |
|
AT492/20 |
AT1222/21 |
RTCV03 |
40,0% |
|
N |
94,1% |
17,4% |
0,0% |
|
Labnovation
SARS-CoV-2 Antigen Rapid Test Kit (Immunochromatography) |
Labnovation
Technologies, Inc. |
|
AT127/20 |
AT1284/21
/ AT1155/21 |
B63000 |
36,0% |
|
N |
83,3% |
13,0% |
0,0% |
|
NADAL®
COVID-19 Ag Schnelltest |
nal
von minden gmbh |
|
AT021/20 |
AT1293/21 |
243103N-20 |
36,0% |
|
N |
88,2% |
13,0% |
0,0% |
|
Wizbiotech
SARS-CoV-2 Antigen Rapid Test |
Xiamen
WIZ Biotech Co., Ltd. |
|
AT109/20 |
AT1297/21 |
51232012 |
34,0% |
|
N |
94,1% |
4,3% |
0,0% |
|
Flowflex
SARS-CoV-2-Antigenschnelltest |
ACON
Biotech (Hangzhou) Co., Ltd |
|
AT155/20 |
AT1217/21 |
L031-11815 |
|