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. 2021 Nov 4;26(44):2100441. doi: 10.2807/1560-7917.ES.2021.26.44.2100441

Table 3. Comparative evaluation results of SARS-CoV-2 antigen rapid diagnostic tests passing the sensitivity criteria (sorted by performance in the subgroups of the evaluation panel), Germany, 2020–2021 (n = 96).

RDT Manufacturer Test name Sensitivity
Cq ≤ 25 Cq >25– <30 Cq ≥ 30 Cq 17–36
Subgroup of RDT with detection rates of 100% for Cq ≤ 25 and of >75% for Cq >25– <30
77 Shenzhen Lvshiyuan Biotechnology Co., Ltd. Green Spring SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) 100.0% 95.7% 40.0% 86.0%
84 Toda Pharma Toda Coronadiag Ag 100.0% 95.7% 40.0% 86.0%
79 Shenzhen Watmind Medical Co.,Ltd. SARS-CoV-2 Ag Diagnostic Test Kit (Colloidal Gold) 100.0% 95.7% 20.0% 82.0%
86 ulti med Products (Deutschland) GmbH COVID-19 Antigen Speicheltest (Immunochromatographie) 100.0% 95.7% 20.0% 82.0%
50 LumiQuick Diagnostics, Inc. QuickProfile Covid-19 Antigen Test Card 100.0% 91.3% 20.0% 80.0%
72 ScheBo Biotech AG ScheBo SARS-CoV-2 Quick Antigen 100.0% 91.3% 10.0% 78.0%
7 AmonMed (Xiamen) Biotechnology Co., Ltd. COVID-19 Antigen Rapid Test Kit (Colloidal Gold) 100.0% 87.0% 30.0% 80.0%
19 Beijing Tigsun Diagnostics Co.;Ltd. Tigsun COVID-19 Saliva Antigen Rapid Test 100.0% 87.0% 30.0% 80.0%
60 New Gene (Hangzhou) Bioengineering Co., Ltd. Covid-19-Antigen-Testkit 100.0% 87.0% 20.0% 78.0%
85 Triplex International Biosciences (China) Co., Ltd. SARS-CoV-2 Antigen Rapid Test Kit 100.0% 87.0% 20.0% 78.0%
96 Zhejiang Orient Gene Biotech Co., Ltd Coronavirus Ag Rapid Test Cassette (Swab) 100.0% 87.0% 0.0% 76.0%
82 Siemens Healthineers CLINITEST Rapid COVID-19 Antigen Test 100.0% 87.0% 0.0% 76.0%
33 Getein Biotech, Inc. One Step Test for SARS-CoV-2 Antigen (Colloidal Gold) 100.0% 82.6% 0.0% 72.0%
53 Merlin Biomedical (Xiamen) Co., Ltd. SARS-CoV-2 Antigen Rapid Test Cassette 100.0% 82.6% 0.0% 72.0%
22 BioRepair GmbH Covid 19 Antigen Schnelltest 100.0% 78.3% 0.0% 70.0%
6 Ameda Labordiagnostik GmbH AMP Rapid Test SARS-CoV-2 Ag 100.0% 78.3% 0.0% 70.0%
23 BIOSYNEX SWISS SA BIOSYNEX COVID-19 Ag BSS 100.0% 78.3% 11.1% 74.0%
41 Hangzhou Lysun Biotechnology Co., Ltd. Lysun COVID-19 Antigen Rapid Test Device (Colloidal Gold) 100.0% 78.3% 0.0% 70.0%
45 Jiangsu Diagnostics Biotechnology Co., Ltd COVID-19 Antigen Rapid Test Cassette (Colloidal Gold) 100.0% 78.3% 0.0% 68.0%
88 Wantai (Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.) SARS-CoV-2 Ag Rapid Test (FIA) 100.0% 78.3% 0.0% 72.0%
Subgroup of RDT with detection rates of 100% for Cq ≤ 25 and of <75% for Cq >25– <30
83 Sugentech, Inc. SGTi-flex COVID-19 Ag 100.0% 73.9% 0.0% 68.0%
89 Wuhan EasyDiagnosis Biomedicine Co., Ltd COVID-19 (SARS-CoV-2) Antigen Test Kit 100.0% 73.9% 0.0% 68.0%
10 ASAN PHARM.CO.,LTD. Asan Easy Test COVID-19 Ag 100.0% 69.6% 0.0% 66.0%
49 Lumigenex (Suzhou) Co., Ltd. PocRoc SARS-CoV-2, Antigen Schnelltest Set (Kolloidales Gold) 100.0% 65.2% 0.0% 64.0%
75 SD BIOSENSOR STANDARD F COVID-19 Ag FIA 100.0% 65.2% 0.0% 66.0%
21 BIONOTE NowCheck COVID-19 Ag Test 100.0% 65.2% 0.0% 66.0%
1 Abbott Rapid Diagnostics Jena GmbH PanbioCOVID-19 Ag Rapid Test Device (NASOPHARYNGEAL) 100.0% 60.9% 0.0% 64.0%
11 Atlas Link Technology Co., Ltd. Nova Test SARS-CoV-2 Antigen Rapid Test Kit 100.0% 60.9% 0.0% 62.0%
25 Chil Tibbi Mal. San. Tic. Ltd. Şti COVID-19 Antigen Schnell Test (Nasopharyngeal / Oropharyngeal Tupfer Kassette) 100.0% 60.9% 0.0% 62.0%
47 Joinstar Biomedical Technology Co., Ltd (CIV care impuls Vertrieb) COVID-19 Antigen Schnelltest (Colloidal Gold) 100.0% 60.9% 0.0% 64.0%
65 Precision Biosensor Inc. (Axon Laboratory AG) Exdia COVID-19-Ag-Test 100.0% 60.9% 0.0% 64.0%
70 Safecare Biotech Hangzhou Co., Ltd. Safecare COVID-19 Ag Rapid Test Kit (Swab) 100.0% 60.9% 0.0% 62.0%
80 Shenzhen Watmind Medical Co.,Ltd. SARS-CoV-2 Ag Diagnostic Test Kit (Immuno-fluorescence) 100.0% 60.9% 0.0% 62.0%
59 Nantong Diagnos Biotechnology Co., Ltd. COVID-19 Antigen Saliva Test Kit (Colloidal Gold) 100.0% 56.5% 0.0% 60.0%
90 Wuhan Life Origin Biotech Joint Stock Co., Ltd. SARS-CoV-2 Antigen Assay Kit (Immunochromatography) 100.0% 56.5% 0.0% 60.0%
36 Guangdong Wesail Biotech Co., Ltd. COVID-19 Ag Test Kit 100.0% 52.2% 11.1% 62.0%
8 Anbio (Xiamen) Biotechnology Co., Ltd Rapid Covid-19 Antigen Test (Colloidal Gold) 100.0% 52.2% 0.0% 58.0%
13 AXIOM Gesellschaft für Diagnostica und Biochemica mbH Axiom Diagnostics COVID-19 Ag Schnelltest 100.0% 52.2% 0.0% 58.0%
51 LumiraDX LumiraDx SARS-CoV-2 Ag Test 100.0% 52.2% 0.0% 60.0%
63 PCL, Inc. PCL COVID19 Ag Gold Saliva 100.0% 52.2% 0.0% 58.0%
78 Shenzhen Microprofit Biotech Co., Ltd fluorecare COVID-19 SARS-CoV-2 Spike Protein Test Kit (Colloidal Gold Chromatographic Immunoassay) 100.0% 47.8% 10.0% 58.0%
17 Beijing Hotgen Biotech Co., Ltd. Novel Coronavirus 2019-nCoV Antigen Test (Colloidal gold) 100.0% 47.8% 0.0% 56.0%
42 Hangzhou Testsea Biotechnology Co., Ltd Testsealabs Rapid Test Kit COVID-19 Antigen Test Cassette 100.0% 47.8% 0.0% 56.0%
52 MEDsan GmbH MEDsan SARS-CoV-2 Antigen Rapid Test 100.0% 47.8% 0.0% 58.0%
54 Mölaboratory GmbH mö-screen Corona Antigen Test 100.0% 47.8% 0.0% 58.0%
4 Affimedix TestNOW - COVID-19 Antigen 100.0% 47.8% 0.0% 58.0%
55 MP Biomedicals Germany GmbH Rapid SARS-CoV-2 Antigen Test Card 100.0% 43.5% 0.0% 54.0%
68 Qingdao Hightop Biotech Co., Ltd. Hightop SARS-CoV-2 (Covid-19) Antigen Rapid Test 100.0% 43.5% 0.0% 54.0%
92 Xiamen Boson Biotech Co., Ltd SARS-CoV-2 Antigen Schnelltest 100.0% 43.5% 0.0% 54.0%
27 DNA Diagnostic A/S. Covid-19 Antigen Detection Kit 100.0% 39.1% 10.0% 54.0%
9 Anhui Deepblue Medical Technology Co., Ltd. COVID-19 (SARS CoV-2) Antigen Test Kit (Colloidal Gold) 100.0% 39.1% 0.0% 52.0%
28 Edinburgh Genetics Limited Edinburgh Genetics ActivXpress + COVID-19 Antigen Complete Testing Kit 100.0% 34.8% 0.0% 50.0%
20 BIOMERICA Inc. COVID-19-Antigen-Schnelltest (Nasopharyngeal-Abstrich) 100.0% 30.4% 0.0% 48.0%
87 Vitrosens Biyoteknoloji Ltd. Sti RapidFor SARS-CoV-2 Rapid Antigen Test Colloidal Gold 100.0% 30.4% 0.0% 48.0%
18 Beijing Lepu Medical Technology Co., Ltd SARS-CoV-2 Antigen Rapid Test Kit 100.0% 26.1% 0.0% 46.0%
30 Fujirebio Inc. (Mast Diagnostica GmbH) ESPLINE SARS-CoV-2 100.0% 21.7% 0.0% 46.0%
69 R-Biopharm AG RIDAQUICK SARS-CoV-2 Antigen 100.0% 17.4% 0.0% 44.0%
64 PerGrande BioTech Development Co., Ltd. SARS-CoV-2 Antigen Detection Kit (Colloidal Gold Immunochromatographic Assay) 100.0% 17.4% 0.0% 42.0%
Subgroup of RDT with detection rates of <100% for Cq ≤ 25
66 ProGnosis Biotech Rapid Test Ag 2019-nCoV 94.1% 65.2% 10.0% 64.0%
31 Genrui Biotech Inc. Genrui SARS-CoV-2 Antigen Test Kit (Colloidal Gold) 94.1% 56.5% 0.0% 58.0%
38 Hangzhou Clongene Biotech Co., Ltd. Clungene COVID-19 Antigen Rapid Test 94.4% 34.8% 0.0% 50.0%
29 Eurobio Scientific EBS SARS-CoV-2 Ag Rapid Test 94.1% 34.8% 0.0% 48.0%
62 Oncosem Onkolojik Sistemler San. Ve Tic. A.S. CAT Antigen Covid Rapid Test 94.1% 30.4% 0.0% 46.0%
95 Zhejiang Anji Saianfu Biotech Co., Ltd. reOpenTest COVID-19 Antigen Rapid Test (Colloidal Gold) 94.1% 30.4% 0.0% 46.0%
44 IVC Pragen Healthcare GenBody COVID-19 Ag 94.4% 26.1% 0.0% 46.0%
57 Nanjing Norman Biological Technology Co.,Ltd Novel Coronavirus (2019-nCOV) Antigen Testing Kit (Colloidal Gold) 94.1% 26.1% 0.0% 44.0%
76 SGA Mühendislik DAN. EG. Icve DIS.Ltd.STI V-Chek SARS-CoV-2 Rapid Ag Test Kit (Colloidal Gold) 94.1% 26.1% 0.0% 44.0%
46 Jiangsu Medomics Medical Technology Co., Ltd SARS-CoV-2-Antigen-Testkit (LFIA) 94.1% 21.7% 0.0% 42.0%
61 Novatech Tibbi Cihaz Ürünleri San. Ve Tic.A.S. novacheck-Ag SARS-CoV-2 Covid-19 Antigen Rapid Test 94.1% 21.7% 0.0% 42.0%
40 Hangzhou Laihe Biotech Co., Ltd. (Lissner Qi GmbH) Lyher Novel Coronavirus (COVID-19) Antigen Test Kit (Colloidal Gold) 94.4% 17.4% 0.0% 42.0%
48 Labnovation Technologies, Inc. Labnovation SARS-CoV-2 Antigen Rapid Test Kit (Immunochromatography) 94.1% 17.4% 0.0% 40.0%
24 BTNX, Inc. (Biotrend Chemikalien Gmbh) Rapid Response COVID-19 Rapid Test Device 94.1% 13.0% 10.0% 40.0%
12 Avalun Ksmart SARS-COV2 Antigen Rapid Test 94.1% 13.0% 0.0% 38.0%
32 GenSure Biotech Inc. DIA-COVID COVID-19 Ag Rapid Test Kit 94.1% 13.0% 0.0% 38.0%
2 ACON Biotech (Hangzhou) Co., Ltd Flowflex SARS-CoV-2-Antigenschnelltest (Nasopharynxtupfer) 94.1% 4.3% 0.0% 34.0%
Subgroup of RDT with detection rates of <90% for Cq ≤ 25
73 SD BIOSENSOR (Roche Diagnostics GmbH) SARS-CoV-2 Rapid Antigen Test 88.9% 30.4% 0.0% 46.0%
74 SD BIOSENSOR STANDARD Q COVID-19 Ag Test 88.9% 30.4% 0.0% 46.0%
67 Quidel Corporation Sofia SARS Antigen FIA 88.9% 8.7% 0.0% 36.0%
26 Core Technology Co., Ltd. Canea COVID-19 Antigen Schnelltest 88.2% 26.1% 0.0% 42.0%
43 Humasis Co., Ltd. Humasis COVID-19 Ag Test 88.2% 21.7% 0.0% 40.0%
91 Wuhan UNscience Biotechnology Co., Ltd. SARS-CoV-2 Antigen Rapid Test Kit 88.2% 17.4% 0.0% 38.0%
39 Hangzhou Immuno Biotech Co., Ltd. IMMUNOBIO SARS-CoV-2 Antigen-Schnelltest (COVID-19 Ag) 88.2% 13.0% 0.0% 36.0%
93 Xiamen WIZ Biotech Co., Ltd. Wizbiotech SARS-CoV-2 Antigen Rapid Test 88.2% 13.0% 0.0% 36.0%
58 NanoEntek Inc FRENDTM COVID-19 Ag 88.2% 8.7% 0.0% 34.0%
37 Guangzhou Wondfo Biotech Co. Ltd Wondfo SARS-CoV-2 Antigen Test (Lateral Flow Method) 88.2% 0.0% 0.0% 30.0%
56 nal von minden gmbh NADAL COVID-19 Ag Schnelltest 83.3% 13.0% 0.0% 36.0%
15 Becton Dickinson BD Veritor System for Rapid Detection of SARS-CoV-2 83.3% 8.7% 0.0% 34.0%
34 Green Cross Medical Science Corp. (Weko Pharma GmbH) Genedia W Covid-19 Ag 83.3% 8.7% 0.0% 34.0%
94 Zet Medikal Tekstil Dis Ticaret Ltd. STI. softec SARS COV-2 (Covid-19) Antigen Test Kit 82.4% 21.7% 10.0% 40.0%
3 Aesku Diagnostics GmbH Aesku Rapid SARS-CoV-2 Rapid Test 82.4% 17.4% 0.0% 36.0%
35 Guangdong Hecin Scientific, Inc. 2019-nCoV Antigen Test Kit(colloidal gold method) 82.4% 13.0% 0.0% 34.0%
71 Salofa OY salocor SARS-CoV-2 Antigen Rapid Test Cassette (Nasopharyngeal swab) 82.4% 13.0% 0.0% 34.0%
81 Shenzhen Zhenrui Biotech co. Ltd. Zhenrui COVID-19 (SARS-COV-2) Antigen Test Kits 82.4% 13.0% 0.0% 34.0%
16 Beijing Beier Bioengineering Co., Ltd. Covid-19 Antigen Schnelltest 77.8% 0.0% 0.0% 28.0%
14 Azure Biotech Inc. Dia Sure Covid-19 Antigen Rapid Test Device (Nasopharyngeal/Oropharyngeal Swab) 76.5% 13.0% 20.0% 36.0%
5 Amazing Biotech (Shanghai) Co., Ltd CoroVisio Covid-19 Ag Versieglungsröhrchen Teststreifen (Kolloidales Gold) 76.5% 8.7% 0.0% 30.0%

Cq: quantitative cycle; SARS-CoV-2: severe acute respiratory syndrome coronavirus 2.

Criteria as defined by detection rate of >75% in panel subgroup with Cq ≤ 25.