Table 1. Comparative evaluation results of SARS-CoV-2 antigen rapid diagnostic tests passing the sensitivity criteria (in alphabetical order of manufacturers), Germany, 2020–2021 (n = 96).
| RDT | Manufacturer | Test name | Sensitivity | |||
|---|---|---|---|---|---|---|
| Cq ≤ 25 | Cq >25– <30 | Cq ≥ 30 | Cq 17–36 | |||
| 1 | Abbott Rapid Diagnostics Jena GmbH | PanbioCOVID-19 Ag Rapid Test Device (NASOPHARYNGEAL) | 100.0% | 60.9% | 0.0% | 64.0% |
| 2 | ACON Biotech (Hangzhou) Co., Ltd | Flowflex SARS-CoV-2-Antigenschnelltest (Nasopharynxtupfer) | 94.1% | 4.3% | 0.0% | 34.0% |
| 3 | Aesku Diagnostics GmbH | Aesku Rapid SARS-CoV-2 Rapid Test | 82.4% | 17.4% | 0.0% | 36.0% |
| 4 | Affimedix | TestNOW - COVID-19 Antigen | 100.0% | 47.8% | 0.0% | 58.0% |
| 5 | Amazing Biotech (Shanghai) Co., Ltd | CoroVisio Covid-19 Ag Versieglungsröhrchen Teststreifen (Kolloidales Gold) | 76.5% | 8.7% | 0.0% | 30.0% |
| 6 | Ameda Labordiagnostik GmbH | AMP Rapid Test SARS-CoV-2 Ag | 100.0% | 78.3% | 0.0% | 70.0% |
| 7 | AmonMed (Xiamen) Biotechnology Co., Ltd. | COVID-19 Antigen Rapid Test Kit (Colloidal Gold) | 100.0% | 87.0% | 30.0% | 80.0% |
| 8 | Anbio (Xiamen) Biotechnology Co., Ltd | Rapid Covid-19 Antigen Test (Colloidal Gold) | 100.0% | 52.2% | 0.0% | 58.0% |
| 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% |
| 10 | ASAN PHARM.CO., LTD. | Asan Easy Test COVID-19 Ag | 100.0% | 69.6% | 0.0% | 66.0% |
| 11 | Atlas Link Technology Co., Ltd. | Nova Test SARS-CoV-2 Antigen Rapid Test Kit | 100.0% | 60.9% | 0.0% | 62.0% |
| 12 | Avalun | Ksmart SARS-COV2 Antigen Rapid Test | 94.1% | 13.0% | 0.0% | 38.0% |
| 13 | AXIOM Gesellschaft für Diagnostica und Biochemica mbH | Axiom Diagnostics COVID-19 Ag Schnelltest | 100.0% | 52.2% | 0.0% | 58.0% |
| 14 | Azure Biotech Inc. | Dia Sure Covid-19 Antigen Rapid Test Device (Nasopharyngeal/oropharyngeal swab) | 76.5% | 13.0% | 20.0% | 36.0% |
| 15 | Becton Dickinson | BD Veritor System for Rapid Detection of SARS-CoV-2 | 83.3% | 8.7% | 0.0% | 34.0% |
| 16 | Beijing Beier Bioengineering Co., Ltd. | Covid-19 Antigen Schnelltest | 77.8% | 0.0% | 0.0% | 28.0% |
| 17 | Beijing Hotgen Biotech Co., Ltd. | Novel Coronavirus 2019-nCoV Antigen Test (Colloidal gold) | 100.0% | 47.8% | 0.0% | 56.0% |
| 18 | Beijing Lepu Medical Technology Co., Ltd | SARS-CoV-2 Antigen Rapid Test Kit | 100.0% | 26.1% | 0.0% | 46.0% |
| 19 | Beijing Tigsun Diagnostics Co.;Ltd. | Tigsun COVID-19 Saliva Antigen Rapid Test | 100.0% | 87.0% | 30.0% | 80.0% |
| 20 | BIOMERICA Inc. | COVID-19-Antigen-Schnelltest (Nasopharyngeal-Abstrich) | 100.0% | 30.4% | 0.0% | 48.0% |
| 21 | BIONOTE | NowCheck COVID-19 Ag Test | 100.0% | 65.2% | 0.0% | 66.0% |
| 22 | BioRepair GmbH | Covid 19 Antigen Schnelltest | 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% |
| 24 | BTNX, Inc. (Biotrend Chemikalien GmbH) | Rapid Response COVID-19 Rapid Test Device | 94.1% | 13.0% | 10.0% | 40.0% |
| 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% |
| 26 | Core Technology Co., Ltd. | Canea COVID-19 Antigen Schnelltest | 88.2% | 26.1% | 0.0% | 42.0% |
| 27 | DNA Diagnostic A/S. | Covid-19 Antigen Detection Kit | 100.0% | 39.1% | 10.0% | 54.0% |
| 28 | Edinburgh Genetics Limited | Edinburgh Genetics ActivXpress + COVID-19 Antigen Complete Testing Kit | 100.0% | 34.8% | 0.0% | 50.0% |
| 29 | Eurobio Scientific | EBS SARS-CoV-2 Ag Rapid Test | 94.1% | 34.8% | 0.0% | 48.0% |
| 30 | Fujirebio Inc. (Mast Diagnostica GmbH) | ESPLINE SARS-CoV-2 | 100.0% | 21.7% | 0.0% | 46.0% |
| 31 | Genrui Biotech Inc. | Genrui SARS-CoV-2 Antigen Test Kit (Colloidal Gold) | 94.1% | 56.5% | 0.0% | 58.0% |
| 32 | GenSure Biotech Inc. | DIA-COVID COVID-19 Ag Rapid Test Kit | 94.1% | 13.0% | 0.0% | 38.0% |
| 33 | Getein Biotech, Inc. | One Step Test for SARS-CoV-2 Antigen (Colloidal Gold) | 100.0% | 82.6% | 0.0% | 72.0% |
| 34 | Green Cross Medical Science Corp. (Weko Pharma GmbH) | Genedia W Covid-19 Ag | 83.3% | 8.7% | 0.0% | 34.0% |
| 35 | Guangdong Hecin Scientific,Inc. | 2019-nCoV Antigen Test Kit(colloidal gold method) | 82.4% | 13.0% | 0.0% | 34.0% |
| 36 | Guangdong Wesail Biotech Co., Ltd. | COVID-19 Ag Test Kit | 100.0% | 52.2% | 11.1% | 62.0% |
| 37 | Guangzhou Wondfo Biotech Co. Ltd | Wondfo SARS-CoV-2 Antigen Test (Lateral Flow Method) | 88.2% | 0.0% | 0.0% | 30.0% |
| 38 | Hangzhou Clongene Biotech Co., Ltd. | Clungene COVID-19 Antigen Rapid Test | 94.4% | 34.8% | 0.0% | 50.0% |
| 39 | Hangzhou Immuno Biotech Co.,Ltd. | IMMUNOBIO SARS-CoV-2 Antigen-Schnelltest (COVID-19 Ag) | 88.2% | 13.0% | 0.0% | 36.0% |
| 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% |
| 41 | Hangzhou Lysun Biotechnology Co., Ltd. | Lysun COVID-19 Antigen Rapid Test Device (Colloidal Gold) | 100.0% | 78.3% | 0.0% | 70.0% |
| 42 | Hangzhou Testsea Biotechnology Co., Ltd | Testsealabs Rapid Test Kit COVID-19 Antigen Test Cassette | 100.0% | 47.8% | 0.0% | 56.0% |
| 43 | Humasis Co., Ltd. | Humasis COVID-19 Ag Test | 88.2% | 21.7% | 0.0% | 40.0% |
| 44 | IVC Pragen Healthcare | GenBody COVID-19 Ag | 94.4% | 26.1% | 0.0% | 46.0% |
| 45 | Jiangsu Diagnostics Biotechnology Co., Ltd | COVID-19 Antigen Rapid Test Cassette (Colloidal Gold) | 100.0% | 78.3% | 0.0% | 68.0% |
| 46 | Jiangsu Medomics Medical Technology Co., Ltd | SARS-CoV-2-Antigen-Testkit (LFIA) | 94.1% | 21.7% | 0.0% | 42.0% |
| 47 | Joinstar Biomedical Technology Co., Ltd (CIV care impuls Vertrieb) | COVID-19 Antigen Schnelltest (Colloidal Gold) | 100.0% | 60.9% | 0.0% | 64.0% |
| 48 | Labnovation Technologies, Inc. | Labnovation SARS-CoV-2 Antigen Rapid Test Kit (Immunochromatography) | 94.1% | 17.4% | 0.0% | 40.0% |
| 49 | Lumigenex (Suzhou) Co., Ltd. | PocRoc SARS-CoV-2, Antigen Schnelltest Set (Kolloidales Gold) | 100.0% | 65.2% | 0.0% | 64.0% |
| 50 | LumiQuick Diagnostics, Inc. | QuickProfile Covid-19 Antigen Test Card | 100.0% | 91.3% | 20.0% | 80.0% |
| 51 | LumiraDX | LumiraDx SARS-CoV-2 Ag Test | 100.0% | 52.2% | 0.0% | 60.0% |
| 52 | MEDsan GmbH | MEDsan SARS-CoV-2 Antigen Rapid Test | 100.0% | 47.8% | 0.0% | 58.0% |
| 53 | Merlin Biomedical (Xiamen) Co., Ltd. | SARS-CoV-2 Antigen Rapid Test Cassette | 100.0% | 82.6% | 0.0% | 72.0% |
| 54 | Mölaboratory GmbH | mö-screen Corona Antigen Test | 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% |
| 56 | nal von minden gmbh | NADAL COVID-19 Ag Schnelltest | 83.3% | 13.0% | 0.0% | 36.0% |
| 57 | Nanjing Norman Biological Technology Co.,Ltd | Novel Coronavirus (2019-nCOV) Antigen Testing Kit (Colloidal Gold) | 94.1% | 26.1% | 0.0% | 44.0% |
| 58 | NanoEntek Inc | FRENDTM COVID-19 Ag | 88.2% | 8.7% | 0.0% | 34.0% |
| 59 | Nantong Diagnos Biotechnology Co., Ltd. | COVID-19 Antigen Saliva Test Kit (Colloidal Gold) | 100.0% | 56.5% | 0.0% | 60.0% |
| 60 | New Gene (Hangzhou) Bioengineering Co., Ltd. | Covid-19-Antigen-Testkit | 100.0% | 87.0% | 20.0% | 78.0% |
| 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% |
| 62 | Oncosem Onkolojik Sistemler San. Ve Tic. A.S. | CAT Antigen Covid Rapid Test | 94.1% | 30.4% | 0.0% | 46.0% |
| 63 | PCL, Inc. | PCL COVID19 Ag Gold Saliva | 100.0% | 52.2% | 0.0% | 58.0% |
| 64 | PerGrande BioTech Development Co., Ltd. | SARS-CoV-2 Antigen Detection Kit (Colloidal Gold Immunochromatographic Assay) | 100.0% | 17.4% | 0.0% | 42.0% |
| 65 | Precision Biosensor Inc. (Axon Laboratory AG) | Exdia COVID-19-Ag-Test | 100.0% | 60.9% | 0.0% | 64.0% |
| 66 | ProGnosis Biotech | Rapid Test Ag 2019-nCoV | 94.1% | 65.2% | 10.0% | 64.0% |
| 67 | Quidel Corporation | Sofia SARS Antigen FIA | 88.9% | 8.7% | 0.0% | 36.0% |
| 68 | Qingdao Hightop Biotech Co., Ltd. | Hightop SARS-CoV-2 (Covid-19) Antigen Rapid Test | 100.0% | 43.5% | 0.0% | 54.0% |
| 69 | R-Biopharm AG | RIDAQUICK SARS-CoV-2 Antigen | 100.0% | 17.4% | 0.0% | 44.0% |
| 70 | Safecare Biotech Hangzhou Co., Ltd. | Safecare COVID-19 Ag Rapid Test Kit (Swab) | 100.0% | 60.9% | 0.0% | 62.0% |
| 71 | Salofa OY | salocor SARS-CoV-2 Antigen Rapid Test Cassette (Nasopharyngeal swab) | 82.4% | 13.0% | 0.0% | 34.0% |
| 72 | ScheBo Biotech AG | ScheBo SARS-CoV-2 Quick Antigen | 100.0% | 91.3% | 10.0% | 78.0% |
| 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% |
| 75 | SD BIOSENSOR | STANDARD F COVID-19 Ag FIA | 100.0% | 65.2% | 0.0% | 66.0% |
| 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% |
| 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% |
| 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% |
| 79 | Shenzhen Watmind Medical Co.,Ltd. | SARS-CoV-2 Ag Diagnostic Test Kit (Colloidal Gold) | 100.0% | 95.7% | 20.0% | 82.0% |
| 80 | Shenzhen Watmind Medical Co.,Ltd. | SARS-CoV-2 Ag Diagnostic Test Kit (Immuno-fluorescence) | 100,0% | 60.9% | 0.0% | 62.0% |
| 81 | Shenzhen Zhenrui Biotech co. Ltd. | Zhenrui COVID-19 (SARS-COV-2) Antigen Test Kits | 82.4% | 13.0% | 0.0% | 34.0% |
| 82 | Siemens Healthineers | CLINITEST Rapid COVID-19 Antigen Test | 100.0% | 87.0% | 0.0% | 76.0% |
| 83 | Sugentech, Inc. | SGTi-flex COVID-19 Ag | 100.0% | 73.9% | 0.0% | 68.0% |
| 84 | Toda Pharma | Toda Coronadiag Ag | 100.0% | 95.7% | 40.0% | 86.0% |
| 85 | Triplex International Biosciences (China) Co., Ltd. | SARS-CoV-2 Antigen Rapid Test Kit | 100.0% | 87.0% | 20.0% | 78.0% |
| 86 | ulti med Products (Deutschland) GmbH | COVID-19 Antigen Speicheltest (Immunochromatographie) | 100.0% | 95.7% | 20.0% | 82.0% |
| 87 | Vitrosens Biyoteknoloji Ltd. Sti | RapidFor SARS-CoV-2 Rapid Antigen Test Colloidal Gold | 100.0% | 30.4% | 0.0% | 48.0% |
| 88 | Wantai (Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.) | SARS-CoV-2 Ag Rapid Test (FIA) | 100.0% | 78.3% | 0.0% | 72.0% |
| 89 | Wuhan EasyDiagnosis Biomedicine Co., Ltd | COVID-19 (SARS-CoV-2) Antigen Test Kit | 100.0% | 73.9% | 0.0% | 68.0% |
| 90 | Wuhan Life Origin Biotech Joint Stock Co., Ltd. | SARS-CoV-2 Antigen Assay Kit (Immunochromatography) | 100.0% | 56.5% | 0.0% | 60.0% |
| 91 | Wuhan UNscience Biotechnology Co., Ltd. | SARS-CoV-2 Antigen Rapid Test Kit | 88.2% | 17.4% | 0.0% | 38.0% |
| 92 | Xiamen Boson Biotech Co., Ltd | SARS-CoV-2 Antigen Schnelltest | 100.0% | 43.5% | 0.0% | 54.0% |
| 93 | Xiamen WIZ Biotech Co., Ltd. | Wizbiotech SARS-CoV-2 Antigen Rapid Test | 88.2% | 13.0% | 0.0% | 36.0% |
| 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% |
| 95 | Zhejiang Anji Saianfu Biotech Co., Ltd. | reOpenTest COVID-19 Antigen Rapid Test (Colloidal Gold) | 94.1% | 30.4% | 0.0% | 46.0% |
| 96 | Zhejiang Orient Gene Biotech Co., Ltd | Coronavirus Ag Rapid Test Cassette (Swab) | 100.0% | 87.0% | 0.0% | 76.0% |
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.