Table 2. Comparative evaluation results of SARS-CoV-2 antigen rapid diagnostic tests missing the sensitivity criteria (in alphabetical order of manufacturers), Germany, 2020–2021 (n = 26).
| RDT | Manufacturer | Test name | Sensitivity | |||
|---|---|---|---|---|---|---|
| Cq ≤ 25 | Cq >25– <30 | Cq ≥ 30 | Cq 17–36 | |||
| 97 | Acro Biotech Inc | Acro COVID-19 Antigen Rapid Test | 16.7% | 0.0% | 0.0% | 6.0% |
| 98 | Aikang Diagnostics Co., Ltd. | SARS-CoV-2 Antigen Test Kit (Immunochromatography) | 11.8% | 0.0% | 0.0% | 4.0% |
| 99 | Beijing Savant Biotechnology Co., Ltd | New Coronavirus (SARS-CoV-2) N Protein Detection Kit (Fluorescence Immunchromatography) | 0.0% | 0.0% | 0.0% | 0.0% |
| 100 | CertestT Biotec S. L. | CerTest Biotec SARS-CoV-2 Ag Test | 29.4% | 0.0% | 0.0% | 10.0% |
| 101 | Coris Bioconcept | COVID-19 Ag Respi-Strip | 33.3% | 0.0% | 0.0% | 12.0% |
| 102 | Hangzhou AllTest Biotech Co. Ltd. | COVID-19 AG AllTest | 16.7% | 0.0% | 0.0% | 6.0% |
| 103 | Hangzhou Biotest Biotech Co., Ltd. | Lumiratek SARS-CoV-2 Antigen Rapid Test Cassette | 29.4% | 0.0% | 0.0% | 10.0% |
| 104 | Hangzhou Genesis Biocontrol Co., Ltd | KaiBiLi COVID-19 Antigen Rapid Test Device | 52.9% | 0.0% | 0.0% | 18.0% |
| 105 | Hangzhou Realy Tech Co., Ltd. | Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Cassette (swab) | 58.8% | 0.0% | 0.0% | 20.0% |
| 106 | Inzek International Trading | Biozek medical COVID-19 Antigen Rapid Test Cassette | 52.9% | 0.0% | 0.0% | 18.0% |
| 107 | Joinstar Biomedical Technology Co., Ltd | COVID-19 Antigen Rapid Test (Latex) | 0.0% | 0.0% | 0.0% | 0.0% |
| 108 | Joysbio (Tianjin) Biotechnology Co., Ltd. | Joysbio SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) | 47.1% | 4.3% | 0.0% | 18.0% |
| 109 | Lionex GmbH | Lionex COVID-19 Ag Rapid Test | 0.0% | 0.0% | 0.0% | 0.0% |
| 110 | Medicon Co., Ltd. | Trueline COVID-19 Ag Rapid Test | 58.8% | 4.3% | 0.0% | 22.0% |
| 111 | Mexacare GmbH Heidelberg | QuickTestCorona COVID-19 Antigen Schnelltest | 52.9% | 4.3% | 0.0% | 20.0% |
| 112 | nal von minden GmbH | dedicio Medical Test COVID-19 Ag plus Test | 35.3% | 0.0% | 0.0% | 12.0% |
| 113 | Rapigen | Biocredit COVID-19 Ag | 16.7% | 0.0% | 0.0% | 6.0% |
| 114 | Servoprax | Cleartest Coronaantigen | 66.7% | 0.0% | 0.0% | 24.0% |
| 115 | Spring Healthcare Services SP zoo | SARS-Cov-2 Antigen Rapid Test Cassette (swab) | 29.4% | 0.0% | 0.0% | 10.0% |
| 116 | SureScreen Diagnostics Ltd | COVID-19 Antigen Rapid Test Cassette | 52.9% | 0.0% | 0.0% | 18.0% |
| 117 | TaiDoc Technology Corp. | FORA COVID-19 ANTIGEN RAPID TEST | 27.8% | 0.0% | 0.0% | 10.0% |
| 118 | Unioninvest | Unibioscience COVID-19 Rapid Antigen Test | 0.0% | 0.0% | 0.0% | 0.0% |
| 119 | VivaChek Biotech (Hangzhou) Co, Ltd. | VivaDiag SARS-CoV-2 Ag Rapid Test | 50.0% | 0.0% | 0.0% | 18.0% |
| 120 | VivaChek Biotech (Hangzhou) Co, Ltd. | VivaDiag Pro SARS-CoV-2 Ag Rapid Test | 64.7% | 0.0% | 0.0% | 22.0% |
| 121 | W.H.P.M, Inc | First SIGN SARS-CoV-2 Antigen Test | 47.1% | 0.0% | 0.0% | 16.0% |
| 122 | Xiamen Zhongsheng Langjie Biotechnology Co., Ltd | Covid-19 Antigen Test Cassette | 11.8% | 0.0% | 0.0% | 4.0% |
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.