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.