Table 1.
Limit of detection and manufacturer’s characteristics of RATs. Intensity: LOD determined by digital scanning. Visual: LOD determined by visual inspection. LFIA lateral flow immunoassay, VFIA vertical flow immunoassay, LFFIA lateral flow fluorescence immunoassay.
| Limit of Detection (PCR cT) | Method | Antigen | Manufaturer’s | Manufaturer | ||||
|---|---|---|---|---|---|---|---|---|
| Intensity | Visual | Average | Sensitivity% | Specificity% | ||||
| Wantai LFFIA | 35.3 | 34.1 | 34.7 | Fluorescence LFFIA | Nucleocapsid protein | 95.71 | 100 | Wantai SARS-CoV-2, LFFIA (Wantai Biological Pharmacy Enterprise Co., Ltd., Beijing, China) |
| Healgen | 33.6 | 33.5 | 33.6 | Colloidal Gold LFIA | Nucleocapsid protein | 96.72 | 99.22 | Healgen Coronavirus Ag Rapid Test Cassette (Healgen Scientific, Houston, Texas, USA) |
| Biosynex | 32.4 | 32.5 | 32.5 | Colloidal Gold LFIA | Nucleocapsid protein | 96 | 100 | Biosynex COVID-19 Ag BSS (BIOSYNEX SWISS SA, Suisse) |
| Wantai LFIA | 32.5 | 32.1 | 32.3 | Colloidal Gold LFIA | Nucleocapsid antigen | 93.44 | 100 | Wantai SARS-CoV-2 Antigen Rapid Test (Colloidal Gold) (WANTAI Biological Pharmacy Enterprise Co., Ltd., Beijing, China) |
| AMP | 31.3 | 30.7 | 31 | Colloidal Gold LFIA | Nucleocapsid antigen | 97.3 | 100 | AMP Rapid Test SARS-CoV-2 Ag (AMEDA Labordiagnostik GmbH, Graz, Austria) |
| LEPU | 29.7 | 31 | 30.4 | Colloidal Gold LFIA | Nucleocapsid antigen | 92 | 99.26 | LEPU SARS-CoV-2 Antigen Rapid Test Kit (Lepu Medical Technology Co., Ltd., Beijing,P.R. China) |
| Viva | 30.2 | 29.5 | 29.9 | Colloidal Gold LFIA | Nucleocapsid antigen | 82.86 | 100 | VivaDiag™ SARS-CoV-2 Ag Rapid Test (VivaChek Biotech Co., Ltd., Hangzhou, China) |
| Roche/SD-biosensor | 30.1 | 29.3 | 29.7 | Colloidal Gold LFIA | Nucleocapsid antigen | 96.52 | 99.68 | Roche/SD-biosensor Standard™ COVID-19 Ag (SD Biosensor Inc., Republic of Korea, distributed by Roche Diagnostics) |
| Hotgen | 28.8 | 28.8 | 28.8 | Colloidal Gold LFIA | N/A | 96.62 | 99.76 | Hotgen Novel Coronavirus 2019-nCoV Antigen Test (Hotgen Biotech Co., Ltd., Beijing P.R. China) |
| Salocor | 28.6 | 28.2 | 28.4 | Colloidal Gold LFIA | Nucleocapsid antigen | 95 | 99.2 | Salocor COVID-19 Antigen Rapid Test Cassette (Salofa Oy, Salo, Finland) |
| Dynamiker | 27.6 | 27.7 | 27.7 | Colloidal Gold LFIA | N/A | 95 | 97.8 | Dynamicer SARS-CoV-2 Ag COVID Rapid Test (Launch Diagnostics Ltd., Kent, England) |
| TestNow | 27.5 | 27.2 | 27.4 | Colloidal Gold LFIA | Nucleocapsid antigen | 93.7 | 98.8 | TestNOW®—COVID-19 Antigen (Affimedix Diagnostics, San Francisco CA, US) |
| CiTest | 27.3 | 26.9 | 27.1 | Colloidal Gold LFIA | Nucleocapsid & spike antigen | 85 | 98.3 | CITEST COVID-19 Antigen Rapid Test (Citest Diagnostics INC., Canada) |
| Coris | 27.2 | 26.3 | 26.8 | Colloidal Gold VFIA | Nucleocapsid antigen | 60.1 | 99.2 | Coris COVID-19 Ag Respi-Strip (Coris BioConcept, Belgium) |