Antigen Rapid Diagnostic Test Nasal Swab Fast Test Throast SwabTest Kits Antigen Test
Cross Reactivity
Many types of pneumonia are companied by fever, cough and other respiratory symptoms. In order to eliminate similar clinical symptoms of other types of pneumonia effects, pneumonia mycoplasma, influenza A, pneumococcus etc. were detected for the specific assessment. Each of the organism and viruses were tested in the absence or presence of heat inactivated SARS-CoV-2 virus (308 TCID50/ml), No cross-reactivity or interference was seen.
Potential Cross-Reactant | Test Concentration | Result | ||
Absence of SARS-CoV-2 | presence of SARS-CoV-2 | |||
Staphylococcus aureus | 1.0×105 TCID50/ml | - | + | |
Streptococcus pneumoniae | 1.0×106 Cells/ml | - | + | |
Measles virus | 1.0×105 TCID50/ml | - | + | |
Mumps virus | 1.0×105 TCID50/ml | - | + | |
Adenovirus type 3 | 1.0×105 TCID50/ml | - | + | |
Mycoplasma pneumoniae MP | 1.0×106 Cells/ml | - | + | |
Parainfluenza type 2 | 1.0×105 TCID50/ml | - | + | |
Metapneumovirus | 1.0×105 TCID50/ml | - | + | |
Coronavirus OC43 | 1.0×105 TCID50/ml | - | + | |
Coronavirus 229E | 1.0×105 TCID50/ml | - | + | |
Bordetella parapertussis | 1.0×106 Cells/ml | - | + | |
Influenza B virus (Victoria series) | 1.0×105 TCID50/ml | - | + | |
Influenza B virus (Y series) | 1.0×105 TCID50/ml | - | + | |
Influenza A H1N1 (2009) virus | 1.0×105 TCID50/ml | - | + | |
Influenza A H3N2 virus | 1.0×105 TCID50/ml | - | + | |
Avian influenza virus H7N9 | 1.0×105 TCID50/ml | - | + | |
Avian influenza virus H5N1 | 1.0×105 TCID50/ml | - | + | |
EB virus | 1.0×105 TCID50/ml | - | + | |
Enterovirus CA16 | 1.0×105 TCID50/ml | - | + | |
Rhinovirus | 1.0×105 TCID50/ml | - | + | |
Interference
Potential Endogenous Interference of the COVID-19 Antigen Rapid Test was evaluated using natural clinical samples. No Antigen false negative or false positive results were observed with the following potential interference substances at the stated concentrations:
Human Blood | 1% V/V |
Mucosal protein | 1mg/ml |
Phenylephrine | 1% V/V |
Oxymetazoline | 1% V/V |
Triamcinolone | 50mg/L |
Ribavirin | 50mg/L |
Overall Clinical Performance of Antigen Test Kit
A total of above 157 positive samples and 260 negative samples were detected to evaluate the clinical performance of the COVID-19 Antigen Rapid Test Kit. The Result is below:
Sansure Covid-19 RT-PCR Assay | ||||
Positive | Negative | Total | ||
Kewei COVID-19 Antigen Rapid Assay | Positive | 143 | 0 | 143 |
Negative | 14 | 260 | 274 | |
Total | 157 | 260 | 417 |