1. Limit of Detection (LoD)
Test Procedure
a. Trained professional personnel collected natural negative nasopharyngeal swab specimens per the Instruction for use.
b. Virus culture was assessed with UV radiation to inactive and dilute into series of concentration with ddH2O. For detail dilution method refer to table below:
Dilution Factor and Final Concentration of Series Dilutions | |||||
Dilution Factor | 1 | 10 | 100 | 250 | 500 |
Final Conc. | 250000 | 25000 | 2500 | 1000 | 500 |
Dilution Factor | 1250 | 1,667 | 2,500 | 5,000 | 10,000 |
Final Conc. | 200 | 150 | 100 | 50 | 25 |
c. Trained professional personnel tests specimens per the instruction for use, each concentration for 20 replicates.
d. Record and test results.
Test Result
Table 1-Results of TCID50 (Lot: 20200323)
Starting Material Concentration | Diluent Concentration | ||||
2.5×105 TCID50/mL | 200 | 150 | 100 | 50 | 25 |
Positive/Total | 20/20 | 20/20 | 20/20 | 20/20 | 14/20 |
Result prove that the LoD of NOVAtest ® SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold Immunochromatography) is 50 TCID50/ml.
Under this dilution 100% specimen are detected.
2. Cross-reactivity Analytical Specific Study
Pathogen materials
Type | Cross-reactivity specimens | Concentration |
Nasal Wash | Pooled human nasal wash | N/A |
Virus | Human metapneumovirus (hMPV) | 1.0 x 105 TCID50/ml |
Human coronavirus 229E | 1.0 x 105 TCID50/ml | |
Human coronavirus OC43 | 1.0 x 105 TCID50/ml | |
Human coronavirus NL63 | 1.0 x 105 TCID50/ml | |
Adenovirus | 1.0 x 105 TCID50/ml | |
Parainfluenza virus 1 | 1.0 x 105 TCID50/ml | |
Parainfluenza virus 2 | 1.0 x 105 TCID50/ml | |
Parainfluenza virus 3 | 1.0 x 105 TCID50/ml | |
Parainfluenza virus 4 | 1.0 x 105 TCID50/ml | |
Influenza A | 1.0 x 105 TCID50/ml | |
Influenza B | 1.0 x 105 TCID50/ml | |
Enterovirus | 1.0 x 105 TCID50/ml | |
Respiratory syncytial virus | 1.0 x 105 PFU/ml | |
Rhinovirus | 1.0 x 105 PFU/ml | |
Bacteria | Haemophilus influenzae | 1.0 x 106 CFU/ml |
Streptococcus pneumoniae | 1.0 x 106 CFU/ml | |
Streptococcus pyogenes | 1.0 x 106 CFU/ml | |
Candida albicans | 1.0 x 106 CFU/ml | |
Bordetella pertussis | 1.0 x 106 CFU/ml | |
Mycoplasma pneumoniae | 1.0 x 106 U/ml | |
Chlamydia pneumoniae | 1.0 x 106 CFU/ml | |
Legionella pneumophila | 1.0 x 106 CFU/ml |
Test Result
The results demonstrated that NOVAtest® SARS-CoV-2 Antigen Rapid Test kits have no significant cross-reactivity with these specimens (1 nasal wash, 14 viruses, 8 bacteria).
3. Endogenous Interference Substances Study
Endogenous interference substances
Interference substances | Concentration |
Acetaminophen | 20 mg/dL |
Acetylsalicylic acid | 20 mg/dL |
Ascorbic acid | 20 mg/dL |
Caffeine | 20 mg/dL |
Gentesic acid | 20 mg/dL |
Phenylpropanolamine | 20 mg/dL |
Salicylic acid | 20 mg/dL |
EDTA | 80 mg/dL |
Benzoylecgonine | 10 mg/dL |
Atropine | 20 mg/dL |
Cannabinol | 10 mg/dL |
Ethanol | 1% |
Methanol | 1% |
Albumin | 2,000mg/dL |
Glucose | 2,000mg/dL |
Bilirubin | 1,000mg/dL |
Hemoglobin | 1,000mg/dL |
Triglyceride | 50 mg/dL |
Total cholesterol | 6mmol/L |
Test Result
Table 1-Results of endogenous interference with different levels of virus
Interfering chemical analytes | SARS-CoV-2 Virus | ||||
Name | concentration | High | Moderate | Low | Assay diluent |
Blank control | NA | 3/3(+++) | 3/3(++) | 3/3(+) | 3/3(-) |
| 20 mg/dL | 3/3(+++) | 3/3(++) | 3/3(+) | 3/3(-) |
Acetylsalicylic acid | 20 mg/dL | 3/3(+++) | 3/3(++) | 3/3(+) | 3/3(-) |
Ascorbic acid | 20 mg/dL | 3/3(+++) | 3/3(++) | 3/3(+) | 3/3(-) |
Caffeine | 20 mg/dL | 3/3(+++) | 3/3(++) | 3/3(+) | 3/3(-) |
Gentesic acid | 20 mg/dL | 3/3(+++) | 3/3(++) | 3/3(+) | 3/3(-) |
Phenylpropanolamine | 20 mg/dL | 3/3(+++) | 3/3(++) | 3/3(+) | 3/3(-) |
Salicylic acid | 20 mg/dL | 3/3(+++) | 3/3(++) | 3/3(+) | 3/3(-) |
EDTA | 80 mg/dL | 3/3(+++) | 3/3(++) | 3/3(+) | 3/3(-) |
Benzoylecgonine | 10 mg/dL | 3/3(+++) | 3/3(++) | 3/3(+) | 3/3(-) |
Atropine | 20 mg/dL | 3/3(+++) | 3/3(++) | 3/3(+) | 3/3(-) |
Cannabinol | 10 mg/dL | 3/3(+++) | 3/3(++) | 3/3(+) | 3/3(-) |
Ethanol | 1% v/v | 3/3(+++) | 3/3(++) | 3/3(+) | 3/3(-) |
Methanol | 1% v/v | 3/3(+++) | 3/3(++) | 3/3(+) | 3/3(-) |
Albumin | 2,000mg/dL | 3/3(+++) | 3/3(++) | 3/3(+) | 3/3(-) |
Glucose | 2,000mg/dL | 3/3(+++) | 3/3(++) | 3/3(+) | 3/3(-) |
Bilirubin | 1,000mg/dL | 3/3(+++) | 3/3(++) | 3/3(+) | 3/3(-) |
Hemoglobin | 1,000mg/dL | 3/3(+++) | 3/3(++) | 3/3(+) | 3/3(-) |
Triglyceride | 50 mg/dL | 3/3(+++) | 3/3(++) | 3/3(+) | 3/3(-) |
Total cholesterol | 6mmol/L | 3/3(+++) | 3/3(++) | 3/3(+) | 3/3(-) |
The results are presented on the table demonstrate that the substances did not affect the performance of the NOVAtest® SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold Immunochromatography).
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