Manufacturer for Flu Test Nose Swab - Rapid 2019-ncov coronavirus Antigen test – Immuno
Manufacturer for Flu Test Nose Swab - Rapid 2019-ncov coronavirus Antigen test – ImmunoDetail:
The IMMUNOBIO Rapid coronavirus Antigen test kit is a Rapid detection method of COVID-19 antigen. Anti-2019-ncov monoclonal antibody was coated on a test line and conjugated with colloidal gold.During the test, the sample reacted with the anti-2019-ncov antibody conjugate in the test strip. The mixture then migrated up the membrane by capillary action and reacted with another anti-2019-ncov monoclonal antibody from the test area.
The IMMUNOBIO Antigen test kit is a rapid test for the qualitative detection of antigens to the novel coronavirus SARS-CoV-2 in human throat and nasal secretions. For professional in vitro diagnostic use only
PERFORMANCE CHARACTERISTICS
1. Sensitivity, Specificity and Accuracy The SARS-CoV-2 Antigen Rapid Test (COVID-19 Ag) has been compared with a commercial gold standard reagent (PCR). The result showed the relative sensitivity and specificity
| Method | Gold standard reagent(PCR) | Total Results | ||
| SARS-CoV-2 Antigen Rapid Test (COVID-19 Ag) | Results | Positive | Negative | |
| Positive | 87 | 0 | 87 | |
| Negative | 4 | 300 | 304 | |
| Total Result | 60 | 300 | 391 | |
Relative Sensitivity: 95.60% （95%CI: 88.89%～98.63%）
Relative Specificity: 100% （95%CI：98.78%～100.00%）
Accuracy: 98.98% （95%CI：97.30%～99.70%）
2. Limit of Detection (LOD)
The limit of detection of the SARS-CoV-2 Antigen Rapid Test (COVID-19 Ag) has been studied. The LOD of the test to the SARS-CoV-2 N protein is around 0.2-0.5ng/mL.The LOD of the test to the SARS-CoV-2 virus (inactivated) is about 2-5X102 TCID50/mL
| Concentration | Positive/Result | Agreement Rate |
| 0.5ng/mL N protein | 100/100 | 100% |
| 5X102 TCID50/mL | 100/100 | 100% |
3. Cross-reactivity:
The SARS-CoV-2 Antigen Rapid Test (COVID-19 Ag) is associated with a panel of proteins of other human coronavirus recombinant antigens and other respiratory symptoms relative virus. The results showed in below sheet:
| Substance | Concentration | Result |
| SARS-CoV-2 N protein | 0.001μg/mL | positive |
| SARS-CoV N protein | 1μg/mL | negative |
| MERS-CoV N protein | 1μg/mL | negative |
| HCoV-NL63 N protein | 1μg/mL | negative |
| HCoV-229E N protein | 1μg/mL | negative |
| HCoV-HKU1 N protein | 1μg/mL | negative |
| Parainfluenza virus | 1X105TCID50/mL | negative |
| Influenza A virus | 1X105TCID50/mL | negative |
| Influenza B virus | 1X105TCID50/mL | negative |
| Chlamydia pneumoniae | 1X105TCID50/mL | negative |
| Adenovirus | 1X105TCID50/mL | negative |
| Mycoplasma pneumoniae | 1X105TCID50/mL | negative |
| Respiratory syncytial virus | 1X105TCID50/mL | negative |
4.Interfering Substances:
The following compounds have been tested using the SARS-CoV-2 Antigen Rapid Test (COVID-19 Ag) and no interference was observed.
Substance | Concentration | Result |
Alpha-interferon | 3millionIU | No interference |
Purified Mucin | 1000ng/Ml | No interference |
Authorized certifications
1. CE/ISO13485/White List
2. Registered in Germany Ministry of Health
TEST PROCEDURE
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