China Gold Supplier for One Step Rapid Diagnostic Test - Rapid 2019-ncov coronavirus Antigen test – Immuno
China Gold Supplier for One Step Rapid Diagnostic Test - 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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Now we have highly developed devices. Our items are exported towards the USA, the UK and so on, enjoying a great popularity among the customers forChina Gold Supplier for One Step Rapid Diagnostic Test - Rapid 2019-ncov coronavirus Antigen test – Immuno, The product will supply to all over the world, such as: Rome, Salt Lake City, Poland, Our production have been exported to more than 30 countries and regions as first hand source with lowest price. We sincerely welcome customers from both at home and abroad to come to negotiate business with us.