Big discounting Coronavirus Neutralizing Antibodies - Rapid 2019-ncov coronavirus Antigen test – Immuno
Big discounting Coronavirus Neutralizing Antibodies - 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
Product detail pictures:
Related Product Guide:
Our company since its inception, always regards product quality as enterprise life, continuously improve production technology, improve product quality and continuously strengthen enterprise total quality management, in strict accordance with the national standard ISO 9001:2000 forBig discounting Coronavirus Neutralizing Antibodies - Rapid 2019-ncov coronavirus Antigen test – Immuno, The product will supply to all over the world, such as: Porto, Serbia, United Arab emirates, Our professional engineering group will always be ready to serve you for consultation and feedback. We're able to also offer you with absolutely free samples to meet your requirements. Finest efforts will likely be produced to offer you the ideal service and goods. For anyone who is thinking about our company and merchandise, be sure to contact us by sending us emails or contact us quickly. As a way to know our merchandise and firm. lot more, you can come to our factory to find out it. We'll always welcome guests from all over the world to our business to build company relations with us. Be sure to feel free to get in touch with us for business and we believe we've been intending to share the top trading practical experience with all our merchants.