OEM/ODM China Rapid Test Human Coronavirus - Rapid 2019-ncov coronavirus Antigen test – Immuno
OEM/ODM China Rapid Test Human Coronavirus - 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 insists all along the quality policy of "product good quality is base of enterprise survival; buyer fulfillment will be the staring point and ending of an company; persistent improvement is eternal pursuit of staff" and also the consistent purpose of "reputation very first, shopper first" forOEM/ODM China Rapid Test Human Coronavirus - Rapid 2019-ncov coronavirus Antigen test – Immuno, The product will supply to all over the world, such as: Bolivia, Iran, Kyrgyzstan, In order to make more people know our products and to enlarge our market, we have devoted a lot of attention to technical innovations and improvement, as well as replacement of equipment. Last but not the least, we also pay more attention to training our managerial personnel, technicians and workers in planned way.