Semi-quantitative Covid 19 neutrolizing antibody test
Semi-quantitative Covid 19 neutrolizing antibody test
1.Features for COVID Antibody Test kits Neutraliazing AB Rapid Test
A. Blood test, finger whole blood is feasible.
B. Detection of Limit: Cutoff：100ng/ml, Detection range：50~5000ng/ml
C. Small specimens are required. Serum, plasma 10ul or whole blood 20ul is enough.
2.Characteristics of rapid detection technology for colloidal gold
1. Convenient operation: the operation steps are sample, no special equipment is required, the sample does not need special processing, the test results can be directly interpreted with the naked eye, and there is no special skill requirement for the operator
2. Fast and quick: only 10-15 mins will produce results. While other methods such as ELISA require 1-2 hours， PCR takes longer.
3. Strong specificity: because the technology is mostly labeled with monoclonal anyibodies, it determined that it only detects a certain antigenic determinant, so it has very good specificity.
4. High sensitivity
5. Convenient to carry: since the colloidal gold labeling protein is a physical binding process, the binding is firm and rarely causes changes in protein activity. Therefore, the reagent is very stable and not affected by externnal factors such as temperature. It can be carried with you for monitoring at any time.
6. Safety and eco-friendly: Compared with other detection methods, immune colloidal gold technology greatly simplifies the operation. No harmful substances such as radioisotopes and o-phenylenediamine are involved in the test, so it will neither harm the health of the operator nor pollute the environment. , Has the safety that can’t be compared with the detection methods such as radioisotope or enzyme label.
3.Test Procedure
4.Reader of Result
5. Quality control
Internal program control is included in the test. The colored lines appearing in the control area (C) are internal program control. It confirms sufficient specimen volume and correct procedure technique.
This kit does not provide control standards; however, it is recommended that positive and negative controls be tested as a good laboratory procedure to confirm the test procedure and verify proper test performance.
6. Performance characteristics
Relative Sensitivity, Specificity and Accuracy
The SARS-CoV-2 Neutralizing Antibody Rapid Test (COVID-19 Ab) has been evaluated with specimens obtained from a population of positive and negative specimen. Results were confirmed by a commercial SARS-CoV-2 Neutralization Antibody Detection Kit (ELISA kit, cutoff 30% signal inhibition).
| Method | A commercial SARS-CoV-2 Neutralization Antibody Detection Kit (ELISA kit) | Total Results | ||
| SARS-CoV-2 Neutralizing Antibody Rapid Test (COVID-19 Ab) | Results | Positive | Negative | |
| Positive | 32 | 0 | 32 | |
| Negative | 1 | 167 | 168 | |
| Total Result | 33 | 167 | 200 | |
Relative Sensitivity: 96.97%（95%CI：83.35%～99.99%）
Relative Specificity: 100.00%（95%CI：97.29%～100.00%）
Accuracy: 99.50%（95%CI：96.94%～99.99%）
7. Tip：The results if carrying COVID-19 vaccination are expected to be like below.
- Before first dose: Negative by rapid test
- 3 weeks after first dose: weak or middle positive
- 1 week after second dose: middle or high positive
- 2 weeks after second dose: middle or high positive
About IMMUNOBIO and Covid-19 test
1.R&d story
we are a national high-tech enterprise with own production, R&D, and export teams.
Since the outbreak of the new COVID at the end of 2019, we have begun to develop COVID-19 testing products.
In February 2020, in just 2 months, we successfully developed the IGG/IGM antibody test and provied strong support to Argentina.
In August 2020, we successfully developed COVID-19 Antigen test and provide high-quality products to Germany.
Realizing that the COVID-19 may become a routine desease that can only be prevanted by vaccine immunization, and that the previous vaccines have not been fully verified by the populaion, we began to introduce Neutralizing antibody tests. Ensuring the effectiveness of vaccines at the individual level adds a layer of protection to epidemic prevention.
2. Authorized certifications for Neutralizing AB Antibodies rapid test
CE Approved
China’s white list approved Neutralizing Antibody Rapid Test
