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COVID-19 Neutralizing Antibody Test Solution

  • Time of issue:2021-06-29 09:44

(Summary description)At present, outbreaks of the India variant (B.1.617.2) have been confirmed in the United Kingdom, China, the United States, Africa and Pacific Rim countries. Studies have shown that it seems to spread more easily and lead to more serious diseases. Countries all over the world are actively carrying forward COVID-19 vaccination in order to achieve mass immunization as soon as possible. With the advent of the post-pandemic era, the vaccination rates in China and abroad are continuously increasing. As of May 2021, a number of COVID-19 vaccines have been approved for marketing in China, including inactivated virus vaccines, subunit vaccines and recombinant adenovirus expression vaccines. At present, the protective efficacy data results of all Chinese COVID-19 vaccines approved for conditional marketing met the relevant technical standards of the World Health Organization and relevant national technical standards. As of June 16, 2021, a total of 2.13 billion doses of COVID-19 vaccines have been injected, with 27.3 doses per 100 people; 900 million doses of COVID-19 vaccines have been injected in China, with 62.82 doses per 100 people. The effect of COVID-19 vaccination and evaluation of effects have become the focus of public attention. NextSARS-CoV-2, its vaccines and neutralizing antibodies are introduced:

COVID-19 Neutralizing Antibody Test Solution

(Summary description)At present, outbreaks of the India variant (B.1.617.2) have been confirmed in the United Kingdom, China, the United States, Africa and Pacific Rim countries. Studies have shown that it seems to spread more easily and lead to more serious diseases. Countries all over the world are actively carrying forward COVID-19 vaccination in order to achieve mass immunization as soon as possible.
With the advent of the post-pandemic era, the vaccination rates in China and abroad are continuously increasing. As of May 2021, a number of COVID-19 vaccines have been approved for marketing in China, including inactivated virus vaccines, subunit vaccines and recombinant adenovirus expression vaccines. At present, the protective efficacy data results of all Chinese COVID-19 vaccines approved for conditional marketing met the relevant technical standards of the World Health Organization and relevant national technical standards. As of June 16, 2021, a total of 2.13 billion doses of COVID-19 vaccines have been injected, with 27.3 doses per 100 people; 900 million doses of COVID-19 vaccines have been injected in China, with 62.82 doses per 100 people. The effect of COVID-19 vaccination and evaluation of effects have become the focus of public attention. NextSARS-CoV-2, its vaccines and neutralizing antibodies are introduced:

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  • Time of issue:2021-06-29 09:44
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COVID-19 Neutralizing Antibody Test Solution

 
 At present, outbreaks of the India variant (B.1.617.2) have been confirmed in the United Kingdom, China, the United States, Africa and Pacific Rim countries. Studies have shown that it seems to spread more easily and lead to more serious diseases. Countries all over the world are actively carrying forward COVID-19 vaccination in order to achieve mass immunization as soon as possible.
With the advent of the post-pandemic era, the vaccination rates in China and abroad are continuously increasing. As of May 2021, a number of COVID-19 vaccines have been approved for marketing in China, including inactivated virus vaccines, subunit vaccines and recombinant adenovirus expression vaccines. At present, the protective efficacy data results of all Chinese COVID-19 vaccines approved for conditional marketing met the relevant technical standards of the World Health Organization and relevant national technical standards. As of June 16, 2021, a total of 2.13 billion doses of COVID-19 vaccines have been injected, with 27.3 doses per 100 people; 900 million doses of COVID-19 vaccines have been injected in China, with 62.82 doses per 100 people. The effect of COVID-19 vaccination and evaluation of effects have become the focus of public attention. NextSARS-CoV-2, its vaccines and neutralizing antibodies are introduced:

 

  1. SARS-CoV-2

SARS-CoV-2 mainly encodes four structural proteins, namely spike protein (S), membrane protein (M), envelope small protein (E) and nucleoprotein (N)[1] (Figure 1).
 

Figure 1: SARS-CoV-2 structure

 

2.SARS-CoV-2 invasion mechanism

Studies have shown that the SARS-CoV-2 spike glycoprotein is like a key that can be bind to angiotensin converting enzyme 2 (ACE2) , the corresponding lockon the cell surface of the host (such as human body), enabling the host cells to open the door, and allow the virus to infect themselves without vigilance, and replicate and proliferate [1]. (Figure 2)
 

Figure 2: SARS-CoV-2 invading cells and its life cycle[1]

 

 
Therefore, to prevent virus replication, the first thing is to prevent the virus from binding to ACE2 to enter cells. How to stop the virus from binding to ACE2? The answer is: neutralizing antibodies.

 

3.Neutralizing antibody and neutralizing antigen epitope

When the body's immune system is stimulated by pathogens, B lymphocytes in the body will secrete immunoglobulins that specifically bind to viral proteins, some of which can bind to S protein/RBD protein of the virus, and then block the invasion of pathogens into the body to cause infection. These immunoglobulins are neutralizing antibodies, and not all antibodies are neutralizing antibodies.
 

Figure 3: Neutralizing antibodies inhibit the binding of viruses to cells

 

How do neutralizing antibodies block virus infection: neutralizing antibodies change the virus surface configuration by binding to virus receptor domain RBD, prevent virus molecules from being adsorbed on ACE2 receptors, and prevent virusfrom penetrating into cells to proliferate; In addition, neutralizing antibodies and virus form immune complex, which is easy to be phagocytized and cleared by macrophages [2].

 

4. Vaccine effects and its evaluation

Vaccines are an active immune preparations made from pathogenic microorganisms (such as viruses) and their metabolites through artificial attenuation, inactivation or genetic engineering for preventing infectious diseases. Vaccine retains the pathogen's properties of stimulating animal immune systems. When animal bodies come into contact with this harmless pathogen, their immune system will produce certain protective substances, such as cytokines, active physiological substances, neutralizing antibodies, etc; When animal bodies come into contact with the pathogen again, their immune system will utilize its original memory and produce more protective substances to prevent damage caused by the pathogen. In the inactivated virus, the whole virus particle is the immunogen, and its S protein can cause human immune response to produce protective neutralizing antibodies. At present, the WHO has announced that two new COVID-19 vaccines from Sinopharm Group and Sinovac Biotech have been included in the WHO Emergency Use List.

Guidelines for Clinical Evaluation of Preventive Vaccines for COVID-19 indicates that the primary endpoint of vaccine efficacy evaluation should be prevention of onset of COVID19. In a placebo-controlled trial, the protective efficacy of the target population should reach more than 70% preferably, or 50% at least, with the lower limit of 95% confidence interval not be less than 30%. Meanwhile, the Guidelines has pointed out that the safety and clinical protective efficacy of the vaccine should be continuously observed with vaccination on a large scale, and the persistence of protection should be continuously studied.

 

  1. Rapid neutralizing antibody test

The Guidelines for Research and Development of Preventive COVID-19 Vaccines indicates that the first choice of in vivo efficacy test is the neutralizing antibody test method (such as mouse ED 50), in which an appropriate experimental animal should be selected to establish methods to detect neutralizing antibodies or total antibodies in animal serum, including studies on neutralization test strains, coating antigens and reference materials. Therefore, it is of great significance to establish a rapid neutralizing antibody test method.

Based on the characteristics of neutralizing antibody binding to COVID-19 and the mechanism of virus infection, Vazyme has introduced various strategies for rapid testing of neutralizing antibodies.

  1.  The IgG antibody specific to S-RBD protein is detected by capture method;
  2.  In the detection of neutralizing antibodies by the competitive method, the presence of neutralizing antibody in the sample can inhibit the binding of recombinant human ACE2 protein and virus RBD protein in vitro. The neutralizing antibody can be tested quantitatively or qualitatively by competitive inhibition.

 

 

 Vayzme COVID-19 neutralizing antibody test material recommendation

 

Competitive method test kit:

 

 

Capture method test kit:

 

 

Product performance:

 

(1) CG205 and CG201 antigen reactivity

 

      

                                                                                    ACE2 protein shows good reactivity with RBD protein

 

 

In addition, Vazyme provides materials related to the detection of COVID-19 variants, as listed below:

 

 

Previously, Vayzme has successfully developed an overall immunology evaluation solutions applicable to different application scenarios in addition to the colloidal gold method and ELISA, and colloidal gold antibody test reagents that were successfully developed before, which can provide a rapid test solution for post COVID-19 vaccination evaluation and continue to aid in global efforts to contain the pandemic.

 

[REFERENCES]

Sara Platto, Tongtong Xue and Ernesto Carafoli. COVID19: an announced pandemic

Peter C. Taylor , Andrew C. Adams, Matthew M. Hufford.Neutralizing monoclonal antibodies for treatment of COVID-19

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