Novel coronavirus (sars-cov-2) antigen detection kit CE

一、 Product features:

1.High-quality monoclonal paired antibodies with high affinity, using double antibody sandwich method.

2.High total coincidence rate, not affected by virus mutation,no cross-reaction with common respiratory viruses.

3.Non-invasive sampling, sample type: oropharyngeal swab, sputum (saliva), testing anytime, anywhere. 

4.Storage temperature: 4℃-30℃, convenient for transportation at room temperature. 

5.Detection time 15-20 minutes.

6.Convenient operation, no equipment, no cold chain transportation.

7.Can be used for home testing, testing at designated institutions (such as hospitals), screening before the resumption of work or school.  

二、 Product usage:

三、 Interpretation of results

四、 What is the difference between nucleic acid detection, antibody detection and antigen detection of novel coronavirus?

1. Nucleic acid detection of novel coronavirus

Nucleic acid detection has the characteristics of early diagnosis, high sensitivity and specificity. It is the “gold standard” for the diagnosis of covid-19. At present, the most widely used is real-time fluorescent quantitative RT-PCR. Generally, two targets located on orf1ab and N genes are detected. The same sample must meet the requirements of double target positive or repeated detection as single target positive or both samples meet the requirements of single target at the same time to confirm sars-cov-2 virus nucleic acid positive

 2，Detection of serum antibody to novel coronavirus

  Seven days after the onset of novel coronavirus pneumonia, serum specific antibodies were gradually produced, first immunoglobulin IgM antibody, and then IgG antibody. Therefore, the increase of IgM antibody indicates recent acute infection, and the increase of IgG antibody indicates previous infection.

   The biggest advantage of serological testing is that it is convenient and fast, and the testing time is short. It can effectively break through the restrictions of existing testing technology on personnel and places, and shorten the testing time. It has been written into the diagnosis and treatment plan for novel coronavirus pneumonia (trial version     7). If the serum specific IgM and IgG antibodies of suspected cases are positive,   the     IgG antibody changes from negative to positive, or the recovery period is 4 times or more higher than that in the acute phase, they can be diagnosed as infected withnovel coronavirus. 

Interpretation of the results of combined detection of nucleic acid, IgG and IgM antibodies

3. Detection of antigen of novel coronavirus

Covid-19 antigen detection can directly detect whether human samples contain novel coronavirus. The diagnosis is fast, accurate and requires low equipment and personnel. Using double antibody sandwich method and using two antigen-specific antibodies to recognize and combine different epitopes of a target antigen can greatly reduce the probability of cross reaction and effectively improve its specificity.

4. Joint detection

The nucleic acid / antibody / antigen detection of novel coronavirus has its own emphasis and cannot be replaced each other. A variety of detection methods are applied together to complement each other. By combining molecular biology and immune level detection, we can give full play to their respective advantages, improve sensitivity and specificity, effectively shorten the detection window, improve the positive detection rate, and provide double protection for all possible risk groups