- Storage method
- Room temperature
1. What is an antigen detection reagent?
The novel coronavirus gene encodes multiple structural proteins, such as N protein, E protein, and S protein. These proteins include multiple epitopes. Using the principle of specific binding of antigens and antibodies, the presence of antigens can be detected by antibodies to directly Prove that the sample contains the new coronavirus. The applicable sample types for antigen detection reagents are generally samples from infected sites, such as throat swabs.
2. What is an antibody detection reagent?
The above-mentioned antigens of the new coronavirus can be used as immunogens. After the virus infects the human body, it stimulates plasma cells to produce specific antibodies. Using the principle of specific binding between antigens and antibodies, the presence of antibodies can be detected by antigens, thereby indirectly proving that the human body has been infected. Novel coronavirus. The applicable sample types for antibody detection reagents are generally blood, including serum, plasma and whole blood.
The antibodies detected are mainly divided into two types: IgM and IgG. At present, there is no systematic research on the production and duration of these two types of antibodies against the new coronavirus. Under normal circumstances, IgM antibodies are produced early. Once infected, they are produced quickly, maintained for a short time, and disappear quickly. A positive blood test can be used as an indicator of early infection. IgG antibody is produced late, lasts for a long time, and disappears slowly. A positive test in the blood can be used as an indicator of infection and past infection.
3. Methods of using antigen/antibody detection reagents
Antigen/antibody detection reagents are all based on the immunological principle of the specific binding of antigen and antibody. Commonly used methodologies mainly include colloidal gold method, immunofluorescence chromatography, enzyme-linked immunoassay and chemiluminescence method. The colloidal gold method is convenient to operate and can be directly visually interpreted, and the detection is usually completed in 15 minutes; the immunofluorescence chromatography method is as convenient as the colloidal gold method, and the detection is rapid, but it requires instrument interpretation; the enzyme-linked immunoassay can use conventional enzyme labels The instrument's interpretation is generally more sensitive, but the detection time is longer (about 1.5 hours or more), and there are many operating steps. Measures should be taken to avoid infection during the operation. The chemiluminescence method generally has high sensitivity. The automatic chemiluminescence immunoassay analyzer is used to complete the detection without too much manual operation. The detection time is generally about half an hour.
4. Positioning of antigen/antibody detection reagents
In view of the characteristics and status of antigen/antibody detection reagents, their sensitivity and specificity are currently limited and cannot be used as the only basis for the diagnosis and exclusion of new coronary pneumonia. It is not suitable for screening of the general population and can only be used as a supplement to existing viral nucleic acid detection reagents. .
The intended use of the product is recommended to be limited to supplementary testing indicators for suspected cases with negative nucleic acid testing, or to be used in conjunction with nucleic acid testing in the diagnosis of suspected cases.
Through the combined application of multiple detection methods of nucleic acid, antigen and antibody, it shortens the detection window period and increases the positive detection rate. It plays a very important role in the auxiliary diagnosis of new coronary pneumonia
5. The key to antigen/antibody detection reagents
The key to antigen/antibody detection reagents is to obtain highly sensitive and specific antigens and antibodies for detection. However, the antibody preparation process is tedious and time-consuming, and the recombinant antigen technology is relatively fast, but the selection of the best antigen also requires time and experimental basis. In addition, since the production and disappearance of antibodies is a dynamic process, choosing a reasonable sampling timing is also very important, but there is still a lack of relevant research data.
6. Review and approval of antigen/antibody detection reagents
Approval Center pays great attention to the new coronavirus antigen/antibody detection reagents, and has researched and formulated relevant review points to guide companies in product verification confirmation and registration application work. Regarding the reagents related to epidemic prevention and control, our center strives to improve the efficiency of review while ensuring product quality to fully serve the needs of epidemic prevention and control.