Views:4 Author:Site Editor Publish Time: 2020-04-10 Origin:Site
Antigen / antibody detection reagents are based on the immunological principle of the specific binding of antigen and antibody. Common methodologies include colloidal gold method, immunofluorescence chromatography, enzyme-linked immunoassay and chemiluminescence. The colloidal gold method is easy to operate and can be directly visually interpreted, and the detection can be completed in 15 minutes. Immunofluorescence chromatography is as convenient as the colloidal gold method, and the detection is rapid, but it requires instrument interpretation. Interpretation by the instrument generally has higher sensitivity, but the detection time is longer (about 1.5 hours or more), and there are many operation steps. Measures should be taken to avoid infection during the operation. The chemiluminescence method generally has higher sensitivity. The automatic chemiluminescence immunoanalyzer can be used to complete the detection without too much manual operation. The detection time is generally about half an hour.
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 new coronavirus detection. However, the antibody preparation process is cumbersome and time-consuming, and the recombinant antigen technology is relatively fast. However, it takes time and test basis to select the best antigen. In addition, since the generation and disappearance of antibodies is a dynamic process, it is also critical to choose a reasonable sampling timing, but there is still a lack of relevant research data.
Antigen / antibody detection reagent positioning
In view of the characteristics and current 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 elimination of new coronary pneumonia. They are not suitable for general population screening and can only be used as a supplement to existing viral nucleic acid detection reagents .
Recommendations for the intended use of the product are limited to supplementary detection indicators for suspected cases with negative nucleic acid tests, or used in conjunction with nucleic acid detection in the diagnosis of suspected cases.
Through the combined application of multiple detection methods of nucleic acid, antigen and antibody, the detection window period is shortened and the positive detection rate is increased. It has a very important role in the auxiliary diagnosis of new coronary pneumonia.
Review and approval of antigen / antibody detection reagents
The device review center pays close attention to the antigen / antibody detection reagents of new coronaviruses, and has researched and formulated relevant review points to guide enterprises to verify and confirm products and register and declare products. With regard to the relevant reagents for epidemic prevention and control, our center strives to improve the efficiency of the review, ensure product quality, and fully serve the needs of epidemic prevention and control.