Berger Medical Novel Coronavirus 2019-nCoV Antigen Diagnostic Kit (Colloidal Gold Method) has completed a total of 597 cases in three clinical institutions, including 217 positive cases and 380 negative cases. The results showed that the specificity of the reagent was as high as 99.74%, and the sensitivity was also 93.55%. As early as before obtaining the approval of the State Food and Drug Administration, Berger Medical's new crown antigen reagent has also obtained CE certification and has access conditions for the EU market.
According to reports, the domestic market has put forward higher requirements for the performance of the new crown antigen detection reagent: the higher the specificity, the possibility of false positive will be greatly reduced; and the sensitivity is closely related to the probability of missed detection reagents. So, how to improve the specificity of antigen detection products? The technology of colloidal gold products mostly uses dual antibody sandwich method to measure antigens, so its composition can be divided into sample pad, colloidal gold pad, NC film and PVC bottom plate. The reaction principle is that when the sample is inleted, it first binds to the new coronavirus antibody-gold conjugate embedded in the colloidal gold pad, and then enters the NC membrane pre-coated with the new crown antibody under the diffusion action to form an antibody-antigen-antibody complex, and finally develop color at the detection line. Therefore, a good antigen detection product, the quality of its raw materials is crucial, especially the core raw materials (new crown virus N protein antibodies), but also determines the performance basis of the product. This is also the main reason for the performance difference between the products of different enterprises.
The person in charge of product research and development said that in the development of this new crown antigen detection product, in order to ensure the best sensitivity and specificity, Berger research compared a variety of antibodies, NC membranes and other raw materials at home and abroad, and finally adopted the current formula and product design, and the product performance reached an advanced level. The manager of the project management department of Berger Medical also said that the certification was actively helped by the science and technology commissions at both levels in the urban area to promote the declaration of new products and provide high-quality services for enterprises.