Biocredit Covid-19 Ag is a medical technology product IVD (in vitro diagnostic medical device), which is manufactured by the company RapiGEN INC. and is distributed in Greece by the company ASK Pharmaceutical. Biocredit Covid-19 Ag is utilizing the principle of immunochromatographic analysis.
In Biocredit COVID-19 Ag, the capsid N protein is defined as the antigen (from the coronavirus nucleocapsid), thus the antigen test measures whether the capsid N protein of the SARS – CoV-2 is present in the sample. The nitrocellulose membrane of the device, hereinafter substrate, has the ability to transfer the sample naturally using the diffusion-wetting principle. This substrate acts as a “sponge” and retains excess liquid from the test sample. If the sample is positive, the antibodies that are conjugated to the chromophore (gold particles) bind to the corresponding antigen (protein N).
The complex of antigens and chromophore-conjugated antibodies flows to the rest of the substrate, interacts with the pre-coated areas, and accordingly yields a typical color change. There are typically two areas: one referred to as the control area, which traps any molecule and thus ensures that the analysis process is completed correctly, and the second area, the test area, which contains a specialized trapped molecule that binds only to the complex of antigens and chromophore-conjucated antibodies of the sample.