Korea’s Sugentech Granted FDA EUA for Gold Nanoparticle-Based Immunochromatographic COVID-19 Test

Sugentech, Inc. (Daejeon, Korea) has been granted Emergency Use Authorization by the US Food and Drug Administration for the company’s SGTi-flex COVID-19 IgG which is designed to detect immunoglobulin G antibodies against SARS-CoV-2 in serum, plasma, and venous whole blood.

The SGTi-flex COVID-19 IgG from Sugentech is a gold nanoparticle-based immunochromatographic test kit for the qualitative determination of COVID-19’s IgG antibodies in human whole blood (finger prick or venous), serum or plasma. The kits are accurate and easy to use and the results can be observed with the naked eye within 10 minutes. The test detects the presence of antibodies, which are specific proteins made in response to infections. Antibodies can be found in the blood of those who are tested after infection. The antibodies detected by the test indicate that a person had an immune response to COVID-19, whether the symptoms developed from the infection or the infection was asymptomatic.

Antibody test results are important in detecting infections with few or no symptoms. As there is no medicine or vaccine, the best way to combat this infection is isolation. A significant number of infected people do not have any symptoms, making quick diagnosis very important. The SGTi-flex COVID-19 IgM/IgG enables healthcare workers to identify people with infection and isolate the ones without any symptoms but are suspected of having COVID-19.