바이오스펙테이터

바이오스펙테이터 Sungmin Kim 기자

Export of 3 million kits to 20 countries worldwide, including Italy, Spain, Philippines, Indonesia and Brazil...Discussing product registration with U.S. FDA and product supplies with the state govern

The export of the covid-19 antibody rapid diagnostic kit ‘SGTi-flex COVID-19 IgG/IgM’, developed by Sugentech, has begun in earnest.

Sugentech said that they have begun exporting primarily produced 50,000 Covid-19 antibody rapid diagnostic kits to 20 countries worldwide, including Italy, Spain, Philippines, Indonesia, and Brazil, from the 31st. The primary production was supposed to be exported to six countries, but the spread of covid-19 worldwide flooded priority supply requests from many countries, expanding exports to 20 countries.

Also, Sugentech is promoting FDA product registration for use in the United States, and in a discussion with state authorities to supply products. Against this background, the United States, China, the WHO, and others have recommended that blood-based antibody diagnostics be used in parallel with molecular diagnostics (PCR). In particular, the recent surge in the number of people infected with Covid-19 in the United States has highlighted the importance of rapid diagnostic kits for antibodies to prevent its spread.

Sugentech's antibody rapid diagnostic kit, SGTI-flex COVID-19 IgG/IgM, in particular, simultaneously diagnoses IgG and IgM antibodies without the need for ‘plasma separation’ process of fingertip or whole blood. As a result, most of the overseas countries where there are a shortage of testing facilities and large-scale equipment essential for molecular diagnostic methods, specialized clinical illnesses, etc., are highly requesting for the diagnostic kits given that dropping just a drop of blood in the kit can quickly advance to diagnose the infection within 10 minutes.... <계속>