South Korean IVD Company, SUGENTECH's, COVID-19 IgM-IgG Rapid Test Listed on FDA

South Korean IVD Company, SUGENTECH's, COVID-19 IgM-IgG Rapid Test Listed on FDA

Press Release ( - SEOUL, South Korea - Apr 08, 2020 - ‘SGTi-flex COVID-19 IgM&IgG’ is an immunochromatographic test kit for the qualitative determination of COVID-19’s IgM and IgG antibodies in whole blood (finger prick or venous), serum or plasma. The kits are accurate and easy to use, and results can be observed with the naked eye within 5-10 minutes. It has already received CE-IVD certification and is approved for exports from South Korean MFDS, and it showed 94.4% accuracy in clinical trials, which has been done with 250 samples in Daegu, South Korea.

‘SGTi-flex COVID-19 IgM&IgG’ is already being distributed in many countries in the EU and Asia, and in recent field tests in many renowned labs, including LMZ Dr. Risch Group in Switzerland, ‘SGTi-flex COVID-19 IgM&IgG’ has shown prominent performance in the neutralization test and been recognized even significant detection of early patient with IgM. SUGENTECH is planning to go further to seek EUA from the U.S. FDA.

Limits of RT-PCT for COVID-19

The real-time PCT (RT-PCR) test seeking the COVID-19 specific virus suffers from some inherent drawbacks such as 1) limitation of good sample patients (recent study tells that the upper respiratory sample has 30% sensitivity), 2) the need for specially trained technicians and equipped certified labs to run the test, and 3) high level of need in resources, e.g. cost and time. 

Moreover, it has been reported that many COVID-19 virus-shedding patients are asymptomatic or have very few symptoms, and the period of virus shedding starts very early and stays so long, even when the virus titer is quite low.

SGTi-flex COVID-19 IgM&IgG’ is a serological (blood) rapid test.

‘SGTi-flex COVID-19 IgM&IgG’ detects the presence of COVID-19 specific lgM & lgG antibodies, which are specific proteins made within days after infection, even in patients that don’t have symptoms. The antibodies detected by this test indicate that a person had an immune response to COVID-19, whether symptoms developed from infection or the infection was asymptomatic. Antibody test results are important in detecting infections with few or no symptoms. It covers the entire course of infection and improves the overall diagnosis of COVID-19 in acute phases of illness.

It is very important to diagnose COVID-19 to defend against the expansion of COVID-19. ‘SGTi-flex COVID-19 IgM/IgG’ helps communities to identify infection and isolate people without symptoms but suspected to be infected by COVID-19.


SUGENTECH is a South Korean IVD company and is listed on the Korean Stock Exchange (KOSDAQ 253840). For more information, please visit: or contact 

Jongyoon Park, CFO/Managing Director​

Source : SUGENTECH Inc.

CATEGORIES : Diagnostics


Or using ePRNews Account

Don't have an account ? Sign Up

Register New Account

Already have an account ? Login

Reset Password

Already have an account ? Login


If you have any concerns regarding this press release, please contact the Author / Media Contact / Business of this press release. ePRNews is not resposible for the accuracy of the news posted and do not endorse, support any product/ services/ business mentioned and hereby disclaims any content contained in this press release.