[Infostock Daily=Reporter Park Jeong-Do] Sugentech announced on the 7th that the SGTi-flex IgG, a Covid-19 antibody rapid diagnostic kit, passed the US National Cancer Center (NCI) performance evaluation and was approved for emergency use by the US Food and Drug Administration (FDA) for the first time in Korea.
Sugentech's novel coronavirus (Covid-19) antibody rapid diagnosis kit recorded a sensitivity of 97% and specificity of 100% in the NCI performance evaluation conducted during the FDA approval process. This is far more than 90% sensitivity and 95% specificity, which are US FDA approval standards.
Sugentech has applied for the US FDA's approval for emergency use of two types of 'rapid diagnostic kits' that diagnose both lgM and lgG antibodies at the same time and 'lgG antibody alone diagnosis rapid diagnosis kit'. The FDA first evaluated the IgG antibody test diagnostic kit. In developed countries, mainly in the United States and Europe, the marketability of the IgG test kit is evaluated higher because it is judged mainly through IgG antibody tests to determine whether it is possible to return to daily life after Covid-19 treatment.
So far, the US FDA has approved 13 rapid diagnostic kits worldwide, including Susentech, which is the only rapid diagnostic kit in Korea.
Already in developed countries such as the United States and Europe, "antibody rapid diagnostic kits" are used with molecular diagnostics (RT-PCR). In developing and underdeveloped countries, which lack the anti-virus infrastructure, are also using antibody rapid diagnostic kits as an alternative to molecular diagnosis, which is in wide demand worldwide.
In particular, as the accuracy issue of Chinese rapid diagnostic kits used in the early days of Corona 19 spread has become a problem, it has become difficult to enter the market by country unless it is recognized for quality from the second half of this year. Demand for proven products is high because the number of suppliers recognized for quality is limited worldwide.
Reporter Park Jeong-Do newface0301@naver.com
