SLS Bio has won approval from the Ministry of Food and Drug Safety to export its Covid-19 antibody test kit.
The company will also apply for licenses for its SsmarTest Covid-19 IgG/IgM detection to foreign regulators, including Conformite Europeen (CE) mark and U.S. Food and Drug Administration. SLS Bio is to enter global markets and commercialize its product as early as possible, it said.
SsmarTest Covid-19 IgG/IgM detection kit is a device that uses immunoassay to test the presence or absence of new coronavirus-specific antibodies, immunoglobulin G and M (IgG/IgM), in human blood.
The test of samples collected from patients with Covid-19 symptoms showed an accuracy of 90 percent or higher in both positive and negative cases. “Our product can diagnose asymptomatic patients or those in the latent phase, and it is suitable for testing a massive number of patients who have been infected more than five days,” SLS Bio CEO Lee Young-tae said.
The company is also conducting research and development of its SsmarTest Covid-19 Ag detection kit and SsmarTest Covid-19 Neutralizing Ab detection kit by using the nano-technology multiplex diagnostic platform to commercialize them in the fourth quarter of 2020, he added.
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