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Sugentech said it would begin the mass production of its antibody-based testing kit for COVID-19. The South Korean medical diagnostics company last week completed its product registration with the U.S. Food and Drug Administration (FDA).
Sohn Mi-jin, chief executive of Sugentech, said that the company plans to ship 400,000 test kits per week from mid-April. Then, it aims to deliver 1 million test kits starting May to meet the growing demand from markets abroad, including the United States.
Korean-made COVID-19 testing kits need to undergo the FDA’s Emergency Use Authorization (EUA) process to have products exported to the U.S. Manufacturers could also acquire an order from a state government for shipment to a state through registering with the FDA.
Sugentech initially received approval from Korean health authorities late March to sell its fast testing kit abroad. The company also acquired CE-IVD certification for the shipment of its product in European countries.
Sugentech’s fast testing kit could detect infection within 10 minutes without a trained analyzer or analysis equipment. The SGTi-flex COVID-19 IgG/IgM is a gold nanoparticle-based immunochromatographic test kit for qualitative determination of COVID-19`s IgM and IgG antibodies in human blood, serum or plasma. The test works with a blood sample with a low sample risk, as in the molecular diagnostic method (RT-PCR).
Sohn said alongside RT-PCR tests, health professionals should also conduct an essential parallel antibody test, as the RT-PCR has its limitations. She added that the diagnostic accuracy of its fast testing kit reached 94.4 percent after a large-scale clinical trial in Daegu hospital involving 250 specimens.
With the RT-PCR assay, health professionals could accurately detect and analyze even the tiniest amount of coronavirus. However, improper extraction could render it useless. Sohn explained that that is why the U.S., China, and the World Health Organization (WHO) recommended antibody testing in conjunction with the RT-PCR to yield higher accuracy.
Sohn co-founded Sugentech in 2011 with two colleagues after working at LG Life Science’s diagnostic research laboratory. The company, as an IVD solutions provider, manufactures diagnostic kits and diagnostic equipment tech in South Korea.