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The Ministry of Food and Pharmaceutical Safety announced on the 6th that it has also approved the product of the ‘Real-Q 2019-nCoV Detection Kit’, a COVID-19 diagnostic reagent from Bioseum.
As a result, there are currently two officially licensed products in Korea. Previously, the SD Biosensor diagnostic reagent ‘STANDARDTM M nCoV Real-Time Detection kit’ was approved by the Ministry of Food and Drug Safety in August.
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Like the first product, the Bioseum diagnostic kit is a product that has been approved for US and national emergency use and export license through the ‘genetic diagnostic (RT-PCR)’ method. The approval period, which normally takes more than a year, has been reduced to approximately 4 months through the ‘Support Plan for Rapid Approval of Corona 19 Diagnostic Reagents’ promoted by the Ministry of Food and Drug Safety. In the RT-PCR method, a small number of viral genes are isolated from patient samples collected through the nose and mouth and amplified with a measurable amount to verify the presence or absence of the virus.
The Ministry of Food and Drug Safety is evaluating a total of 26 products (as of October 5). The diagnostic reagents that have requested formal authorization are 10 genetic diagnostic reagents, 5 antigen diagnostic reagents and 11 antibody diagnostic reagents.
With the “ emergency use approval ”, 16 products are being used in the national medical fields to diagnose Corona 19. There are 7 products for confirmatory tests and 9 products for emergency detection.
The Ministry of Food and Drug Safety said: “The maximum daily production of products for confirmatory inspection used for home quarantine is about 160,000 people, and we are ensuring sufficient quantities.” I did.”
In addition, the Ministry of Food and Drug Safety has licensed the export of 182 products from 93 companies, including 95 genetic diagnostic reagents, 20 antigen diagnostic reagents, and 67 antibody diagnostic reagents.
17 household diagnostic reagents (gene 15, antibody 2) received emergency use authorization (US) from the United States Food and Drug Administration (FDA), and one product (antigen 1) was obtained from the World Organization Health (WHO). It is registered on the Emergency Use List (EUL).
On the other hand, two companies are conducting clinical performance tests on three products for the simultaneous diagnosis of Corona 19 and influenza for domestic use.
The Food and Drug Safety Ministry said: “It is expected to end in October.”
He added, “We will do our best to ensure that the Korean people can receive diagnostic and treatment opportunities by continuously monitoring the approval status of Corona 19 diagnostic reagents and actively supporting the rapid development and approval of high-quality products.”
