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The Ministry of Food and Drug Safety announced on the 6th that it officially approved two additional reagents for the diagnosis of infection by the new coronavirus (Corona 19), the core of the K quarantine system.
As the first product, this product is a product that has received emergency approval for domestic and US use and export license through the genetic diagnostic method (RT-PCR).
The RT-PCR method is a method of separating a small number of viral genes from patient samples collected through the nose and mouth and amplifying them to a measurable quantity to verify the presence or absence of a virus.
This permit shortened the approval period, which normally takes more than a year, to approximately 4 months through the support plan for the rapid approval of Corona 19 diagnostic reagents promoted by the Ministry of Food and Drug Safety.
Furthermore, at present, the diagnostic reagents that have applied for formal approval are 10 genetic diagnostic reagents, 5 antigen diagnostic reagents and 11 antibody diagnostic reagents, a total of 26 products under review.
Meanwhile, there are a total of 16 products that have been approved for emergency use and are being used in domestic medical fields for the diagnosis of Corona 19, including 7 products for confirmatory tests and 9 products for emergency detection.
The maximum daily production of products for confirmatory inspection in use in home quarantine is about 160,000 people, and 3.83 million people have been produced from February to the present, of which 3.61 million people have been supplied.
Currently, export licenses have been approved for 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 (EUA) from the US Food and Drug Administration (FDA), and one product (antigen 1) was obtained from the Organization World Health Organization (WHO). It is registered on the Emergency Use List (EUL).
The co-diagnostic reagent for COVID-19 flu is undergoing clinical performance testing on three products by two companies, and is expected to be completed in October.
The Ministry of Food and Drug Safety said: “We are providing personalized consulting so that simultaneous diagnostic reagents can be approved quickly and we plan to allow their approval before the flu pandemic.” “We will do everything possible to ensure diagnostic and treatment opportunities by actively supporting the rapid development and approval of excellent products.”
