New Coronavirus Testing at Private Hospitals from the 7th... Emergency Use Authorization for Diagnostic Reagents

On the 4th, an official at Yonsei University in Seodaemun-gu, Seoul, is installing a banner with guidelines for preventing the novel coronavirus infection. Photo by Moon Honam munonam@

[Asia Economy Reporter Choi Dae-yeol] The Korea Centers for Disease Control and Prevention (KCDC) and the Ministry of Food and Drug Safety announced on the 4th that they have granted emergency use authorization for a reagent product capable of diagnosing the novel coronavirus infection (Wuhan pneumonia). This emergency use authorization is the second, following those for MERS and Zika virus diagnostic reagents in 2016.

The reagent approved this time is a product made by a company called CoGen Biotech (PowerChekTM 2019-nCoV Real-time PCR Kit), which will be supplied to private medical institutions designated by the KCDC for patient diagnosis. The emergency use authorization system allows the Minister of Food and Drug Safety to approve the manufacture, sale, and use of diagnostic reagents requested by the KCDC on a temporary basis when there is concern about a pandemic and no approved products are available domestically.

The Ministry of Food and Drug Safety evaluated the diagnostic accuracy of the product through company application data, performance tests, and expert reviews, and approved its emergency use. This reagent evaluation was conducted jointly by private organizations such as the Korean Society for Laboratory Medicine and the Korean Association of External Quality Assessment Service, along with the government. The approved product passed both document review and actual performance tests. Usage may be discontinued once the infectious disease outbreak ends.

To enhance test reliability, accuracy assessments will be conducted at medical institutions performing tests during the emergency introduction period. After education and accuracy evaluations, and the medical institutions' own test preparation process, testing is expected to be possible from the 7th. Jeong Eun-kyung, director of the KCDC, stated, "There are some additional companies that have applied, so more diagnostic kits will be distributed in the future."

She added, "The expansion of diagnostic testing medical institutions through emergency use authorization of infectious disease testing reagents means that diagnostic methods can be practically applied in a short time to protect the public from nationwide spread," and "Monitoring of confirmed cases at the community level will be strengthened."

This content was produced with the assistance of AI translation services.