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[Press Release, Feb 4, 2020] Emergency Use of COVID-19 test kit authorized, COVID-19 tests also conducted at medical institutions
  • Registration Date 2020-06-17
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[Press Release, Feb 4, 2020 / unofficial translation ]

Emergency Use of COVID-19 test kit authorized, COVID-19 tests also conducted at medical institutions
- to be available at private medical institutions from Feb. 7 -

◇ (Overview) 1 COVID-19 test kit emergency use authorization (Ministry of Food and Drug Safety)
◇ (Timetable for testing) At private medical institutions from Feb. 7
◇ (Test centers) 50 centers (among those accredited with excellent laboratory certification) approved by the Director of KCDC (to be announced later)
◇ (Test subjects) Those suspected to have COVID-19 or those who require testing by medical professionals

□ The KCDC (Director: Jung, Eun-Kyung) and Ministry of Food and Drug Safety (Minister: Lee, Eui-Kyung) have authorized the emergency use of a COVID-19 test kit* on Feb 4. They announced that the authorized product will be supplied to private medical institutions designated by the KCDC for use in diagnosis.
* PowerChekTM 2019-nCoV Real-time PCR Kit, Manufacturer: Kogene Biotech, South Korea
* Second domestic case following Zika virus or MERS test kit from 2016

○ “Emergency Use Authorization” is a system that allows temporary production, sales, and use of test kits on the brink of a pandemic when there is no authorized product available in the domestic market. The authorization of the product shall be requested by the Director of KCDC and approved by the Minister of Food and Drug Safety.
- The Ministry of Food and Drug Safety authorized the product for emergency use based on the application documents filed by test kit manufacturers, performance test results, and expert review and.
* Article 46 (2) of the Medical Device Act and Article 13 (3) of its Enforcement Decree

○ The assessment of the test kit was jointly carried out by a public-private partnership (Korean Society for Laboratory Medicine and Korean Association of External Quality Assessment Service), and the authorized product passed both document review and performance evaluation.

□ Following Emergency Use Authorization, COVID-19 testing is temporarily* offered at the medical institutions designated by the Director of the KCDC (including contract organizations specializing in testing)**.
* The use of the product may be halted when the pandemic ends.
** The list of designated medical institutions is to be released on Feb. 7.

□ Meanwhile, the accuracy of tests conducted by medical institutions will be evaluated to ensure reliable testing.

○ The Korean Society for Laboratory Medicine and Korean Association of External Quality Assessment Service will be conducting a test-related training (Feb. 4) and an accuracy evaluation (Feb. 5); the testing is expected to become available after individual preparations by each medical institution.

□ KCDC explained that the purpose of the expansion of testing capacity through the “Emergency Use Authorization for infectious disease test kits” is to protect the public from the nationwide-spread of the virus and to put test kits to practical use in a short period of time.

○ They also expressed the hope of enhancing the monitoring capacity of confirmed cases on a local level by securing test kits and their distribution to private medical institutions.

○ Expanding tests to private clinical laboratories will enhance the sensitivity and speed of tests, and this will allow the early detection of the infected and the rapid implementation of follow-up measures such as and prompt self-isolation.

○ Ultimately, the EUA is expected to lay the foundation for the promotion of effective quarantine policy as well as COVID-19 forecasts via public-private cooperation.

[Reference] Related Q&A

1. Who are eligible for testing?

○ Anyone who qualifies according to the definition of COVID-19 case is eligible for testing. Detailed procedures for testing shall be announced later (by KCDC).

2. Where can people get tested, and how long testing will take?

○ (Testing institutions) The authorized test kits are available for testing at medical institutions recognized by the KCDC (Laboratory Medicine Foundation-accredited medical institutions for excellent laboratory) The list of appointed medical institutions shall become available at the KCDC website from Feb. 7.

○ (Testing schedule) Medical institutions that carry out testing shall receive training (Feb. 4) and accuracy assessment (Feb. 5), and testing shall become available from Feb. 7, although the schedule may vary according to individual medical institutions.

3. Any plans for future product authorization?

○ The application for assessment for emergency use authorization is from Jan. 28 to Feb 28. The KCDC and Ministry of Food and Drug Safety shall review and assess the applications received during such period to handle COVID-19 effectively.

○ Furthermore, those who did not receive authorization in this assessment may re-apply after improving their applications.

4. What kind of testing method is used in this authorized product?

○ The methodology used in the authorized product is real-time gene extraction testing. This methodology amplifies and extracts 2 virus specific genes in COVID-19, and the result can be generated within 6 hours via one-time testing.
Attached File
  • 2.4 Emergency use for COVID19 kit.pdf Download preview

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