[Press Release, Dec 4, 2020 / unofficial translation ]

International Standard on Infectious Disease Diagnostics, 1st Korea's Response to COVID-19 model to be approved as international standard
- Korea takes the lead the international standardization of the nucleic acid - amplification - based diagnostics for COVID-19 and other infectious diseases -

□ The Ministry of Food and Drug Safety (MFDS, Minister Kim Ganglip) and the Ministry of Trade, Industry and Energy (MOTIE, Minister Sung Yun-mo) announced that the International Standard on the diagnostics of COVID-19 and other infectious diseases proposed by Korea was approved and published by the International Organization for Standardization (ISO) on Dec. 2, 2020.
※ The official title of the International Standard for the diagnostics of infectious diseases including COVID-19
: In vitro diagnostic test systems - Nucleic acid amplification-based examination procedures for detection and identification of microbial pathogens - Laboratory quality practice guide (ISO 17822)
○ The approval and publication as an International Standard have major significance as it is the first “Korea's Response to COVID-19 model” to be established successfully as an international standard since the Korean government announced the “strategic initiative for the international standardization of the 3T (Test-Trace-Treat) Korea's Response to COVID-19 model” in June.

□ The International Standardization (IS) of infectious disease diagnostics was initiated in a response to spread of novel infectious diseases such as the Novel Influenza in 2009 and MERS-CoV in 2015 and the following awareness on the global need for the standardization of the procedures and methods of the infectious disease diagnostics.
○ The international standardization effort was commenced through the submission of new proposal of International Standard prepared by the National Mirror Committee in MFDS to the ISO.
○ Korea has closely cooperated with the technical advisors of ISO in Germany, the U.S. and other countries and discussed ways to achieve international standardization.
- As a result, the Final Draft International Standard (FDIS) on infectious disease diagnostics was approved without objection in October 2020 and then the IS was published on December 2, 2020 following the final modifications by member states.

※ Status within ISO standard development process

[ Date / standard development process ]

Oct. 2016 / Approval of New work item Proposal (NP)

Oct. 2016 ~ Mar. 2019 / Review and revision of Working Draft (WD)

May 2019 / Committee Draft (CD)

Feb. 2020 / Approval of Draft International Standard (DIS)

Oct. 2020 / Approval of Final Draft International Standard (FDIS)

Dec. 2020 / Publication of International Standard (IS)

□ The recently approved IS defines the operational procedure and methods for laboratories conducting in-vitro diagnostic tests based on “Nucleic acid amplification methods.”
○ The IS can be applied to a wide range of infectious disease test kits such as the Real Time Polymerase Chain Reaction kits used for the diagnosis of COVID-19.
○ Considering that even minor variations in operational procedures can affect the results nucleic acid ? amplification - based diagnostics, the establishment of the IS is expected to contribute to increasing the accuracy of the diagnostic tests for infectious diseases including COVID-19.

□ “Amid the recent increase in the export of COVID-19 test kit manufactured by Korean companies,
○ the approval of as the International Standard would greatly help the Korean businesses in taking the lead in the global market by enhancing the reliability of infectious disease diagnostic products manufactured in Korea,” said the representative of the MFDS and the MOTIE.
- The two ministries also expressed their commitments on the implementation of the strategic initiative announced in June to buttress the global advancement of the Korean bio industry.