Establishment of International Standards for Infectious Disease Diagnostic Testing Techniques by South Korea

"K-Quarantine Model Achieves First Success in International Standardization"

[Image source=Yonhap News]

[Asia Economy Reporter Moon Chaeseok] The Ministry of Trade, Industry and Energy and the Ministry of Food and Drug Safety announced on the 3rd that an international standard related to infectious disease diagnostic testing methods in South Korea was established on the 2nd.

This marks the first success in international standardization of the K-quarantine model following the government's announcement in June of the 'K-Quarantine 3T (Test-Trace-Treat) International Standardization Promotion Strategy.'

As infectious diseases such as the 2009 H1N1 flu and the 2015 Middle East Respiratory Syndrome (MERS) spread, South Korea's National Standards Technical Committee prepared an international standard proposal and submitted it to the International Organization for Standardization (ISO).

South Korea has closely collaborated with ISO technical committees from countries including Germany and the United States to successfully lead discussions on international standardization.

The newly established international standard defines the operational procedures and methods for laboratories conducting in vitro diagnostic tests using the 'nucleic acid amplification method.'

This standard can be applied to various infectious disease diagnostic tests, including the real-time nucleic acid amplification technique used in COVID-19 diagnostic kits.

Officials from the Ministry of Trade, Industry and Energy and the Ministry of Food and Drug Safety stated, "Recently, exports of related products such as COVID-19 diagnostic reagents by our companies have been active," adding, "The establishment of this international standard is expected to greatly help enhance the international credibility of South Korea's infectious disease diagnostic products and lead the global market in the future."

They also said, "We will faithfully implement the 'K-Quarantine 3T (Test-Trace-Treat) International Standardization Promotion Strategy' announced in June to globalize South Korea's bio industry."

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