Aju Business Daily

SEOUL -- South Korea will be able to lead the development of international standards related to the gene amplification method used for diagnostic testing devices. A draft international standard has been approved by ISO/TC 212, a technical committee of the International Organization for Standardization.

ISO/TC 212 is responsible for standardization and guidance in the field of laboratory medicine and in vitro diagnostic test systems. The Ministry of Trade, Industry and Energy said in a statement on Monday that an international standard would be established by the end of this year.

The standard defines the entire procedure and method for in vitro diagnosis of the nucleic acid amplification method, which can be used for the diagnosis of various infectious diseases, the ministry said, adding that it can be applied to various nucleic acid amplification methods, such as real-time polymerase chain reaction (PCR) used for COVID-19 screening.

The committee's approval means that diagnostic kits developed with domestic technology will become a global standard, the ministry said. "With South Korea's recent diagnosis capability of COVID-19 gaining global attention, we expect it to enhance the international community's trust in South Korea's infectious disease diagnostic devices and help local companies make inroads into overseas markets."