Securing International Credibility for South Korea's COVID-19 Diagnosis

Emergency International Comparison of 'COVID-19 Virus RNA Measurement Methods' by 21 Institutions from 16 Countries
Korea's Measurement Method Secures International Equivalence and Gains Global Trust
Broad Applications Expected in Future Variant Virus Diagnosis and RNA-Based Vaccine Measurement

COVID-19 Virus Genetic Standard Material Developed by Korea Research Institute of Standards and Science

[Asia Economy Reporter Junho Hwang] South Korea's measurement method for novel coronavirus disease (COVID-19) RNA has been recognized as having international equivalence. Measurement results were compared among national metrology institutes from countries including the United States and the United Kingdom to verify the validity of the measurement values, and mutually reliable measurement results were acknowledged. Along with South Korea's RNA measurement technology, the reliability of standard materials and COVID-19 diagnostic methods utilizing this technology has also been secured, which is expected to contribute to the global market entry of K-quarantine in the future.

The Korea Research Institute of Standards and Science (KRISS) announced on the 14th that it participated in an international comparison of 'COVID-19 RNA measurement methods' with metrology experts from various countries last December and secured international equivalence.

The Consultative Committee for Amount of Substance: Metrology in Chemistry and Biology (CCQM), one of the 10 advisory committees under the International Committee for Weights and Measures (CIPM), conducted an urgent international comparison involving 21 national metrology institutes from 16 countries in response to COVID-19. The measurement target was COVID-19 virus RNA. Most institutes used reverse transcription digital polymerase chain reaction (RT-dPCR). This technology enables absolute quantification of genes, allowing accurate estimation of the presence and quantity of COVID-19 virus in samples. As a result of the international comparison, all 21 institutes submitted equivalent results, securing international equivalence.

KRISS also submitted measurement values obtained using its self-developed single-molecule counting method and received recognition for international equivalence. The single-molecule counting method is a measurement technique that counts target substances one by one to accurately determine their quantity. It is an intuitive and direct measurement method that can serve as a reference for other methods.

Regarding the international comparison results, KRISS stated, "Not only the RNA measurement technology but also the COVID-19 standard material developed by KRISS last July using this technology have achieved international equivalence." Standard materials are like answer sheets to given problems. By providing standard materials (problems) and accurate measurement results (answer sheets) to testing institutions, companies can calibrate their equipment or improve the accuracy of their methods. KRISS's COVID-19 standard materials have been sold a total of 74 units to date. Most purchasers utilize the standard materials for developing and validating diagnostic kits. The securing of international equivalence has also increased trust in the quality of domestically produced diagnostic kits.

Dr. Sang-Yeol Park, principal researcher who has served as chair of CCQM since 2019, said, "This activity was conducted as an urgent international comparison to respond swiftly to the unprecedented situation of COVID-19," and added, "We are pleased that KRISS's capabilities have been internationally recognized through these results."

Bioanalysis Standards Group Leader Young-Kyung Bae expressed, "We take great pride in having been able to respond timely to humanity's challenges with KRISS's measurement capabilities," and said, "We will continue research in related fields such as variant virus diagnostics and precise measurement of RNA-based vaccines."