KRISS Attains International Equivalence for Reliable COVID-19 Diagnosis 

- Participation in key comparison of SARS-CoV-2 RNA measurement methods between 21 institutions from 16 countries - 

- Wide range of applications expected in diagnosis of future virus variations and RNA-type vaccine testing etc. -

 ▲ KRISS researchers measuring SARS-CoV-2 RNA

The Korea Research Institute of Standards and Science (KRISS, President Hyun-Min Park) participated in a comparison study of SARS-CoV-2 (COVID-19) viral RNA measurement methods in December. The comparison study was somewhat informal than a regular key comparison (KC) because of the emergency situation, but it followed most rules and practices of a KC.

A key comparison is a procedure conducted between national metrology institutes such as KRISS to compare measurements and confirm their accuracy. When the measurements are concluded as valid through the key comparison, international equivalence is said to have been reached.

○ National metrology institutes use measurements with international equivalence to provide technical foundation for agreements on trade, e-commerce and regulations. Governments and enterprises then conduct fair international trade based on such agreements. 

21 national metrology institutes and expert laboratories from 16 countries in the CCQM(Consultative Committee for Amount of Substance: Metrology in Chemistry and Biology)* participated in this comparison, which took place over 10 months from March to December 2020, as an emergency response to the unprecedented situation of the COVID-19 pandemic.

 * CCQM(Consultative Committee for Amount of Substance: Metrology in Chemistry and Biology): One of the 10 consultative committees under the International Committee for Weights and Measures(CIPM), which discusses key issues in measurement standards for chemistry and biology 

Most national metrology institutes used reverse transcription digital polymerase chain reaction to measure SARS-CoV-2 RNA. This technology enables the absolute quantification of genetic material, allowing for accurate approximation of the presence of the virus as well as viral load within the specimen.

The KRISS team also submitted measurement results from its uniquely developed molecular direct counting* method, on top of the reverse transcription digital polymerase chain reaction method, to enhance the reliability of the results.

 * Molecular direct  counting method: Measurement method which uses direct numerical counting of target substances to determine its quantity. Because of the intuitive and certain measurement principle, the method can provide reference values for other measurement methods. 

All 21 institutions participating in the emergency comparison submitted equivalent results to achieve international equivalence. With this, international equivalence was achieved for KRISS’s own RNA measurement technology as well as the SARS-CoV-2 reference material it developed in July using the technology.

○ Reference materials are like test questions that come with answer keys. Testing institutions are provided with the reference materials (questions) and the accurate measurement results (answer key), which enable the institutions calibrating their equipment or improving the accuracy of their methodology.

○ 74 sales have been made of the ‘SARS-CoV-2 RNA reference material’ produced by KRISS to date. According to the companies that purchased the reference material, it is mainly being used in the development and verification of diagnostic kits. With KRISS reference materials with international equivalence being used in the development and testing of diagnostic kits, the reliability of domestically produced diagnostic kits has been enhanced.

▲ KRISS Researchers

(From left, Principal Research Scientist Incheol Yang, 

Head of Biometrology Group Young Kyung Bae, Principal Research Scientist Sang-ryoul Park)

KRISS Principal Research Scientist Sang-Ryoul Park who has been serving as CCQM President since 2019 explained, “the procedure was carried out in the form of an emergency key comparison to respond quickly to the unprecedented global pandemic of COVID-19,” adding, “KRISS is glad to have received international recognition of its capacities with the result.”

Head of the KRISS Biometrology Group Dr. Young Kyung Bae commented, “we are proud of KRISS’s measurement capabilities that were able to respond to a humanity-wide issue in a timely manner,” adding, “we will continue research in this field, with the diagnosis of varients and precise measurements of RNA-type vaccines.”