Reference material to improve accuracy of COVID-19 diagnosis kit

- Korea becomes world’s second to develop COVID-19 reference material -

- Expected to enhance efficiency and reliability of COVID-19 diagnosis -

The Korea Research Institute of Standards and Science (KRISS, President Hyun-Min Park) and the Center for Convergent Research of Emerging Virus Infection (CEVI, Director Beom-tae Kim) succeeded in developing Korea’s first COVID-19 reference material.

 

▲ COVID-19 reference material developing process

 

The proposed COVID-19 genetic reference material is the world’s second, with China’s being the first. It is expected to minimize false positives, and significantly enhance the efficiency and reliability of diagnosis.

 

COVID-19 is diagnosed using real-time polymerase chain reaction (RT-PCR). During RT-PCR, primers anneal to specific sequences found only in COVID-19, and amplify them. The number of amplification cycles is represented by Cq, where a value lower than the reference means positive, and a value higher than the reference means negative.

 

▲ COVID-19 genetic reference material developed by KRISS

 

The problem is that diagnostic kits have different reference values. Using the same product each time is impossible due to the limited supply of diagnostic kits and surge in numbers of patients. If two different products use different standards to test for positives, it is difficult to determine which value is more reliable. This issue can be resolved by developing a reference material containing accurate genetic information about COVID-19.

 

 ? A reference material is often described as a problem with an answer sheet. If given a reference material (problem) and accurate measurements (answer sheet), product accuracy can be improved through comparison with other companies. 

 

 

▲ Seil Kim, principal researcher of the Microbiological Analysis Team, is producing COVID-19 reference material

 

The research team succeeded in developing its COVID-19 reference material by employing Reverse Transcription Digital PCR (RT-dPCR). This method is capable of absolute quantitative analysis, enabling users to determine not only the presence of COVID-19, but also the specific number of strains in a specimen.

 

The team’s COVID-19 reference material covers about 90% of the entire genome, which is 10% more than the reference material developed by China. Since it contains more genetic information, it allows rapid response to viral variants.

 

▲ The research team of KRISS is producing COVID-19 reference material

 

The proposed reference material can be applied to COVID-19 diagnostic kits for immediate use. It will contribute to enhancing the reliability and accuracy of domestic diagnostic kits, which have seen a consistent increase in export demand.

 

Seil Kim, principal researcher of the Microbiological Analysis Team, said, “Through cooperation with CEVI, we were able to secure COVID-19 genes and genomes. We are currently developing a reference material that is of a more similar form to the COVID-19 virus particle.”

 

Young-Kyung Bae, principal researcher of the Biopharmaceutical Metrology Team, said, “The reference material will be useful in quality management of diagnostic kits being exported around the world.”

 

▲ The research team of KRISS

(Clockwise from the top left) Seil Kim(principal researcher), Heemin Yoo(senior researcher), Young-Kyung Bae(principal researcher), Da-hye Lee(senior researcher)

 

Hyun-Min Park, president of KRISS, said, “The new reference material is the result of two specialized teams working together following the team-unit reorganization implemented this year. We will continue to address national issues, and produce results that directly benefit citizens. Together with the Korean Agency for Technology and Standards, we will develop reference materials for antigen and antibody detection.”

 

The study was supported by KRISS and the Multidisciplinary Research Group Program of the National Research Council of Science & Technology.