Development of Korea's First Standard Material for COVID-19 Delta Variant Virus

Korea Research Institute of Standards and Science "Utilized for Diagnostic Kit Development and Evaluation"

Mutation information of the spike protein in major variants of the COVID-19 virus (SARS-CoV-2) RNA. Image provided by Korea Research Institute of Standards and Science.

[Asia Economy Reporter Kim Bong-su] The Korea Research Institute of Standards and Science (KRISS) announced on the 24th that it has succeeded in developing the country's first standard material for the genetic material of the COVID-19 Delta variant virus.

This standard material was urgently developed to respond to the rapidly spreading Delta variant virus, following the COVID-19 virus genetic standard material developed in 2020. It can be used for product development and evaluation of diagnostic kits currently in use or under development, and is expected to significantly improve the efficiency and reliability of Delta variant diagnosis.

Since 2020, COVID-19, which has been a global pandemic, has designated Alpha, Beta, Gamma, and Delta as major variants. However, currently, most of the detected COVID-19 viruses are the Delta variant, and the situation is similar in Korea.

Due to this shift in dominant variants, it is necessary to evaluate whether the diagnostic methods previously used are effectively applicable to the Delta variant. Also, future diagnostic methods must be able to effectively diagnose the Delta variant, so the need for Delta variant standard material has greatly increased.

The research team cultured the Delta variant strain isolated domestically, extracted genomic RNA, and quantified individual genes using digital PCR to manufacture the standard material with these characteristic values. Unlike existing standard materials produced through gene synthesis, this one was made by culturing the actual virus. It includes 100% of the entire genome, making it expected to be useful for developing COVID-19 virus genome analysis methods.

Additionally, by using a common standard material, the performance of domestically developed diagnostic kits can be objectively demonstrated. It is also expected to contribute to the export of Korean diagnostic kits.

Seil Kim, Principal Researcher of the Microbial Analysis Standards Team at KRISS, stated, "KRISS is the first national measurement standards institution to produce standard material for the Delta variant," and explained, "This standard material improves the accuracy of positive/negative judgment criteria, enhancing diagnostic reliability, and can also evaluate the sensitivity and accuracy of genome analysis methods."

Meanwhile, the COVID-19 virus RNA standard material developed in 2020 has been distributed over 280 times to date, and the Delta variant standard material is available for purchase at the KRISS Standard Performance Fair.

The results of this research were published online in the international journals Journal of Microbiology and Biotechnology and International Journal of Molecular Science.

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