[Production and Management of Reference Materials for Infectious Disease Laboratory Testing]

Reference materials (RMs) are essential for ensuring the accuracy and reliability of infectious disease test results. Since 2016, the Korea Disease Control and Prevention Agency has established annual RM project plans that systematically review various requirements and produce high-quality RMs according to the guidelines established by the Korean Industrial Standards (KS) A International Organization for Standardization (ISO) Guide 35 (Guidance on the Evaluation of Homogeneity and Stability of Reference Materials), KS A ISO 17034 (General Requirements for the Competence of Reference Material Producers), and the World Health Organization Technical Report Series. RMs are produced by establishing a material production plan, acquiring raw materials and production materials, and dispensing and packaging materials that have been confirmed to possess conformity characteristics. RMs are produced from manufactured candidate reference materials that have been confirmed to have homogeneous and stable characteristics through homogeneity and stability assessments. The resulting RMs serve multiple purposes, functioning as positive controls for infectious disease testing, internal quality assurance materials, and as a basis for development and validation of testing methodologies for emerging diseases. Additionally, select items are deposited in the National Culture Collection for Pathogens to facilitate their accessibility by relevant public and private organizations.