Development of Operational Guide for Proficiency Testing of Infectious Disease Diagnostic Laboratories: Background, Key Contents, and Expected Effects.

OBJECTIVES: Diagnostic results for infectious diseases underpin patient care and public health responses, requiring continuous verification of laboratory competency. Proficiency testing (PT) provides an objective assessment of laboratory performance through interlaboratory comparisons, ensuring the reliability of test results. However, there has been no domestic reference document directly applicable to PT design, operation, and result evaluation for infectious disease diagnostic laboratories. This report outlines the background and key contents of the Operational Guide for Proficiency Testing of Infectious Disease Diagnostic Laboratories developed by the Korea Disease Control and Prevention Agency (KDCA). METHODS: Domestic and international standards were reviewed, covering requirements for PT providers, interlaboratory comparison statistics, the assessment of PT material homogeneity and stability, and the production of reference materials. These standards included: KS Q ISO/IEC 17043, KS Q ISO 13528, KS A ISO 17034, the KOLAS (Korea Laboratory Accreditation Scheme) Proficiency Testing Operation Procedure, and KDCA's Standard Operating Procedures for the National Reference Laboratory. To reflect laboratory workflows, PT preparation, implementation, reporting, and improvement were integrated into a single framework. RESULTS: Built on the framework of KDCA's National Reference Laboratory for Infectious Diseases, the guide can be used by any organization that operates PT (i.e., a PT provider). The design stage defines the objectives, target diseases, participant criteria, test methods, PT material preparation, and statistical analysis. It also provides procedures for verifying homogeneity and stability, determining assigned values, selecting statistical techniques, and reporting results. Following each round, feedback from experts and participants is incorporated into subsequent operations. CONCLUSIONS: The guide enables continuous management of PT from preparation through feedback, rather than serving as a one-time evaluation. Its consistent application and periodic revision are expected to improve operational consistency, enhance quality assurance, and strengthen national capacity to respond to infectious diseases.