Innovative Organic Metrology for Clinical Diagnostics: Challenges and Opportunities towards Telemedicine, AI, and Preventive Healthcare
Clinical testing using human-derived samples, such as blood and urine, has made remarkable progress due to advacements in measurement technologies and standards, playing a crucial role in supporting human health and well-being. In response to emerging trends and evolving healthcare demands, there are several challenges in this field that need to be addressed. Key cahllenges include, 1) ensuring the reliability of measurements for the implementation of telemedicine and centralized testing, which has seen explosive demand since the COVID-19 pandemic; 2) improving the quality of medical data for the successful integration of AI technologies; and 3) enabling early diagnosis and disesase prevention in response to the global aging trend. To address these challenges, the Korea Research Institute of Standards and Science (KRISS) is conducting innovative research and development efforts. Firstly, as part of standardizing micro-sampling blood collection methods that maximize the advantages of remote blood sampling (home sampling) and easy delivery for the establishment of telemedicine and remote testing systems, KRISS is developing certified reference materials for dried blood spots, the most widely used micro-sampling platform. It is also conducted fundamental research on traceability and bias factors to improve the measurement reliability of this sampling method. Additionally, in collaboration with the National Health Insurance Service of Korea, KRISS is developing national reference standards based on the big data originated from huge Korea National Healthcare System. The projects have improved the quality of accumulated medical database, an outstanding national resource of Korea by assessment of measurement traceability and uncertainty for integration with AI data validation. This effort is paving the way for improving national healthcare and public well-being through data qualification. Lastly, in response to the global aging trend and the growing emphasis on preventive healthcare, KRISS is developing standards for precision medicine. These standards aim to assess environmental hazard exposure and enable early disease detection. The reference materials for the purposes take roles in qualification to evaluate the bio-exposure toxicity and efficacy of diverse environmental factors. These materials will also play a crucial role in quality control for laboratories, ensuring consistent and reliable results that contributes to national policies and healthcare programs through the establishment of a national measurement system. The strength of organic metrology lies in its straightforward apporach to both measurands and measurement procedures, even in complex biological applications. It ensures completely established measurement traceability to the International System of Units (SI) and utilizes matrix-matched reference materials, which are essential for building a global measurement network and ensuring reliability across the world. Over the past decades, significant progress has been made in developing measurement system and standardization based on organic metrology, driven by the efforts of the Organic Analysis Working Group (CCQM-OAWG) and the Joint Committee for Traceability of Laboratory Medicine (JCTLM). In the coming century, this strong foundation is expected to play a key role in realizing telemedicine, AI-powered healthcare, and precision medicine for the 'sustainable’ health and well-being of humanity.