Hosogaya Shigemi
Rinsho Byori. 2016 Mar;64(3):278-83.
Clinical laboratory data used in medical examinations and health screening need to have a guaranteed analytical reliability. To ensure the reliability of measurement data, each constituent is required to be compatible with its traceability chain, and any constituent whose traceability chain has yet to be established is required to be appropriately harmonized in the current measurement system. The inter-laboratory reproducibility of standardized measurement values obtained from the external quality assessments conducted by the Japan Medical Association and Japanese Association of Medical Technologists was estimated to evaluate the analytical reliability of clinical tests in Japan. The estimated inter-laboratory reproducibility was then compared with the permissible error limits which have been reported domestically and internationally based on inter- and intra-individual biological variations of healthy subjects. The results showed that most of the measurement uncertainties were sufficiently lower than the permissible limits. This study proposes that the measurement uncertainty of the standardized measurement method has the potential to be a new assessment standard for analytical reliability.
医学检查和健康筛查中使用的临床实验室数据需要具备有保证的分析可靠性。为确保测量数据的可靠性，要求每个成分与其溯源链兼容，对于任何溯源链尚未建立的成分，要求在当前测量系统中进行适当协调。通过日本医学协会和日本医学技术人员协会进行的外部质量评估获得的标准化测量值的实验室间再现性进行了估计，以评估日本临床检验的分析可靠性。然后将估计的实验室间再现性与基于健康受试者个体间和个体内生物学变异在国内和国际上报告的允许误差限进行比较。结果表明，大多数测量不确定度远低于允许限。本研究提出，标准化测量方法的测量不确定度有可能成为分析可靠性的新评估标准。
