Beastall Graham H, Brouwer Nannette, Quiroga Silvia, Myers Gary L
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Clin Chem Lab Med. 2017 Jul 26;55(8):1100-1108. doi: 10.1515/cclm-2017-0060.
Laboratory medicine results influence a high percentage of all clinical decisions. Globalization requires that laboratory medicine results should be transferable between methods in the interests of patient safety. International collaboration is necessary to deliver this requirement. That collaboration should be based on traceability in laboratory medicine and the adoption of higher order international commutable reference materials and measurement procedures. Application of the metrological traceability chain facilitates a universal approach. The measurement of serum cholesterol and blood HbA1c serve as examples of the process of method standardization where an impact on clinical outcomes is demonstrable. The measurement of plasma parathyroid hormone and blood HbA2 serve as examples where the current between-method variability is compromising patient management and method standardization and/or harmonization is required. Challenges to the widespread adoption of traceability in laboratory medicine include the availability of reference materials and methods, geographical differences, the use of variable units, complex analytes and limited global coordination. The global collaboration requires the involvement of several different stakeholder groups ranging from international experts to laboratory medicine specialists in routine clinical laboratories. A coordinated action plan is presented with actions attributable to each of these stakeholder groups.
检验医学结果影响着绝大部分临床决策。全球化要求检验医学结果在不同方法间具有可转移性，以保障患者安全。国际合作对于实现这一要求至关重要。这种合作应基于检验医学的可追溯性以及采用更高层级的国际通用参考物质和测量程序。计量可追溯链的应用促进了一种通用方法。血清胆固醇和血液糖化血红蛋白（HbA1c）的测量作为方法标准化过程的示例，其对临床结果的影响是可证明的。血浆甲状旁腺激素和血液糖化血红蛋白A2（HbA2）的测量作为示例，说明当前方法间的变异性正在影响患者管理，需要进行方法标准化和/或协调。检验医学中广泛采用可追溯性面临的挑战包括参考物质和方法的可获得性、地域差异、单位的使用差异、复杂分析物以及全球协调有限。全球合作需要多个不同利益相关者群体的参与，从国际专家到常规临床实验室的检验医学专家。本文提出了一项协调行动计划，明确了每个利益相关者群体应采取的行动。
