Jing Rongrong, Wang Huimin, Ju Shaoqing, Cui Ming
Department of Laboratory Medicine, Affiliated Hospital of Nantong University, Nantong, China.
Department of Laboratory Medicine, Affiliated Hospital of Nantong University, Nantong, China.
Clin Biochem. 2018 Jun;56:11-17. doi: 10.1016/j.clinbiochem.2018.04.015. Epub 2018 Apr 18.
Molecular diagnoses have become more widespread in many areas of laboratory medicine where qualitative or quantitative approaches are used to detect nucleic acids. The increasing number of assay methods and the targets for molecular diagnostics contribute to variability in the test results among clinical laboratories. Thus, reference materials (RMs) are required to enhance the comparability of results.
This review focuses on the definition of RMs as well as the production and characteristics of higher order RMs from different organizations and their future strategies.
We describe the recent progress in RMs, including the definition of RMs by the Joint Committee for Guides in Metrology, as well as the production and characteristics of higher order RMs by international official bodies.
There is an urgent need for RMs in nucleic acid testing, especially higher order RMs. To advance the harmonization and standardization of clinical nucleic acid detection, cooperation between the above organizations is proposed and different approaches to higher order RMs development are also needed.
分子诊断在许多医学检验领域已更为普遍，这些领域采用定性或定量方法来检测核酸。分子诊断检测方法及检测靶点数量的不断增加，导致临床实验室间检测结果存在差异。因此，需要参考物质（RM）来提高结果的可比性。
本综述聚焦于参考物质的定义，以及不同组织生产的高级参考物质的特性及其未来策略。
我们描述了参考物质的最新进展，包括计量指南联合委员会对参考物质的定义，以及国际官方机构生产的高级参考物质的特性。
核酸检测迫切需要参考物质，尤其是高级参考物质。为推动临床核酸检测的协调与标准化，建议上述组织之间开展合作，同时也需要开发高级参考物质的不同方法。
