Braga Federica, Pasqualetti Sara, Panteghini Mauro
Research Centre for Metrological Traceability in Laboratory Medicine (CIRME), University of Milan, Milan, Italy.
Research Centre for Metrological Traceability in Laboratory Medicine (CIRME), University of Milan, Milan, Italy.
Clin Biochem. 2018 Jul;57:23-28. doi: 10.1016/j.clinbiochem.2018.02.004. Epub 2018 Feb 9.
Once an in-vitro diagnostic (IVD) measuring system has been marketed and introduced into daily practice, the possible sources of degradation of its performance are numerous. It is therefore essential to put in place a continuous post-market surveillance of the quality of performance of the IVD system and of the laboratories that perform measurements in clinical setting. The participation to external quality assessment (EQA) schemes that meet specific metrological criteria is central to the evaluation of performance of clinical laboratories in terms of standardization and clinical suitability of their measurements. In addition to the use of commutable materials, in this type of EQA it is necessary to assign values (and uncertainty) to them with reference procedures and to define and apply clinically permissible analytical performance specifications to substantiate the suitability of laboratory measurements in the clinical setting. Unfortunately, there are still few permanent EQA programs fully covering these requirements because some practical constraints, including technical and economic aspects, which limit their introduction. It is, however, clear that these issues should be quickly overcome, since EQA schemes are in a unique position to add substantial value to the practice of laboratory medicine, by identifying analytes that need improved harmonization and by stimulating and sustaining standardization initiatives that are needed to support clinical practice. Importantly, this will definitively help those manufacturers that produce superior products to demonstrate the superiority of those products and oblige end users (and consequently industry) to abandon assays with demonstrated insufficient quality.
一旦体外诊断（IVD）测量系统上市并引入日常实践，其性能下降的可能来源众多。因此，对IVD系统以及在临床环境中进行测量的实验室的性能质量进行持续的上市后监测至关重要。参与符合特定计量标准的外部质量评估（EQA）计划，对于评估临床实验室测量的标准化和临床适用性方面的性能至关重要。除了使用可互换材料外，在这类EQA中，有必要使用参考程序为其赋值（及不确定度），并定义和应用临床允许的分析性能规范，以证实实验室测量在临床环境中的适用性。不幸的是，由于包括技术和经济方面在内的一些实际限制，目前仍很少有能完全满足这些要求的永久性EQA计划。然而，很明显这些问题应尽快克服，因为EQA计划处于独特地位，能够通过识别需要改进协调的分析物，以及通过推动和维持支持临床实践所需的标准化举措，为检验医学实践增添重大价值。重要的是，这将最终帮助那些生产优质产品的制造商证明其产品的优越性，并迫使终端用户（进而行业）放弃已证明质量不足的检测方法。
