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Analytical performance specifications for EQA schemes - need for harmonisation

机译：EQA方案的分析性能规范-协调需求

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摘要

External Quality Assurance (EQA) is a vital tool in laboratory medicine to assess individual laboratory analytical performance and also the differences between the results from different laboratories. This information is also useful for professional bodies and manufacturers as part of post-market surveillance. The process involves the measurement of one or more samples by many laboratories and then assessment of the results. Individual results are generally assessed by how far they lie from a target, which may be established using reference methods or a median of some or all of the submitted results. The distance of a result from the target is compared with analytical performance specifications in order to assess the analytical quality. One of the uses of the Stockholm hierarchy of performance goals is to set the performance specifications for analysis of EQA results. Fifteen years after the Stockholm consensus meeting, EQA analytical performance specifications appear to still vary widely between EQA providers. This can be due to a range of factors, including the rationale for setting the criteria, the expected response to a failure to meet the specified performance, the clinical meaning behind meeting the specifications, and the possible need for further analytical improvements. There are also differences in the models chosen to set the criteria, usually either state of the art or biological variation, and then differences in how these are applied. While harmonisation of EQA performance specifications may be some time off, all EQA providers should define the nature of their specifications and the basis for their selection and make this information available to customers.
机译：外部质量保证（EQA）是实验室医学中评估单个实验室分析性能以及不同实验室结果之间差异的重要工具。此信息对于专业机构和制造商在售后监控中也很有用。该过程涉及许多实验室对一个或多个样品的测量，然后评估结果。单个结果通常通过它们离目标的距离来评估，这可以使用参考方法或部分或全部提交结果的中值来确定。将结果与目标之间的距离与分析性能指标进行比较，以评估分析质量。斯德哥尔摩绩效目标层次结构的用途之一是为EQA结果分析设置绩效规范。在斯德哥尔摩共识会议召开15年之后，EQA分析人员之间的EQA分析性能指标似乎仍然相差很大。这可能是由于一系列因素所致，包括设置标准的理由，对未达到指定性能的预期响应，满足规格要求的临床意义以及可能需要进行进一步的分析改进。选择设置标准的模型也存在差异，通常是现有技术水平或生物学差异，然后是如何应用这些差异。虽然统一EQA性能规范可能需要一些时间，但所有EQA提供者都应定义其规范的性质和选择的依据，并将此信息提供给客户。

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