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两种不同外部质量评估方案的结果比较支持稳健质量规范的实用性。

Comparison of the results from two different External Quality Assessment Schemes supports the utility of robust quality specifications.

机构信息

PROLARIT, Milan, Italy.

出版信息

Clin Chem Lab Med. 2011 Jul;49(7):1143-9. doi: 10.1515/CCLM.2011.196. Epub 2011 May 17.

DOI:10.1515/CCLM.2011.196
PMID:21574887
Abstract

BACKGROUND

The definition of quality goals to evaluate the performance of laboratories participating in External Quality Assessment Schemes (EQAS) is currently not homogeneous. The aim of the work was to verify the applicability of quality goals based on biological variation comparing the results from two different EQAS.

METHODS

We evaluated the performance of the laboratories participating in two Italian EQAS, presenting similar characteristics in terms of number of participants, type of EQA-samples, and program organization. The results were obtained during 2007 for 27 components in the regional scheme of Lombardy (RGL) and in the national scheme of Prolarit (PRL). The percentage total error of single measurements was calculated for each reported EQA value. The total error values at the 68th percentile, at selected critical concentration values, were compared with maximum tolerable error derived from biological variation.

RESULTS

The performance of laboratories participating in the RGL scheme was significantly better. The frequency of satisfactory performance at, respectively, minimum, desirable and optimum levels was 98%, 80% and 59% in the RGL scheme, and 73%, 56% and 22% in the PRL scheme.

CONCLUSIONS

Due to the different performance shown in the two programs, objective analytical goals based on biological variability constitute the optimal solution.

摘要

背景

目前,用于评估参与外部质量评估计划(EQAS)的实验室绩效的质量目标的定义并不统一。这项工作的目的是通过比较两个不同 EQAS 的结果来验证基于生物学变异的质量目标的适用性。

方法

我们评估了在意大利两个 EQAS 中参与的实验室的性能,这两个 EQAS 在参与者数量、EQA 样本类型和项目组织方面具有相似的特征。结果是在 2007 年获得的,涉及伦巴第地区(RGL)的区域计划和 Prolarit(PRL)的全国计划中的 27 个成分。为每个报告的 EQAS 值计算了单次测量的总误差百分比。在选定的临界浓度值处,将第 68 个百分位的总误差值与从生物学变异得出的最大允许误差进行比较。

结果

参与 RGL 计划的实验室的性能明显更好。在 RGL 计划中,分别在最低、理想和最佳水平的满意度性能频率为 98%、80%和 59%,而在 PRL 计划中则为 73%、56%和 22%。

结论

由于两个方案中的性能不同,基于生物学变异性的客观分析目标是最佳解决方案。

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