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实验室间质量控制的外部质量控制程序

External quality control program for inter-laboratory quality control.

作者信息

Bewarder N, Müller P

机构信息

BIOREF GmbH, Dammweg 1, D-63776, Mömbris, Germany.

出版信息

Anticancer Res. 2000 Nov-Dec;20(6D):5213-6.

Abstract

BACKGROUND

The accuracy and precision of tumor marker testing is of high clinical importance requiring the implementation of effective quality control procedures in the diagnostic laboratory. An external quality control program including an inter-laboratory comparison could be of help in improving the quality of test results.

MATERIALS AND METHODS

Laboratories using BIOREF reference material sent their routine internal quality control results of each monthly control period to the evaluation center for statistical analysis and inter-laboratory comparison.

RESULTS

The inter-laboratory comparison showed that the mean values of test results obtained by different laboratories can vary considerably especially when different test kits are used. A comparison of test results of laboratories using the same test kit showed much better correlation but discrepancies of coefficients of variation between these laboratories were still observed.

CONCLUSION

An external quality control program revealed problems in the accuracy and precision of tumor marker test results in the individual laboratory, which could serve as a basis for the improvement of test performance.

摘要

背景

肿瘤标志物检测的准确性和精密度具有高度临床重要性,要求诊断实验室实施有效的质量控制程序。包括实验室间比对在内的外部质量控制计划有助于提高检测结果的质量。

材料与方法

使用BIOREF参考物质的实验室将每个月度质控期的常规内部质量控制结果发送至评估中心进行统计分析和实验室间比对。

结果

实验室间比对表明,不同实验室获得的检测结果均值可能存在相当大的差异,尤其是在使用不同检测试剂盒时。使用相同检测试剂盒的实验室的检测结果比对显示出更好的相关性,但这些实验室之间变异系数的差异仍然存在。

结论

外部质量控制计划揭示了单个实验室肿瘤标志物检测结果在准确性和精密度方面存在的问题,这可为改进检测性能提供依据。

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