2004～2006年全国凝血试验室间质量评价数据分析

External Quality Assessment Scheme of Coagulation Test in China from 2004 to 2006

目的 分析全国凝血试验室间质量评价的结果，了解凝血试验室间质评的状况，提出改进措施。方法 定期向参加凝血试验室间质评的实验室发放质评物，参评实验室对质评物进行检测，并回报结果，按照不同检测水平和仪器试剂分组后，计算加权均值、变异系数和及格率，并对及格率进行统计分析。结果 2004～2006年各项目（包括PT、INR、APTT和Fbg）在正常水平内的及格率较高（89．O％～99．oN），在高度异常水平（除Fbg外）及格率较低（74．3％～84．0％）。各水平组不同年度间及格率经x^2检验差异均无显著性（P〉0.05）；每年每个项目3种水平（除Fbg外）的及格率经x^2检验，差异有显著性；仪器试剂分组后，各项目变异系数较大组的及格率较低。结论 异常水平样本的PT和APTT质评结果变异较大，非配套系统的PT、INR、APTT和Fbg的质评结果变异较大，建议选择配套系统，定期校准仪器，并开展异常水平的室内质控，使用非配套系统的实验室应与配套系统进行结果比对。

Objective To grasp and improve the current status of the external quality assurance scheme （EQA） for coagulation tests （PT,APTT,Fbg） by analysis of the results of EQA. Methods We provided the control materials to EQA participants twice a year from 2004 to 2006. These laboratories measured them using their routine methods, then the results were returned. We calculated the average, coefficient of variation （CV） and pass rates of blood coagulation tests at different levels and different groups of assaying system, and tested the pass rates with chi-square test. Results The pass rates of blood coagulation tests in normal level were higher with the ranging from 89.0% to 99.0% while those in abnormal level were lower with the ranging from 74.3% to 84.0%. There was no significant difference on statistics （P〉0. 05） among the pass rates of different years. The results of the pass rates of three levels in every items from 2004 to 2006 had significant difference （P〈0. 05）. After grouping by different instruments and reagents, the groups of bigger CV had lower pass rates. Conclusion The abnormal sample and the incompatible testing system have high CV. It is suggested that the participants should use the compatible testing systems, calibrate the testing system in a given day, perform internal quality control in abnormal level. And the participants with incompatible testing system should compare their results with those from compatible testing system.