摘要：
Objective To investigate current status and problems of anticoagulant proteins assay in domestic laboratories so as to provide suggestions for implementing the standardization and quality improvement.Methods Two hundred and seventy-four laboratories those had developed or prepared to do anticoagulant proteins assay were selected from one thousand and five hundred participants in the national coagulation screening External Quality Assessment (EQA) program by an internet survey and then a questionnaire and quality control materials were sent to them to carry out a further survey.The questionnaire information was analyzed statistically.The results of quality control materials were grouped by the reagents and the average,median,standard deviation (s),coefficient variation (CV) of each group were calculated.The deviations or percentage deviations were determined by comparing the results of each laboratory to the target defined as the peer-group median after exclusion of outliers,and then the pass rates were calculated based on the criterion of RCPA,DGKL and the allowable total error based on biological variation.Results Two hundred and thirty-five questionnaires were collected.The number of laboratories testing antithrombin (AT),protein C(PC) and protein S(PS) activity were 194,63 and 50 respectively.The instruments and reagents were mainly from abroad (more than 96％),the matching rate of which were above 94％.For AT,PC and PS activity testing,there were 30.4％,33.3％,34.0％ of laboratories did not perform verification assays respectively,and 8.8％,7.9％,14.0％ of laboratories did not renew calibration curve when the reagent lots were changed.11.3％,17.5％,16.0％ of laboratories didn't run internal quality control,and 34.9％,26.9％,21.4％ of laboratories only performed a single level of quality control.4.1％ of laboratories set the reference intervals of AT activity according to different age groups,and the percentage of that of PC and PS activity were 1.6％ and 2.0％.16.0％ of laboratories set the reference interval of PS activity by sex.For normal control materials,the CV of AT,PC and PS activity results were 5.7％-12.9％,4.2％-7.7％ and 18.4％-33.1％ while the CV for abnormal level were 13.3％-38.3％,6.1％-14.4％ and 31.5％-34.5％ respectively.The pass rate was different when it was judged by different criteria.A suitable criterion for each item should be selected according to the concentration level of quality control materials.Conclusion The comparability between laboratory results are not satisfactory and in order to promote quality improvement,it is necessary to develop guidelines,organize trainings and establish a national EQA scheme.%目的 了解国内实验室抗凝蛋白检测现状及存在问题,为实施抗凝蛋白检测的规范化及质量改进提供依据.方法 通过对1 500家参加全国凝血试验实验室间质量评价的实验室进行网络调查,筛选出已开展或准备开展抗凝蛋白检测的274家实验室作为调查对象进行问卷及质控物检测调查.对问卷回报信息进行统计分析;将质控物检测结果按试剂品牌分组,计算各组均值、中位数、标准差(s)及变异系数(CV),以组内剔除离群值后的中位数为靶值,计算各实验室检测结果与靶值的绝对或相对偏差;以澳大利亚皇家病理学会(RCPA)、德国临床化学和检验医学学会(DGKL)和基于生物学变异允许总误差的要求为评价标准,计算各项目各组实验室检测结果的及格率.结果 235家实验室回报了问卷,其中开展抗凝血酶(AT)、蛋白C(PC)和蛋白S(PS)活性检测的实验室分别为194、63和50家.所用仪器和试剂以进口品牌为主(占96％以上),仪器和试剂配套率均在94％以上.对于AT、PC和PS活性检测,分别有30.4％、33.3％和34.0％实验室未对所用仪器进行性能验证,8.8％、7.9％和14.0％实验室未在更换试剂批号时进行定标,11.3％、17.5％和16.0％实验室未常规开展室内质控,34.9％、26.9％和21.4％实验室仅进行单个浓度水平的质控.分别有4.1％、1.6％和2.0％实验室按年龄分组设置AT、PC和PS活性参考区间,16.0％实验室按性别分组设置PS活性参考区间.质控物检测结果显示,正常水平质控物AT、PC和PS活性检测结果的CV范围分别为5.7％～12.9％、4.2％ ～7.7％和18.4％ ～33.1％;异常水平质控物的CV范围分别为13.3％～38.3％、6.1％～14.4％和31.5％～34.5％.使用不同评价标准的及格率存在差异,各项目应根据浓度水平分别选择合适的评价标准.结论 不同实验室间检测结果可比性较差,拟通过制订相关技术要求、加强人员培训及开展全国室间质量评价等方式实施质量改进.
