希森美康系列全自动凝血分析仪检测结果间可比性分析
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摘要
目的希森美康(Sysmex)CA7000和CS5100全自动凝血分析仪常规凝血项目结果可比性分析。方法参照中华人民共和国卫生行业标准WS/T407-2012《医疗机构内定量检验结果的可比性验证指南》及WS/T406-2012《临床血液学检验常规项目分析质量要求》,验证Sysmex CA7000和CS5100凝血酶原时间(PT)、活化部分凝血活酶时间(APTT)、纤维蛋白原(FIB)、凝血酶时间(TT)、D-二聚体(D-D)、纤维蛋白(原)降解产物(FDP)不精密度,计算比对数据相对偏差并分析直线回归方程,判断仪器间结果可比性。结果批内精密度正常标本和异常标本变异系数(CV)均在规定范围内。相对偏差≤1/2CLIA′88,直线回归分析显示r~2>0.950或r>0.975。结论 Sysmex CA7000及CS5100凝血分析仪常规检测项目结果准确可靠,具有可比性。
Objective To analyze the comparability of detection results in routine blood coagulation items between the Sysmex CA7000 and CS5100 automatic blood coagulation analyzer.Methods According to the health industrial standards of the People′s Republic of China WS/T407-2012 the Guidelines for the Verification of Comparability of Quantitative Test Results in Medical Institutions and WS/T406-2012" the Analytical Quality Requirements of Routine Items of Clinical Hematologic Detection,the imprecision of prothrombin time(PT),activated partial clotting enzyme live time(APTT),fibrinogen(FIB),thrombin time(TT),D-Dimer(D-D),fibrin/degradation products(FDP)detected by Sysmex CA7000 and CS5100 were verified,the relative deviations of comparative data were calculated,the linear regression equation was analyzed,then the comparability between the instruments was judged.Results The coefficient of variation(CV)of within-run precision in normal and abnormal samples was within the prescribed scope.The relative deviation≤ 1/2 CLIA′88,the linear regression analysis showed that r~2>0.950 or r>0.975.Conclusion The results of routine detection items by Sysmex CA7000 and CS5100 automatic blood coagulation analyzers are accurate and reliable with comparability.
Objective To analyze the comparability of detection results in routine blood coagulation items between the Sysmex CA7000 and CS5100 automatic blood coagulation analyzer.Methods According to the health industrial standards of the People′s Republic of China WS/T407-2012 the Guidelines for the Verification of Comparability of Quantitative Test Results in Medical Institutions and WS/T406-2012" the Analytical Quality Requirements of Routine Items of Clinical Hematologic Detection,the imprecision of prothrombin time(PT),activated partial clotting enzyme live time(APTT),fibrinogen(FIB),thrombin time(TT),D-Dimer(D-D),fibrin/degradation products(FDP)detected by Sysmex CA7000 and CS5100 were verified,the relative deviations of comparative data were calculated,the linear regression equation was analyzed,then the comparability between the instruments was judged.Results The coefficient of variation(CV)of within-run precision in normal and abnormal samples was within the prescribed scope.The relative deviation≤ 1/2 CLIA′88,the linear regression analysis showed that r~2>0.950 or r>0.975.Conclusion The results of routine detection items by Sysmex CA7000 and CS5100 automatic blood coagulation analyzers are accurate and reliable with comparability.
引文
[1]中华人民共和国卫生部.关于医疗机构间医学检验,医学影像互认有关问题的通知[A].北京:中华人民共和国卫生部,2006.
[2]中华人民共和国卫生部.医疗机构内定量检验结果的可比性验证指南:WS/T407-2012[S].北京:中国标准出版社,2012.
[3]中华人民共和国卫生部.临床血液学检验常规项目分析质量要求:WS/T 406-2012[S].北京:中国标准出版社,2012.
[4]秦晓光.“检查结果互认”和质量管理[J].中华检验医学杂志,2007,30(2):132-135.
[5]中国合格评定国家认可委员会.医学实验室质量和能力认可准则:CNAS-CL02[S].北京:中国标准出版社,2013.
[6]吴际,郑卫东,李广华,等.不同检测系统凝血四项结果的可比性验证[J].临床输血与检验,2015,17(1):26-29.
[7]贾连玲,龙宪连,门帅,等.两台凝血分析仪检测结果的可比性研究[J].国际检验医学杂志,2014,35(22):3137-3138.
[8]丛玉隆.血栓与止血试验诊断的现状及发展[J].中华检验医学杂志,2001,24(1):5-7.
[9]苏杨.实验室内两台全自动凝血分析仪凝血酶原时间的校准与检验结果可比性研究[J].临床和实验医学杂志,2012,11(5):361-363.
[10]何新发,李燕妮.比较Sysmex CS5100与Sysmex CA1500全自动凝血分析仪凝血四项的检测[J].国际检验医学杂志,2014,35(20):2830-2831.
[11]阳建,余赛红,文艳,等.2种全自动血凝分析仪检验结果的线性分析[J].国际检验医学杂志,2013,34(23):3226-3227.
[12]中华人民共和国卫生部.医疗机构临床实验室管理办法[A].北京:中华人民共和国卫生部,2006.
[2]中华人民共和国卫生部.医疗机构内定量检验结果的可比性验证指南:WS/T407-2012[S].北京:中国标准出版社,2012.
[3]中华人民共和国卫生部.临床血液学检验常规项目分析质量要求:WS/T 406-2012[S].北京:中国标准出版社,2012.
[4]秦晓光.“检查结果互认”和质量管理[J].中华检验医学杂志,2007,30(2):132-135.
[5]中国合格评定国家认可委员会.医学实验室质量和能力认可准则:CNAS-CL02[S].北京:中国标准出版社,2013.
[6]吴际,郑卫东,李广华,等.不同检测系统凝血四项结果的可比性验证[J].临床输血与检验,2015,17(1):26-29.
[7]贾连玲,龙宪连,门帅,等.两台凝血分析仪检测结果的可比性研究[J].国际检验医学杂志,2014,35(22):3137-3138.
[8]丛玉隆.血栓与止血试验诊断的现状及发展[J].中华检验医学杂志,2001,24(1):5-7.
[9]苏杨.实验室内两台全自动凝血分析仪凝血酶原时间的校准与检验结果可比性研究[J].临床和实验医学杂志,2012,11(5):361-363.
[10]何新发,李燕妮.比较Sysmex CS5100与Sysmex CA1500全自动凝血分析仪凝血四项的检测[J].国际检验医学杂志,2014,35(20):2830-2831.
[11]阳建,余赛红,文艳,等.2种全自动血凝分析仪检验结果的线性分析[J].国际检验医学杂志,2013,34(23):3226-3227.
[12]中华人民共和国卫生部.医疗机构临床实验室管理办法[A].北京:中华人民共和国卫生部,2006.