GLP体系下全自动血凝分析仪的3Q验证  

3Q verification of automatic blood coagulation analyzer under good laboratory practice system

作　　者：张谦[1] 张微[1] 吕晓丽[2] 曹晓东[1] 常福厚[1,2] 

机构地区：[1]内蒙古医科大学新药安全评价研究中心,呼和浩特010110 [2]内蒙古医科大学药学院,呼和浩特010110

出　　处：《国际检验医学杂志》2016年第23期3241-3242,3245,共3页International Journal of Laboratory Medicine

基　　金：国家自然科学基金资助项目(81260499)

摘　　要：目的以Sysmex CA7000全自动血凝分析仪为例,探究良好实验室规范(GLP)体系下全自动血凝分析仪3Q验证过程。方法选择凝血酶原时间(PT)、活化部分凝血活酶时间(APTT)、凝血酶时间(TT)、纤维蛋白原(FIB)4项检验指标,对仪器的批内精密度、日间精密度、准确性、线性、携带污染率进行性能验证。结果 PT、APTT、TT、FIB的批内精密度CV值分别为1.33%、1.57%、1.47%、1.90%;日间精密度CV值分别为1.73%、1.52%、1.55%、2.14%;在准确度方面,PT、APTT、TT、FIB的正常质控CV值分别为7.45%、3.88%、-4.98%、4.36%,PT、APTT的异常质控CV值分别为8.11%、8.77%;FIB的线性相关系数(r)值为0.999 3,a值为1.02;标本携带污染率最高CV值为2.15%;所测结果均符合行业通用标准和仪器厂家要求。结论通过GLP体系下的3Q验证,Sysmex CA7000血凝分析仪各方面性能优良,可以用于临床检验部的检验工作。Objective To explore the procedures of 3Qvalidation for blood coagulation analyzer under the good laboratory practice（GLP）system based on the Sysmex CA7000 automatic blood coagulation analyzer.Methods Four test indicators of PT,APTT,TT and FIB were chosen to conduct the performance verification in the within-run precision,between-day precision,accuracy,linearity,carry-over contamination rate of the automatic blood coagulation analyzer.They were prothrombin time（PT）,activated partial thromboplastin time（APTT）,thrombin time（TT）,and fibrinogen（FIB）.Results The within-run precision CV values of PT,APTT,TT and FIB were 1.33%,1.57%,1.47% and 1.90%,respectively;the inter-day precision CVvalues of PT,APTT,TT and FIB were 1.73%,1.52%,1.55% and 2.14% respectively;in terms of accuracy,the normal quality control CVvalues were7.45%,3.88%,-4.98% and 4.36% respectively;the abnormal quality control CV values of PT and APTT were 8.11% and8.77% respectively;the r value of FIB linear correlation coefficient was 0.999 3,the a value was 1.02;the highest CVvalue of carry-over contamination rate was 2.15%;the detected results all conformed to the general industry standards and requirements of instrument manufacturer.Conclusion The 3Qvalidation under the GLP system proves that the Sysmex CA7000 automatic blood coagulation analyzer is good in performance and is appropriate for the laboratory work of clinical laboratory department.

关 键 词：良好实验室规范 全自动血凝分析仪 3Q验证 

分 类 号：R446.1[医药卫生—诊断学]