一期凝固法凝血因子Ⅷ活性检测医学决定水平的性能验证  

The Validation of Medical Determination Level of Coagulation FactorⅧActivity by One-Stage Coagulation Method

作　　者：李敏[1,2] 寿玮龄[1] 范连凯[1] 陈倩[1] 吴卫[1] LI Min;SHOU Weiling;FAN Liankai;CHEN Qian;WU Wei(Department of Laboratory Medicine,Peking Union Medical College Hospital,Chinese Academy of Medical Sciences,Beijing 100730,China;Department of Laboratory Medicine,Weifang People’s Hospital,Weifang 261041,China)

机构地区：[1]中国医学科学院北京协和医院检验科,北京100730 [2]潍坊市人民医院检验科,山东潍坊261041

出　　处：《标记免疫分析与临床》2022年第6期1015-1020,共6页Labeled Immunoassays and Clinical Medicine

基　　金：北京市临床重点专科医学检验科卓越项目(编号:2K201000);潍坊市卫健委基金项目(编号:wfwsjk_2019_069)。

摘　　要：目的对一期凝固法凝血因子Ⅷ活性(FⅧ:C)检测系统进行性能验证。方法依据中国合格评定国家认可委员会(CNAS)-GL037《临床化学定量检验程序性能验证指南》及相关卫生行业标准提供的方案,对ACL TOP 700全自动凝血分析仪及其配套试剂一期凝固法测定FⅧ:C精密度、正确度、准确度、线性范围、可报告范围、定量检出限、医学决定水平不精密度、携带污染率、抗干扰实验及参考范围进行验证。结果批内不精密度变异系数(CV)值为1.8%~4.1%(≤5%),批间不精密度CV值为3.5%~3.9%(≤10%)。正确度:偏倚为-1.3%(在±10%范围内)。准确度:两个浓度室间质评物质偏倚差分别为1.81%和-0.87%(均在±10%范围内)。线性范围:14.6%~142.7%(R^(2)=0.9939)。定量检出限:1%,与厂商声称相符。医学决定水平(1%、3%、5%)不精密度为5.1%~8.6%(≤10%)。稀释验证:在32倍及以下稀释时,R值均在80%~120%之间。可报告范围:1%~428.1%。携带污染率:0(≤10%)。干扰实验结果显示有较强的抗干扰能力。参考范围(50%~150%)验证:20例表观健康人有19例检测结果在参考范围内,验证通过。结论一期凝固法Ⅷ因子活性检测系统精密度、正确度、准确度、线性范围、可报告范围、检出限、医学决定水平不精密度、携带污染率、抗干扰能力、参考范围验证等各项性能指标均满足国际标准化组织(ISO)15189的要求,可用于临床检测。Objective To verify the performance of the coagulation factorⅧactivity(FⅧ:C)detection system.Methods According to the program provided by(CNAS)-GL037《Guidance on the Verification of Quantitative Measurement Procedures used in the Clinical Chemistry》and relevant health industry standards,the precision,trueness,accuracy,linear range,reportable range,quantitative detection limit,imprecision of medical decision level,contamination rate,anti-interference experiment and reference range of the detection system were verified.Results The imprecision test results showed that the intra-and inter-batch imprecision coefficient of variation(CV)were 1.8%-4.1%(≤5%)and 3.5%-3.9%(≤10%),respectively.For trueness,the bias was 1.3%(within±10%),while for accuracy,the difference of substance bias between the two levels were 1.81%and-0.87%(both within±10%),respectively.Linear range was 14.6%-142.7%(R^(2)=0.9939).Quantitative detection limit was 1%,in line with manufacturer’s claim.The imprecision of medical decision level was 5.1%-8.6%(≤10%).For Dilution Verification,R value was between 80%and 120%when the dilution was 32 times or less.Reptable range was 1%-285.4%and contamination rate was 0(≤10%).The results of interference test showed that each concentration level had strong anti-interference ability.Reference range(50%-150%)validation showed 19 out of 20 cases of apparent health were in the reference range,suggested the validation passed.Conclusion The precision,trueness,accuracy,linear range,reportable range,detection limit,polution carrying rate,anti-interference ability and reference range verification of the coagulation factorⅧactivity detection system all meet the requirements of the International Organization for Standardization(ISO)15189,suggesting that it can be used in clinical examinations.

关 键 词：性能验证 FⅧ:C 医学决定水平 一期凝固法 

分 类 号：R392-33[医药卫生—免疫学]