相同项目在两台凝血分析仪测定结果的可比性分析

Comparative Study on Result of Same Test with Different Automatic Coagulation Analyzer

目的通过对两台凝血分析仪进行方法学比较和偏差评估,了解不同凝血分析仪间对相同项目的测定结果是否具有可比性并判断其偏差的临床可接受性。方法选取北京市二龙路医院2017年6月收集不同浓度的新鲜血浆样本40例,在两台不同的凝血分析仪(CA530、BECompact)测定凝血酶原时间(PT)、活化部分凝血酶原时间(APTT)和纤维蛋白原(Fg),对结果进行统计学分析,以美国临床实验室修正法规(CLIA’88)规定的室间质量评价允许误差范围的1/2为标准,判断两个不同检测系统间测定结果的可比性。结果CA530的PT、INR、APTT测定结果与BECompact比较差异均无统计学意义(P>0.05),相关系数(r)分别为0.981、0.980、0.980;CA530的Fg测定结果与BECompact比较,差异有统计学意义(P<0.05),r=0.978。医学决定水平处的系统误差均<总允许误差的1/2(PT:T±7.5%;APTT:T±7.5%;Fg:T±10%)。结论以CA530作为参比系统,BECompact的测定结果具有临床可接受性;当用两个或以上的检测系统对同一项目进行测定时,应进行方法学比对,使检验结果具有一致性,以适应临床需要。

Objective To understand the comparability and clinical acceptability of the results measured by different coagulation analyzers for the same items through methodology comparison and deviation evaluation for two coagulation analyzers.Methods Forty fresh plasma samples with different concentrations during June in 2017 in our laboratory were collected and measured by two different coagulation analyzers(CA530 and BECompact)for PT,APTT and Fg.The comparability of the results measured by two different test systems was identified with 1#2 of the allowable error range of external quality assessment prescribed in Clinical Laboratory Improvement Amendment 1988(CLIA’88)as the standard.Results The difference between the PT,INR and APTT results measured by CA530 and BECompact was insignificant(P>0.05),and the correlation coefficients(r)were 0.981,0.980 and 0.980,respectively.The difference between the Fg results measured by CA530 and BECompact was significant(P<0.05),with r=0.978.The system errors at medical decision level were less than 1#2 of the total allowable error(PT:T±7.5%;APTT:T±7.5%;Fg:T±10%).Conclusion With the CA530 system as reference,the results measured by BECompact are clinically acceptable.In case of using two or more test systems to measure the same item,methodology comparison shall be conducted to get consistent results and meet the clinical needs.