凝血分析仪流水线4个SYSMEX CS5100模块的凝血酶原时间性能验证

Prothrombin time performance verification of four SYSMEX CS5100 coagulation analyzer modules of an automation chain

目的验证凝血分析仪流水线四个SYSMEX CS5100模块的凝血酶原时间(Prothrombin Time,PT)检测的分析性能。方法随机收集不同PT水平的血液样本并分离血浆,参考临床血液学检验常规项目分析质量要求WS/T 406-2012和美国临床和实验室标准协会(Clinical and Laboratory Standards Institute,CLSI)发布的文件,在室间质评试验的同时,验证四个凝血分析仪模块PT的准确性、精密度,然后进行比对实验并纳入室间质评偏倚,进行分析和评估。结果准确性验证结果(平均偏倚)模块2、3、4、5、分别为-4.1%、-2.3%、-1.904%、-0.3%,准确性验证结果都符合实验要求。精密度验证结果模块2低值和高值试样的批内精密度CV分别为1.89%和1.78%,日间精密度CV分别为2.80%和2.93%;模块3低值和高值试样的批内精密度CV分别为0.62%和0.85%,日间精密度CV分别为2.64%和3.11%;模块4低值和高值试样的批内精密度CV分别为1.97%和2.95%,日间精密度CV分别为3.72%和3.50%;模块5低值和高值试样的批内精密度CV分别为0.91%和0.83%,日间精密度CV分别为2.70%和3.31%,精密度验证结果都符合实验要求。比对实验验证结果,各模块与靶机的比对结果3个模块符合率均为100%,模块2、3、5平均偏倚CV分别为-5.52%、-3.62%、-4.92%;比对试验纳入室间质评偏倚分析后模块3和模块2符合率100%、模块5符合率95%,模块2、3、5平均偏倚CV分别为-7.42%、-5.52%、-6.82%;四个模块间计算相对偏倚均CV<15%,模块2、3、4、5平均CV分别为-2.10%、-0.13%、3.72%、-1.48%,符合率100%;四个模块间互为靶机两两比对,相对偏倚均CV<15%,符合率100%,比对实验验证结果都符合实验要求。结论四个SYSMEX CS5100凝血分析模块组成的流水线检测PT性能参数得到了验证,便于发现流水线各模块间的差异并用以改进,能够对临床提供可靠的实验数据。

Objective To verify the analytical performance of four SYSMEX CS5100 modules of an automation chain for prothrombin time(PT)detection.Methods Blood samples with different PT levels were randomly collected and plasma was separated,According to the analysis quality requirements for routine tests of clinical hematology WS/T 406-2012 and the documents issued by the Clinical and Laboratory Standards Institute(CLSI),in addition to the EQA test,the accuracy and precision of the PT of four coagulation analyzer modules were verified,the comparison experiments and the bias of external quality assessment were analyzed and evaluated.Results The accuracy verification results(average bias)of modules 2,3,4,5 were -4.1%,-2.3%,-1.904%,-0.3%,respectively,and the accuracy verification results met the experimental requirements.Precision verification results:In module 2,the CV of within-run precision for low-value and high-value samples were 1.89% and 1.78%,and the CV of inter-day precision were 2.80% and 2.93%,respectively.In module 3,the CV of within-run precision for low-value and high-value samples were 0.62% and 0.85%,and the CV of inter-day precision were 2.64%and 3.11%,respectively.In module 4,the CV of within-run precision for low-value and high-value samples were 1.97% and 2.95%,and the CV of inter-day precision were 3.72% and 3.50%,respectively.In module 5,the CV of within-run precision for low-value and high-value samples were 0.91% and 0.83%,and the CV of inter-day precision were 2.70% and 3.31%,respectively.The precision verification results met the experimental requirements.The experimental verification results were compared.The coincidence rate of the three modules was 100%,and the average relative deviation CV of modules 2,3 and 5 were -5.52%,-3.62% and -4.92%,respectively.The coincidence rate of module 3 and module 2 was 100%,and the coincidence rate of module 5 was 95%.The average relative deviation CV of module 2,3 and 5 were -7.42%,-5.52% and -6.82%,respectively.The CV of relative bias among the four modules was less than 15%.The average CV of modules 2,3,4 and 5 were -2.10%,-0.13%,3.72% and -1.48%,respectively,and the coincidence rate was 100%.Each of the four modules was a pairwise comparison of the target,the relative bias CV was less than 15%,and the coincidence rate was 100%.The results of the comparison experiment were consistent with the experimental requirements.Conclusion The performance parameters of PT measured by four SYSMEX CS5100 coagulation analysis modules were verified,it is easy to find the differences between the modules of the pipeline and use them for improvement,it can provide reliable experimental data for clinical practice.