应用抗Xa活性测定肝素、低分子肝素及利伐沙班的性能验证

目的评价CS5100全自动血凝仪(简称CS5100)应用抗Xa活性检测血浆肝素、低分子肝素(LMWH)水平及利伐沙班的性能验证。方法参照美国临床和实验室标准协会文件对CS5100应用抗Xa活性检测血浆肝素、LMWH及利伐沙班水平的精密度(批内精密度及日间精密度)、准确度、线性、参考区间、携带污染率性能进行验证。结果CS5100检测血浆肝素、LMWH及利伐沙班水平的批内精密度及日间精密度符合厂家说明书给定的标准;准确性验证结果偏倚在生物学变异系数(CV)要求内;应用试剂配套稀释液时血浆肝素水平的线性验证试验未达标;应用体检健康者血浆作稀释液时肝素、LMWH及利伐沙班水平的线性验证试验理论值和实测值的回归方程均符合要求;携带污染率各参数CV<10%;参考区间验证通过。结论CS5100检测血浆肝素、LMWH及利伐沙班水平的精密度、准确度、携带污染率、线性结果均符合质量控制要求,能够保证检验质量。但要注意检测结果超过线性时,要使用体检健康者血浆作稀释液手动上机检测。

Determination of heparin,low molecular weight heparin and rivaroxaban by anti-Xa activity

Objective To evaluate the performance verification of CS5100 automatic hemagglutination apparatus(CS5100 for short)using anti-Xa activity to detect plasma heparin,low molecular weight heparin(LMWH)levels and rivaroxaban.Methods According to the documents of national committee for Clinical and Laboratory Standards Institute,the accuracy,linearity,reference range and carrying pollution rate of CS5100 in the determination of heparin,LMWH and rivaroxaban in plasma were verified.Results The intra batch and intra day precision of CS5100 in detecting heparin,LMWH and rivaroxaban levels were in accordance with the standards given in the manufacturer′s instructions,the deviation of accuracy verification results was within the requirements of biological coefficient of variation(CV),and the linear verification test of heparin level in plasma was not up to the standards when using reagent matching diluent;the regression equation of the theoretical value and the measured value of the linear validation test of heparin,LMWH and rivaroxaban were all in line with the requirements when the healthy people plasma was used as the diluent;the CV of the parameters carrying pollution rate was less than 10%;the reference interval validation was passed.Conclusion The precision,accuracy,carryover contamination rate and linearity of CS5100 in detecting heparin,LMWH and rivaroxaban are all in line with the quality control requirements,which can guarantee the quality of the test.However,it should be noted that when the test results are more than linear,healthy people plasma should be used as diluent for manual on-line test.