摘要
目的：探讨D-二聚体(DD)试剂在不同全自动血凝仪上的性能以及检测结果的一致性。方法按照临床和实验室标准协会(CLSI)相关文件，进行精密度试验、回收实验及线性实验，对日本积水DD试剂在ACL-TOP和CA-7000血凝分析仪的性能进行评价；根据EP9-A2文件，对积水DD试剂在两台血凝仪上的结果进行可比性分析，同时对ACL-TOP血凝仪使用积水试剂和配套试剂检测DD结果进行比较。结果积水DD试剂在CA-7000血凝仪和ACL-TOP血凝仪上日内和日间精密度均<10%，平均回收率分别为105.42%和92.44%，线性范围分别为0-58.9μg/ml和0-57.4μg/ml。线性回归方程为Y=0.9528X-0.0158，R2=0.9766，相对偏差均<10%，ACL-TOP血凝仪使用积水试剂和配套试剂的结果差异无统计学意义。结论积水DD试剂在ACL-TOP和CA-7000上的性能达到临床应用要求，且在两台血凝仪上的检测结果具有一致性和可比性。
Abstract
Objective To survey the consistency of D-dimer(DD) detection in different automatic coagulation analyzer. Methods Do precision test recover test and linear test to evaluate DD reagent performance in ACL-TOP and CA-700 coagulation analyzer according to CLSI document, do cooperation analysis with the detected data in two coagulation analyzer according to EP9-24 document. Results Intraday and interday precision of the two instrument were all <10%, mean recovery were 105.42% and 92.44% respectively, linear range were 0-55.9μg/ml and 0-57.4μg/ml respectively, the linear regression equation was Y=0.9528X-0.0158, R2=0.9766, relative deviation were all <10%, character of DD reagent in ACL-TOP and CA-700 reached the clinical requirement. The detection results in the two instruments were consistent and comparable.
NETL
NSTL
维普
万方数据