CA1500凝血仪配套D-二聚体试剂在生化分析仪上的应用探讨

CA1500 Automatic Coagulation Analyzer D--Dimer kit applying into the versatile biochemical analyzer

目的：探讨CA1500凝血仪配套D-二聚体试剂在AU400生分仪上的应用。方法：用CA1500凝血仪配套D-二聚体试剂在AU400生化分析仪上建立D-二聚体定量检测系统，根据NCCLS系列文件（EP5-A2、EP6P、EP-9A2）和其它相关文献的实验方案，对所建立的系统进行精密度、线性、方法比对等方面进行分析。结果：批内和批间变异系数分别为2．41～3．35％和2．99—4．43％；线性达4600μg／L;根据EP9-A2实验方案，比较分析AU400生化仪的检测系统与CA1500凝血仪检测系统测定D-二聚体的结果，其线性回归方程为Y=0．9681X＋5．4151（r2=0．9893），预期偏差可接受。结论：在Au400生化仪上建立的D-二聚体定量检测系统的主要分析性能符合质量目标要求。

Objective To discuss the use of CA1500 Automatic Coagulation Analyzer D--Dimer kit applying into the versatile biochemical analyzer Method：Using the CA1500 Automatic Coagulation Analyzer D--Dimer kit to set up the system and detect into the AU400 versatile biochemical analyzer. NCCLS Protoeols（EP5--A2,EP6P,EP--9A2）and other pertinent literatures were used for validating and evaluating the precision, accuracy, linear- ity, interference analysis. Result： The within and between--day coefficients of variation（CV）varied from 2.41 to 3.35%and 2.99 to 4.43%, respectively;The linearity range reach to 4600μg/L, Compared with the results tested D--Dimer of AU400 and CA1500 according to the EP9--A2 protocol respectively, of which the equation of linear regression is Y=0. 9681X＋5. 4151 （r2 =0. 9893） and the bias could be acceptable between the CA1500 system and AU400 system. Conclusion： The major analysis performances of D--Direct tested by AU400 automatic biochemical analyzer were accord with acceptable standards.