摘要
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.
出处
《医学信息(下旬刊)》
2010年第8期248-248,250,共2页
Medical information