不同试剂参数下CA-1500血凝仪检测血浆D-二聚体结果的可比性研究

Study on comparability of results of Sysmex CA-1500 coagulation analyzer for detecting plasma D-dimer with different reagent parameters

目的比较不同试剂参数下CA-1500血凝仪检测血浆D-二聚体(DD)结果的可比性。方法依据美国临床实验室标准化委员会(CLSI)颁布的EP9-A2文件,在CA-1500血凝仪上修改DD-Innovance试剂参数,比较修改参数前后的血浆DD检测值,评价二者的可比性。结果以参数修改前所测DD结果为X,参数修改后所测DD结果为Y,对结果进行回归分析,所得方程为Y=0.959 7 X+0.046 5,r=0.998,修改参数前后的DD检测结果具有可比性。结论在保证仪器检测质量的前提下,可以通过调整检测系统的检测参数,缩减试剂用量,节约分析成本。

Objective To compare the comparability of the Sysmex CA‐1500 coagulation analyzer for detecting plasma D‐dimer（DD） under different reagent parameters .Methods According to the EP9‐A2 file issued by CLSI ,the DD‐Innovance reagent parameters were modified in the Sysmex CA‐1500 blood coagulation analyzer .The detection values were compared between before and after modification for evaluating their comparability .Results With the DD detection results before the parameter modification as X and which after the parameter modification as Y ,the detec‐tion results were performed the regression analysis ,the obtained equation was Y = 0 .959 7X ＋ 0 .046 5 ,r = 0 .998 , showing that the DD detection results had the comparability between before and after the parameter modification . Conclusion Under the premise of ensuring the instrument detection quality ,adjusting the detection parameter of the detection system can reduce the reagent consumption and save the analytical costs .