老年患者应用D-二聚体床旁测定的性能评价

目的 探讨AQT90 FLEX免疫分析仪床旁快速检测全血D-二聚体(D-dimer)的临床性能并评估其在老年患者中的应用价值.方法 参考我国卫生行业标准《D-二聚体定量检测》(WS/T 477-2015)中提供的设备性能评价方法,对AQT90 FLEX免疫分析仪检测全血D-二聚体(D-dimer)进行性能评价.选择2015年北京大学第一医院老年科60岁及以上住院患者,同时采取静脉血193份(男158份,女35份),比较AQT90 FLEX免疫分析仪和ACL TOP全自动凝血仪测定D-二聚体结果的相关性.结果 高值和低值样品的批内不精密度分别为2.619％和2.767％;携带污染率为0.12％;AQT90 FLEX免疫分析仪与ACL TOP全自动凝血仪检测结果的相关系数为0.9491 (P＜0.01),AQT90 FLEX免疫分析仪检测结果为2.52,ACL TOP全自动凝血仪检测结果+0.15,在女性、高龄患者,倍数关系略增加.结论 AQT90 FLEX免疫分析仪床旁测定全血D-二聚体浓度精密度高,与ACL TOP全自动凝血仪检测结果相关性好,AQT90 FLEX免疫分析仪的检验结果约为ACL TOP全自动凝血仪检验结果的2.52倍.将其应用于门急诊及重症监护室老年人群的血栓性疾病筛查结果可靠.

Evaluation of point-of-care testing for D-dimer in elderly patients

Objective To evaluate the clinical performance of AQT90 FLEX,a novel time-resolved fluorescence based point-of-care test (POCT) for quantification of D-dimer in elderly patients.Methods The method from Quantitative D-dimer assay (WS/T 477-2015) for testing equipment performance was used as a reference to evaluate the clinical performance of AQT90 FLEX.The correlation was compared between testing results of D-dimer using the AQT90 immune-assay analyzer and those using the ACL TOP coagulation analyzer.Results At high concentration of D-dimer,the within-run precision coefficient of variation (CV)was 2.619％,and at low concentration of D-dimer,the within-run precision CV was 2.767％.The pollution-carrying rate was 0.12％.The measured data from AQT90 and ACL TOP had a correlation coefficient of r =0.9491 (P ＜ 0.01).The equation of the line of best fit for D-dimer with which all AQT90 results can be adapted to the ACL TOP was:AQT90 =2.52 ACL TOP + 0.15.The number from the equation was slightly greater in female than that in male,and it was also increased in elderly.Conclusions The AQT90 FLEX had rational precision and linearity in determination of concentration.There was a high agreement between the testing results from AQT90 and those from ACL TOP.It was recommended to use a slope of 2.52 and an intercept of 0.15 to adjust the D-dimer values of the ACL TOP to the AQT90 FLEX assay systems.POCT for D-dimer by AQT90 FLEX raises feasibility for use in elderly patients.