血浆D二聚体测定的量值比较与一致性研究

Quantitative Analysis and Correspondence of Different D-dimer Reagents in Clinical Use

目的 调查D二聚体定量试剂检测临床标本的性能,探讨开展质量评估的可能性.方法 分别使用STA Liatest、Innovance D-二聚体和HS500三种试剂检测149例临床标本血浆D二聚体,分为0.2～1.00、1.01～4.00和4.01 ～ 20 mg/L三浓度区间统计方法间的偏差和在中高值区间的相关性,并以cutoff值（0.5 mg/L）作为定性判断的依据判断阴性符合率.结果 Innovance、HS500与Liatest相比,低值区间偏差低于0.05 mg/L,中值区间偏差为0.75和0.87mg/L,高值区间2.18和1.82 mg/L;线性关系具有统计学意义,分别为y=1.14x＋0.18（r=0.92,P＜0.01）和y=0.96x＋ 0.59（r=0.863,P＜0.01）.以0.5 mg/L为cutoff值,两者与Liatest相比的阴性符合率为91.4％和80％,总体符合率为94％和89％.结论 三种血浆D二聚体定量检测作静脉血栓定性的定性筛查时有较高符合率,同时其定量结果的一致性为开展质量评价提供了前提.

Objective To investigate performance of major quantitative reagents in plasma D-Dimer analysis from clinical patients,looking for the feasibility of quality assessment in D-dimer.Methods Plasma from 149 patients were collected and analyzed.Biases in 0.2 ～ 1.00,1.01 ～4.00 and 4.01 ～20 mg/L three consecutive levels of D-dimer concentration,correlations in higher level（＞ 1.0 mg/L） and correspondence around cutoff（0.5 mg/L）between methods are calculated.Results Compared with Liatest D-dimer,Biases from innovance and HS 500 are less than 0.05 in 0.2-1.00 mg/L,0.75 and 0.87 mg/L in median,2.18 and 1.82 mg/L in high level.The statistical linearity lie in y =1.14 x ＋ 0.18（r =0.92,P ＜0.01）from innovance and y =0.96 x ＋ 0.59（r =0.863,P ＜ 0.01）from HS 500,negative coincidence rates are 91.4％ and 80％,respectively,and higher total coincidence are 94％ and 89％.Conclusion As measure in excluding diagnostic of venous thromboembolism,reagents investigated show their conformability on basis of clinical evaluation,and suggest the probability for quality assessment in D-Dimer.