几种心肌肌钙蛋白I测定试剂盒的初步评价

The evaluation of several commercial chemilunescent immunoassay kits for cardiac troponin I

目的 对ACCESS一代、Opus和immulite三种心肌肌钙蛋白I(cTnI)测定试剂盒的参考值、相关性、测定的稳定性和抗凝剂的影响等进行评价。方法 cTnI测定全部采用化学发光法 ,试剂 (包括校正品 )与专用仪器相配套。结果 (1 )三种测定方法间具有良好的相关性 ,但不同方法所测cTnI参考值和病人血清中cTnI含量相差悬殊。 (2 )肝素抗凝对ACCESS一代试剂有负干扰 ,而对另外两个系统无显著影响 (P >0 0 5) ;EDTA抗凝对ACCESS一代试剂无显著影响 ,但对Opus和immulite测定系统影响显著 (P <0 0 5)。 (3)对于ACCESS一代试剂、OPus和immulite试剂 ,以O pus批内变异相对较大。 (4)采用ACCESS一代试剂测定时 ,血清标本置于 4℃和 2 8℃ ,其cTnI测定结果随时间的延长而下降 ,2h下降 1 0 %左右 ;采用Opus和immulite两测定系统测定时 ,样品于 4℃和 2 8℃孵育 ,cTnI测定结果在 2h内有所上升 ,上升幅度 <1 0 % ,4h后开始下降。结论 首先 ,cTnI参考值应与实验所用仪器及其特定试剂相配套。其次 ,抗凝对不同厂商出品的cTnI测定试剂影响程度不尽相同 ,测定时应谨慎选取抗凝剂。另外 ,immulite测定的再现性比较好 ,Opus相对较差 ,采用OpuscTnI测定系统进行检测时 ,对可疑标本应做双份检测。再者 ,ACCESS一代试剂测定病人血?

Objective To evaluate ACCESS?Opus and immulite cardiac troponin I (cTnI) immunoassays in the following aspects:reference range,correlation,within run imprecision(CV) and the influence of anticoagulants.Methods The three analyzers use chemiluminescent detection to measure cTnI in serum and plasma with specific reagents(including calibrator).Results (1)Good correlations of cTnI measured with the three immunoassays were observed.However,the reference values and cTnI concentrations in a given patient sample are significant biases among the three cTnI immunoassays.(2) The concentrations of cTnI in heparin plasma measured with ACCESS immunoassay are markedly lower than in serum(P<0.05).However,Opus and immulite assays produced significant biases between serum and EDTA plasma(P<0.05).(3) Within run imprecision for cTnI measured with Opus compared with ACCESS and immulite cTnI was larger.(4) To evaluate the stability of cTnI measured with each assay in serum,we incubated patients samples at 4℃ and 28℃.The cTnI concentrations at different time points measured with ACCESS assay showed a steady decrease,ten percent within 2 h.In contrast,when analyzed with the Opus and immulite assays showed an initial increase within 2 h with the variation lease than ten percent and then a slow decrease of the apparent concentration after 4 h incubation.Conclusion Firstly, reference range of cTnI should be defined according to different immunoassays with specific reagents.Secondly,The influence of anticoagulants on cTnI concentrations in the three immunoassays is different.When analyzed with one of them,the same matrix for measurement should be used.Thirdly,the intraassay reproducibility for Opus assay is the worst among the three cTnI immunoassays.We recommend that all the suspected specimens should be analyzed in duplicate with the Opus cTnI assay.Finally, the first generation reagents of Beckman ACCESS assay,with which cTnI measured showed a significant decrease with time extened,will not be recommended to use.For the Opus and immulite assays,the cTnI concentrations in serum or plasma should be measured within 2 h.