AxSYM平台心肌肌钙蛋白I先进方法的分析性能评估：与旧方法及Access系统的比较

Evaluation of the analytical performance of the advanced method for cardiac troponin I for the AxSYM platform: comparison with the old method and the Access system.

作者信息

Storti Simona, Prontera Concetta, Parri Maria Serena, Iervasi Annalisa, Vittorini Simona, Emdin Michele, Zucchelli Gian Carlo, Longombardo Giovanni, Migliorini Paola, Clerico Aldo

机构信息

CNR Institute of Clinical Physiology, University of Pisa, Pisa, Italy.

出版信息

Clin Chem Lab Med. 2006;44(8):1022-9. doi: 10.1515/CCLM.2006.175.

DOI:10.1515/CCLM.2006.175

PMID:16879072

Abstract

BACKGROUND

The determination of cardiac troponins is routinely used for rule in/out, risk stratification, and follow-up of patients with acute coronary artery syndrome. We evaluated the analytical and clinical performance of the advanced immunoassay for troponin I (cTnI) carried out on an AxSYM platform (Abbott Diagnostic Division) and compared these characteristics to those of the previous version of this assay and to cTnI on the Access 2 immunoassay system (Beckman Coulter, Inc.).

METHODS

We assayed plasma samples from healthy subjects (n=66) and cardiac patients (n=132) using AxSYM Plus system assays called the old (OLD AxSYM) and advanced TnI (ADV AxSYM) methods and using an Access system.

RESULTS

An improvement in analytical sensitivity (detection limit) was observed for the advanced cTnI AxSYM compared to the previous method (0.014 vs. 0.31 microg/L), while the cTnI value for the 10% CV (i.e., functional sensitivity) was 0.41 microg/L for the ADV and 1.9 microg/L for the OLD method. The kinetics of cTnI release was similar, as evaluated in 25 patients with typical acute myocardial infarction (AMI). A close linear relationship was found between the two methods on the AxSYM system (OLD cTnI=7.436+6.858 ADV cTnI; R=0.968, n=214) and with the Access system (OLD AxSYM=7.154+7.9 Access, R=0.876, n=158; ADV AxSYM=0.23+1.209 Access, R=0.927, n=160). However, wide bias was found between the OLD and ADV AxSYM methods (mean difference 118.4 microg/L, p<0.0001), while more similar results were found between the ADV AxSYM and Access methods (mean difference 2.6 microg/L, corresponding to a mean percentage difference of 17%, p<0.0001). In 106 patients with symptomatic rheumatoid arthritis with high rheumatoid factor (RF) concentration, the mean cTnI measured by the ADV AxSYM method was 0.009+/-0.031 mug/L (range 0-0.23 microg/L) with a significant correlation (R=0.316, p=0.001) between cTnI and RF values. Furthermore, in 60 of these serum samples the cTnI concentration was also measured using the Access method; significant correlation with the values found by the ADV AxSYM method was observed (R=0.468, p=0.0002).

CONCLUSIONS

The present study indicates that the AxSYM Troponin-I ADV immunoassay shows improved analytical sensitivity compared to the OLD AxSYM method, as well as very similar clinical results to those determined using the Access method.

摘要

背景

心肌肌钙蛋白的测定常用于急性冠状动脉综合征患者的诊断、危险分层及随访。我们评估了在AxSYM平台（雅培诊断部）上进行的肌钙蛋白I（cTnI）先进免疫测定法的分析性能和临床性能，并将这些特性与该测定法的先前版本以及Access 2免疫测定系统（贝克曼库尔特公司）上的cTnI特性进行比较。

方法

我们使用AxSYM Plus系统的旧版（OLD AxSYM）和先进TnI（ADV AxSYM）方法以及Access系统对健康受试者（n = 66）和心脏病患者（n = 132）的血浆样本进行检测。

结果

与先前方法相比，先进的AxSYM cTnI分析灵敏度（检测限）有所提高（0.014对0.31μg/L），而ADV方法的10%变异系数（即功能灵敏度）对应的cTnI值为0.41μg/L，旧版方法为1.9μg/L。在25例典型急性心肌梗死（AMI）患者中评估发现，cTnI释放动力学相似。在AxSYM系统上两种方法之间发现密切的线性关系（OLD cTnI = 7.436 + 6.858 ADV cTnI；R = 0.968，n = 214），与Access系统也有密切线性关系（OLD AxSYM = 7.154 + 7.9 Access，R = 0.876，n = 158；ADV AxSYM = 0.23 + 1.209 Access，R = 0.927，n = 160）。然而，OLD和ADV AxSYM方法之间存在较大偏差（平均差异118.4μg/L，p < 0.0001），而ADV AxSYM和Access方法之间的结果更为相似（平均差异2.6μg/L，对应平均百分比差异17%，p < 0.0001）。在106例类风湿因子（RF）浓度高的有症状类风湿关节炎患者中，ADV AxSYM方法测得的平均cTnI为0.009±0.031μg/L（范围0 - 0.23μg/L），cTnI与RF值之间存在显著相关性（R = 0.316，p = 0.001）。此外，在这些血清样本中的60份中也使用Access方法测量了cTnI浓度；观察到与ADV AxSYM方法测得的值有显著相关性（R = 0.468，p = 0.0002）。