CAJ | 학술논문

目的评价3种敏感cTnI检测方法的分析性能,并观察比较临床应用,为实验室选择检测方法提供帮助.方法收集表面健康人群(474名)及急诊胸痛入院患者(112例)血清,评价雅培、贝克曼-库尔特和强生3种敏感cTnI检测方法的功能灵敏度(CV=10%),建立相应的参考范围,根据Apple提出的评判模式对3种系统的分析性能进行比较,比较不同检测方法之间的相关性,评估不同检测方法的初步临床应用价值,并对实验室自建参考范围进行验证.结果雅培、贝克曼-库尔特和强生检测方法CV=10%和表面健康人群第99百分位值分别为0.030μg/L和0.021 μg/L、0.04 μg/L和0.02μg/L以及0.013 μg/L和0.026μg/L.胸痛入院患者入院即刻样本ROC曲线分析显示,雅培、贝克曼-库尔特和强生检测方法的曲线下面积(AUC)分别为0.852、0.909和0.910,对任两种检测方法比较AUC,差异无统计学意义(Z1=1.18,Z2=1.21,Z3=0.026,P值均＞0.05);入院即刻样本的AMI诊断性能比较中,使用实验室自建和厂商声明为判断值之间的一致性较好(雅培、贝克曼-库尔特和强生Kappa值分别为1.000、0.730、0.893,P值均＜0.01).结论本实验采用的3种敏感cTnI检测方法中有两种方法的分析性能达到"临床可接受"水平,一种达到了"导则可接受"水平.3种方法均能检测到部分表面健康人血中的cTnI,方法间的检测结果存在差异,临床应用的诊断特性差异不明显.
목적 평개3충민감cTnI검측방법적분석성능,병관찰비교림상응용,위실험실선택검측방법제공방조.방법 수집표면건강인군(474명)급급진흉통입원환자(112례)혈청,평개아배、패극만-고이특화강생3충민감cTnI검측방법적공능령민도(CV=10%),건립상응적삼고범위,근거Apple제출적평판모식대3충계통적분석성능진행비교,비교불동검측방법지간적상관성,평고불동검측방법적초보림상응용개치,병대실험실자건삼고범위진행험증.결과 아배、패극만-고이특화강생검측방법CV=10%화표면건강인군제99백분위치분별위0.030μg/L화0.021 μg/L、0.04 μg/L화0.02μg/L이급0.013 μg/L화0.026μg/L.흉통입원환자입원즉각양본ROC곡선분석현시,아배、패극만-고이특화강생검측방법적곡선하면적(AUC)분별위0.852、0.909화0.910,대임량충검측방법비교AUC,차이무통계학의의(Z1=1.18,Z2=1.21,Z3=0.026,P치균＞0.05);입원즉각양본적AMI진단성능비교중,사용실험실자건화엄상성명위판단치지간적일치성교호(아배、패극만-고이특화강생Kappa치분별위1.000、0.730、0.893,P치균＜0.01).결론 본실험채용적3충민감cTnI검측방법중유량충방법적분석성능체도"림상가접수"수평,일충체도료"도칙가접수"수평.3충방법균능검측도부분표면건강인혈중적cTnI,방법간적검측결과존재차이,림상응용적진단특성차이불명현.
Objective To assess the analytical performance of three sensitive cardiac troponin Ⅰ assays and compare the clinical application to provide help in choosing the detection method for clinical laboratory. Methods A total of 474 serum samples were collected from apparently healthy subjects and a total of 112 serum samples were collected from patients presenting with symptoms suggestive of acute myocardial infarction. The functional sensitivities of three assays from Abbott, Beckman-Coulter and Ortho were determined ( CV = 10% ). The reference ranges have been established. The analytic performance was compared according to the assessment mode described by Apple. The relationship was compared among the different assays. The preliminary clinical application value for different detection methods has been evaluated and validated with self-established reference ranges. Results The functional sensitivities ( CV = 10% ) of the cTnI assays for Abbott, Beckman-Coulter and Ortho were 0. 030, 0. 04 and 0. 013 μg/L, respectively.The 99th percentiles of cTnI in healthy volunteers were 0. 021, 0. 02 and 0. 026 μg/L respectively. The analytical data of ROC curve showed that the area under curve (AUC) of the cTnI assays for Abbott,Beckman-Coulter and Ortho for diagnosis of AMI was 0. 852,0. 909 and 0. 910,respectively. There was no statistical difference between any two methods(Z1 = 1.18 ,Z2 = 1.21 ,Z3 =0. 026,all P ＞0. 05). There were good consistency between the 99th percentile obtained from our laboratory and suggested by manufacturers (Kappa value were 1. 000, 0. 730 and 0. 893 respectively, all P ＜ 0. 01 ). Conclusions The analytical performance of two cTnl assays is "clinical accepted" ,the other one is accepted according to guideline. All of them could detect cTnI in apparently healthy subjects. There exist differences among three assays, but their diagnostic characteristics for AMI are not significantly different.