增强型化学发光法检测高敏心肌肌钙蛋白I的效果评价  

Analytical performance of high-sensitivity cardiac troponin I detection by VITROS ECIQ with enhanced chemiluminescence method

作　　者：李永妹 梁海青[2] 韩雪晶[1] 石萍[1] 贾克刚[1] 

机构地区：[1]天津医科大学心血管病临床学院泰达国际心血管病医院检验科,300457 [2]天津医科大学心血管病临床学院心内科重症监护室,300457

出　　处：《中华检验医学杂志》2015年第7期461-465,共5页Chinese Journal of Laboratory Medicine

基　　金：天津市自然科学基金面上项目（12JCYBJC17400）;滨海新区医药卫生科技重点项目（2011BHKZ003）

摘　　要：目的评价VITROSECIQ增强型化学发光法检测高敏心肌肌钙蛋白I（cTnI）的效果。方法方法学评价，参照美国临床实验室标准化协会（CLSI）EP-17A、EP．6A、EP-15A文件和相关文献，采用VITROSECIQ增强型化学发光法对cTnI的检出限、功能灵敏度、精密度、线性范围进行了验证同时建立了表观健康人群第99百分位值。收集2013年1至11月于泰达国际心血管病医院急诊因胸痛就诊的共652例患者相关资料，其中323例急性ST段抬高型心肌梗死（STEMI）及非sT段抬高型心肌梗死（NSTEMI）患者为病例组，排除其他诊断329例，选取303例表观正常人群为对照组，应用ROC曲线分析cTnI在STEMI、NSTEMI诊断中的灵敏度和特异性。非正态分布的定量资料比较采用非参数检验Mann-WhitneyU。结果VITROS检测cTnI的空白限（LoB）为0．0065ng／ml、检出限（LoD）为0．0155．g／ml、功能灵敏度（Fs）为0．01676ng／ml；重复性精密度CV为1．73％-2．33％，中间精密度CV为4．93％～9．96％，均满足试剂盒声明的不精密度；线性范围为0．0155～78．4ng／ml（R2=0．9999），表观健康人群第99百分位值为0．017ng／ml。ROC曲线分析发现，cTnI的曲线下面积（AUC）为0．986，95％C10．973～0．994，以0．017ng／ml为诊断截点时，其在急性心肌梗死诊断中的敏感性和特异性分别为90．09％、99．34％。胸痛人院即刻STEMI、NSTEMI两组间cTnI水平差异无统计学意义（Z=-0．485，P〉0．05），STEMI组与对照组cTnI水平差异有统计学意义（Z=-19．567，P〈0．001），NSTEMI组与对照组cTnI水平差异有统计学意义（Z=-14．598，P〈0．001）。结论VITROSECIQ增强型化学发光法检测cTnI具有良好的灵敏度、精密度、线性范围，可满足临床检测要求.Objective To evaluate the performances of high-sensitivity cardiac troponin I （cTnI） on VITRO ECIQ with enhanced chemiluminescence method. Methods This verification study validated the limited of detection, function sensitivity, imprecision, finearity of the high-sensitivity cardic troponin used VITROS ECIQ according to the document EP-17A, EP-6A, EP-15A published by Clinical and Laboratory Standards Institute （CLSI） and determined 99th percentiles. All 652 patients with chest pain on immediale admission in TEDA International Cardiovascular Hospital during January to November 2013 were enrolled in this study. Including 323 cases of acute ST segment elevation myocardial infarction and non ST segment elevation myocardial infarction patients as the case group, exclude 329 cases of other diagnosis ,303 cases of apparent normal people as control group. The receiver operating characteristic curve was used to evaluated the sensitivity and the specificity of cTnI. Non-normal distribution of quantitative data were used nonparametric test Mann-Whitney U, With P 〈 0.05 for the difference was statistically significant. Results The LoB was 0. 006 5 ng/ml and the LoD was 0. 015 5 ng/ml; the FS was 0. 016 76 ng/ml;repeatability CVwas 1.73 % - 2. 33 % , reproducibility CV was 4. 93% - 9. 96%. The imprecision were lower than that declared by assay producer. The linearity was 0. 015 5 -78.4 ng/ml（R2 = 0. 999 9） ; the 99th percentile reference value was 0. 017 ng/ml. The area under the curve（AUC） of cTnI was 0. 986,95% CI 0. 973 - 0. 994, with the cut-off value as 0. 017 ng/ml, the diagnostic sensitivity and specificity in CIN were 90. 09 % and 99. 34%. Compared between STEMI and NSTEMI groups after admission, the levels of cTnI had no significantly difference, Z were - 0. 485, P 〉 0. 05 ; compared between STEMI and control groups after admission, the levels of cTnI had significantly difference, Z were - 19. 567 ,P 〈 0. 001 ; compared between NSTEMI and control groups after admission, the levels of cTnl had si

关 键 词：肌钙蛋白I 心肌梗死 发光 免疫测定 敏感性与特异性 

分 类 号：R542.2[医药卫生—心血管疾病]