可溶性ST2的检测性能评价及对心力衰竭患者的诊断价值  

The performance evaluation of soluble ST2 detection kit and the clinical application of sST2 indiagnosing heart failure

作　　者：戴谦[1] 吴炯[1] 郭玮[1] 张春燕 潘柏申[1] 

机构地区：[1]复旦大学附属中山医院检验科,上海200032

出　　处：《中华检验医学杂志》2014年第5期394-398,共5页Chinese Journal of Laboratory Medicine

基　　金：国家临床重点检验专科建设项目资助;“十二五”国家科技支撑计划子课题“中国人群常用临床检验项目参考区间及相关技术支撑体系的建立”资助（2012BA137801）

摘　　要：目的对可溶性ST2（sST2）ELISA双抗夹心法试剂的检测性能进行评价。初步评估sST2的临床应用价值。方法方法学评价。参考美国临床和实验室标准协会（CLSI）EP-15A、EP6-A方案对该项目的精密度、线性范围进行验证，选取上海地区5个社区的表面健康人300名（年龄20～85岁，男124名，女176名）建立参考区间，选取2013年5至7月中山医院临床诊断心力衰竭患者117例，根据美国纽约心脏病学会（NYHA）心功能分级结果对患者进行分组，比较患者sST2与NT-proBNP、左心室射血分数（LVEF）、NYHA心功能分级结果之间的相关性，使用ROC曲线比较血清sST2、NT-proBNP、LVEF对心力衰竭患者进行诊断及分层的能力。结果sST2检测试剂盒批内CV〈4％、批间CV〈10％；0～200ng/ml范围内线性良好（Y=0．995X＋0．005，R^2=0．999）；依据300名表面健康人血清sST2水平得m参考区间（男10．2～41．0μg/L，女8．9～28．1μg/L）。心力衰竭患者血清sST2浓度与NT-ProBNP、NYHA心功能分级相关（Spearman相关系数分别为0．301、0．413），而sST2与LVEF不相关。sST2在NYHA心功能≤II级与〉Ⅱ级患者中的中位数（IQR）分别为28．3（19．5～39．2）；45．1（34．1～85．6），P〈0．01。sST2区分正常人与心力衰竭患者的AUC为0．815，诊断敏感性为51．2％，特异性为92．7％。sST2、sST2联合NT-ProBNP、三者联合（sST2、NT-ProBNP、LVEF）区分NYHA心功能≤Ⅱ级与〉Ⅱ级患者的AUC分别为0．743、0．810、0．831，三者联合后诊断敏感性增加为94．7％。结论sST2检测试剂盒检测性能符合临床要求，临床实验表明：血清sST2与NT-ProBNP，NYHA相关。sST2不受年龄、肾功能损害和体重指数的影响。联合sST2可以有助于NT—ProBNP与LVEF更好地区分心力衰竭患者。（手华检验医学杂志，2014，37：394-398）Objective To evaluate the performance of sST2 ELISA kit and investigate the clinical application of sST2. Methods This verification study validated the precision, finearity of sST2 ELISA kit according to the CLSI EP-15A, EP-6A protocols. 300 healthy adults（ aged from 20 to 85, 124 male and 176 female） from 5 different districts of Shanghai were used to establish serum sST2 reference interval. The correlations between sST2, NT-ProBNP, LVEF and NYHA class were analyzed in 117 patients diagnosed with heart failure who were grouped according to the New York heart association （NYHA）. Receiver operating characteristic （ROC） curve was used to compare the ablity of sST2, NT-ProBNP, LVEF in distinguishing heart failure patients. Results The within-lot and between-lot variation of three level samples were below 4% and 10% respectively. There was a good linear correlation （ Y = 0. 995X ＋ 0. 005, R^2 = 0. 999） between theoretical value and actual detection result in the range of 0 to 200 μg/ml. The reference interval of sST2 was 10. 2 to 41.0 μg/ml for males and 8.9 to 28. 1 μg/ml for females, sST2 was positively correlated with NT-ProBNP and NYHA class but did not correlate with LVEF in heart failure patients.Patients with NYHA class 〉 II （ Median ： 28.3, IQR： 19.5 - 39. 2） had higher serum sST2 level than patients with NYHA class ~〈 II （ Median ： 45. 1, IQR ： 34. 1 - 85.6 ）, P 〈 0. 05. The AUC of sST2 in distinguishing heart failure patients from normal people was O. 815 （sensitivity ：51.2% , specificity：92. 7% ）. The AUC of sST2 , sST2 ＋ NT-ProBNP and sST2 ＋ NT-ProBNP ＋ LVEF in distinguishing patients between NYHA class II and 〉 IIwere 0. 743, 0. 810, 0. 831 respectively and the sensitivity of sST2 ＋ NT-ProBNP ＋ LVEF was 94. 7%. Conclusions Experimental results show that this sST2 ELISA kit has a good performance in the precision, linearity, sST2 correlates with NT-ProBNP and NYHA class but do not correlates with LVEF. Serum sST2 level is not influenced by age

关 键 词：心力衰竭患者 检测试剂盒 诊断价值 可溶性 NYHA心功能分级 NT-PROBNP NT-PROBNP 性能 

分 类 号：R541.6[医药卫生—心血管疾病]