sST2检测的性能评价及其在心力衰竭中的临床应用

Evaluation and its clinical application in heart failure of the soluble ST2 kit

目的对可溶性生长刺激表达基因2蛋白(soluble growth stimulating express gene 2,sST2)检测试剂盒的性能进行评价,并探讨sST2在心力衰竭中的临床应用。方法选取2015年8月—2016年8月确诊为心力衰竭的患者60例作为实验组和健康体检者50例作为对照组,检测两组sST2和N末端脑钠肽前体(N terminal pro B-type natriureticpeptide,NT-proBNP)浓度,探讨sST2水平与心力衰竭的临床联系,比较两指标对心衰的诊断价值和相关性分析。结果 sST2检测试剂盒批内精密度变异系数(coefficient of variation,CV)%分别为4.8%和2.8%,批间精密度CV%分别为5.9%和6.7%,线性范围为0~206.622 ng/mL。实验组sST2浓度为(52.63±9.38)ng/mL,与对照组(20.93±9.76)ng/mL相比,差异有统计学意义(P<0.05);实验组sST2浓度与心功能分级和不同左心室射血分数(left ventricular ejectionfractions,LVEF)有关,Ⅱ级、Ⅲ级和Ⅳ级心衰患者的sST2浓度分别为(30.42±10.43)ng/mL、(38.10±12.61)ng/mL和(68.52±11.76)ng/mL,差异均有统计学意义(P<0.05);LVEF>0.5和LVEF<0.5的患者sST2浓度分别为(39.41±10.32)ng/mL和(64.35±9.89)ng/mL,差异有统计学意义(P<0.05);sST2浓度在心衰患者起病病因中差异无统计学意义(P>0.05);实验组sST2和NT-proBNP相关系数为0.420,心衰患者sST2水平与NT-proBNP存在相关性。结论 sST2检测性能满足实验室检测要求。sST2作为一种新型血清标志物,可与NT-proBNP联合检测,提高对心衰的诊断价值。

Objective To verify the performance of the soluble ST2（sST2） assay kit and to explore the clinicalapplication of sST2 in heart failure. Methods A total of 60 cases patients with heart failure disease were selected and 50 healthy cases were also chosen from August 2015 to August 2016. They were regarded as experimental group and healthycontrol group, respectively. sST2 and NT-proBNP levels of the groups were recorded. Then the relationship between sST2 andheart failure diseases were analyzed, diagnostic capabilities between sST2 and NT-proBNP testing were compared.Results CV% values were 4.8% and 2.8% in intra precision, 5.9% and 6.7% in inter batch precision, linear range was 0-206.622 ng/mL. sST2 level was（52.63 ± 9.38）ng/mL in experimental group, there were statistically significance（P〈0.05）compared with healthy control group（20.93±9.76） ng/mL. sST2 level were（30.42±10.43）ng/mL,（38.10±12.61）ng/mL and（68.52±11.76）ng/mL in Ⅱ, Ⅲ and Ⅳ grading, respectively. The differences were statistically significant（P〈0.05）. The levelwere（39.41 ± 10.32） and（64.35 ± 9.89） ng/mL in LVEF0.5 and LVEF0.5 groups, the differences were statisticallysignificant（P〈0.05）. There were no significance in LVEF and pathogeny（P〉0.05）. sST2 and NT-proBNP correlationcoefficient was 0.420 in experimental group, sST2 levels in patients with heart failure was associated with the NT-proBNP.Conclusion The performance of sST2 assay kit was validated, it can be used in routine sST2 testing. As a new serummarkers, it can be good for improving the diagnostic value of the disease tested with NT-proBNP.