南通地区健康人群血清NSE电化学发光法检测参考区间的调查

目的 调查和建立南通地区表观健康人群神经元特异性烯醇化酶(neuron-specific enolase,NSE)的参考值区间。方法 选取2017年1月～2018年1月南通大学附属医院体检中心3 874例健康体检者作为研究对象,其中男性2 767例,女性1 107例,通过问卷调查和体格检查排除神经系统、血液病、炎症、肿瘤等疾病,采用罗氏cobase 411全自动电化学发光仪检测NSE水平。根据性别、年龄将受检者分组(男女各7组:<30岁,30～39岁,40～49岁,50～59岁,60～69岁,70～79岁,>80岁),对结果进行统计学分析,建立相应的参考区间。分析性别、年龄分组后的组间差异是否有统计学意义; 将获得的参考区间与试剂盒提供的生物参考区间进行比较,并进行参考区间的验证。结果 NSE水平呈正态分布,男性血清NSE水平(15.79±3.52ng/ml)明显高于女性(13.79±3.04 ng/ml),差异有统计学意义(t=3.102,P=0.037)。但独立样本t检验进行各年龄组间两两比较差异无统计学意义(P>0.05)。采用(-overx)&#177; 1.96s确定参考区间,NSE参考区间为8.47～21.07 ng/ml,男性为8.72～21.36 ng/ml,女性为8.06～20.10 ng/ml,对该研究建立的NSE参考区间进行验证符合标准。结论 初步建立了适合该地区表观健康人群的血清NSE参考区间。NSE的参考区间有性别差异,根据不同性别建立的参考区间,可为疾病的诊断和治疗提供准确的依据。

Investigate of Serum NSE Reference Range of Healthy Peoplein Nantong with Electrochemiluminescence

Abstract:Objective To investigate and establish a reference range of neuron-specific enolase(NSE)in apparently healthy population inNantong region.Methods A total of 3 874 healthy examinees from the medical examination center of the Affiliated Hospital of Nantong University were included in the study of which 2 767 were males and 1 107 were females.NSE was detected using a Roche Cobase 411 automatic electrochemiluminometer.There were classified according to gender and age(divided into 7 age groupsfor men and women:<30 years,30～39 years,40～49 years,50～59 years,60～69 years,70～79 years,>80 years).The results were statistically analyzed and the corresponding reference intervals was established.Statistically significant differences between groups after gender and age were analyzed.Compared the reference interval obtained with the instrument manual biological reference interval. Results NSE levels were normally distributed.Here was a statistically significant difference in NSE levels between males and females(t=3.102,P=0.037).There was no significant difference between the two age groups in the independent sample t test(P>0.05).Determine the referenceinterval using (-overx)&#177; 1.96s,NSE reference interval 8.47～21.07 ng/ml,male NSE reference interval 8.72～21.36 ng/ml.Female NSE reference interval(8.06～20.10 ng/ml),and there was a difference with the reference interval provided by the manufacturer.Validation of reference intervals meets standards. Conclusion A preliminary set of serum NSE reference intervals suitable for apparently healthy people in the region was established.The reference range of NSE in healthy people in this region was related to gender,soit is possible to establish their own reference ranges according to different genders to provide an accurate basis for the diagnosis and treatment of diseases.