摘要
目的开发建立新型高敏锌转运体8自身抗体(ZnT8A)电化学发光检测法(ECL-ZnT8A),并初步评价其临床应用价值。方法选择自2016年1月至2019年12月就诊于南京医科大学第一附属医院的1型糖尿病(T1DM)患者100例、2型糖尿病(T2DM)患者150例、健康对照者360例(158例用于方法的建立,202例用于方法灵敏度和特异度的鉴定)进行ECL-ZnT8A检测,120例(60例健康对照,50例T1DM,10例ZnT8A阳性血清)同时检测ECL-ZnT8A和放射免疫沉淀法(RBA)-ZnT8A。经t检验、单因素方差分析和χ^2检验比较各组间ZnT8A指数和阳性率的差异。结果(1)400 ng/ml的ZnT8-Biotin和200 ng/ml的ZnT8-Sulfo-TAG是ECL-ZnT8A反应体系的最适浓度。(2)ECL-ZnT8A批内变异系数为3.4%~8.2%,批间变异系数为10.5%~12.8%,阴、阳性结果判断重复性100%。(3)ECL-ZnT8具有较高的灵敏度(97.7%)和特异度(96.1%),与RBA-ZnT8A的一致率为96.70%(116/120,Kappa值为0.929),指数呈显著正相关(r=0.806,P<0.01)。(4)T1DM患者ECL-ZnT8A阳性率为52.00%(52/100),显著高于健康对照组的0.99%(2/202)(χ^2=118.528,P<0.01)和T2DM组的1.33%(2/150),差异具有统计学意义(χ^2=90.955,P<0.01)。结论ECL-ZnT8A检测操作简便无放射污染,具有很好的临床应用价值。
Objective To establish a new electrochemiluminescence-zinc transporter 8 autoantibody(ECL-ZnT8A),and evaluate its clinical application value.Methods From January 2016 to December 2019,100 patients with type 1 diabetes mellitus(T1DM),150 patients with type 2 diabetes mellitus(T2DM)and 360 healthy controls(158 for establishing the method,202 for identifying the sensitivity and specificity of the method)were detected by ECL-ZnT8A.120 patients(60 healthy controls,50 T1DM patients and 10 with positiveserum ZnT8A)were detected by both of ECL-ZnT8A and radio-binding assay(RBA)-ZnT8A.The differences of ZnT8A index and prevalence among the groups were compared by t test,one-way ANOVA and chi square test.Results(1)The optimal concentrations of ZnT8-Biotin and ZnT8-Sulfo-TAG were 400 ng/ml and 200 ng/ml respectively.(2)ECL-ZnT8A intra-batch coefficient of variation(CV)was 3.4%-8.2%,inter-batch CV was 10.5%-12.8%,and the repeatability of negative or positive results was 100%.(3)ECL-ZnT8 showed high sensitivity(97.7%)and specificity(96.1%).The consistent rate with RBA-ZnT8A was 96.70%(116/120,Kappa=0.929),and the index of ZnT8A was positively correlated(r=0.806,P=0.01).(4)The prevalence of ECL-ZnT8A in the patients with T1DM was 52.00%(52/100),significantly higher than 0.99%(2/202)in the healthy controls(χ^2=118.528,P<0.01)or 1.33%(2/150)in the T2DM patients(χ^2=90.955,P<0.01).Conclusion ECL-ZnT8A assay can be detected without radioactive concern,it has promising clinical application value.
作者
陈恒
沈敏
戴皓
赵瑞苓
杨涛
顾愹
Chen Heng;Shen Min;Dai Hao;Zhao Ruiling;Yang Tao;Gu Yong(Department of Endocrinology and Metabolism,the First Affiliated Hospital of Nanjing Medical University,Nanjing 210029,China)
出处
《中华糖尿病杂志》
CAS
CSCD
北大核心
2020年第8期613-618,共6页
CHINESE JOURNAL OF DIABETES MELLITUS
基金
国家自然科学基金项目(81300668,81770777)
上海市医药卫生发展基金会2019年十大糖尿病临床研究项目二类资助。
关键词
糖尿病
1型
锌转运体8自身抗体
胰岛自身抗体
电化学发光法
Diabetes mellitus,type 1
Zinc transporter 8 autoantibody
Islet autoantibodies
Electrochemiluminescence assay
