25-羟维生素D_3电化学发光免疫分析仪测定及临床应用

Determination and clinical application of 25-hydroxyvitamin D_3 by electrochemiluminescence immunoassay

目的探讨25-羟维生素D_3竞争法在电化学发光自动分析仪测定中的方法评价及其在糖尿病诊断中的临床意义。方法收集该院2016年1月至2017年5月收治的140例糖尿病患者(糖尿病组)、76例糖尿病肾病患者(糖尿病肾病组)和72例健康人群(健康对照组)的血清标本,采用竞争法和酶法分别检测血清25-羟维生素D_3水平、糖化血清清蛋白(GA)水平,计算GA%,并对结果进行相关分析。结果竞争法测定25-羟维生素D_3在3.2~55.6 ng/mL内线性良好;批内变异系数(CV)≤3.3%,批间CV为4.8%。糖尿病肾病组及糖尿病组25-羟维生素D_3水平[(19.22±9.31)、(20.57±12.48)ng/mL]均低于健康对照组[(35.26±9.18)ng/mL],差异均有统计学意义(P<0.05);糖尿病肾病组及糖尿病组GA%水平[(25.04±13.35)、(27.65±10.79)]均高于健康对照组(13.64±1.16),差异均有统计学意义(P<0.01)。糖尿病肾病组血清25-羟维生素D_3水平与GA值呈负相关(rs=-0.42,P<0.05)。结论 25-羟维生素D_3竞争法具有可行性、简便性、重复性和正确度好,适用于全自动免疫分析仪常规检测。糖尿病肾病组25-羟维生素D_3与糖尿病GA值有良好的相关性,可作为糖尿病血糖水平控制和预后诊断的敏感指标,具有实际应用价值。

Objective To investigate the methodological evaluation of25-hydroxyvitamin D3(25-OH-Vit D3)competition method in the determination of electrochemiluminescence automatic analyzer and its clinical significance in the diagnosis of diabetes mellitus(DM).Methods The serum samples were collected from140patients with DM(DM group),76patients with diabetic nephropathy(DN group)and72healthy subjects(healthy control group)in this hospital from January2016to May2017.The levels of serum25-OH-Vit D3and glycated albumin level(GA)were measured by adopting the competitive and enzymatic methods,caculated GA%,and the results were performed the correlation analysis.Results The level of25-OH-Vit D3had good linearity in the range of3.2-55.6ng/mL by the competitive method.The intra-batch CV was≤3.3%and the inter-batchCV was4.8%h.The levels of25-OH-Vit D3in the DN group and DM group were(19.22±9.31)ng/mL and(20.57±12.48ng/mL,which were lower than(35.26±9.18)ng/mL in the health control group,the difference was statistically significant(P<0.05).The GA levels in the DN group and DM group were25.04±13.35and27.65±10.79,which was higher than13.641.16in the health control group,the difference was statistically significant(P<0.01).There was a negative correlation between serum25-OH-Vit D3and GA value in the DN group(rs=-0.42,P<0.05).Conclusion The competitive method has feasibility,simplicity,reproducibility and good accuracy,is suitable for the routine detection of automatic immunoassay analyzer.The25-OH-Vit D3level has a good correlation with GA value in DM,can serve as a sensitive indicator for controlling blood glucose level and diagnosing the prognosis in the patients with DM and has practical application value.