颗粒增强免疫比浊法测定血清同型半胱氨酸的方法学评价

Methodology evaluation of detecting serum homocyteine by particle enhanced immunoturbidimetric method ycteine

目的：对胶乳颗粒免疫比浊法测定血清同型半胱氨酸（HCY）的方法学进行初步评价。方法：应用胶乳颗粒免疫比浊法测定HCY的精密度、标准曲线、干扰实验、稳定性实验、并与循环酶法测定血清HCY的结果进行相关性分析。结果：颗粒增强免疫比浊法测定HCY的精密度（批内CV为1.87%、0.75%，批间CV为2.29%、5.35%）较高；HCY浓度在0μmol/L～50μmol/L范围内线性良好；当抗坏血酸浓度1107mg/L、胆红素浓度445 umol/L、血红蛋白浓度6.7 g/L；甘油三酯浓度14.6 mmol/L、氨离子浓度75 umol/L时均未对测定结果产生干扰；试剂开瓶后稳定周期也可达到25天；颗粒增强免疫比浊法和循环酶法测定HCY相关性良好（y =0.9904x ＋0.0813，r=0.9981）。结论：颗粒增强免疫比浊法测定血清HCY具有较高的精密度，结果准确可靠，适合临床实验室推广。

Objective：To evaluate the detection of serum homocysteine （ HCY） with Particle Enhanced Immunoturbidimetric. Methods：The precision, calibration curve, Anti interference test,on-board stability studies,and the determination of serum HCY and enzymatic cycling assay results by correlation analysis.Results： The Particle Enhanced Immunoturbidimetric method revealed good precision （ CV 1.87%、0.75% , 2.29%、5.35%） .The linear range is0μmol/L～ 50μmol/L.The assay demonstrated less than 10% interference deviation in the presence of Vic-C（1107mg/L）, bilirubin（445 umol/L）, hemoglobin（ 6.7 g/L）,TG（14.6 mmol/L）, ammoniumion（75 umol/L）.samples can be stable after 25 days on-board stability.the Particle enhanced immunoturbidimetric method showed a good correlation with enzymatic cycling assay （y = 0.9904x ＋0.0813,r= 0.9981）.Conclusions：The Particle enhanced immunoturbidimetric method is precise, reliable and suitable for determinations of serum HCY concentration in a clinical laboratory.