免疫比浊法测定血清视黄醇结合蛋白方法学评价

Turbidimetric immunoassay for detection of retinol-binding protein in serum

目的对免疫透射比浊法测定血清视黄醇结合蛋白(RBP)进行方法学评价。方法采用免疫比浊测定法,根据美国临床实验室标准化委员会(NCCLS)相关文件,对该方法进行精密度、线性、准确性等评价及临床初步应用。结果批内CV%<4.0%,批间CV%<5.0%。抗干扰性强,Hb≤4.0g/L、胆红素小于或等于420μmol/L、三酰甘油小于或等于10mmol/L对测定无影响;与进口试剂对比,Y=1.0075X+0.0029,r=0.9995,两者相关性良好,试剂开瓶稳定性良好。结论免疫比浊测定血清视黄醇结合蛋白,方法简便、快速、灵敏,结果准确,可用自动分析仪测试,适合临床检验科应用。

Objective To evaluate the methodology of turbidimetric immunoassay for detection of retinol binding protein（RBP）in serum. Methods According to relevant documents of NCCLS,the precision,linearity and accuracy of this method were determined and a clinical application tried. Results Within day CV was less than 4.0% and between-day CV was less than 5.0%. The performance of anti-jamming was strong, in which hemoglohin（≤4.0 g/ L） ,bilirubin（≤420 μmol/L） ,triglytceride（≤10 mmol/L. The comparison between imported RBP（Y）and this kit（X） gave following results：Y= 1. 007 5X＋0. 002 9,r 0. 999 5. There was good correlation between them. According to the statistical data,this kit would be stable after first used. Conclusion The RBP assay kit is convenient, fast,accurate and suitable for automation analysis. The method of particle-enhanced turbidimetric immunoassay can be applied on automatic analyzer for detection of RBP in serum.