全自动生化仪免疫比浊法检测血清白蛋白的方法学评价

The methodology evaluate for the Auto-Biochemical analyzer immune turbidimetry to detect the serum albumin

目的使用免疫比浊法对血清白蛋白(ALB)测定的方法学进行评价。方法根据美国临床实验室标准化委员会(NCCLS)的标准,对免疫比浊法测定血清白蛋白的精密度、线性范围、回收率及准确性等指标进行测试,同时与溴甲酚绿法进行相关性的比较。结果精密度批内CV<4.0,批间CV<5.0。ALB线性范围可达5～89g/L,平均回收率为102.3%;抗干扰性强,当Hb≤50g/L,胆红素≤400μmol/L,TG≤23.0mmol/L时对测定无影响;与溴甲酚绿法对比,直线回归方程Y=1.05X+5.56(Y:免疫比浊法;X:溴甲酚绿法),相关系数r=0.926,提示两种方法有良好的相关性。结论免疫比浊法检测血清白蛋白是较为理想的新方法,完全能满足临床需要。

Objective To evaluate immune turbidimetry in the detection of serum albumin （ALB）. Methods The precision,linear, range,recovery rate and accuracy of serum albumin were tested according to the U.S.committee for standardization of clinical laboratory （NCCLS） standards.The comparison of correlation was compared with the ones of bromocresol green method. Results Intra-assay precision：CV〈4.0,between-run precision：CV〈5.0.ALB linear range was 5-89 g/L.The average recovery rate was 102.3% .It had strong anti-interference,there was no effect on the determination of Hb ≤ 50 g/L, bilirubin ≤400 μmol/L and TG≤23.0 mmol/L; In the comparison with the bromocresol green method,linear regression equation was Y=1.05 X＋5.56 （Y：immune turbidimetry; X：bromocresol green method）.The correlation coefficient of r = 0.926,which showed that,the two methods had the good correlation. Conclusion It is the new methods of ideal for the immune turbidimetry to detect the serum albumin,which can meet the clinical needs completely.