两种血清视黄醇结合蛋白生化试剂的比较和评价

A evaluation and comparison of two different kinds of biochemical reagents of serum retinol-binding protein

目的观察两种不同的血清视黄醇结合蛋白(RBP)试剂在同一台生化分析仪上的检测结果是否具有可比性。方法用两种试剂进行血清视黄醇结合蛋白测定,并对两种试剂的准确性、重复性、线性范围等结果进行了评价比较。结果金斯尔试剂与北加试剂比较,两种试剂间健康对照组回归方程Y=1.011X、r^2=0.960 4,患者组回归方程Y=1.043 8X、r^2=0.965 7,r^2>0.95,测定高、低值质控品的相对偏差分别为-2.32%和-4.64%,其准确性偏差小于10%;高、低值质控品测定值的CV分别为0.9%和2.3%,患者标本测定值CV为1.3%,其重复性CV小于10%;在0.35～25 mg/dL范围内,线性误差不超过10%。结论北京九强公司的金斯尔血清视黄醇结合蛋白检测试剂与上海北加试剂其检测结果具有可比性,可用于临床血清视黄醇结合蛋白的测定。

Objective The evaluation and comparison of two different kinds of serum retinol-binding protein （RBP） reagents in the same biochemical analyzer. Methods Use the reagents of Shanghai Beijia biochemical reagents company and Beijing Jiuqiang biochemical limited company for serum retinol-binding protein determination. Their accuracy,repeatability, sensitivity,linear range and interference are compared. Results The results of Gcell reagents and Beijia reagents were evaluated,which regression equation was Y= 1.011X,r^2= 0.9604 in the normal group and Y=1.043 8X,r^2=0.9657 in the patient group; TheCV% of high level and low level controls were 0.9% and 2.3% respectively. The CV% of patients was 1.3% ;The results range in 0.35-25 mg/dI.,the linear error was less than 10%. Conclusion The results of Gcell reagents and Shanghai Beijia reagents are comparable and Gcell reagents can be safely used in clinical analysis.