血清清蛋白不同方法学建立可比性分析

目的探讨溴甲酚绿法与溴甲酚紫法测定血清清蛋白（ALB）是否可以建立可比性。方法用RocheCobas8000（溴甲酚绿法）检测系统为靶机，建立BeckmanDXC800（溴甲酚紫法）检测系统。按照NCCLS的EP9-A2方案，分别测定患者血清ALB，分析测定结果并对数据进行统计学分析。以美国临床实验室修正法规（CLIA’88）规定的室间质量评价允许误差范围的1／2为临床接受范围，判断可比性。结果溴甲酚绿（BCG）法与溴甲酚紫（BCP）法测定结果相比，在线性范围内，两者差异无统计学意义（P〉0．05），二者呈高度相关（Y=1．053X—1．6l，r=0．993）。在医学决定水平为20，35和52g／L时，BCP法预期相对偏倚分别为-2．721％，0．73％和2．234％。结论临床接受性能评价结果显示，不同方法学测定血清清蛋白在精密度、正确度可接受、线性范围相同的情况下可以建立可比性，结果可以互认。

Comparable Analysis of Serum Albumin Different Methodology Establish

Objective The article discusses bromocresol green method with bromocresol purple for determination of serum al- bumin （ALB） whether can build comparability. Methods Established Beckman DXC800 detection system with Roche Cobas 8 000 detection system for drone. According to NCCLS standardization document EP9-A2, the serum albumin of patients samples were respectively measured with Beckman DXC800 and Roche Cobas 8 000,the results and data were analyzed sta- tistically. Through the American Cinical Laboratory Fixed Regulations （CLIA＇ 88） regulation of interventricular quality eval- uation permissible error range of 1/2 for clinical accept range,judged the comparability. Results The difference between the test result measured with BCG method and BCP method was not statistically significant （P〉0. 05）, but they were closely correlative with each other （Y= 1. 053X-- 1.61, r= 0. 993）. When medical decisions were 20,35 and 52 g/L, the expected relative deviations of BCP method were --2. 721% ,0.73% and 2. 234%. Conclusion Clinical accept performance evaluation results showed that different methodology determination results of serum albumin with precision and accurateness acceptable and linear range of the same case can build comparability and resultant-accreditation.