Roche E170检测系统测定CA19-9的线性评价及临床可报告范围的建立  

Roche E170 detection system for measuring the linear evaluation and clinical CA19-9 report laboratory

作　　者：蒋娅玲 

机构地区：[1]广东省江门市第三人民医院,529000

出　　处：《实用医技杂志》2013年第8期821-823,共3页Journal of Practical Medical Techniques

摘　　要：目的利用美国国家临床实验室标准化委员会（NCCtS）的线性判定指南EP6-A验证RocheE170检测系统测定CAl9—9的线性范围，建立CAl9—9检测的临床可报告范围。方法收集足够的在预期线性范围浓度附近的高低浓度CAl9—9血清标本，并将其混合成等间距的不同稀释浓度的6个血清标本，每个标本共测定3次，数据用多项式回归分析，验证CAl9—9的线性范围，结合最大稀释度试验建立其临床可报告范围。结果最适多项式为一次多项式，Y=0．9895X＋6．2758，RocheE170化学发光检测系统测定的线性范围为0．6～1000U／mL，与厂家声明基本一致，最大稀释度为1：25，临床可报告范围为0．6～25000U／mL。结论EP6一A指南评价方案方便易行，RocheE170检测系统测定CAl9—9的线性范围与临床可报告范围能满足临床要求。Objective To evaluate the linearity of CA19-9 by Roche El70 detection system according to NCCLS evaluation protocols EP6-A. And establish the clinical reportable range （CRR） of CA19-9. Methods Collect sufficient concentration in the vicinity of the expected linear range of the high and low concentrations of CA19-9 serum samples. Six equally spaced concentrations containing CA19-9 were measured three times at each level. The data were analyzed by polynomial regression, and to confirm the linearity range of CA19-9 by the results. For the maximum allowable dilution experiment, combined with the maximum dilution limit can be to establish its clinical report range. Results The best fit model was the linear equation, Y=0.989 5X＋6.275 8, its maximum allowable dilution for CA19-9 was 1：25. The linear range of CA19-9 with Roche El70 detection system is 0.6-1 000 U/mL. The clinical reportable range is 0.6- 25 000 U/mL. Conclusion EP6-A evaluation protocols is convenient and easy. The linear range and the clinical reportable range of CA19-9 with Roche El70 detection system can satisfy the requirement of clinic.

关 键 词：临床实验室技术 规划 线性 疾病报告 

分 类 号：R446[医药卫生—诊断学]