特定蛋白分析仪测定C3、C4的分析性能实验与评价  

Assessment of the performance of an automated analysis system in detecting C3 and C4

作　　者：孙蕾[1] 黄宪章[1] 庄俊华[1] 徐建华[1] 林莲英[1] 柯培锋[1] 

机构地区：[1]广东省中医院检验科,广东广州510120

出　　处：《南方医科大学学报》2009年第5期884-886,共3页Journal of Southern Medical University

基　　金：国家科技支撑计划项目(2006BAI14B00)

摘　　要：目的验证和评价德灵BNⅡ全自动特定蛋白分析仪检测C3、C4的分析性能。方法根据CLSI系列文件(EP15-A、EP6-A、EP9-A2)和其他相关文献的试验方案,分析DADA BNⅡ全自动特定蛋白分析对C3、C4检测的精密度、准确度、线性等性能,结果与公认的质量标准进行比较。结果精密度试验:C3、C4的精密度均小于CLIA'88允许误差的1/3水平,精密度性能均符合临床要求;比对试验:德灵BNⅡ与罗氏Modular系统对C3、C4的检测性能不相当,不能被接受;线性试验:C3检测呈一次线性(R2>0.95,P<0.05),线性范围分别为0.18～5.1g/L,C4由于未收集到高值标本而未能进行线性评价试验。结论德灵BNⅡ全自动特定蛋白分析仪检测C3、C4的主要分析性能基本符合质量目标要求,但仍需进一步的比对试验。Objective To evaluate the performance of BNII auto-analyzer system in detecting C3 and C4. Methods CLSI protocols （EP15-A, EP6-A, EP9-A2） and other relevant literatures were use to or evaluate the precision, accuracy, linearity of C3 and C4 detection by the auto-analyzer system, and the results were compared with the recognized standards. Results The relative bias of C3 and C4 was less than one third of the CLIA＇88 standard and the precision met the clinical requirement. The results tested by DADE BNII system were not compatible with those by Roche Modular System. C3 showed good linearity in the tests （R^2〉0.975, P〈0.05） with a linearity range of 0.18-5.1 g/L. The linearity of C4 was not available because of lack of high-level samples. Conclusion The performances ofDADE BNII System basically meet the recognized standards in clinical detection of C3 and C4, but the method comparison needs further validation.

关 键 词：CLSI 性能评价 C3 C4 补体 特定蛋白分析仪 

分 类 号：R446.6[医药卫生—诊断学]