[自动分析系统检测C3和C4性能的评估]
[Assessment of the performance of an automated analysis system in detecting C3 and C4].
作者信息
Sun Lei, Huang Xian-zhang, Zhuang Jun-hua, Xu Jian-hua, Lin Lian-ying, Ke Pei-feng
机构信息
Clinical Laboratory, Guangdong Provincial Hospital of Traditional Chinese Medicine, Guangzhou 510120, China.
出版信息
Nan Fang Yi Ke Da Xue Xue Bao. 2009 May;29(5):884-6.
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 (R2>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 of DADE BNII System basically meet the recognized standards in clinical detection of C3 and C4, but the method comparison needs further validation.
目的
评估BNII自动分析仪系统检测C3和C4的性能。
方法
采用CLSI协议（EP15-A、EP6-A、EP9-A2）及其他相关文献来评估该自动分析仪系统检测C3和C4的精密度、准确性和线性度，并将结果与公认标准进行比较。
结果
C3和C4的相对偏差小于CLIA'88标准的三分之一，精密度符合临床要求。DADE BNII系统检测结果与罗氏模块化系统的结果不具可比性。C3在测试中显示出良好的线性（R2>0.975，P<0.05），线性范围为0.18 - 5.1 g/L。由于缺乏高浓度样本，C4的线性度无法得出。
结论
DADE BNII系统在临床检测C3和C4方面的性能基本符合公认标准，但方法比较需要进一步验证。
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