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


CONCLUSIONS
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.
Sun
Lei
L
Clinical Laboratory, Guangdong Provincial Hospital of Traditional Chinese Medicine, Guangzhou 510120, China.
Huang
Xian-zhang
XZ
Zhuang
Jun-hua
JH
Xu
Jian-hua
JH
Lin
Lian-ying
LY
Ke
Pei-feng
PF
D001322:Autoanalysis / Q000379:methods; D001774:Blood Chemical Analysis / Q000295:instrumentation / Q000379:methods*; D003176:Complement C3 / Q000032:analysis*; D003181:Complement C4 / Q000032:analysis*; D006801:Humans; D009391:Nephelometry and Turbidimetry / Q000295:instrumentation / Q000379:methods; D011506:Proteins / Q000032:analysis; D012680:Sensitivity and Specificity
D003176:Complement C3; D003181:Complement C4; D011506:Proteins