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

To evaluate the performance of BNII auto-analyzer system in detecting C3 and C4.

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.

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.

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.