Performance verification and evaluation of a self-developed biochemical assay system by Roche Cobas automatic biochemistry analyzer

Objective To verify and evaluate the immunoglobulin G (IgG) testing in a self-developed biochemical assay system by Roche Cobas c311 automatic biochemistry analyzer. Methods Verification experiments were taken to measure the precision, accuracy, analytical measurement range (AMR), clinical reportable range (CRR), contrast experiment, interference experiment of IgG testing in a self-developed biochemical assay system. Results The low and high values of coefficient variation (CV) of within-run precision were 3.34% and 3.57%, and those of day to day precision were 5.27% and 4.74%, which were all less than the CV provided by the 1/4 CLIA’88 and 1/3 CLIA’88 requirements. Relative bias was 3.32% and -6.34%, less than 1/2 CLIA’88 standard. Analytical measurement range was 2.81~31.44 g/L, and the clinical reportable range was 2.81~188.64 g/L. Comparison with Roche Cobas c501 automatic biochemistry assay system showed r=0.901, y=0.95x+0.55. Conclusion Self-developed biochemical assay system by Roche Cobas c311 automatic biochemistry analyzer can be used for clinical testing IgG project. The main performances are according with acceptable standards.