Performance evaluation and analysis of CRP tested by nephelometry

Objective To evaluate the performance of CRP dectected by DADE BNII automatic special protein auto-analyzer.Methods The precision,accuracy,comparability and interference analysis were performed according to CLSI protocols(EP15-A,EP9-A2,EP7-A2) and other literatures.The results were compared with manufacturer's statement or international standards.Results The intra-assay inaccuracy(CV) of CRP at 13.84 mg/L and 55.6 mg/L was 3.32% and 3.58% respectively,which was less than the CV provided by manufacture(4.0% and 5.7%).The relative bias between the results detected for calibrator at two levels and given value from SIEMENS was 6.06% and 6.16%,less than 1/2 CLIA'88 standard(12.5%).The nephelometry was correlated with Roche Modular automatic biochemical analyzer(r=0.999 5,y=0.952 7x+0.355 2).The bias was acceptable between the two systems.Interference analysis showed the interference was limited when F-Bil at 0.2 g/L,hemoglobin at 4.82 g/L,chyle at 835 FTU.Conclusion The major performances of CRP detected by DADE BNII automatic special protein autoanlayzer was according with acceptable standards.