Performance Evaluation of the i-CHROMA~(TM) READER Fluorescence Immunoassay Analyzer

Objective To evaluate the performance of i-CHROMATMREADER fluorescence immunoassay analyzer.Methods CRP was chosen as the item to evaluate the precision,stability,linearity,comparability and anti-interfered ability of the analyzer according to CLSI.Results Coefficients of variation of the inter-batch testing,day precision testing and stability testing were 2.40%～3.33%,3.59%～3.95% and 2.90%,respectively,between the range supplied by the manufacturer.The practical value and the theoretical value detected by the analyzer had good linear relationship(r=0.998).The results tested by the analyzer showed no significant difference compared with those tested by the Beckman Immage specialized protein analyzer(P0.05).The interference rate of TBIL and TG was-3.4%～3.9%,-3.5%～4.6%,respectively.Conclusion The analyzer is a POCT product suitable to out-patient,emergency and community medicine treatment.