Methodological evaluation of performance of immunofluorescence analyzer i-CHROMA~(TM) READER for detecting C-reactive protein

Objective:To evaluate the performance of immunofluorescence analyzer i-CHROMATM READER for detecting C-reactive protein(CRP).Methods:With reference to the series of documents by U.S.A Association of clinical and laboratory standards(CLSI)combined with actual practice,an validation program was designed to testify and evaluate the precision,accuracy,linearity,and anti-interference ability of immunofluorescence analyzer i-CHROMATM READER for detecting serum C-reactive protein.The experimental results were compared with the performance indicators provided by the manufacturer(Korea Boditech Med Inc company)or recognized quality metrics.Results:On quantifying C-reactie protein(CRP),the variation coefficient inside batch and between batches conformed to the relevant requirements.Linear and accuracy experiments showed that the test results by immunofluorescence analyzer i-CHROMATM READER and Japan OlympusAU2700(scattering ratio turbidity method)had good correlation.The linearity was in close range with that provided by the manufacturers,Regression equations proved to be meaningful.The effect of triglycerides and bilirubin on test results was in acceptable range.Conclusion:The analyzing performance of immunofluorescence analyzer i-CHROMATM READER for detecting serum CRP meets the performance indicators provided by the manufacturers.It also has the advantage of simple operation,which can be operated at bedside in all sorts of health care organizations.