Performance verification of the 7600 biochemical analyzer detection system

Abstract

Objective　To verify the main analyzing performance of the 7600 automatic biochemical analyzer，production of Hitachi Corporation of Japan.Methods　Following the method how EP5­A，EP6­A were tested as described in the instruction of the National Committee for Clinical Laboratory Standards (NCCLS)，precision，linearity and reportable range of the selected biochemical testing items were evaluated.Results　All the within­run precision of Hitachi 7600 testing items were within the required 1/4 CLIA ′88 but Na，all the between­run precision were within the required 1/3 CLIA ′88 but Na；the linear verification results got the regression equation of the theoretical and measured values y＝bx＋a，in which b was within the range of 0.97­1.03，a was within an acceptable range；the reportable range verification results showed that after the samples being diluted by different proportions，the theoretical/measured values were all between 90% and 110%，indicating that within a certain range of sample dilution the test results were reliable.Conclusions　Precision，linearity and reportable range of the detection system met the basic requirements of the experiments in clinical diagnosis and the method detecting Na should be improved.