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《Chinese Journal of Blood Transfusion》 2014-04
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Comparison of performance of equipments in blood testing laboratory in blood center

YU Lei;CHEN Yu;JIA Junjie;GAO Feng;WANG Rui;HUANG Liqin;SUN Jing;GE Hongwei;Beijing Red Cross Blood Center;  
Objective To evaluate the concordance of test result from different instruments in blood testing laboratory.Methods:1) Performance comparison of two full-automatic blood grouping analyzers with different model:the two analyzer tested 1 519 samples and then Kappa test was performed to evaluate the consistency of test results.2) Performance comparison of two sets of auto chemistry analyzer:the imprecision and deviation of test results from the two analyzers with low and high ALT concentration quality control sample respectively during seven months was compared,the two analyzers tested 40 samples and then regression analysis was performed to evaluate the consistency of test results.3) Performance comparison of ELISA process systems:the ELISA process systems tested HBsAg,anti-HCV,anti-HIV,TP serum panels and routine blood samples respectively,finally,the consistency of ELISA process systems was evaluated using χ2and Kappa test.Results 1) The consistent rate of Olympus PK7200 and PK7300 is 99.0%(1 504 /1 519) and K = 0.99.2) The deviation of PNU and PPU from the two analyzers is 0.26% and 0.86%,which met the requirement of 6%.3) The consistent rates of six FAME instruments are all 100%(80 /80),except used the anti-HBV kit of Xinchuang and Biomerieux are 99.2%(119 / 120).Conclusion For blood group test,the validation process for one week in user laboratory is essential and Kappa test is usable for data analysis.QC sample and routine donor blood sample with different ALT concentration can be used in comparison of chemistry analyzer.The comparison of performance of ELISA process system should use known positive and negative sample and panel.χ2test can be used in data analysis.
【Fund】: 卫生部卫生公益性行业科研专项资助项目(200902008)
【CateGory Index】: R446.6
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