Reuse evaluation of remaining reagents in Roche E601 electrochemiluminescence immunoassay analyzer
Objective To analyze the feasibility by using mixed reagent for the detection of Treponema pallidum antibody(TP),human immunodeficiency virus(HIV)antibody and antigen(P24),hepatitis C virus antibody(HCV)on Roche E601 electrochemiluminescence immunoassay analyzer,to provide reference for reducing the detection cost.Methods The critical values(COⅠ value)of TP,HIV and HCV were detected by mixing residual reagents,the precision and accuracy were analyzed.The same serum samples were detect by using original and mixed reagents,the mean values were compared and the correlation analysis was conducted.Results The intra batch precision of mixed TP reagent was 1.80％and 3.35％,the inter batch precision was 8.20％and 3.60％,respectively.The intra batch precision of the mixed HIV reagent was 3.70％and 2.17％,the inter batch precision was 9.60％and 3.14％,respectively.The intra batch precision of mixed HCV reagents were 0.00％and 5.60％,the inter batch precision was 0.00％and 6.50％,respectively.The accuracy test of TP,HIV,HCV mixed reagents were all consistent with the inter laboratory quality evaluation report.The positive and negative conformity rate of the three items were all 100％.The three items correlation coefficient was 0.999 6,0.998 6,0.998 4,r≥0.975,indicated a good correlation between the two reagents.Conclusion The remaining reagents of HCV,HIVand TP used in Roche E601 electrochemiluminescence analyzer could be mixed with reagents of the same batch.
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