Analysis of test results using residual reagents in electrochemiluminescence immunoassay analyzer / 国际检验医学杂志

ABSTRACT

Objective To evaluate the detection efficiency of residual reagent used in electrochemiluminescence immunoassay an-alyzer .Methods Alpha fetoprotein (AFP) ,carcino-embryonic antigen(CEA) and total prostate specific antigen(TPSA) were de-tected by using remaining reagents .The precision and recovery rate of remaining reagents were analyzed .Referring to the document of NCCLS EP9-A2 ,8 clinic samples were detected everyday by residual reagent and new reagent respectively .The test results of to-tal 40 samples were recorded within 5 days .The test results derived from 2 kinds of reagents were analyzed comparatively and their bias was evaluated by using new reagent as a control method and residual reagent as experimental methods .Results The within-run and between-run coefficients of variation(CV) of the 3 items measured by residual reagents in low and high levels of quality control products met the related standard .The recovery rate was variable from 90% to 110% .The test rewults of the 2 kinds of reagents were positively correlated(r2 >0 .95) .Their anticipated biases were within allowed biases on the medical decision level of CEA ,AFP and T PSA .Conclusion Residual reagent of electrochemiluminescence immunoassay analyzer can meet the clinical practice needs , which also can ensure the quality of measurement and the reduction of the cost .