The contrast research and application of electrochemiluminescence immuno-assay determination kits of human embryonic antigen / 国际检验医学杂志

ABSTRACT

Objective To evaluate the comparability of test results of self-built human carcinoembryonic antigen(CEA)electro-chemiluminescence immunoassay(ECLIA)and imported reagent.Methods A total of different concentrations 77 fresh serum speci-mens were collected and detected CEA by two kinds of ECLIA kit.The results were analyzed with Excel2003 and SPSS1 9.0 soft-ware.Results The difference between each dose was significant (P 0.05);the sensitivity of the assay was 0.3 ng/mL,the intra coefficient of variation was 4.58%-5.83%,the inter coefficient of variation was 5.07%-5.97%,the analytical recovery was 99.13%-107.28%,the specificity of the assay had no cross reaction with CA1 99 and AFP.The correlation coefficient between two kinds of reagents determination results was greater than 0.95,with imported reagent as reference test,self-built carcinoembryonic antigen ECLIA clinical performance evaluation was acceptable.Conclusion The precision of the two kinds of ECLIA in detection of CEA accord to clinical requirement.Comparability exists in evaluating the acceptability of clinical.