Analytical capability of flow cytometric bead array for lung cancer markers / 药物评价研究

ABSTRACT

Objective To appraise the analytical capability of flow cytometric bead array for lung cancer markers through the tests of limit of detection,relative standard deviation,specificity,methods comparation and linearity rang.Methods The limit of detection,relative standard deviation,specificity and linearity rang in detection of Carcinoembryonic antigen (CEA),cytokeratin 19 (Cyfra21-1) and neuron specific enolase (NSE) in serum were evaluated by flow cytometer.Western blotting method was ultilized to validate the specificity of antibody-antigen recognization.The interference of hemoglobin,three acyl glycerol and bilirubin on the detection of CEA,Cyfra21-1 and NSE was tested.Compared to electrochemiluminescence immunoassay,the relative error for flow cytometric bead array was assessed.Results Flow cytometric bead array demonstrated that the limit of detection was 1.71 pg/mL for CEA,3.97 pg/mL for cyfra21-1,and 2.27 pg/mL for NSE.The relative standard deviation for intra-assay and inter-assay were below 10％ and 15％,respectively.The pair of antibodies can defferentially recognize antigens.The measurement for CEACAM6,CK18,NSE appeared that there was no significant cross-talking reaction.Three acyl glycerol and bilirubin did not significantly interfere with the detection for serum samples.Hemoglobin of 500 ng/mL can significantly interfere with the detection of Cyfra21-1 (P ＜ 0.05) and NSE (P ＜ 0.05).The correlation coefficient between flow cytometric array and electrochemiluminescence immunoassay was 0.984 2 for serum CEA,0.962 2 for serum cyfra 21-1 and 0.982 0 for serum NSE.The linearity ranged from 355.76 pg/mL to 367.74 ng/mL for CEA,from 87.89 pg/mL to 107.8 ng/mL for cyfra21-1,and from 90.12 pg/mL to 86.07 ng/mL for NSE.Conclusion Flow cytometric array for lung cancer markers may be of use in clinical detection.