Methodology evaluation of the determination of tumor markers based on flowcytometry fluorescence immunoassay method

Objective To evaluate the reliability of the quantitative determination of tumor markers using reagent kit based on the flowcytometry fluorescence immunoassay method.Methods The precision,linearity,rate of carryover and interference-resistance of the kits were evaluated using the automated analyzer LuminexTM-100 as determination instrument,and the results were compared with a comparative determination using Bio-Ekon Serozyme Ⅰ system.Results The chemical character evaluation showed that the within-run and between-run coefficients of variation(CV) were less than 10% and 14% respectively.The results demonstrated excellent linearity(r0.99).The rates of carryover were generally acceptable(0.5%).The assay had no significant interference by haemoglobin(Hb),bilirubin(Bil) and triglyceride(TG)(P0.05).The correlation between the evaluated kits with LuminexTM-100 and Bio-Ekon Serozyme Ⅰ system was excellent(r0.975).The tumor markers of serum samples from 506 healthy subjects(24 years old to 84 years old) were determined,and the reference result was alpha fetoprotein(AFP)15 ng/mL,carbohydrate antigen 125(CA125)35 U/mL,carcinoembryonic antigen(CEA)5 ng/mL,carbohydrate antigen 199(CA199)35 U/mL and prostate specific antigen(PSA)4 ng/mL.Conclusions The quantitative assay is safe,precise,accurate and easy to operate,and it is worthy to extend for clinical application.