Clinical Performance Evaluation Of Urinary Cyfra21-1 And FDP And Their Combined Detection With ECLIA In Bladder Cancer Diagnosis

Objective: To evaluate the laboratory diagnostic performance of the electrochemiluminescent CYFRA21-1 and FDP kits and the diagnostic value of electrochemiluminescent CYFRA21-1,FDP,and their combined detection for bladder cancer.Methods: We evaluated the performances of Cytokeratin 19 fragment(Cyfra21-1)assay kit(electrochemiluminescence)and/or Fibrin/fibrinogen degradation products(FDP)assay kit(electrochemiluminescence)in detecting bladder cancer.Cyfra21-1and FDP levels were determined in urine samples from 467 participants in South China Hospital of Shenzhen University and Shenzhen Luohu People’s Hospital.Among them,70 were diagnosed with bladder cancer and the remaining 397(control group)were healthy individuals and patients diagnosed with urinary calculi and infection.We performed performance validation of the Cyfra21-1 and FDP kits,established normal biological reference intervals,and finally analyzed the data to assess their diagnostic efficacies alone or in combination.Results: The minimum detection limit of the CYFRA21-1 kit was ≤0.1 ng/ml,the linearity range was 0.1 ng/ml-500.0 ng/ml,and the intra assay precision was ≤6%;The minimum detection limit of the FDP kit is ≤1.0 μg/ml,the linear range is 2.5μg/ml-80.0 μg/ml,and the intra assay precision is ≤8%;The relative deviation of the two kits in trueness did not exceed±10%,interference deviation in interference test was≤±10%,and the relative recovery of rheumatoid factor was in the range of 90%-110%.The areas under the receiver operating characteristic curves(ROC-AUCs)of Cyfra21-1,FDP and Cyfra21-1+FDP were 0.929,0.857 and 0.935,respectively,for discriminating bladder cancer cases from controls.The ROC-AUC of Cyfra21-1 and FDP in combination was higher than that of any index alone.Correlation analysis suggested that FDP could be used as an auxiliary diagnostic predictor of bladder cancer progression.Conclusions: The performances of Cyfra21-1 and FDP kits met the clinical requirements.Both Cyfra21-1 and FDP have good diagnostic values in predicting bladder cancer.In addition,combined detection of urinary Cyfra21-1 and FDP by electrochemiluminescence has better differentiation ability compared with each index alone,and may be used for early screening and recurrence monitoring in bladder cancer.Figure [5] Table [17] Reference [115]...