PURPOSE: We assessed sensitivity, specificity, accuracy, positive predictive value and negative predictive value of the bladder tumor antigen (Bard BTA), fibrinogen/fibrin degradation products (AuraTek FDP), urinary cytology and hemoglobin dipstick tests in the urine of patients presenting to a urology clinic. MATERIALS AND METHODS: A total of 130 patients (60 with bladder cancer) provided a urine sample, which was divided into appropriate aliquots for each of the tests cited above. The endoscopist, pathologist, cytologist and the person performing the BTA/FDP/hemoglobin dipstick were blinded as to the results of the other tests, and the tests were read independently by a second blinded evaluator. RESULTS: Comparative results demonstrate a clear superiority of FDP in sensitivity (81%) and overall accuracy in bladder cancer detection (p = 0.0001) while cytology and BTA were marginally better than FDP in specificity. CONCLUSIONS: The anticipated lack of specificity of the hemoglobin dipstick was confirmed as well as the inadequacy of urinary cytology, particularly in the well differentiated tumors. Our findings with BTA were disappointing. The superiority of the FDP, first demonstrated here, was particularly striking in its ability to detect even well differentiated tumors. The simplicity and significantly better overall performance of FDP make it a reliable test for detection of transitional cell carcinoma of the bladder and a potential alternative to urinary cytology with important implications for clinical practice and health economics.
PURPOSE: We assessed sensitivity, specificity, accuracy, positive predictive value and negative predictive value of the bladder tumor antigen (Bard BTA), fibrinogen/fibrin degradation products (AuraTek FDP), urinary cytology and hemoglobin dipstick tests in the urine of patients presenting to a urology clinic. MATERIALS AND METHODS: A total of 130 patients (60 with bladder cancer) provided a urine sample, which was divided into appropriate aliquots for each of the tests cited above. The endoscopist, pathologist, cytologist and the person performing the BTA/FDP/hemoglobin dipstick were blinded as to the results of the other tests, and the tests were read independently by a second blinded evaluator. RESULTS: Comparative results demonstrate a clear superiority of FDP in sensitivity (81%) and overall accuracy in bladder cancer detection (p = 0.0001) while cytology and BTA were marginally better than FDP in specificity. CONCLUSIONS: The anticipated lack of specificity of the hemoglobin dipstick was confirmed as well as the inadequacy of urinary cytology, particularly in the well differentiated tumors. Our findings with BTA were disappointing. The superiority of the FDP, first demonstrated here, was particularly striking in its ability to detect even well differentiated tumors. The simplicity and significantly better overall performance of FDP make it a reliable test for detection of transitional cell carcinoma of the bladder and a potential alternative to urinary cytology with important implications for clinical practice and health economics.