A comparative analysis of rapid urine tests for the diagnosis of upper urinary tract malignancy.

OBJECTIVES: To compare the effectiveness of two rapid urine tests fibrinogen/fibrin degradation products FDP (Aura Tek FDP, PerImmune Inc., Rockville, Maryland, USA) and bladder tumor antigen BTA (Bard BTA, Bard Canada Inc., Mississauga, Ontario, Canada) to urinary cytology in establishing the diagnosis of transitional cell carcinoma (TCC) in patients with suspected upper tract malignancy.

MATERIALS AND METHODS: In a prospective study, urine samples were collected from 29 patients with abnormalities of the upper tracts highly suspicious for malignancy. Sensitivity and specificity of the BTA and FDP tests were determined and compared to those of cytology. All persons interpreting the individual tests were blinded to the other test results.

RESULTS: Of the 29 patients evaluated, 14 were found to have upper tract TCC. The overall sensitivity of FDP, BTA and urinary cytology was found to be 100%, 50% and 29%, respectively. The accuracy of the FDP test was 83% as compared to 62% for BTA and 59% for cytology.

CONCLUSION: Urinary cytology lacks sensitivity in the diagnosis of upper tract TCC. This preliminary study suggests that the point-of-care test, FDP, has better test characteristics than urinary cytology. Further evaluation of these tests is warranted for their potential to improve and facilitate the diagnosis of upper tract tumors.