Comparative predictive values of urinary cytology, urinary bladder cancer antigen, CYFRA 21-1 and NMP22 for evaluating symptomatic patients at risk for bladder cancer

Purpose: We study the potential diagnostic use of urinary bladder cancer an tigen, CYFRA 21-1 and NMP22* for evaluating symptomatic patients who presen t with microscopic hematuria and are at risk for bladder cancer. Materials and Methods: Urinary tumor markers were determined in 187 samples from 112 patients symptomatic of bladder cancer (group 1), and 75 with ben ign and other urological conditions (group 2). Immunoassays were used to me asure the 3 selected biomarkers. Sensitivity and specificity were establish ed by previously defined cut points. Biomarker results were reported as cor rected and uncorrected for urinary creatinine, Urinalysis was performed in all samples. Results: Positive and negative predictive values were 85.5%, 80.5% and 81.1 %, and 80.8%, 79.2% and 76.5% for urinary bladder cancer antigen, CYFRA 21- 1 and NMP22, with the cutoffs 9.7 mug./l., 5.4 mug./l and 10.0 units per mi ., respectively. These predictives values were 85.2% and 72.5%, respectivel y, for urinary cytology. The combination of biomarkers decreased the positi ve predictive values to 72.3% to 78.6% and increased negative predictive va lues to 84.2% to 86.1%. Urinary tract infection, inflammation and malignanc y associated with other genitourinary organs were the primary cause for fal se-positive test results in the 3 assays evaluated. Conclusions: With a single biomarker, around 80% of the positive results wo uld have correctly identified symptomatic patients for cystoscopy. Of the n egative results 75% would have correctly reduced the number of cystoscopies . Sensitivity and negative predictive values could be improved with the com bination of biomarkers but with a loss of specificity and positive predicti ve values. Urinary tract inflammation and other genitourinary malignancies might contribute to the reduction in specificity of these tests.