Between 1997 and 2000 we investigated in a prospective study the voided urine samples of all consecutive patients undergoing cystoscopy independent from their clinical background (n = 705) with the BTA-TRAK assay (Bard Diagnostics, Redmont, USA) detecting a
complement factor H-related
protein (CFHrP) and the
NMP22 assay (Matritech, Newton, USA) measuring a
nuclear matrix protein, which is supposed to be specific for
bladder cancer. The individuals were divided into three groups concerning the clinical background: 233 patients had
urological diseases, 268 patients had
urinary bladder cancer and 150 patients had other urological
malignancies. Based on the clinical findings we compared our results with well established diagnostic methods for
urinary bladder cancer such as cytology and the detection of
hematuria. In addition, we investigated urine samples from 30 healthy individuals and 24 patients with
urinary tract infection without performing cystoscopy. Following the recommendations of the European Group on
Tumor Markers we used 95% specificity for benign
urological diseases and
urinary tract infections, which resulted in a sensitivity of 17% for active
bladder cancer for the BTA-TRAK assay and 31% for
NMP22. We compared these results with the detection of
hematuria (specificity: 72%) and cytology, which had a sensitivity of 64% and 89%, respectively. Subsequently, we calculated sensitivity and specificity for the detection of relapse of the disease. Again using 95% specificity, in this case for patients with no evidence of disease (NED), in patients with recurrent disease the BTA-TRAK assay showed 8% sensitivity as compared to 12% for the
NMP22 assay. Due to an insufficient specificity and sensitivity, both tests can neither be clinically useful in screening of high risk patients, nor in primary diagnosis of
bladder cancer. They cannot replace neither cystoscopy nor cytology. In the
follow-up care more investigations may be necessary to prove the benefit of existing diagnostic strategies for the discrimination between active and inactive
bladder cancer.