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  3. Medizin - Open Access LMU - Teil 13/22 Podcast
  4. Measurements of complement factor H-related protein (BTA-TRAK (TM) assay) and nuclear matrix protein (NMP22 assay) - Useful diagnostic tools in the diagnosis of urinary bladder cancer?
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(TM) assay (Bard Diagnostics, Redmont, USA) detecting
complement factor H-related protein (CFHrP) and the NMP22 assay
(Matritech, Newton, USA) measuring 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(TM) 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(TM) assay showed % 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.

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„Measurements of complement factor H-related protein (BTA-TRAK (TM) assay) and nuclear matrix protein (NMP22 assay) - Useful diagnostic tools in the diagnosis of urinary bladder cancer?“

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