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Multicenter Trial of the Quantitative BTA TRAK Assay in the Detection of Bladder Cancer

¹ Laboratory Medicine, Krankenhaus Nordwest, Steinbacher Hohl 2, D-60489 Frankfurt, Germany.

² Urology Department, Technical University of Munich, Ismaninger Strasse 22, 81675 Munich, Germany.

³ Urology Clinic, University of Vienna, Währinger Gürtel 18-20, Vienna A-1090, Austria.

⁴ Nuclear Medicine Division, National Tumor Institute, Via Venezian 1, I-20133 Milan, Italy.

⁵ Institute of Urology, University of Padova, Via Giustiniani 2, 35128 Padova, Italy.

⁶ Fondazione Vincenzo Pansadoro, Via Aurelia 559, 00165 Rome, Italy.

⁷ Urology Clinic and
⁸ Nuclear Medicine, Hôpital Bichat, 46 rue Henri Huchard, Paris Cedex 18, France.

⁹ Urology Clinic, Hôpital Pitie-Salpetriere, 47-83 bd de l'hopital, 75634 Paris Cedex 13, France.

¹⁰ Clinical Trials, Bion Diagnostic Sciences, 12277 134th Avenue NE, Redmond, WA 98052.
^a Address correspondence to this author at: Krankenhaus Nordwest, Laboratoriumsmedizin, Steinbacher Hohl 2, D-60489, Frankfurt, Germany. Fax 49 69 7601 3647; e-mail th-books{at}t-online.de

Background: Human complement factor H-related protein (hCFHrp) is produced by several bladder cancer cell lines and may be useful as a cancer marker. The aim of this study was to compare urinary hCFHrp and cytology for the detection of bladder cancer found by cystoscopy in patients with suggestive signs, symptoms, or preliminary test results.

Methods: The BTA TRAK^TM assay, a quantitative enzyme immunoassay for the bladder tumor-associated antigen in urine, was compared with exfoliative cytology in 220 patients (155 men, 65 women; mean age, 64.2 years) presenting with signs, symptoms, or preliminary diagnostic results suggestive of this disease. Cystoscopy was the standard of detection.

Results: In the 100 patients found to have bladder cancer, the overall sensitivities of the BTA TRAK assay (at a previously determined decision threshold of 14 kilounits/L) and cytology were 66% (66 of 100) and 33% (33 of 100), respectively (P <0.001). The BTA TRAK assay proved to be statistically more sensitive than cytology for tumor grades I and II and for stage T_a and T₁ tumors. In contrast, the overall specificity of the BTA TRAK assay in the 120 patients without cystoscopically confirmed bladder cancer was 69% (83 of 120) and that of cytology was 99% (119 of 120; P <0.001). The specificity of the BTA TRAK assay was higher in patients without benign or malignant genitourinary disease other than bladder cancer (76%; n = 89) than in patients with these conditions. When the BTA TRAK assay and cytology were used together such that a positive result in either test was scored as positive and the results compared with those of the BTA TRAK assay alone, increases in overall sensitivity and equivalent specificity were observed.

Conclusion: Because of its relatively high sensitivity, the BTA TRAK assay could complement cytology as an adjunct to cystoscopy in the diagnosis and follow-up of most patients with bladder cancer.© 1999 American Association for Clinical Chemistry

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