Multicenter Trial of the Quantitative BTA TRAK Assay in the Detection of Bladder Cancer Lothar Thomas, 1* Herbert Leyh, 2 Michael Marberger, 3 Emilio Bombardieri, 4 Pierfrancesco Bassi, 5 Francesco Pagano, 5 Vito Pansadoro, 6 Cora N. Sternberg, 6 Laurent Boccon-Gibod, 7 Vincent Ravery, 7 Dominique Le Guludec, 8 Alain Meulemans, 8 Pierre Conort, 9 and Laura Ishak 10 Background: Human complement factor H-related pro- tein (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 prelim- inary test results. Methods: The BTA TRAK TM assay, a quantitative en- zyme immunoassay for the bladder tumor-associated antigen in urine, was compared with exfoliative cytol- ogy 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 T 1 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 Patients with bladder cancer are most often diagnosed after seeking medical attention because of gross hematu- ria. Less frequently, their visits to their physicians are prompted by dysuria, nocturia, frequency of urination, or urinary urgency. In addition, microhematuria, detected during urinalysis performed as part of a regular medical checkup or for the diagnosis of another medical condition, may be the first sign of bladder cancer. Fortunately, 75– 85% of newly diagnosed bladder tu- mors are confined to the bladder mucosa, are not life threatening, and can be treated relatively easily by trans- urethral resection. The risk of recurrence or new tumor growth in these patients, however, is 75% (1). Recur- rence at the original site may indicate incomplete removal of the initial tumor. New tumor growth at sites other than the original may be the result of carcinogens in the urine 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, Wa ¨hringer Gu ¨ rtel 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, Ho ˆ pital Bichat, 46 rue Henri Huchard, Paris Cedex 18, France. 9 Urology Clinic, Ho ˆ pital 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. *Address correspondence to this author at: Krankenhaus Nordwest, Labo- ratoriumsmedizin, Steinbacher Hohl 2, D-60489, Frankfurt, Germany. Fax 49 69 7601 3647; e-mail th-books@t-online.de. Received July 20, 1998; accepted January 21, 1999. Clinical Chemistry 45:4 472– 477 (1999) Test Utilization and Outcomes 472 Downloaded from https://academic.oup.com/clinchem/article/45/4/472/5643083 by guest on 08 May 2023