Qualitative determination of urinary human complement factor H-related protein (hcfHrp) in patients with bladder cancer, healthy controls, and patients with benign urologic disease

Objectives: To assess the diagnostic quality of human complement factor H-r elated protein (hcfHrp, BTA STAT(TM)) as a qualitative urinary marker for b ladder cancer. Methods: Urine samples of 354 individuals (76 healthy volunt eers, 111 patients with benign urologic disorders, 167 patients with histol ogically proven bladder cancer) were examined prior to thera py for the pre sence of hcfHrp. Results: Overall test sensitivity was 62.9%. Sensitivity o f low-grade/low-stage tumors was <50% and was thus comparable to published sensitivities of urinary cytology. In high-stage, high-grade tumors sensiti vity was 100 and 77.3%, respectively. Superficial tumors with high risk of progression (pT1G3) were detected significantly better (88.9% sensitivity) than low-risk superficial tumors (pTa G1-3/pT1G1-2; 48.2%; p < 0.001). The overall specificity (healthy individuals and patients with benign urologic disease) was 93.0%. Conclusion: Since test sensitivity is comparable to uri nary cytology and specificity is excellent, hcfHrp should be further evalua ted in prospective studies focussing on the follow-up of patients with blad der cancer. Copyright (C) 2000 S. Karger AG, Basel.