Immunocytology in the assessment of patients with painless gross haematuria

OBJECTIVE To evaluate, in a prospective study, the role of immunocytology in assessing patients with gross haematuria. Due to the high prevalence of urothelial cancer in this population, a thorough assessment is mandatory to identify all patients with tumours. PATIENTS AND METHODS We used Ucyt® (DiagnoCure Inc., Quebec, Canada), a commercially available immunocytological assay based on the microscopic detection of tumour-associated antigens on the membrane of urothelial cells by immunofluorescence. Between October 2000 and March 2007, 61 consecutive patients with a first episode of painless gross haematuria, but no previous transitional cell carcinoma, were included. Urine samples were obtained from all patients and examined cytologically and immunocytologically. RESULTS Clinically (by physical examination, laboratory tests, endoscopy and imaging) there was bladder cancer in 17 patients (28%); further diagnoses were benign prostatic enlargement (20, 33%), urinary tract infection (seven, 12%), urolithiasis (two, 3%), and ‘further conditions’ (seven, 12%). In 10 patients (16%) the reasons for haematuria were not disclosed. Of the 61 samples, 59 (97%) were assessable by cytology and immunocytology. For cystoscopy, immunocytology and conventional urine cytology the sensitivity was 76%, 88% and 47%, and the specificity 100%, 77% and 95%, respectively. Two bladder tumours were not detected by cystoscopy and immunocytology (one each), and two upper urinary tract tumours were diagnosed by imaging and immunocytology. CONCLUSIONS The combination of cystoscopy and immunocytology gave 100% sensitivity, while combining cystoscopy and cytology only marginally improved the sensitivity of cystoscopy alone. As sensitivity appears to be of key relevance in assessing patients with gross haematuria, we suggest adding immunocytology to the diagnostic protocol in this situation.