Date Published: November 22, 2011
Publisher: Hindawi Publishing Corporation
Author(s): Joerg Hennenlotter, Severine Huber, Tilman Todenhöfer, Ursula Kuehs, David Schilling, Stefan Aufderklamm, Georgios Gakis, Christian Schwentner, Arnulf Stenzl.
Introduction. Several point-of-care tests (POCT) are available for the diagnosis of bladder cancer (BC). We evaluate the impact of HU (hematuria) on performance of POCTs. Materials and Methods. Urine from 10 donors was diluted with blood from 0.5 to 0.00625%. BladderCheckR, BTAstatR, BCMR, and BTAR tests were applied. Tests were additionally conducted in 54 patients with HU. HU was stratified according to the amount of erythrocytes (RBC)/μL using two systems: (1) no HU; mild microscopic HU; severe microscopic HU; gross HU; (2) I <25 RBCs; <250 II; ≥250 III. Results were compared to HU status and histopathology. Results. Gross HU became evident between 2090 RBCs/μL and 1065/μL. Addition of blood led to default tests in all 4: BladderCheckR 0.25%; BCM 0.025%, BioNexia 0.00625%, and BTAstat <0.00625%. Rates of false positives for BladderCheck, BTAstat, BCM, and BioNexia were 5.9, 11.8, 0, and 1.8% without HU and 0, 66.7, 44.4, and 66.7% with HU. BTAstat, BCM, and BioNexia were independently influenced by HU (P < 0.0002). Conclusions. NMP22-BladderCheck was most resistant to blood. The diagnostic yield of all others was significantly influenced by HU. A well-defined HU grading helps to define limits of HU for a reliable interpretation of BC-POCTs.
Bladder cancer (BC) presents as a malignancy with increasing incidence, a significant impact on quality of life, and the highest lifetime treatment costs per patient . Early detection to prevent progressive disease remains the challenge of the disease. Since specific symptoms are lacking and most patients present with unspecific hematuria (HU), invasive measures are still needed for ultimate diagnosis. Hence, cystoscopy is still the gold standard in the diagnostic workup of BC . Noninvasive tests are restricted to urine markers. Beside urine cytology, molecular markers evolved within recent years and play an emerging role in diagnosis and monitoring of BC . However, the diagnostic accuracy of cytology and of molecular markers remains unsatisfactory. Due to insufficient discriminatory power, urine markers are still not able to replace cystoscopy . Recently, office-based point of care test (POCT) systems became available . They are particularly useful for office physicians without direct access to cost-intensive laboratory equipment.
Molecular urine tests are promising biomarkers for BC. However, they are still not well established in daily clinical routine and in the standard diagnostic workup of BC . In contrast to other molecular tests that require elaborate molecular methodology (e.g., FISH, immunocytology, or ELISA), new POCT systems provide the opportunity to be applied by office physicians without direct access to expensive laboratory equipment. However, for being broadly used, adequate test specificity and sensitivity is at least as important as the feasibility.