The UBC Rapid Test (Urinary Bladder Cancer Antigen Rapid Test) is a rapid test procedure for urinary bladder cancer diagnosis. Urinary bladder cancer is suspected by the quantitative detection (concentration or quantity detection) of proteins associated with urinary bladder cancer. The evaluation of the procedure is performed using concile Ω100 readers. A positive unique selling point of the UBC Rapid Test is its high sensitivity (percentage of diseased patients in whom the disease is detected by the use of the test, i.e., a positive test result) compared with other rapid test methods for the detection of urinary bladder carcinoma.
Indications (areas of use)
- Suspected new-onset bladder cancer – For patients presenting to the physician with symptoms of bladder cancer, the UBC Rapid Test is the current optimal method for detection. Classic early symptoms may include painless macrohematuria (amount of blood visible to the eye in the urine), pollakiuria (urge to urinate frequently without increased urination), dysuria (difficult (painful) urination), and recurrent (recurring) infections. Early detection of bladder cancer is enormously important, because with early diagnosis, minimally invasive therapy (surgical intervention with minimal trauma) of bladder cancer may be possible, while more advanced stages require a radical approach with removal of the bladder.
- Exclusion of recurrence (recurrence of the tumor) – in clinical trials, the value of the UBC Rapid Test for recurrence control has been investigated in addition to the detection of new-onset bladder cancer. Due to the high sensitivity of the procedure, the UBC Rapid Test can also be used to exclude recurrence of bladder cancer.
Contraindications
There are currently no absolute contraindications. However, because the procedure is based on the detection of tumor-associated proteins, sensitivity may vary depending on the tumor entity (tumor type) in the urinary bladder. The most common type of bladder cancer is urothelial carcinoma, which accounts for 95% of all malignant (malignant) bladder tumors. However, much rarer tumors such as neuroendocrine carcinomas of the urinary bladder are sometimes associated with other tumor-associated proteins.
Before the examination
Before performing the UBC Rapid test, a detailed history should be taken, which in all circumstances must include a thorough discussion of symptoms, previous illnesses, and risk factors such as smoking and occupational exposure to hazardous substances. The indication for performing the procedure should be made by the treating physician.
The procedure
The UBC Rapid Test can be used to determine tumor-associated cytokeratin fragments 8 and 18 from urothelial (urinary bladder) cells in urine as a parameter for the presence of urinary bladder cancer. Cytokeratin or the respective fragments are also produced by the covering cells of the urothelium in healthy patients. Nevertheless, a clear distinction can be made between the presence of a tumor and a healthy urinary bladder. The detection of cytokeratins is also successfully used for the detection of other carcinomas. The evaluation of the test can be performed with the naked eye or by means of a handy POC measuring device (concile Ω100). By using the concile Ω100 reader, quantification of cytokeratin fragments is also possible. In clinical studies, the UBC Rapid Test showed a significantly better sensitivity of 57% than NMP22 comparative test, for which only a sensitivity of 16% was found. Also, compared with the current standard clinical chemistry procedure for urinary bladder cancer diagnosis, urine cytology, the UBC Rapid Test had a higher sensitivity in this study (57% vs 51%).
After the examination
Depending on the results of the procedure and clinical symptoms, further diagnostic methods must be performed to confirm urinary bladder carcinoma. For apparative diagnostics, sonography (ultrasound) of the urinary bladder and kidneys as well as urethrocystoscopy (urethra and bladder endoscopy) and/or ureterorenoscopy (endoscopic inspection of the ureter and renal pelvis) are performed, among others. Furthermore, a computer tomography with contrast medium of the abdomen (abdominal organs; abdominal CT) and the thorax (chest; thoracic CT) is necessary.