This study aimed to evaluate the validity of the BTA STAT and BTA TRAK as biomarker tests in patients with suspected urinary bladder cancer (UBC) using histopathology as a reference method, and to clarify the relationship between the results of these tests and tumor grades.
This is a cross sectional study that was carried out in Basrah, Southern of Iraq, from 1st of October 2010 to the 31st of March 2012. A total of 102 patients with signs and symptoms suggestive of UBC admitted to the urology ward in Basrah General Hospital were enrolled. A voided urine sample was obtained from each patient for analysis of BTA STAT and BTA TRAK prior to cystoscopy.
The sensitivity and specificity of the BTA STAT test were 93.1% and 33.3% while for the BTA TRAK test were 97.7% and 33.3%, respectively. The sensitivity of the two studied urinary bladder cancer biomarkers rose with the increase in the grade of UBC and there was an elevation in the median and mean values of BTA TRAK test with the increase in the grade of UBC, although it was not significant.
In conclusion, the sensitivity of both BTA STAT and BTA TRAK tests was very high; but their specificity was very low with high false positive results, however, they may be helpful in early detection and monitoring of recurrence of the disease in patients suffering from UBC.