Sensitivity and specificity of 47 kDa polyclonal antibody for detection of bladder cancer cells in urine of hematuria patients

Abstract

Objective: To investigate the performance analysis of immunocytochemistry using 47 kDa polyclonal antibody compared with cytology in urine of patients hematuria symptom.
Patients and methods: Patients with a suspicion of bladder tumor based on workup of hematuria were prospectively collected. The voided urine was performed for cytology and test with 47 kDa polyclonal antibody.
Results: This study involved 39 patients consisting of 35 (89.74%) male and 4 (10.25%) female patients. For male patients, they showed 6 (17.14%) of positive cytology cases and 25 (71.42%) of positive immunocytochemistry cases. For female patients, they showed 0 (0.00%) of positive cytology cases and 2 (50.00%) of positive immunocytochemistry cases. The sensitivity and specificity value for immunocytochemistry using polyclonal antibody to the 47 kDa were 100.00% (95% CI = 54.07%–100.00%) and 36.36% (95% CI = 20.40%–54.88%), respectively. The positive and negative predictive value for immunocytochemistry of polyclonal antibody to the 47 kDa were 22.22% (95% CI = 8.62%–42.26%) and 100.00% (95% CI = 73.54%–100.00%), respectively. In conclusion, urine detection with 47 kDa polyclonal antibodies has higher sensitivity value and negative predictive value (100.00%) than urine cytology.
Conclusion: This technique becomes an alternative early detection of bladder cancer for high-risk populations which can be easily and specifically carried out in primary care in Indonesia.