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

摘要

ObjectiveTo investigate the performance analysis of immunocytochemistry using 47kDa polyclonal antibody compared with cytology in urine of patients hematuria symptom.Patients and methodsPatients with a suspicion of bladder tumor based on workup of hematuria were prospectively collected. The voided urine was performed for cytology and test with 47kDa polyclonal antibody.ResultsThis 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 47kDa 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 47kDa were 22.22% (95% CI=8.62%–42.26%) and 100.00% (95% CI=73.54%–100.00%), respectively. In conclusion, urine detection with 47kDa polyclonal antibodies has higher sensitivity value and negative predictive value (100.00%) than urine cytology.ConclusionThis 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.