Abstract
Background
In this study, we investigated the influence of hematuria on the performance of the bladder tumor antigen (BTA) tests in a clinical cohort and in an experimental model.
Materials and methods
Urine samples from a cohort of 126 subjects (64 with BCa and 62 controls) were analyzed by ELISA for hemoglobin and BTA. The experimental model involved the spiking of urine with blood from the same subject, and hemoglobin, red blood cell count, and BTA levels (BTA stat© and BTA-TRAK©). BTA-TRAK© analyses were also performed on serum samples obtained from 40 subjects (20 with confirmed with BCa).
Results
In the 126 subject cohort, correlation between hemoglobin and BTA was 0.732. Of the 64 BCa samples, 72 % had a positive BTA assay, but 47 % of controls were also positive. The sensitivity and specificity of BTA to detect BCa was 72 and 53 %, respectively. Hematuria, measured by urinary hemoglobin, was a better indicator of BCa with 75 % sensitivity and 90 % specificity. Spiking of BTA-negative urine samples with as little as 1 μl/10 ml was enough to produce a positive BTA test. High levels of BTA were found equally in the serum of subjects with or without BCa (mean BTA levels 355,159 vs. 332,329 U/ml, respectively).
Conclusions
Rather than detecting a bladder tumor antigen, urinary BTA assays may be measuring serum cFH introduced by bleeding, a common presenting factor in BCa subjects. The presence of hematuria in subjects without malignant disease can result in false-positive BTA assays.
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Acknowledgments
This work was supported by the research grants from the Florida Department of Health James and Esther King Team Science Award 10KT-01 (CJR), the National Cancer Institute RO1 CA116161 (SG), and the Flight Attendant Medical Research Institute (CJR).
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The authors declare that they have no conflict of interest.
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Miyake, M., Goodison, S., Rizwani, W. et al. Urinary BTA: indicator of bladder cancer or of hematuria. World J Urol 30, 869–873 (2012). https://doi.org/10.1007/s00345-012-0935-9
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DOI: https://doi.org/10.1007/s00345-012-0935-9