The Bta Stat Test Is Nonspecific for Hematuria: An Experimental Hematuria Model

Öge, Ömer; Kozacı, Didem; Gemalmaz, Hakan

doi:10.1016/s0022-5347(05)65290-1

Cited by 52 publications

(17 citation statements)

References 19 publications

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“…Hematuria severely affected the specificity of the BTAsta [9] and NMP22 [8, 31] detection and increased the false-positive results. We used the same methods of spiking urine specimens with whole blood as described previously [8, 9, 31], and found that hematuria did not affect the specificity of the SNCG ELISA detection.…”

Section: Discussionmentioning

confidence: 99%

“…We used the same methods of spiking urine specimens with whole blood as described previously [8, 9, 31], and found that hematuria did not affect the specificity of the SNCG ELISA detection. This finding was further supported by the absence of a correlation between the urine levels of SNCG and Hb-α or Hb-β.…”

Section: Discussionmentioning

confidence: 99%

“…Urine-based biomarkers, such as bladder tumor antigen (BTA) and nuclear matrix protein-22 (NMP22), may be more sensitive than urine cytology [5, 7], making them useful for detecting low-grade tumors, but noncancerous conditions, including hematuria, can interfere with the detection of BTA and NMP22 [8, 9]. Consequently, none of these biomarkers is recommended for BCa detection [10].…”

Section: Introductionmentioning

confidence: 99%

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Urine gamma-synuclein as a biomarker for the diagnosis of bladder cancer

Liu

Shi

Hao³

et al. 2016

Oncotarget

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Gamma-synuclein (SNCG) is secreted from tumor cells and elevated in the urine of bladder cancer (BCa) patients, however, the diagnostic and prognostic values of urine SNCG for BCa remain unknown. Here, we used enzyme immunoassay and western blotting to measure urine SNCG levels. Patients with BCa or other urological diseases and healthy controls were enrolled at four Chinese hospitals from April 2010 to November 2014. Diagnostic performance was evaluated by analyzing the area under receiver operating characteristic curves (AUROCs). The AUROC was 0.903 ± 0.019 (95% confidence interval [CI], 0.867 - 0.940) for the test and 0.929 ± 0.015 (95% CI, 0.901 - 0.958) for the validation cohort. The optimal cutoff value yielded sensitivities of 68.4%, 62.4% and specificities of 97.4%, 97.8% for the test and validation cohort, respectively. Urine SNCG levels were decreased after tumor resection, but were higher in BCa patients with recurrence than those without (P = 0.001). The urine SNCG levels in patients with urological benign diseases were significantly lower than BCa patients (all P < 0.05) but higher than healthy controls (all P < 0.05). Hematuria did not interfere with the SNCG detection by spiking urine specimens with whole blood. Compared with a nuclear-matrix-protein-22 assay in an additional cohort excluding hematuria, SNCG showed a similar sensitivity and higher specificity. In summary, our results demonstrated that urine SNCG can discriminate BCa from urinary diseases, and is a useful prognosticator of postsurgical recurrence.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Urine gamma-synuclein as a biomarker for the diagnosis of bladder cancer

Liu

Shi

Hao³

et al. 2016

Oncotarget

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“…The BTA tests (BTA stat™ and BTA TRAK™ (Polymedco Inc. Cortlandt Manor, NY, USA) have diagnostic sensitivities ranging from 29-83% and specificities ranging from 56-86% [3,4]. In addition, we and others have demonstrated in an experimental model that hematuria adversely affects the accuracy of the BTA assay [5,6]. The NMP-22 tests (NMP22® Bladder Cancer ELISA Test Kit and the NMP22® BladderChek® point-of-care test, Alere Scarborough, Inc. Waltham, MA) have diagnostic sensitivities ranging from 47-100% and specificities ranging from 55-98% [7,8].…”

Section: Introductionmentioning

confidence: 99%

Investigation of CCL18 and A1AT as potential urinary biomarkers for bladder cancer detection

et al. 2013

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BackgroundIn this study, we further investigated the association of two biomarkers, CCL18 and A1AT, with bladder cancer (BCa) and evaluated the influence of potentially confounding factors in an experimental model.MethodsIn a cohort of 308 subjects (102 with BCa), urinary concentrations of CCL18 and A1AT were assessed by enzyme-linked immunosorbent assay (ELISA). In an experimental model, benign or cancerous cells, in addition to blood, were added to urines from healthy controls and analyzed by ELISA. Lastly, immunohistochemical staining for CCL18 and A1AT in human bladder tumors was performed.ResultsMedian urinary protein concentrations of CCL18 (52.84 pg/ml vs. 11.13 pg/ml, p < 0.0001) and A1AT (606.4 ng/ml vs. 120.0 ng/ml, p < 0.0001) were significantly elevated in BCa subjects compared to controls. Furthermore, the addition of whole blood to pooled normal urine resulted in a significant increase in both CCL18 and A1AT. IHC staining of bladder tumors revealed CCL18 immunoreactivity in inflammatory cells only, and there was no significant increase in these immunoreactive cells within benign and cancerous tissue and no association with BCa grade nor stage was noted. A1AT immunoreactivity was observed in the cytoplasm of epithelia cells and intensity of immunostaining increased with tumor grade, but not tumor stage.ConclusionsFurther development of A1AT as a diagnostic biomarker for BCa is warranted.

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“…For BCa detection, urinary BTA tests have diagnostic sensitivities ranging from 29–83% and specificities ranging from 56–86% [4,5]. Recently, Oge et al demonstrated that hematuria adversely affects the accuracy of BTA assays [6]. …”

Section: Introductionmentioning

confidence: 99%

Influencing factors on the NMP-22 urine assay: an experimental model

Miyake¹,

Goodison²,

Giacoia³

et al. 2012

BMC Urol

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BackgroundThe commercial NMP-22 urine assays for bladder cancer (BCa) detect nuclear mitotic apparatus protein 1 (NUMA1) using monoclonal antibodies. It remains unclear whether these assays are monitoring a tumor antigen or some other phenomenon associated with the disease state. In this study, we investigated the influence of urinary cellular and protein concentration, and hematuria on the performance of the NMP-22 tests in an experimental model.MethodsPooled urine from healthy subjects were spiked with varying concentrations of benign (UROtsa) cells, cancer cells (RT4, T24, KU-7 and UM-UC-14), whole blood or serum, prior to analysis with both NMP22® Bladder Cancer ELISA test and the NMP22® BladderChek® point-of-care test.ResultsUrines from control subjects were negative for NMP-22. The addition of whole blood at 50ul/10 ml, but not serum, resulted in a false-positive result. Furthermore, the addition of a high concentration of benign urothelial cells (106) or the cell lysate from these cells (306 μg protein) resulted in a false-positive result. High concentrations of pooled-cancer cells (106) or cell lysate (30.6 μg and above) resulted in a positive NMP-22 assay. Concordance between the NMP-22 ELISA assay and the NMP-22 point of care assay was >90%.ConclusionsRather than detecting a specific tumor antigen, urinary NMP-22 assays may be measuring the cellularity or amount of cell turnover that may be introduced into the urine by a variety of conditions, including surface shedding from bladder tumors. The absence of significant urinary cellularity in some cases due to lesion characteristics or the timing of sampling may result in false-negative NMP-2 assays.

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The Bta Stat Test Is Nonspecific for Hematuria: An Experimental Hematuria Model

Abstract: The results of the BTA stat test in the presence of microscopic hematuria must be interpreted in regard to the degree of hematuria. The test is not reliable in urine samples with gross hematuria due to a high false-positive rate.

Cited by 52 publications

References 19 publications

Urine gamma-synuclein as a biomarker for the diagnosis of bladder cancer

Urine gamma-synuclein as a biomarker for the diagnosis of bladder cancer

Investigation of CCL18 and A1AT as potential urinary biomarkers for bladder cancer detection

Influencing factors on the NMP-22 urine assay: an experimental model

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