Literature DB >> 22521093

Reflex ImmunoCyt testing for the diagnosis of bladder cancer in patients with atypical urine cytology.

Anobel Y Odisho1, Anna B Berry, Ardalan E Ahmad, Matthew R Cooperberg, Peter R Carroll, Badrinath R Konety.   

Abstract

BACKGROUND: ImmunoCyt/uCyt (Scimedx, Denville, NJ, USA) is a well-established urinary marker assay with high sensitivity for the diagnosis of urothelial carcinoma (UC) and can function as a second-level test to arbitrate atypical reads of urine cytology.
OBJECTIVE: To determine the utility of uCyt as a reflex test for atypical cytology in patients undergoing a hematuria evaluation or surveillance with a history of UC. DESIGN, SETTING, AND PARTICIPANTS: The uCyt assay was performed as a second-level reflex test on all voided urine cytology tests read as atypical between January 2007 and June 2010 in an academic medical center. Records were retrospectively reviewed. Three hundred twenty-four patients underwent a total of 506 uCyt assays. INTERVENTION: Reflex uCyt assay on atypical urine cytology. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The uCyt test characteristics include sensitivity, specificity, negative predictive value (NPV), and positive predictive value (PPV). RESULTS AND LIMITATIONS: Reflex uCyt was performed on 506 atypical voided urine samples that were followed by cystoscopy within 90 d. Reflex uCyt with a history of UC showed a sensitivity of 73%, a specificity of 49%, and an NPV of 80%. In those with a history of low-grade UC, reflex uCyt had a sensitivity of 75%, a specificity of 50%, and an NPV of 82%, while in those with a history of high-grade UC, it had a sensitivity of 74%, a specificity of 44%, and an NPV of 79%. Without prior history of UC, reflex uCyt had a sensitivity of 85%, a specificity of 59%, and an NPV of 94%. This study's limitations include its retrospective design and interobserver variability inherent to cystoscopy, which was used as the reference test.
CONCLUSIONS: When used as a reflex test on atypical urine cytology, negative uCyt may predict a negative cystoscopy in select patients and modulate the urgency and further work-up in those with no prior history or low-grade disease. Published by Elsevier B.V.

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Year:  2012        PMID: 22521093      PMCID: PMC3443544          DOI: 10.1016/j.eururo.2012.04.019

Source DB:  PubMed          Journal:  Eur Urol        ISSN: 0302-2838            Impact factor:   20.096


  25 in total

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Review 2.  The World Health Organization/International Society of Urological Pathology consensus classification of urothelial (transitional cell) neoplasms of the urinary bladder. Bladder Consensus Conference Committee.

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5.  Use of urinary biomarkers for bladder cancer surveillance: patient perspectives.

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6.  Patient opinion of urinary tests versus flexible urethrocystoscopy in follow-up examination for superficial bladder cancer: a utility analysis.

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8.  Performance characteristics of a new monoclonal antibody test for bladder cancer: ImmunoCyt trade mark.

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9.  Diagnostic significance of atypical category in the voided urine samples: A retrospective study in a tertiary care center.

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10.  Comparison of ImmunoCyt, UroVysion, and urine cytology in detection of recurrent urothelial carcinoma: a "split-sample" study.

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5.  Urothelial Bladder Cancer Urinary Biomarkers.

Authors:  Aidan P Noon; Alexandre R Zlotta
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Review 6.  The contemporary role and impact of urine-based biomarkers in bladder cancer.

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Review 7.  Review of the Clinical Approaches to the Use of Urine-based Tumor Markers in Bladder Cancer.

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8.  ImmunoCyt test compared to cytology in the diagnosis of bladder cancer: A meta-analysis.

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Review 9.  Molecular markers in bladder cancer.

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  9 in total

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