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Eur Urol. 2013 May;63(5):936-40. doi: 10.1016/j.eururo.2012.04.019. Epub 2012 Apr 14.

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

Author information

1
Department of Urology and the Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, San Francisco, CA, USA.

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.

PMID:
22521093
PMCID:
PMC3443544
DOI:
10.1016/j.eururo.2012.04.019
[Indexed for MEDLINE]
Free PMC Article

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