TY - JOUR
T1 - Reflex ImmunoCyt testing for the diagnosis of bladder cancer in patients with atypical urine cytology
AU - Odisho, Anobel Y.
AU - Berry, Anna B.
AU - Ahmad, Ardalan E.
AU - Cooperberg, Matthew R.
AU - Carroll, Peter R.
AU - Konety, Badrinath R.
PY - 2013/5
Y1 - 2013/5
N2 - 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.
AB - 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.
KW - Bladder cancer
KW - Cystoscopy
KW - Cytology
KW - ImmunoCyt
UR - http://www.scopus.com/inward/record.url?scp=84876024861&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84876024861&partnerID=8YFLogxK
U2 - 10.1016/j.eururo.2012.04.019
DO - 10.1016/j.eururo.2012.04.019
M3 - Article
C2 - 22521093
AN - SCOPUS:84876024861
SN - 0302-2838
VL - 63
SP - 936
EP - 940
JO - European Urology
JF - European Urology
IS - 5
ER -
