MP22-10 IMPROVING DIAGNOSTIC PERFORMANCE OF THE UROVYSION® ASSAY BY USING MODIFIED CRITERIA FOR A POSITIVE TEST RESULT
2014-03-28

You have accessJournal of UrologyBladder Cancer: Detection & Screening1 Apr 2014MP22-10 IMPROVING DIAGNOSTIC PERFORMANCE OF THE UROVYSION® ASSAY BY USING MODIFIED CRITERIA FOR A POSITIVE TEST RESULT Tilman Todenhöfer, Jörg Hennenlotter, Philipp Guttenberg, Valentina Gerber, Ursula Kühs, Stefan Aufderklamm, Georgios Gakis, Arnulf Stenzl, and Christian Schwentner Tilman TodenhöferTilman Todenhöfer More articles by this author , Jörg HennenlotterJörg Hennenlotter More articles by this author , Philipp GuttenbergPhilipp Guttenberg More articles by this author , Valentina GerberValentina Gerber More articles by this author , Ursula KühsUrsula Kühs More articles by this author , Stefan AufderklammStefan Aufderklamm More articles by this author , Georgios GakisGeorgios Gakis More articles by this author , Arnulf StenzlArnulf Stenzl More articles by this author , and Christian SchwentnerChristian Schwentner More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2014.02.858AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES The UroVysion® fluorescence-in-situ-hybridization (FISH) test has become one of the most frequently used tests for urine-based diagnosis of bladder cancer (BC). The test analyzes chromosomal aberrations of chromosomes 3, 7 and 17 and loss of the 9p21 locus. To date, various evaluation strategies exist to interpret chromosomal aberrations with differing criteria for a positive UroVysion® test. Aim of the present study was to externally validate and compare different evaluation strategies of the UroVysion® assay. METHODS In total, 1048 patients who reported symptoms suspicious for BC were included. In all patients cystoscopy was performed. Urine samples of all patients were analyzed by the UroVysion® FISH assay (Abbott) and urine cytology. Sensitivity, specificity, accuracy, and area under the curve (AUC) were calculated for the evaluation strategy proposed by the manufacturer -based on a study by Sokolova et al. 2000- and the strategy proposed by Bubendorf et al. 2001, respectively. On the basis of these results, new criteria for a positive UroVysion® test were introduced and evaluated. RESULTS Of the 1048 patients, 618 underwent primary evaluation of BC and 430 had a history of non-muscle-invasive BC (NMIBC). 232 patients (22.1%) had BC at time of assessment. Sensitivity, specificity, accuracy and AUC of the test criteria proposed by the manufacturer were 72.4%, 69.6%, 70.1% and 0.71. Of 248 false positive tests, 96 (38.7%) were positive due to tetraploidic cells. Sensitivity, specificity, accuracy and AUC of the test criteria proposed by Bubendorf et al were 76.7%, 63.0%, 66% and 0.69. When applying new criteria for a positive FISH test (≥4 cells with multiple chromosomal gains or ≥5 cells with a tetraploidic pattern), sensitivity, specificity, accuracy and AUC were 65.1%, 79.3%, 76% and 0.72. Both in patients undergoing primary evaluation and surveillance, these new criteria showed increased accuracy and AUC compared to the manufacturer's criteria and criteria proposed by Bubendorf et al. CONCLUSIONS The currently proposed strategies for interpreting chromosomal aberrations detected by the UroVysion® assay show broad variability with regards of sensitivity and specificity. New criteria not including patterns of 9p21 provide superior accuracy compared to established criteria. Future efforts have to be made to better understand patterns of chromosomal abberations detected by the UroVysion® test to further improve test performance. In this context, the diagnostic value of chromosomal abberations of the 9p21 locus has to be discussed. © 2014FiguresReferencesRelatedDetails Volume 191Issue 4SApril 2014Page: e238 Advertisement Copyright & Permissions© 2014MetricsAuthor Information Tilman Todenhöfer More articles by this author Jörg Hennenlotter More articles by this author Philipp Guttenberg More articles by this author Valentina Gerber More articles by this author Ursula Kühs More articles by this author Stefan Aufderklamm More articles by this author Georgios Gakis More articles by this author Arnulf Stenzl More articles by this author Christian Schwentner More articles by this author Expand All Advertisement Advertisement Loading ...