TITLE

Validation and Clinical Utility Assessment of an Automated Capture/Analysis System for FISH to Detect Urothelial Carcinoma

AUTHOR(S)
Fowler, Elizabeth B.; Woolworth, Julie Ann; Quigley, Denise I.; Ellerbe, Caitlyn; Wolf, Daynna J.
PUB. DATE
September 2012
SOURCE
Journal of the Association of Genetic Technologists;2012 3rd Quarter, Vol. 38 Issue 3, p101
SOURCE TYPE
Academic Journal
DOC. TYPE
Article
ABSTRACT
Bladder cancer is a common cancer with a significant risk for recurrence and progression to invasive disease; therefore, sensitive diagnostic and surveillance testing is of utmost importance. The purpose of this study was to evaluate the utility of the automated fluorescence in situ hybridization (FISH) scoring system, BioView, to detect new and recurrent cases of transitional cell carcinoma (TCC). For initial validation studies, eighty-four samples were read manually and subsequently assessed using the BioView system. The concordance rate between methods was 87%. Of the eleven discordant cases, seven were found to be negative by manual analysis, but positive by BioView. The clinical performance characteristics of BioView FISH analysis was subsequently assessed by comparing results of the first 300 consecutive cases studied by BioView to results of 300 consecutive cases previously scored using the manual method. Positivity rates were similar (24% for manual and 19% for BioView). BioView versus manual interpretations showed increased sensitivity (73% versus 60.5%) and specificity (85% versus 74%) when compared to histological data and a significant decrease in time spent on case interpretation compared with the manual method. While validation of BioView interpretations has been accessible, various laboratory measures including sensitivity and specificity are lacking. Based on the advantages of the BioView system including superior results, decreased technologist time, and improved workflow with better turnaround times, the BioView system was determined to provide a sensitive and Cost-effective alternative to manual scoring.
ACCESSION #
82161280

 

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