UroToday - In the June 2008 issue of Analytical & Quantitative Cytology & Histology, the authors assessed the reproducibility of the UroVysion fluorescence in situ hybridization (FISH) assay to detect bladder cancer in clinical urine specimens. Thirteen specimens (2 negative, 3 low-level positive [1-10% abnormal cells], 5 mid-level positive [11-75%], and 3 high-level positive [>75%]) were analyzed by 7 cytotechnologists. Each cytotechnologist rendered an overall diagnosis of positive or negative and determined the percentage of abnormal urothelial cells for all positive specimens.

The interobserver reproducibility of the assay was 100% for mid-level and high-level positive specimens - 93% for negative specimens, and 78% for low-level positive specimens. The range of percent abnormal determinations was highest for mid-level positive specimens, with mean standard deviations of 1.8%, 16.4% and 10.1% for the low-, mid-, and high-level positives, respectively. The authors conclude that there is a high level of reproducibility among the mid- and high-level positive specimens. However, the reproducibility for low-level positive specimens was poor, suggesting that such specimens should be reviewed by a second technologist to ensure an accurate diagnosis.

These findings should be considered by Urologists when using the UroVysion fluorescence in situ hybridization (FISH) assay to detect bladder cancer. For patients with low level positive findings, a repeat analysis is warranted before instituting biopsy or therapy.

Brankley SM, Adams EJ, Christensen MR, Everts CR, Lund JD, Oberg TN, Plagge AM, Zieman AH, Kipp BR, Halling KC

Anal Quant Cytol Histol. 2008 Jun;30(3):145-51

Reported by UroToday Contributing Editor David P. Wood, MD

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