Denice Smith G, Sangle Nikhil A, Wilson Andrew, Chadwick Barbara E, Bentz Joel S, Gopez Evelyn V, Pyne Michael T, Tripp Sheryl R, Layton Michelle, Pasi Alexandra, Jarboe Elke A, Collins Brian T
ARUP Institute for Clinical and Experimental Pathology®, ARUP Laboratories, Inc, Salt Lake City, Utah, USA.
Diagn Cytopathol. 2013 May;41(5):437-47. doi: 10.1002/dc.22881. Epub 2012 Aug 4.
UroVysion FISH detects chromosomal aberrations associated with urothelial carcinoma. In our laboratory, UroVysion FISH was initially evaluated manually with a change to image-aided interpretation using the BioView Duet imaging system. This retrospective study examined diagnostic findings over an 8.6 year period, with 1,869 manual interpretations over 4.8 years and 3,936 image-aided interpretations over 3.8 years. Although the initial goal was to evaluate possible impacts of the imaging system on diagnostic interpretations, the most important finding was that the demographics of the test population changed significantly. Female specimens increased incrementally from an average of 29% compared to 43% of the samples during periods of manual interpretation versus image-aided interpretation, respectively. The shift may reflect a gradual increase in the percentage of low-risk hematuria patients being evaluated for initial diagnosis of bladder cancer, rather than bladder cancer recurrence. Interpretation rates, evaluated separately for males and females, changed significantly over the test period. Male interpretation results were negative (75.1 vs. 67%), positive (18.6 vs. 14.6%), unsatisfactory (5.0 vs. 16.9%), and equivocal (1.4 vs. 1.5%) during periods of manual versus image-aided interpretation, respectively (Fisher Exact Test P-value = <0.0001). For females, results were negative (86.1 vs. 79.3%), positive (9.2 vs. 11.1%), unsatisfactory (2.8 vs. 8.9%), and equivocal (1.8 vs. 0.7%) over the same periods (Fisher Exact Test P-value = <0.0001). Logistic regression analysis identified the change in test population as the variable with the greatest impact on observed interpretation rate changes.
UroVysion荧光原位杂交（FISH）检测与尿路上皮癌相关的染色体畸变。在我们实验室，UroVysion FISH最初采用手工评估，之后改为使用BioView Duet成像系统进行图像辅助解读。这项回顾性研究考察了8.6年期间的诊断结果，其中4.8年有1869次手工解读，3.8年有3936次图像辅助解读。尽管最初的目标是评估成像系统对诊断解读的可能影响，但最重要的发现是检测人群的人口统计学特征发生了显著变化。女性样本分别从手工解读期间平均占比29%逐步增加到图像辅助解读期间的43%。这种转变可能反映出在膀胱癌初始诊断（而非复发诊断）评估中，低风险血尿患者的比例逐渐增加。在测试期间，按男性和女性分别评估的解读率发生了显著变化。在手工解读与图像辅助解读期间，男性的解读结果分别为阴性（75.1%对67%）、阳性（18.6%对14.6%）、不满意（5.0%对16.9%）和不明确（1.4%对1.5%）（Fisher精确检验P值 = <0.0001）。对于女性，同期结果分别为阴性（86.1%对79.3%）、阳性（9.2%对11.1%）、不满意（2.8%对8.9%）和不明确（1.8%对0.7%）（Fisher精确检验P值 = <0.0001）。逻辑回归分析确定检测人群的变化是对观察到的解读率变化影响最大的变量。
