Department of Pathology, Renaissance School of Medicine, Stony Brook University, Stony Brook, NY, USA.
Program of Public Health and Department of Preventative Medicine, Renaissance School of Medicine, Stony Brook University, Stony Brook, NY, USA.
Am J Clin Pathol. 2021 Oct 13;156(5):926-933. doi: 10.1093/ajcp/aqab050.
The microscopic features of urine cytology specimens are subjective and may not reliably distinguish between benign urothelial cells and low-grade urothelial carcinoma (UC). Prior studies demonstrated that keratin 17 (K17) detection in biopsies is highly sensitive for UC. The current study aimed to define K17 diagnostic test performance for initial screening and detect recurrent UC in urine specimens.
K17 was detected by immunocytochemistry (ICC) in consecutively collected urine specimens (2018-2019). A qualitative score for the K17 test was determined in 81 samples (discovery cohort) and validated in 98 samples (validation cohort). K17 sensitivity and specificity were analyzed in both cohorts across all grades of UC.
Based on the discovery cohort, the presence of 5 or more K17 immunoreactive urothelial cells (area under the curve = 0.90; P < .001) was the optimal threshold to define a K17-positive test. The sensitivity of the K17 ICC test for biopsy-confirmed UC was 35 of 36 (97%) and 18 of 21 (86%) in the discovery and validation cohorts, respectively. K17 was positive in 16 of 19 (84%) specimens with biopsy-confirmed low-grade UC and in 34 of 34 (100%) of specimens with high-grade UC.
K17 ICC is a highly sensitive diagnostic test for initial screening and detection of recurrence across all grades of UC.
尿细胞学标本的微观特征具有主观性，可能无法可靠地区分良性尿路上皮细胞和低级别尿路上皮癌（UC）。先前的研究表明，活检中角蛋白 17（K17）的检测对 UC 具有高度敏感性。本研究旨在确定 K17 诊断测试在初始筛选中的性能，并检测尿液标本中的复发性 UC。
连续收集尿标本（2018-2019 年）进行免疫细胞化学（ICC）检测 K17。在 81 个样本（发现队列）中确定 K17 检测的定性评分，并在 98 个样本（验证队列）中进行验证。分析了两个队列中所有级别 UC 的 K17 敏感性和特异性。
基于发现队列，存在 5 个或更多 K17 免疫反应性尿路上皮细胞（曲线下面积=0.90；P<0.001）是定义 K17 阳性测试的最佳阈值。K17 ICC 测试对活检证实的 UC 的敏感性在发现队列和验证队列中分别为 36 例中的 35 例（97%）和 21 例中的 18 例（86%）。在活检证实的低级别 UC 的 19 个标本中有 16 个（84%）和高级别 UC 的 34 个标本中 34 个（100%）标本 K17 阳性。
K17 ICC 是一种高度敏感的诊断测试，可用于初始筛选和检测所有级别的 UC 复发。
