Journal
AMERICAN JOURNAL OF CLINICAL PATHOLOGY
Volume 156, Issue 5, Pages 926-933Publisher
OXFORD UNIV PRESS INC
DOI: 10.1093/ajcp/aqab050
Keywords
Keratin 17; Diagnostic biomarker; Urothelial carcinoma; Urine cytology
Categories
Funding
- Department of Pathology at the Renaissance School of Medicine
- NCI [R00 CA226342]
- Damon Runyon-Rachleff Innovation Award
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The study demonstrates that K17 ICC is highly sensitive and specific for the diagnosis of UC in urine specimens, effective for initial screening and detection of recurrence across all grades of UC.
Objectives: 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. Methods: 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. Results: 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. Conclusions: K17 ICC is a highly sensitive diagnostic test for initial screening and detection of recurrence across all grades of UC.
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