"Indeterminate" UroVysion Fluorescence In Situ Hybridization Results: Clinical Implications of Diagnostic Terminology

Objectives: UroVysion cases with one to three abnormal cells that do not meet the threshold for positivity may be better classified as "indeterminate. " The aim of this study is to determine the incidence and clinical significance of these indeterminate UroVysion results. Methods: The UroV...

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Bibliographic Details
Published inAmerican journal of clinical pathology Vol. 156; no. 3; pp. 427 - 432
Main Authors Xu, Jing, Westfall, Danielle E, Lopategui, Jean R
Format Journal Article
LanguageEnglish
Published Chicago Oxford University Press 01.09.2021
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Summary:Objectives: UroVysion cases with one to three abnormal cells that do not meet the threshold for positivity may be better classified as "indeterminate. " The aim of this study is to determine the incidence and clinical significance of these indeterminate UroVysion results. Methods: The UroVysion fluorescence in situ hybridization (FISH) results over a 4-year period in our institution were retrospectively analyzed. Follow-up of the initial UroVysion cases, including urine cytology or bladder biopsy performed within 12 months of the initial diagnosis of the result, was obtained from pathology reports. Results: A significant fraction (178 of 1,907, 9.3%) of the UroVysion cases had indeterminate results. Overall, the subsequent malignancy rate of the group with indeterminate UroVysion results (14 of 59, 23.7%o) was higher than the group with normal results (48 of 319, 15.0%), although the difference was not significant (P = .124). For patients without a history of urinary tract neoplasm, the subsequent malignancy rate in the group with indeterminate results (7 of 18, 38.9%) was significantly higher than the group with normal results (16 of 103, 15.5%) (P = .044). Conclusions: Our results support that indeterminate UroVysion FISH result may warrant closer clinical follow-up in patients without a history of urinary tract neoplasm. We suggest reporting these cases as "aneusomy of undetermined significance. " Key Words: UroVysion; Molecular diagnostics; Urinary tract neoplasm
ISSN:0002-9173
1943-7722
DOI:10.1093/AJCP/AQAA254