Evaluation of sienna cancer diagnostics hTERT antibody on 500 consecutive urinary tract specimens

Derek B. Allison, Rajni Sharma, Morgan L. Cowan, Christopher J. Vandenbussche

Research output: Contribution to journalArticle

Abstract

Objectives: Telomerase activity can be detected in up to 90% of urothelial carcinomas (UC). Telomerase activity can also be detected in urinary tract cytology (UTC) specimens and indicate an increased risk of UC. We evaluated the performance of a commercially available antibody that putatively binds the telomerase reverse transcriptase (hTERT) subunit on 500 UTC specimens. Study Design: Unstained CytospinTM preparations were created from residual urine specimens and were stained using the anti-hTERT antibody (SCD-A7). Two algorithms were developed for concatenating the hTERT result and cytologic diagnosis: a "no indeterminates algorithm," in which a negative cytology and positive hTERT result are considered positive, and a "high-specificity algorithm," in which a negative cytology and positive hTERT result are considered indeterminate (and thus negative for comparison to the gold standard). Results: The "no indeterminates algorithm" and "high-specificity algorithm" yielded a sensitivity of 60.6 and 52.1%, a specificity of 70.4 and 90.7%, a positive predictive value of 39.1 and 63.8%, and a negative predictive value of 85.0 and 85.8%, respectively. Conclusions: A positive hTERT result may identify a subset of patients with an increased risk of high-grade UC (HGUC) who may otherwise not be closely followed, while a negative hTERT immunocytochemistry result is associated with a reduction in risk for HGUC.

Original languageEnglish (US)
Pages (from-to)302-310
Number of pages9
JournalActa cytologica
Volume62
Issue number4
DOIs
StatePublished - Jul 1 2018

Keywords

  • Ancillary test
  • Telomerase
  • Urinary tract
  • Urine cytology

ASJC Scopus subject areas

  • Pathology and Forensic Medicine
  • Histology

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