Diagnostic and prognostic validity of the human papillomavirus E6/E7 mRNA test in cervical cytological samples of HC2-positive patients

Maria Benevolo, Irene Terrenato, Marcella Mottolese, Ferdinando Marandino, Mariantonia Carosi, Francesca Rollo, Livia Ronchetti, Paola Muti, Luciano Mariani, Stefano Sindico, Giuseppe Vocaturo, Amina Vocaturo

Research output: Contribution to journalArticlepeer-review

Abstract

The study aimed to assess the clinical utility in identifying CIN2 or worse (CIN2+), of the Pretect HPV-Proofer test for E6/E7 mRNA detection in Hybrid Capture 2 (HC2)-positive patients, who underwent colposcopy. In particular, the study analyzed the mRNA test performance as the third test in a subgroup of HC2+ patients with less severe than high-grade squamous intraepithelial lesions (HSIL-). We analyzed 464 cervico-vaginal samples by liquid-based cytology (LBC) and PreTect HPV-Proofer. Moreover 231 patients also had a biopsy at baseline and 75, with HSIL-, were followed up within 2 years by LBC, colposcopy, and histology when indicated. The highest sensitivity for CIN2+ belonged to the mRNA compared to LBC, at the HSIL+ threshold (72% vs. 58%), whereas the LBC showed the highest specificity and positive predictive value (PPV) (99 and 93% vs. 73 and 39%, respectively). Focusing on the 408 HSIL- patients, the mRNA positivity was significantly more associated with CIN2+ than CIN2- lesions (p <0.0001). Moreover, among the 75 HSIL- followed up patients, the mRNA displayed high longitudinal Specificity (89%), even if the sensitivity and the PPV were low (50 and 20%, respectively). The present data suggest that the mRNA test may have a diagnostic and a potentially prognostic role in HC2+/HSIL- patients.

Original languageEnglish
Pages (from-to)869-875
Number of pages7
JournalCancer Causes and Control
Volume22
Issue number6
DOIs
Publication statusPublished - Jun 2011

Keywords

  • Cervical lesions
  • Diagnostic biomarker
  • HPV E6/E7 mRNA
  • Human papillomavirus
  • Prognostic biomarker

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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