Cancer Causes & Control

, Volume 22, Issue 6, pp 869–875 | Cite as

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 VocaturoEmail author
Original paper


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.


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



We would like to thank Michael Kenyon for his formal revision of the manuscript and Maria Assunta Fonsi for her secretarial assistance. This study was supported by the New Idea Award Group in Gynecological Oncology of the Regina Elena Cancer Institute, by the Italian Ministry of Health and by Lega Italiana per la Lotta contro i Tumori.


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Copyright information

© Springer Science+Business Media B.V. 2011

Authors and Affiliations

  • Maria Benevolo
    • 1
  • Irene Terrenato
    • 2
  • Marcella Mottolese
    • 1
  • Ferdinando Marandino
    • 1
  • Mariantonia Carosi
    • 1
  • Francesca Rollo
    • 1
  • Livia Ronchetti
    • 1
  • Paola Muti
    • 4
  • Luciano Mariani
    • 3
  • Stefano Sindico
    • 3
  • Giuseppe Vocaturo
    • 3
  • Amina Vocaturo
    • 1
    Email author
  1. 1.Pathology DepartmentRegina Elena Cancer InstituteRomeItaly
  2. 2.Epidemiology DepartmentRegina Elena Cancer InstituteRomeItaly
  3. 3.Oncologic Gynecology DepartmentRegina Elena Cancer InstituteRomeItaly
  4. 4.Scientific DirectionRegina Elena Cancer InstituteRomeItaly

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