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

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.

• Authors: Maria Benevolo, Irene Terrenato, Marcella Mottolese, Ferdinando Marandino, Mariantonia Carosi, Francesca Rollo, Livia Ronchetti, Paola Muti, Luciano Mariani, Stefano Sindico, Giuseppe Vocaturo, Amina Vocaturo
• Journal: Cancer causes & control : CCC (Cancer Causes Control) Vol. 22 Issue 6 Pg. 869-75 (Jun 2011) ISSN: 1573-7225 [Electronic] Netherlands
• PMID: 21424209 (Publication Type: Evaluation Study, Journal Article, Research Support, Non-U.S. Gov't, Validation Study)

Chemical References

• E6 protein, Human papillomavirus type 16
• Oncogene Proteins, Viral
• Papillomavirus E7 Proteins
• RNA, Messenger
• RNA, Viral
• Repressor Proteins

Topics

• Adolescent
• Adult
• Aged
• Cervix Uteri (metabolism, pathology, virology)
• Cytodiagnosis (methods)
• Diagnostic Techniques, Obstetrical and Gynecological
• Female
• Humans
• Middle Aged
• Oncogene Proteins, Viral (genetics, isolation & purification)
• Papillomavirus E7 Proteins (genetics, isolation & purification)
• Papillomavirus Infections (diagnosis, pathology, virology)
• Predictive Value of Tests
• Prognosis
• RNA, Messenger (isolation & purification)
• RNA, Viral (isolation & purification)
• Repressor Proteins (genetics, isolation & purification)
• Uterine Cervical Neoplasms (diagnosis, pathology, virology)
• Young Adult
• Uterine Cervical Dysplasia (diagnosis, pathology, virology)