title: 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.affiliation: Pathology Department, Regina Elena Cancer Institute, Rome, Italy.
authors.forename: Maria
authors.initials: M
authors.lastname: Benevolo
authors.forename: Irene
authors.initials: I
authors.lastname: Terrenato
authors.forename: Marcella
authors.initials: M
authors.lastname: Mottolese
authors.forename: Ferdinando
authors.initials: F
authors.lastname: Marandino
authors.forename: Mariantonia
authors.initials: M
authors.lastname: Carosi
authors.forename: Francesca
authors.initials: F
authors.lastname: Rollo
authors.forename: Livia
authors.initials: L
authors.lastname: Ronchetti
authors.forename: Paola
authors.initials: P
authors.lastname: Muti
authors.forename: Luciano
authors.initials: L
authors.lastname: Mariani
authors.forename: Stefano
authors.initials: S
authors.lastname: Sindico
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Vocaturo
authors.forename: Amina
authors.initials: A
authors.lastname: Vocaturo
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D002584:Cervix Uteri / Q000378:metabolism / Q000473:pathology* / Q000821:virology; D003581:Cytodiagnosis / Q000379:methods; D003944:Diagnostic Techniques, Obstetrical and Gynecological; D005260:Female; D006801:Humans; D008875:Middle Aged; D009856:Oncogene Proteins, Viral / Q000235:genetics* / Q000302:isolation & purification; D050725:Papillomavirus E7 Proteins / Q000235:genetics* / Q000302:isolation & purification; D030361:Papillomavirus Infections / Q000175:diagnosis* / Q000473:pathology / Q000821:virology; D011237:Predictive Value of Tests; D011379:Prognosis; D012333:RNA, Messenger / Q000302:isolation & purification; D012367:RNA, Viral / Q000302:isolation & purification; D012097:Repressor Proteins / Q000235:genetics* / Q000302:isolation & purification; D002583:Uterine Cervical Neoplasms / Q000175:diagnosis / Q000473:pathology / Q000821:virology; D055815:Young Adult; D002578:Uterine Cervical Dysplasia / Q000175:diagnosis / Q000473:pathology / Q000821:virology
chemical_list: C068651:E6 protein, Human papillomavirus type 16; D009856:Oncogene Proteins, Viral; D050725:Papillomavirus E7 Proteins; D012333:RNA, Messenger; D012367:RNA, Viral; D012097:Repressor Proteins