title: Human papillomavirus (HPV) E6/E7 mRNA as a triage test after detection of HPV 16 and HPV 18 DNA.
abstract: High-risk human papillomavirus (HPV) DNA detection provides high sensitivity but low specificity for moderate-grade cervical intraepithelial neoplasia or worse histological identification. A prospective study evaluated mRNA testing efficacy for predicting this histological diagnosis in case of HPV 16 and/or 18 DNA detection. A total of 165 endocervical samples harboring HPV 16 and/or 18 DNA were tested with NucliSENS-EasyQ® HPV E6/E7-mRNA-assay (Biomerieux, Marcy l´Etoile, France). Women with cytological alterations were referred to colposcopy (n = 111). Moderate-grade cervical intraepithelial neoplasia or worse was diagnosed in 25.8% of women presenting atypical squamous cells of undetermined significance or low-grade squamous intraepithelial lesions and in 89.8% of women with high-grade squamous intraepithelial lesions. mRNA sensitivity was 81.3% and 84.1%, respectively. Specificity was 52.2%, and 80.0%, respectively. Negative predictive value (NPV) was 88.9% in undetermined or low-grade squamous lesions. Positive predictive value (PPV) was 97.4% in high-grade squamous lesions. mRNA reduced colposcopies by 44.3% in undetermined or low-grade squamous lesions. Direct treatment of mRNA-positive cases reduced 77.5% of colposcopies in high-grade squamous lesions. Women without cytological alterations were followed for 18 months (n = 35), and moderate-grade cervical intraepithelial neoplasia or worse was diagnosed in 34.3%; mRNA sensitivity and specificity were 83.3% and 86.9%, respectively. PPV and NPV were 76.9% and 90.9%, respectively for predicting moderate-grade cervical intraepithelial neoplasia or worse in 18 months. mRNA reduced the number of visits for follow-up in 62.2%. In conclusion, NucliSENS-EasyQ® HPV E6/E7-mRNA-assay (Biomerieux) can serve as a triage test in case of HPV 16 and/or 18 DNA detection.
authors.affiliation: Department of Microbiology, University Hospital of Vigo, Vigo, Spain. sonia.perez.castro@sergas.es
authors.forename: Sonia
authors.initials: S
authors.lastname: Perez Castro
authors.forename: Amparo
authors.initials: A
authors.lastname: Iñarrea Fernández
authors.forename: María José
authors.initials: MJ
authors.lastname: Lamas González
authors.forename: María Teresa
authors.initials: MT
authors.lastname: Sarán Diez
authors.forename: Ana
authors.initials: A
authors.lastname: Cid Lama
authors.forename: María Jesús
authors.initials: MJ
authors.lastname: Alvarez Martín
authors.forename: Mónica
authors.initials: M
authors.lastname: Pato Mosquera
authors.forename: Isabel
authors.initials: I
authors.lastname: López-Miragaya
authors.forename: Nuria
authors.initials: N
authors.lastname: Estévez
authors.forename: Julio
authors.initials: J
authors.lastname: Torres Piñón
authors.forename: María
authors.initials: M
authors.lastname: Oña Navarro
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D002584:Cervix Uteri / Q000473:pathology / Q000821:virology; D003127:Colposcopy; D003955:Diagnostic Tests, Routine; D005260:Female; D052162:Human papillomavirus 16 / Q000235:genetics* / Q000302:isolation & purification; D052161:Human papillomavirus 18 / Q000235:genetics* / Q000302:isolation & purification; D006801:Humans; D008875:Middle Aged; D009856:Oncogene Proteins, Viral / Q000032:analysis / Q000235:genetics; D030361:Papillomavirus Infections / Q000175:diagnosis* / Q000473:pathology / Q000821:virology; D011247:Pregnancy; D011446:Prospective Studies; D012333:RNA, Messenger / Q000032:analysis / Q000235:genetics*; D012367:RNA, Viral / Q000032:analysis / Q000235:genetics*; D012680:Sensitivity and Specificity; D014218:Triage; D002583:Uterine Cervical Neoplasms / Q000175:diagnosis* / Q000473:pathology / Q000821:virology; D002578:Uterine Cervical Dysplasia / Q000175:diagnosis* / Q000473:pathology / Q000821:virology
chemical_list: D009856:Oncogene Proteins, Viral; D012333:RNA, Messenger; D012367:RNA, Viral