title: Use of the NucliSENS EasyQ HPV assay in the management of cervical intraepithelial neoplasia.
abstract: Persistent infection by high-risk human papillomavirus is a necessary cause for cervical cancer. DNA-based human papillomavirus (HPV) assays show high sensitivity but poor specificity in detecting high-grade cervical lesions. Assays detecting mRNA of the oncoproteins E6 and E7 show higher specificity but lack either detection of all high-risk genotypes or the ability to specify the detected genotypes. The aim of this study was to evaluate the clinical performance of the NucliSENS EasyQ HPV assay in comparison with the Hybrid Capture 2 test (HC2) and the CLART Human Papillomavirus 2 assay (CLART), using a clinical cut-off of cervical intraepithelial neoplasia grade 2 or worse. In the 554 studied women, the lowest HPV positivity rate was detected for NucliSENS EasyQ HPV assay (55.1%), while HC2 and CLART showed similar results (HC2: 77.4%; CLART: 78.0%). In comparison with the other tests, the NucliSENS EasyQ HPV assay showed a lower clinical sensitivity (79.3% vs. 96.4% for HC2 and 95.9% for CLART) but a higher clinical specificity (72.6% vs. 42.8% for HC2 and 42.5% for CLART). Detection of E6/E7 mRNA transcripts may provide a higher specificity for cervical intraepithelial neoplasia grade 2 lesions or worse, since the oncogenic potential of HPV infection depends on the over-expression of these two oncoproteins.
authors.affiliation: National Reference Laboratory of STI for Human Papillomavirus and Genital Herpes Virus, Department of Infectious Diseases, National Institute of Health, Lisbon, Portugal. ana.oliveira@insa.min-saude.pt
authors.forename: Ana
authors.initials: A
authors.lastname: Oliveira
authors.forename: Nuno
authors.initials: N
authors.lastname: Verdasca
authors.forename: Ângela
authors.initials: Â
authors.lastname: Pista
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D005260:Female; D006801:Humans; D008875:Middle Aged; D025202:Molecular Diagnostic Techniques / Q000379:methods*; D027383:Papillomaviridae / Q000145:classification / Q000235:genetics / Q000302:isolation & purification*; D030361:Papillomavirus Infections / Q000150:complications* / Q000175:diagnosis* / Q000821:virology; D012680:Sensitivity and Specificity; D014773:Virology / Q000379:methods; D055815:Young Adult; D002578:Uterine Cervical Dysplasia / Q000175:diagnosis* / Q000821:virology*
keywords: E6/E7 transcripts; HPV; cervical intraepithelial neoplasia; mRNA testing