title: Comparison of Onclarity Human Papillomavirus (HPV) Assay with Hybrid Capture II HPV DNA Assay for Detection of Cervical Intraepithelial Neoplasia Grade 2 and 3 Lesions.
abstract: Analytical and clinical performance validation is essential before introduction of a new human papillomavirus (HPV) assay into clinical practice. This study compares the new BD Onclarity HPV assay, which detects E6/E7 DNA from 14 high-risk HPV types, to the Hybrid Capture II (HC2) HPV DNA test, to concurrent cytology and histology results, in order to evaluate its performance in detecting high-grade cervical lesions. A population of 567 women, including 325 with ≥ASCUS (where ASCUS stands for atypical cells of undetermined significance) and any HC2 result and 242 with both negative cytology and negative HC2 results, were prospectively enrolled for the study. The overall agreement between Onclarity and HC2 was 94.6% (95% confidence intervals [CI], 92.3% to 96.2%). In this population with a high prevalence of disease, the relative sensitivities (versus adjudicated cervical intraepithelial neoplasia grades 2 and 3 [CIN2+] histology endpoints) of the Onclarity and HC2 tests were 95.2% (95% CI, 90.7% to 97.5%) and 96.9% (95% CI, 92.9% to 98.7%), respectively, and the relative specificities were 50.3% (95% CI, 43.2% to 57.4%) for BD and 40.8% (95% CI, 33.9%, 48.1%) for HC2. These results indicate that the BD Onclarity HPV assay has sensitivity comparable to that of the HC2 assay, with a trend to an increased specificity. Moreover, as Onclarity gives the chance to discriminate between the different genotypes, we calculated the genotype prevalence and the absolute risk of CIN2+: HPV 16 was the most prevalent genotype (19.8%) with an absolute risk of CIN2+ of 77.1%.
authors.affiliation: Division of Laboratory Medicine, European Institute of Oncology, Milan, Italy fabio.bottari@ieo.it.
authors.forename: F
authors.initials: F
authors.lastname: Bottari
authors.affiliation: Preventive Gynecology Unit, European Institute of Oncology, Milan, Italy.
authors.forename: M
authors.initials: M
authors.lastname: Sideri
authors.affiliation: Division of Laboratory Medicine, European Institute of Oncology, Milan, Italy.
authors.forename: C
authors.initials: C
authors.lastname: Gulmini
authors.affiliation: Preventive Gynecology Unit, European Institute of Oncology, Milan, Italy.
authors.forename: S
authors.initials: S
authors.lastname: Igidbashian
authors.affiliation: Division of Laboratory Medicine, European Institute of Oncology, Milan, Italy.
authors.forename: A
authors.initials: A
authors.lastname: Tricca
authors.affiliation: Diagnostic Cytology Unit, European Institute of Oncology, Milan, Italy.
authors.forename: C
authors.initials: C
authors.lastname: Casadio
authors.affiliation: Department of Pathology, European Institute of Oncology, Milan, Italy.
authors.forename: S
authors.initials: S
authors.lastname: Carinelli
authors.affiliation: Preventive Gynecology Unit, European Institute of Oncology, Milan, Italy.
authors.forename: S
authors.initials: S
authors.lastname: Boveri
authors.affiliation: Department of Pathology, Copenhagen University Hospital, Hvidovre, Denmark.
authors.forename: D
authors.initials: D
authors.lastname: Ejegod
authors.affiliation: Department of Pathology, Copenhagen University Hospital, Hvidovre, Denmark Clinical Research Centre, Copenhagen University Hospital, Hvidovre, Denmark.
authors.forename: J
authors.initials: J
authors.lastname: Bonde
authors.affiliation: Division of Laboratory Medicine, European Institute of Oncology, Milan, Italy.
authors.forename: M T
authors.initials: MT
authors.lastname: Sandri
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D003584:Cytological Techniques; D005260:Female; D006651:Histocytochemistry; D006801:Humans; D008875:Middle Aged; D025202:Molecular Diagnostic Techniques / Q000379:methods*; D027383:Papillomaviridae / Q000235:genetics / Q000302:isolation & purification*; D030361:Papillomavirus Infections / Q000175:diagnosis* / Q000473:pathology / Q000821:virology*; D011446:Prospective Studies; D012680:Sensitivity and Specificity; D055815:Young Adult; D002578:Uterine Cervical Dysplasia / Q000175:diagnosis* / Q000473:pathology / Q000821:virology*