Detection of Cervical Neoplasia by Human Papillomavirus Testing in an Atypical Squamous Cells-Undetermined Significance Population: Results of the Becton Dickinson Onclarity Trial

Thomas C Wright Jr, Mark H Stoler, Valentin Parvu, Karen Yanson, Karen Eckert, Salma Kodsi, Charles K Cooper, Thomas C Wright Jr, Mark H Stoler, Valentin Parvu, Karen Yanson, Karen Eckert, Salma Kodsi, Charles K Cooper

Abstract

Objectives: To determine clinical utility of Onclarity human papillomavirus (HPV) assay for atypical squamous cells-undetermined significance (ASC-US) triage, and the value of HPV genotyping within ASC-US.

Methods: Women (n = 33,858; 21 years or older) had HPV testing using Onclarity and Hybrid Capture 2 (HC2). ASC-US individuals (n = 1,960, 5.8%) were referred to colposcopy.

Results: Of ASC-US, 39.1% were HPV positive by Onclarity; HPV 16 was the most prevalent genotype (7.4%). Cervical intraepithelial neoplasia grade 2 (CIN 2) and CIN 3+ prevalences were 4.4% and 2.2%, respectively. Onclarity had sensitivity for CIN 2+ (85.7%) and CIN 3+ (91.4%), and specificities for CIN 2+ (64.1%) and CIN 3+ (62.0%), similar to HC2. Risks for CIN 3+ were 16.1%, 2.8%, 2.5%, and 2.7% with HPV 16, 18, 45, and 11 other genotypes, respectively.

Conclusions: Onclarity is clinically validated for ASC-US triage. Through risk stratification, genotyping could help identify women at highest risk for CIN 3+.

Trial registration: ClinicalTrials.gov NCT01944722.

Figures

Figure 1
Figure 1
Subject reconciliation during baseline enrollment and participation of subjects, aged 21 years or older, with ASC-US cytology, in the trial. aCorresponds to the same specimen. bCorresponds to the same specimens. ASC-US, atypical squamous cells-undetermined significance; CIN, cervical intraepithelial neoplasia; HPV, human papillomavirus; hrHPV, high-risk human papillomavirus; NILM, negative for intraepithelial lesions or malignancies; PI, principal investigator; UNSAT, unsatisfactory cytology.

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