Policy decisions on the age to initiate cervical cancer screening and screening methods are driven in large part by the prevalence of high-risk HPV (hrHPV) infection, cytologic abnormalities, and biopsy-confirmed CIN 2+ in the target screening populations. The distribution of these factors will depend in part on demographics and HPV vaccination status. The BD HPV Onclarity study enrolled 33,858 women 21-83 years presenting for routine cervical cancer screening in the U.S. between August 2013-June 2015. This study provides an opportunity to better understand the prevalence of hrHPV infections and cytologic abnormalities in the U.S.
The BD HPV Onclarity study enrolled women undergoing routine screening at 31 collection sites in 18 states in the U.S. At enrollment, women had a gynecologic examination that included collection of a SurePath cytology specimen that was processed for cervical cytology and also tested for high-risk HPV genotypes using the BD HPV Onclarity assay. This assay provides genotyping information for HPV 16, 18, 31, 33/58, 35/39/68, 45, 51, 52, 56/59/66. In addition, a second cervical specimen was collected into a ThinPrep vial and was tested using Hybrid Capture 2 (HC2). US laboratories performed cytology testing (n=3) and HPV testing (n=4). Subjects with positive cytology (>ASC-US), or a positive HPV test, or unsatisfactory cytology, as well as a random sample of women negative on cytology and HPV were assigned to colposcopy which followed a standardized biopsy protocol. All biopsies underwent consensus panel review that was blinded to cytology and HPV status.
The median age of the subjects was 37.0 years. Race/Ethnicity data showed 19.4% Hispanic, 1.4% Asian, 18.9% Black, and 78.1% White. Vaccination of enrollees was capped at 10%. 14.2% of the subjects had an abnormal Pap in the last 3 years and 8.9% had a colposcopy within the last 5 years. The prevalence of cytologic abnormalities and HPV positivity by age is shown below.
| 21-29 yrs | 30-39 yrs | >40 yrs | Overall | |
| NILM | 86.2% | 91.3% | 93.1% | 90.6% |
| ASC-US | 7.8% | 5.5% | 4.8% | 5.8% |
| >ASC-US | 5.8% | 3.1% | 1.9% | 3.3% |
| Unsat | 0.2% | 0.1% | 0.2% | 0.2% |
| HC2 (+) | 24.0% | 12.9% | 7.8% | 13.8% |
| BD Onclarity Assay (+) | 24.8% | 13.1% | 8.0% | 14.1% |
The BD HPV Onclarity study offers a unique opportunity to better understand factors such as prevalence of high-risk HPV (hrHPV) infection, cytologic abnormalities, and biopsy-confirmed CIN 2+ in U.S. target cervical cancer screening populations. This information will aid in policy decisions on age to initiate cervical cancer screening and screening methods.