Hybrid capture 2 human papillomavirus DNA testing for women with atypical squamous cells of undetermined significance Papanicolaou results in SurePath and ThinPrep specimens

Abstract

Background: Human papillomavirus (HPV) DNA testing using Hybrid Capture 2 assay with ThinPrep Papanicolaou (Pap) collection is the only US Food and Drug Administration-approved method for the triage of women with atypical squamous cells of undetermined significance (ASCUS). Although SurePath Pap collection has been used for Hybrid Capture 2 HPV DNA testing, clinical validation of this method has been scarce.

Methods: From a cervical cancer-screening program in Mississippi, we analyzed data from screenings of 8380 women with ASCUS Pap results who underwent reflex Hybrid Capture 2 HPV DNA tests during a course of 4 years. Of these, 4145 were screened with the ThinPrep collection system, and 4235 were screened with SurePath. Results of follow-up biopsies within 3 months of Pap tests were available for the ThinPrep group (229 cases) and the SurePath group (455 cases). Hybrid Capture 2 positive rates and the follow-up biopsy results from both groups were compared.

Results: Hybrid Capture 2 detected high-risk HPV DNA in 68.8% of ThinPrep and 66.7% of SurePath-collected specimens (P = .37). Detection rates for CIN2+ and CIN3+ were also comparable between ThinPrep (21.4%, 3.1%) and SurePath (15.4%, 4.2%) using Hybrid Capture 2 (P = .06, P = .45). In ThinPrep-collected specimens, 4.4% were quantitatively insufficient for Hybrid Capture 2 testing. Significantly more equivocal Hybrid Capture 2 results were observed in SurePath (11.4%) than in ThinPrep specimens (3.2%). However, 67.4% of women with equivocal Hybrid Capture 2 results had negative 1-year Pap cytology follow-up in the SurePath group.

Conclusions: Hybrid Capture 2 positive rates and CIN2-3 detection rates were comparable for the SurePath and ThinPrep Pap collection systems, thus supporting the use of SurePath for Hybrid Capture 2 testing.