Human Papillomavirus Testing Using Hybrid Capture II and Cobas 4800 with ThinPrep and SurePath Preparations in Gynecologic Cytology

Abstract

Introduction: The majority of the commercially available methods for testing of high-risk human papillomavirus (hr-HPV) were approved by the Food and Drug Administration (FDA) for ThinPrep (TP) but not SurePath (SP) preparations. Recently, questions about the validity of these hr-HPV testing methods have been raised with SurePath. The objective of the current study is to compare the rates of hr-HPV positivity for different diagnostic categories using the Hybrid Capture II (HC II) (Qiagen, Gaitherburg, MD) method and the Roche Cobas 4800 (Cobas) (Roche, Pleasanton, CA) system for both TP and SP preparations. Materials and Methods: A computerized search was performed to retrieve all patients who received a liquid based (LB) Pap test with hr-HPV testing between September and December 2011 and between September and December 2012. HC II and Cobas methods were used for hr-HPV testing during 2011 and 2012, respectively. The Z-test was used for statistical analysis between the hr-HPV rates among various diagnostic categories between the two LB preparations. Results: 28,515 liquid based Pap tests, including 19% TP, were processed September through December 2011; 32% of which were tested for hrHPV. 27,769 liquid based Pap tests, including 24% TP, were processed September through December 2012; 35% of these were tested for hrHPV. The tables below summarize the rate of hr-HPV positivity for each diagnostic category: comparing two test methods and two preparations (Table 1) and comparing different age groups with two preparations (Table 2). Conclusions: Rates of hr-HPV positivity for cases with ASC-US and LSIL were significantly higher with SP than with TP preparation, regardless of the testing method. In addition, the rates of hr-HPV positivity in patients with ASC-US using Cobas with either TP or SP preparation were comparable to that observed in the ATHENA study. Our data validate the clinical use of Cobas with SP preparation. 81