A retrospective analysis of the clinical performance of human papillomavirus testing using SurePath sample collection

IntroductionWe present a retrospective analysis of our high-risk human papillomavirus (hr-HPV) test performance using SurePath samples, and we compare these results to published results from Kaiser Permanente of Northern California, where hr-HPV testing was performed using collection in standard transport medium.Methods and materialsWe retrospectively identified histopathologic cases of cervical intraepithelial neoplasia (CIN) 2+ from 2010 through 2012, as well as all hr-HPV results performed from SurePath samples in these women. Testing for hr-HPV in our laboratory consisted of either Hybrid-Capture 2 or Cervista. These results were used to calculate false negative rates for CIN 2+, CIN 3+, and carcinoma, for both test methods, and these rates are compared with those published by Kaiser Permanente of Northern California.ResultsThe false negative rate for hr-HPV testing from SurePath samples (combined Hybrid-Capture 2 and Cervista) at the histopathologic level of CIN2+ was 7.9% (95% confidence interval: 5.9-10.2). This is compared with the false negative rates from collection in standard transport medium reported by Kaiser Permanente of Northern California for CIN 2+ of 20.4% (95% confidence interval: 18.9-22.0). Similar calculations for CIN 3+ and carcinoma are presented, along with comparison to the Kaiser Permanente of Northern California results. With regard to false negative hr-HPV results, for all levels of histopathologic abnormality, our hr-HPV testing from SurePath samples showed either significantly better performance (for CIN 2+ regardless of method, CIN 3+ using Cervista), or equivalent performance (for CIN 3+ using Hybrid-Capture 2 and carcinoma regardless of method).ConclusionsOur retrospective analysis demonstrates that hr-HPV testing from SurePath samples meets the proposed sensitivity of ≥90% in cases of biopsy proven CIN 2+.