Comparison of the Cepheid Xpert HPV test and the HC2 High-Risk HPV DNA Test for detection of high-risk HPV infection in cervical smear samples in SurePath preservative fluid

PURPOSE: Cytological and histological cervical screening methods for human papillomavirus may be subjective. Current guidelines recommend the use of direct human papillomavirus screening by molecular methods in conjunction with cytology for the detection of high-risk human papillomavirus types with carcinogenic potential. In this study, we compared the performance of the molecular Cepheid Xpert HPV test to the FDA-approved HC2 High-Risk HPV DNA Test on samples from patients presenting for cervical screening, regardless of the cytology results, in which cervical cell samples were originally collected for Papanicolaou (Pap) smear specimens in Becton Dickinson (BD) SurePath preservative fluid. METHODOLOGY: Cervical cells were obtained for Pap smear specimens from 343 women attending Qatif Central Hospital in Saudi Arabia for cervical cancer screening using a Cytobrush Plus GT and immersed in BD SurePath preservative fluid in BD SurePath collection vials. The study was carried out between December 2015 and July 2016. RESULTS: The Xpert HPV test was positive in 27 (7.9 %) of the samples. The HC2 High-Risk HPV DNA Test was positive in 32 (9.3 %) of the samples. The most common HPV types according to the Xpert HPV test were HPV other types, either alone (n=15) or in combination with HPV16 (n=3). The overall concordance rate between the tests was 98.5 %. The positive concordance was 84.4 %. CONCLUSION: The Xpert HPV test is convenient to use on cervical cell samples collected for Pap smear specimens in BD SurePath preservative fluid within an hour and is a viable alternative to the HC2 High-Risk HPV DNA Test for HPV testing.