Formalin fixed paraffin embedded (FFPE) material is amenable to HPV detection by the Xpert® HPV assay

Background: The Xpert (R) HPV Assay (Cepheid (R), Sunnyvale, USA) is a rapid, cartridge-based HPV test validated for use on cervical cytology samples. However, there is an increasing demand for HPV annotation of formalin fixed paraffin embedded (FFPE) material. Objectives: The aim of this study was to determine the suitability of the Xpert HPV assay for the detection of nucleic acid (NA) derived from FFPE samples. Study design: A total of 88, 10 mu m sections derived from FFPE tissue blocks were assessed, 74 originated from oropharyngeal squamous cell carcinomas (OPSCC) and 14 from a range of other sites. All had previously been tested with a sensitive Luminex (R) based assay with a component also tested with p16 immunohistochemistry (IHC). NA was extracted from samples using the easyMag (R) platform and after dilution was added directly to the Xpert cartridge. Agreement between assays was assessed. Results: Overall agreement between the assays was 92%; with a Kappa for HR-HPV detection of 0.833 (95% CI 0.725-0.953). In the 50 samples that had been annotated for p16 status overall agreement between the Xpert assay and the p16 IHC was 90%. Conclusions: These data indicate that FFPE material is amenable to HPV detection by the Xpert assay. To our knowledge, this is the first study to interrogate the use of the Xpert HPV assay for this application. (C) 2016 Elsevier B.V. All rights reserved.