Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology · 2016
Formalin fixed paraffin embedded (FFPE) material is amenable to HPV detection by the Xpert(®) HPV assay.
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Guerendiain Daniel, Moore Catherine, Wells Lucy, Conn Brendan, Cuschieri Kate
Аннотация
BACKGROUND: The Xpert(®) HPV Assay (Cepheid(®), 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 μm 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(®) based assay with a component also tested with p16 immunohistochemistry (IHC). NA was extracted from samples using the easyMag(®) 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.
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 μm 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(®) based assay with a component also tested with p16 immunohistochemistry (IHC). NA was extracted from samples using the easyMag(®) 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.