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

Daniel Guerendiain; Catherine Moore; Lucy Wells; Brendan Conn; Kate Cuschieri

doi:10.1016/j.jcv.2016.02.007

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

Daniel Guerendiain^*, Catherine Moore, Lucy Wells, Brendan Conn, Kate Cuschieri

^*Corresponding author for this work

Research output: Contribution to journal › Article › peer-review

12 Citations (Scopus)

Abstract

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.

Original language	English
Pages (from-to)	55-59
Number of pages	5
Journal	Journal of Clinical Virology
Volume	77
Early online date	11 Feb 2016
DOIs	https://doi.org/10.1016/j.jcv.2016.02.007
Publication status	Published - Apr 2016

Keywords

Biopsy
FFPE
HPV
Oropharyngeal
p16
Squamous cell carcinoma

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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@article{e47015b7dc644279b6fee7ec1a22c517,

title = "Formalin fixed paraffin embedded (FFPE) material is amenable to HPV detection by the Xpert{\textregistered} HPV assay",

abstract = "Background: The Xpert{\textregistered} HPV Assay (Cepheid{\textregistered}, 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{\textregistered} based assay with a component also tested with p16 immunohistochemistry (IHC). NA was extracted from samples using the easyMag{\textregistered} 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{\textregistered} HPV assay for this application.",

keywords = "Biopsy, FFPE, HPV, Oropharyngeal, p16, Squamous cell carcinoma",

author = "Daniel Guerendiain and Catherine Moore and Lucy Wells and Brendan Conn and Kate Cuschieri",

year = "2016",

month = apr,

doi = "10.1016/j.jcv.2016.02.007",

language = "English",

volume = "77",

pages = "55--59",

journal = "Journal of Clinical Virology",

issn = "1386-6532",

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TY - JOUR

T1 - Formalin fixed paraffin embedded (FFPE) material is amenable to HPV detection by the Xpert® HPV assay

AU - Guerendiain, Daniel

AU - Moore, Catherine

AU - Wells, Lucy

AU - Conn, Brendan

AU - Cuschieri, Kate

PY - 2016/4

Y1 - 2016/4

N2 - 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.

AB - 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.

KW - Biopsy

KW - FFPE

KW - HPV

KW - Oropharyngeal

KW - p16

KW - Squamous cell carcinoma

U2 - 10.1016/j.jcv.2016.02.007

DO - 10.1016/j.jcv.2016.02.007

M3 - Article

C2 - 26896874

AN - SCOPUS:84959017322

SN - 1386-6532

VL - 77

SP - 55

EP - 59

JO - Journal of Clinical Virology

JF - Journal of Clinical Virology

ER -

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

Abstract

Keywords

UN SDGs

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