Formalin fixed paraffin embedded (FFPE) material is amenable to HPV detection by the Xpert® HPV assay
Highlights • There is an increasing demand for HPV annotation of FFPE material. • The performance of the Xpert® HPV assay, was assessed for FFPE material. • FFPE material is amenable to HPV detection by the Xpert assay.
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| Published in | Journal of clinical virology Vol. 77; pp. 55 - 59 |
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| Main Authors | , , , , |
| Format | Journal Article |
| Language | English |
| Published |
Netherlands
Elsevier B.V
01.04.2016
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| Abstract | Highlights • There is an increasing demand for HPV annotation of FFPE material. • The performance of the Xpert® HPV assay, was assessed for FFPE material. • FFPE material is amenable to HPV detection by the Xpert assay. |
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| AbstractList | 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.
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.
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.
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%.
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. •There is an increasing demand for HPV annotation of FFPE material.•The performance of the Xpert® HPV assay, was assessed for FFPE material.•FFPE material is amenable to HPV detection by the Xpert assay. 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. 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. A total of 88, 10μm 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. 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%. 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. BACKGROUNDThe 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. OBJECTIVESThe 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 DESIGNA 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. RESULTSOverall 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%. CONCLUSIONSThese 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. Highlights • There is an increasing demand for HPV annotation of FFPE material. • The performance of the Xpert® HPV assay, was assessed for FFPE material. • FFPE material is amenable to HPV detection by the Xpert assay. |
| Author | Wells, Lucy Cuschieri, Kate Conn, Brendan Guerendiain, Daniel Moore, Catherine |
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| CitedBy_id | crossref_primary_10_1016_j_jmoldx_2019_12_004 crossref_primary_10_1097_MOO_0000000000000341 crossref_primary_10_1111_hiv_12661 crossref_primary_10_5858_arpa_2019_0199_OA crossref_primary_10_1016_j_oraloncology_2017_07_016 crossref_primary_10_1016_j_jmoldx_2021_10_008 crossref_primary_10_1099_jmm_0_000723 crossref_primary_10_1136_jclinpath_2021_208054 crossref_primary_10_1097_LGT_0000000000000613 crossref_primary_10_1099_acmi_0_000216 crossref_primary_10_1016_j_jctube_2023_100378 crossref_primary_10_1111_apm_12727 |
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| Snippet | Highlights • There is an increasing demand for HPV annotation of FFPE material. • The performance of the Xpert® HPV assay, was assessed for FFPE material. •... •There is an increasing demand for HPV annotation of FFPE material.•The performance of the Xpert® HPV assay, was assessed for FFPE material.•FFPE material is... 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... BACKGROUNDThe Xpert(®) HPV Assay (Cepheid(®), Sunnyvale, USA) is a rapid, cartridge-based HPV test validated for use on cervical cytology samples. However,... |
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| SubjectTerms | Allergy and Immunology Biopsy Carcinoma, Squamous Cell - diagnosis Carcinoma, Squamous Cell - etiology DNA, Viral FFPE Histological Techniques HPV Humans Infectious Disease Oropharyngeal Oropharyngeal Neoplasms - diagnosis Oropharyngeal Neoplasms - etiology p16 Papillomaviridae - genetics Papillomavirus Infections - complications Papillomavirus Infections - diagnosis Papillomavirus Infections - virology Reagent Kits, Diagnostic Reproducibility of Results Sensitivity and Specificity Squamous cell carcinoma |
| Title | Formalin fixed paraffin embedded (FFPE) material is amenable to HPV detection by the Xpert® HPV assay |
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