TY - JOUR
T1 - Evaluation of the Xpert® HPV assay in the detection of Human Papillomavirus in formalin-fixed paraffin-embedded oropharyngeal carcinomas
AU - Donà, Maria Gabriella
AU - Rollo, Francesca
AU - Pichi, Barbara
AU - Spriano, Giuseppe
AU - Pellini, Raul
AU - Covello, Renato
AU - Pescarmona, Edoardo
AU - Fabbri, Giulia
AU - Scalfari, Manuela
AU - Gheit, Tarik
AU - Benevolo, Maria
PY - 2017/9/1
Y1 - 2017/9/1
N2 - © 2017 Elsevier Ltd Objectives The increasing incidence of HPV-related Oropharyngeal Squamous Cell Carcinoma (OPSCC) and the improved survival of HPV-positive OPSCC highlight the need for effective tools in evaluating HPV status on formalin-fixed paraffin-embedded (FFPE) cancers. To date, there is no agreement regarding the most appropriate method for HPV testing on FFPE materials. We aimed to investigate the performance of the Xpert® HPV assay (Cepheid) on crude lysates from OPSCC FFPE tissues. Materials and methods Crude lysates were obtained by proteinase K digestion of FFPE tissues that had already been analyzed by the INNO-LiPA HPV assay and p16 ink4a immunostaining. Results 159 FFPE OPSCCs were evaluated. All the samples provided valid results with the Xpert, whereas three samples (1.8%) were invalid using the INNO-LiPA. Among the remaining 156 cases, 65 (41.7%) were concordantly positive and 87 (55.8%) concordantly negative (raw agreement 0.97, 95% CI: 0.93–0.99; Cohen K 0.95, 95% CI: 0.90–0.99). Type-specific data for the cases that were positive by both methods were completely concordant. Three samples were HPV16-positive with Xpert but negative with INNO-LiPA, while one OPSCC tested negative with Xpert and positive with INNO-LiPA. A very good agreement was observed between the Xpert and the p16 results, which was slightly higher than that for INNO-LiPA (Cohen K 0.87 vs. 0.85). Conclusion The Xpert HPV assay appears to be a very good method for HPV detection and genotyping on FFPE OPSCCs, and requires no prior purification of nucleic acids. This assay showed a very good agreement with INNO-LiPA and p16 findings.
AB - © 2017 Elsevier Ltd Objectives The increasing incidence of HPV-related Oropharyngeal Squamous Cell Carcinoma (OPSCC) and the improved survival of HPV-positive OPSCC highlight the need for effective tools in evaluating HPV status on formalin-fixed paraffin-embedded (FFPE) cancers. To date, there is no agreement regarding the most appropriate method for HPV testing on FFPE materials. We aimed to investigate the performance of the Xpert® HPV assay (Cepheid) on crude lysates from OPSCC FFPE tissues. Materials and methods Crude lysates were obtained by proteinase K digestion of FFPE tissues that had already been analyzed by the INNO-LiPA HPV assay and p16 ink4a immunostaining. Results 159 FFPE OPSCCs were evaluated. All the samples provided valid results with the Xpert, whereas three samples (1.8%) were invalid using the INNO-LiPA. Among the remaining 156 cases, 65 (41.7%) were concordantly positive and 87 (55.8%) concordantly negative (raw agreement 0.97, 95% CI: 0.93–0.99; Cohen K 0.95, 95% CI: 0.90–0.99). Type-specific data for the cases that were positive by both methods were completely concordant. Three samples were HPV16-positive with Xpert but negative with INNO-LiPA, while one OPSCC tested negative with Xpert and positive with INNO-LiPA. A very good agreement was observed between the Xpert and the p16 results, which was slightly higher than that for INNO-LiPA (Cohen K 0.87 vs. 0.85). Conclusion The Xpert HPV assay appears to be a very good method for HPV detection and genotyping on FFPE OPSCCs, and requires no prior purification of nucleic acids. This assay showed a very good agreement with INNO-LiPA and p16 findings.
KW - FFPE
KW - Head and neck cancer
KW - HPV DNA tests
KW - Human Papillomavirus
KW - Orophrayngeal neoplasms
KW - p16 ink4a
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U2 - 10.1016/j.oraloncology.2017.07.016
DO - 10.1016/j.oraloncology.2017.07.016
M3 - Article
C2 - 28797447
AN - SCOPUS:85024883916
SN - 1368-8375
VL - 72
SP - 117
EP - 122
JO - Oral Oncology
JF - Oral Oncology
ER -