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Incorporation of Cervista Human Papillomavirus 16/18 Assay Into Algorithms for Classifying Human Papillomavirus Status in Formalin-Fixed Paraffin-Embedded Head and Neck Squamous Carcinoma Specimens.

CONTEXT: - Human papillomavirus (HPV) DNA in situ hybridization (ISH) assay and p16 immunohistochemistry (IHC) are used to determine high-risk HPV status in formalin-fixed, paraffin-embedded (FFPE) tissues in oropharyngeal squamous cell carcinoma (SCC). Although high sensitivity and specificity for HPV can be obtained by combined p16-IHC and HPV DNA-ISH, the occasional discrepancy between these assays has prompted evaluation of Cervista HPV assays in FFPE tissue from patients with oropharyngeal SCC.

OBJECTIVE: - To compare the efficacy of Cervista HPV 16/18 and Cervista HPV HR assay to that of HPV DNA-ISH assay and p16-IHC in FFPE tissue in head and neck squamous cell carcinoma of oropharyngeal origin.

DESIGN: - Archived FFPE tissue from 84 patients with SCC of oropharyngeal origin and available HPV DNA-ISH and p16-IHC test results were tested with the Cervista HPV 16/18 assay and further verified by polymerase chain reaction (PCR)-based HPV16/18 genotyping tests in cases with discrepancy.

RESULTS: - Of the 84 specimens, 75% (63 of 84) were positive and 16% (13 of 84) had discrepant or equivocal findings by p16-IHC and HPV DNA-ISH testing. Use of Cervista HPV assays, either to clarify discrepant/equivocal findings or as confirmation after initial p16-IHC/HPV DNA-ISH tests, identified 81% (68 of 84) of HPV-positive cases without equivocal HPV results. Five of 13 cases with discrepancy or equivocal HPV DNA-ISH results tested positively for HPV16 or HPV18 by Cervista HPV 16/18 assay, which was further confirmed by PCR-based HPV16/18 genotyping.

CONCLUSIONS: - The Cervista HPV assays are a reasonable alternative to HPV DNA-ISH in determining HPV status in FFPE tissue specimens from patients with oropharyngeal SCC.

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