Evaluation of Diagnostic Utility of a High-Risk Human Papillomavirus PCR Test on Formalin Fixed, Paraffin-Embedded Head and Neck Tumor Tissues.

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Evaluation of Diagnostic Utility of a High-Risk Human Papillomavirus PCR Test on Formalin Fixed, Paraffin-Embedded Head and Neck Tumor Tissues.

J Mol Diagn. 2017 Dec 19;:

Authors: Huho AN, Yadak N, Bocklage TJ, Yang S

Abstract
The increasing prevalence of high-risk human papillomavirus (HR-HPV)-associated head and neck squamous cell carcinoma (HNSCC) has prompted strong clinical demands for detecting HR-HPV directly in the tumor. Although p16 immunohistochemistry (IHC) has been the standard testing method, it has limitations including false positivity, lack of sensitivity in low tumor cell samples such as fine needle aspirate (FNA), and its subjectivity. We developed a modified method based on the Roche Cobas 4800 HR-HPV PCR assay and evaluated the performance characteristics and the diagnostic utility of this assay for direct HR-HPV detection in the HNSCC samples. HNSCC, formalin-fixed, paraffin embedded blocks were retrieved from archives including 44 Excisions, 63 biopsies, and 16 FNA. Tissue slices were trimmed from the blocks, deparaffinized, lyzed, and loaded on the Cobas 4800 for HR-HPV PCR. All specimens had a concurrent p16 IHC performed. The PCR assay showed high concordance with the p16 IHC (96%; 99/103) and excellent positive agreement (91.5%) and negative agreement (100%). In addition, the PCR assay provided more conclusive results in samples with equivocal p16 IHC results. The modified Cobas 4800 HR-HPV PCR test is a labor efficient, quick, reliable, sensitive, and a specific method for detecting HR-HPV in formalin-fixed, paraffin embedded samples. This assay also demonstrated excellent diagnostic utility in samples with equivocal p16 IHC results, including FNA cell blocks.

PMID: 29277636 [PubMed - as supplied by publisher]

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