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Detection of HPV16 /18 E6 Oncoproteins in Head and Neck Squamous Cell Carcinoma Using a Protein Immunochromatographic Assay
Author(s) -
Menegaldo Anna,
Schroeder Lea,
Holzinger Dana,
Tirelli Giancarlo,
Dal Cin Elisa,
Tofanelli Margherita,
Rigo Stefania,
Mantovani Monica,
Stellin Marco,
Del Mistro Annarosa,
Dei Tos Angelo P.,
Guerriero Angela,
Niero Monia,
Borsetto Daniele,
Da Mosto Maria C.,
Polesel Jerry,
Pawlita Michael,
Waterboer Tim,
BoscoloRizzo Paolo
Publication year - 2021
Publication title -
the laryngoscope
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.181
H-Index - 148
eISSN - 1531-4995
pISSN - 0023-852X
DOI - 10.1002/lary.29184
Subject(s) - medicine , head and neck squamous cell carcinoma , head and neck cancer , negativity effect , metastasis , cancer , oncology , carcinoma , lymph node , lymph , pathology , clinical significance , cancer research , psychology , social psychology
Objectives/Hypothesis The accurate diagnostic assessment of clinically relevant human papillomavirus (HPV) infections in patients with head and neck squamous cell carcinoma represents an urgent unmet medical need. The aim of this study was to determine feasibility, accuracy, and clinical significance of HPV16/18 E6 oncoprotein detection on cytological specimens from oropharyngeal squamous cell carcinoma (OPSCC) and neck lymph node metastasis of SCC from unknown primary tumor (CUP) via a protein immunochromatographic assay. Study Design Cross‐sectional study. Methods Cytological specimens from primary tumor and neck metastases were collected from 34 patients with OPSCC or CUP and applied to a lateral flow format test that detects HPV16 and HPV18 E6 oncoproteins. E6 oncoprotein positivity or negativity in these specimens was compared to the specimens' “HPV‐driven” reference status, defined by presence of HPV‐DNA in combination with p16 INK4a overexpression and/or HPV E6 seropositivity. Results Eighteen of 29 OPSCC (62%) and three of five CUP (60%) were HPV‐driven according to our reference method. The E6 oncoprotein lateral flow test had a sensitivity of 94% (95% CI: 70%–100%) and a specificity of 100% (95% CI: 66%–100%) on primary tumor, and a sensitivity of 88% (95% CI: 64%–99%) and a specificity of 100% (95% CI: 74%–100%) on neck metastases. Test agreement between the E6 lateral flow test and the clinical reference method, HPV‐DNA plus p16 INK4a was excellent, both for primary lesion and neck metastases. Conclusions We found the detection of HPV16/18 E6 oncoproteins to be a feasible, highly reliable, and low‐invasive method to assess “HPV‐driven” status in OPSCC and CUP. Level of Evidence II Laryngoscope , 131:1042–1048, 2021