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. 2024 Mar 27;18(1):27.
doi: 10.1007/s12105-024-01628-3.

Validation of the VisionArray® Chip Assay for HPV DNA Testing in Histology Specimens of Oropharyngeal Squamous Cell Carcinoma

Hani Ibrahim Channir  1 , Simone Kloch Bendtsen  2 , Linea Cecilie Melchior  3 , Pia Rovsing Sandholm  3 , Christine Mordhorst  2 , Amanda-Louise Fenger Carlander  2 , Christian von Buchwald  2 , Katalin Kiss  3
Affiliations

Validation of the VisionArray® Chip Assay for HPV DNA Testing in Histology Specimens of Oropharyngeal Squamous Cell Carcinoma

Hani Ibrahim Channir et al. Head Neck Pathol. .

Abstract

Background: The detection of human papillomavirus (HPV) has several implications in the diagnostic work-up and management of oropharyngeal squamous cell carcinoma (OPSCC). The choice of HPV detection assay and testing algorithms differ across institutions and vary in cost, detection targets, technical feasibility, and turnaround time. In this study, we aimed to validate the VisionArray® HPV Chip for formalin-fixed and paraffin-embedded (FFPE) samples of OPSCC using the previously applied standard pan-HPV DNA PCR assay as a reference.

Methods: The validation cohort consisted of FFPE tissue samples from patients previously diagnosed with HPV DNA-positive OPSCC (n = 80), HPV DNA-negative OPSCC (n = 21), and a benign group of tumor samples consisting of Warthin's tumors (n = 20) and branchial cleft cysts of the lateral neck (n = 14). All samples were tested with p16 immunohistochemistry, pan-HPV DNA PCR, and the VisionArray® HPV Chip.

Results: The overall sensitivity and specificity of the VisionArray® HPV Chip assay were 100% [95% CI 95.5%; 100.0%] and 96.3% [95% CI 87.3%; 99.6%] and the positive predictive value and negative predictive value were 97.6% [95% CI 91.5%; 99.7%] and 100% [95% CI 93.2%; 100%], respectively.

Conclusions: The VisionArray® HPV Chip assay can be recommended for high-risk HPV testing in FFPE tissue samples from OPSCC, providing both a fast and simultaneous genotyping for 41 clinically relevant HPV types.

Keywords: HPV DNA; HPV genotyping; Human papillomavirus; Oropharyngeal cancer; Squamous cell carcinoma; VisionArray.

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Conflict of interest statement

All authors declare no conflicts of interest. VisionArray® is a registered trademark by ZytoVision. The company had no role in the funding or in the conduction of the study.

Figures

Fig. 1
Fig. 1
Flowchart illustrating all samples of oropharyngeal squamous cell carcinoma analyzed by p16 immunohistochemistry, pan-HPV DNA PCR, and the VisionArray® HPV Chip
Fig. 2
Fig. 2
Showing an HPV-negative sample analyzed by the VisionArray® HPV Chip including both the original chip scan and the schematic view. Blue dots in the schematic view illustrates the positive controls meeting threshold requirements
Fig. 3
Fig. 3
Showing an HPV-positive sample analyzed by the VisionArray® HPV Chip including both the original chip scan and the schematic view. The latter illustrates the positive controls (blue dots) and HPV16 positivity (red dots) meeting threshold requirements
See this image and copyright information in PMC

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References

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