Oral HPV prevalence assessment by Linear Array vs. SPF10 PCR-DEIA-LiPA25 system in the HPV Infection in Men (HIM) study

Abstract

Introduction

Oral human papillomavirus (HPV) attributable oropharyngeal cancers are on the rise in many countries. Oral HPV infections among healthy individuals are commonly detected using oral gargle samples. However, the optimal method for HPV genotyping oral gargle specimens in research studies has not been previously evaluated.

Materials and methods

Oral gargle samples from 1455 HPV Infection in Men (HIM) study participants were HPV genotyped using two different methods: Linear Array and the SPF₁₀ PCR-DEIA-LiPA₂₅. The sensitivity of the two tests for detecting individual HPV types and grouped HPV types, high-risk HPV, low-risk HPV, grouped 4-HPV-vaccine types, and grouped 9-HPV-vaccine-types, and the degree of concordance between the two tests was assessed. We also examined whether socio-demographic-behavioral factors were associated with concordance between the two assays.

Results

The sensitivity of SPF₁₀ PCR-DEIA-LiPA₂₅ was higher than Linear Array, with the exception of HPV 70, for the detection of oral HPV. The prevalence ratio of SPF₁₀ PCR-DEIA-LiPA₂₅ to Linear Array varied between 1.0 and 9.0 for individual HPV genotypes, excluding HPV 70, and between 3.8 and 4.4 for grouped 4-valent and 9-valent HPV vaccine types, respectively. There was no association between socio-demographic-behavioral factors and discordance in results between the two tests for oral HPV 16 detection.

Discussion

SPF₁₀ PCR-DEIA-LiPA₂₅ was more sensitive than Linear Array for detecting HPV in oral gargle samples. Given the growing importance of detecting oral HPV infection for research studies of oral HPV natural history and vaccine effectiveness evaluation, we recommend using methods with higher sensitivity such as SPF₁₀ PCR-DEIA-LiPA₂₅ for detecting HPV in oral gargle samples.