Comparative evaluation of the Abbott RealTime High Risk HPV test and INNO-LiPA HPV Genotyping Extra test for detecting and identifying human papillomaviruses in archival tissue specimens of head and neck cancers.

Introduction: The Abbott RealTime is a novel real-time PCR assay designed for concurrent individual genotyping of HPV16 and HPV18 and pooled detection of 12 HPV genotypes: HPV31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68 in cervical swab specimens. In this study, the performance of RealTime for detecting HPV in formalin-fixed, paraffin-embedded tissue specimens of head and neck cancers was compared to the Innogenetics INNO-LiPA assay, which allows identification of 28 HPVs, including all 14 covered by RealTime.
Methods: A total of 60 FFPE tissue specimens obtained from the same number of patients with histologically confirmed cancer of the oral cavity or oropharynx were included in the study. Following DNA extraction using a Qiagen DNA Mini Kit, RealTime and INNO-LiPA were performed on all samples, as instructed by the manufacturers.
Results: A 136-bp fragment of human beta-globin serving as an internal control in RealTime was successfully amplified from all 60 tissue samples included in the study. RealTime and INNO-LiPA showed 100% agreement and detected HPV DNA in 5/60 (8.3%) of the cancer samples, which all contained genotype HPV16.
Conclusions: RealTime assay is a reliable, sensitive, and specific diagnostic tool for the detection and partial genotyping of targeted HPV genotypes in FFPE tissue specimens of oral and oropharyngeal cancer.