Genotyping Test Evaluated for Human Papilloma Virus

A Linear Array HPV test kit identifies, and then specifically genotypes the virus in formalin-fixed, paraffin-embedded (FFPE) tissues from head and neck cancer patients.

In a study performed at Dartmouth Medical School, (Lebanon, NH, USA), scientists evaluated the performance of Roche Linear Array HPV Genotyping test kit assay (F. Hoffmann-La Roche AG, Basel, Switzerland), for accuracy, for intra-assay and interassay precision, and for its limit of detection, using materials with known HPV status. DNA from formalin-fixed, paraffin-embedded tumor sections was isolated and amplified in duplicate, with positive and negative controls, using primers specific to the polymorphic L1 region of the HPV genome.

Thirty-seven genotypes were tested using the linear array. The amplified product (450 base pairs) was visualized by gel electrophoresis and, if positive, reflexed to HPV genotyping. Of these cases, all were determined to have suitable DNA for genotyping based on an internal control gene reaction. The Linear Array HPV Genotyping kit contains positive β-globin high-control and β-globin low-control bands for determining whether the DNA from FFPE tissue is suitable for HPV genotyping using this assay. Nine of the 16 tumors analyzed were HPV positive. The detected genotypes included HPV 6, 16, and 69.

Head and neck tumors commonly arise from the squamous and respiratory mucosa that lines the nasal and oral cavity, sinuses, pharynx, and larynx. The rate of oropharyngeal cancers diagnosed among Americans younger than 50 years is increasing. Infection of the oropharynx and tonsils by the human papillomavirus (HPV) has been linked to preneoplasia and cancer.

The Roche Linear Array HPV Genotyping test was found to be an easy-to-use method for determining HPV genotype in the routine analysis of formalin-fixed, paraffin-embedded tumors. According to the authors, this assay was robust and can be performed routinely in a clinical laboratory setting. The study was published in December 2010, in the Archives of Pathology & Laboratory Medicine.

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Dartmouth Medical School
F. Hoffmann-La Roche