Test Catalog

Test ID: HPVE6    
Human Papillomavirus (HPV) High-Risk E6/E7, RNA In Situ Hybridization

Useful For Suggests clinical disorders or settings where the test may be helpful

Clinical Information Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

This assay is intended to identify the presence of human papillomavirus (HPV) E6/E7 transcripts from high-risk genotypes. This test has been shown to be more sensitive than HPV DNA in situ hybridization (ISH). Patients with HPV-related oropharyngeal squamous cell carcinoma (OPSCC) have shown better disease-specific survival and overall survival when compared to HPV-negative cases of OPSCC. An indication for this test is p16 expression by immunohistochemistry and negative HPV DNA ISH. In this instance, consideration should be given to the possibility of a false-negative HPV DNA ISH result.

Reference Values Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.

Interpretation Provides information to assist in interpretation of the test results

Cautions Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

Age of a cut paraffin section can affect staining quality. Stability thresholds vary widely among published literature. Best practice is for paraffin sections to be cut within 6 weeks.

Clinical Reference Recommendations for in-depth reading of a clinical nature

1. Lindemann ML, Dominguez MJ, de Antonio JC, et al: Analytical comparison of the cobas HPV test with hybrid capture 2 for the detection of high-risk HPV genotypes. J Mol Diagn. 2012 Jan;14(1):65-70

2. Bishop JA, Ma XJ, Wang H, et al: Detection of transcriptionally active high-risk HPV in patients with head and neck squamous cell carcinoma as visualized by a novel E6/E7 mRNA in situ hybridization method. Am J Surg Pathol. 2012 Dec;36(12):1874-1882

3. Mirghani H, Casiraghi O, Guerlain J, et al: Diagnosis of HPV driven oropharyngeal cancers: Comparing p16 based algorithms with the RNAscope HPV-test. Oral oncology. 2016;62:101-108