Human Papillomavirus (HPV) High-Risk E6/E7, RNA In Situ Hybridization
Use
This assay is intended to identify the presence of human papillomavirus (HPV) E6/E7 transcripts from high-risk genotypes. It is useful for the stratification of oropharyngeal squamous cell carcinoma. 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.
Special Instructions
Not provided.
Limitations
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. The test has not been cleared or approved by the US Food and Drug Administration.
New York Approved
Methodology
Chromosomal / Cytogenetics
Biomarkers
No genes
Gene
LOINC Codes
- Obsolete
- 50595-8 - Path Interp Spec-Imp
- 19139-5 - Pathologist name
- 81178-6 - Block description and site Spec
- 62364-5 - Test performance info Spec
- 80398-1 - Unique ID Current sample
Result Turnaround Time
5-7 days
Related Documents
For more information, please review the documents below
Specimen
Tissue (FFPE)
Volume
Not provided
Minimum Volume
Not provided
Container
Immunostain Technical Only Envelope
Collection Instructions
Formalin-fixed, paraffin-embedded tissue block; or 5 unstained glass, 'positively charged' slides with 4-microns, formalin-fixed, paraffin-embedded tissue
Causes for Rejection
Wet/frozen tissue, Cytology smears, Nonformalin fixed tissue, Nonparaffin embedded tissue, Noncharged slides, ProbeOn slides
Stability Requirements
| Temperature | Period |
|---|---|
| Room Temperature | Ambient (preferred) |