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HelpMayo Test ID HPVE6 Human Papillomavirus (HPV) High-Risk E6/E7, RNA In Situ Hybridization
Additional Testing Requirements
If additional interpretation or analysis is needed, request PATHC / Pathology Consultation along with this test.
Shipping Instructions
Attach the green "Attention Pathology" address label (T498) to the outside of the transport container before putting into the courier mailer.
Necessary Information
A pathology/diagnostic report and a brief history are required.
Specimen Required
Supplies: Pathology Packaging Kit (T554)
Specimen Type: Tissue
Container/Tube: 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
Method Name
In Situ Hybridization (ISH)
Reporting Name
HPV E6/E7 ISHSpecimen Type
SpecialSpecimen Stability Information
| Specimen Type | Temperature | Time | Special Container |
|---|---|---|---|
| Special | Ambient (preferred) | ||
| Refrigerated | |||
Reject Due To
| Wet/frozen tissue Cytology smears Nonformalin fixed tissue Nonparaffin embedded tissue Noncharged slides ProbeOn slides |
Reject |
Clinical Information
This assay is intended to identify the presence of human papillomavirus (HPV) E6/E7 transcripts from high-risk genotypes. 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.
Reference Values
Cautions
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
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;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;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
4. Magaki S, Hojat SA, Wei B, So A, Yong WH. An introduction to the performance of immunohistochemistry. Methods Mol Biol. 2019;1897:289-298. doi:10.1007/978-1-4939-8935-5_25
Method Description
In situ hybridization on sections of paraffin-embedded tissue.(Unpublished Mayo method)
Day(s) Performed
Monday through Friday
Report Available
5 to 7 daysSpecimen Retention Time
Until staining is complete.Performing Laboratory
Mayo Clinic Laboratories in Rochester
Test Classification
This test was developed and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. It has not been cleared or approved by the US Food and Drug Administration.CPT Code Information
88365-Primary
88364-If additional ISH
LOINC Code Information
| Test ID | Test Order Name | Order LOINC Value |
|---|---|---|
| HPVE6 | HPV E6/E7 ISH | Obsolete |
| Result ID | Test Result Name | Result LOINC Value |
|---|---|---|
| 71212 | Interpretation | 50595-8 |
| 71213 | Participated in the Interpretation | No LOINC Needed |
| 71449 | Report electronically signed by | 19139-5 |
| 71451 | Material Received | 81178-6 |
| 71597 | Disclaimer | 62364-5 |
| 72114 | Case Number | 80398-1 |