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

Reporting Name

HPV E6/E7 ISH

Method Name

In Situ Hybridization (ISH)

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Specimen Type

Special


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


Specimen 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

Day(s) Performed

Monday through Friday

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

Forms

If not ordering electronically, complete, print, and send 1 of the following forms with the specimen:

-Oncology Test Request (T729)

-Immunohistochemical (IHC)/In Situ Hybridization (ISH) Stains Request (T763)

Secondary ID

71405

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.

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)

Report Available

5 to 7 days

Specimen Retention Time

Until staining is complete.

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.