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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 pathology address label included in the kit to the outside of the transport container.



Necessary Information


A pathology/diagnostic report and a brief history are required.



Specimen Required


Supplies: Pathology Packaging Kit (T554)

Specimen Type: Formalin-fixed, paraffin-embedded tissue block

Specimen Volume: Entire block

 

Specimen Type: Slides

Slides: 5 unstained glass, positively charged slides with 5 (+ or - 1)-microns formalin-fixed, paraffin-embedded tissue


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)

Method Name

In Situ Hybridization (ISH)

Reporting Name

HPV E6/E7 ISH

Specimen Type

Special

Specimen Stability Information

Specimen Type Temperature Time Special Container
Special Ambient (preferred)
  Refrigerated 

Clinical Information

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.

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 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

Day(s) Performed

Monday through Friday

Report Available

5 to 7 days

Test Classification

This test was developed, and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. This test 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
Mayo Clinic Laboratories | IHC Catalog Additional Information:

mcl-ish-interp