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

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Test Code: HPVE6SO

Overview
Ordering
Specimen
Performing
Clinical/Interpretive
Contacts
Coding

Synonyms/Keywords

HPV (Human Papillomavirus), HPV E6/E7, GPHPVE6ISH, ISHPVE6E7IISH, ISNEGHPVE6E7ISH, ISRNAHPVE6E7ISH

Useful For

Stratification of oropharyngeal squamous cell carcinoma.

Specimen Requirements

Fasting Required	Specimen Type	Preferred Container/Tube	Acceptable Container/Tube	Specimen Volume	Specimen Minimum Volume (allows for 1 repeat)	Pediatric Minimum Volume (no repeat)
No	Formalin-fixed, paraffin-embedded tissue block			Entire Block
No	Slides			5 unstained glass, positively charged slides with 5 (+ or -1)-microns formalin-fixed, paraffin-embedded tissue

Collection Processing Instructions

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.

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

Mayo Labs suggests supply: Pathology Packaging Kit (T554)

Specimen Stability Information

Specimen Type	Temperature
Special	Ambient (preferred)
Special	Refrigerated

Rejection Criteria

Wet/frozen tissue

Cytology smears

Nonformalin fixed tissue

Nonparaffin embedded tissue

Noncharged slides

ProbeOn slides

Interference

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.

Performing Laboratory Information

Performing Location	Day(s) Test Performed	Report Available	Methodology/Instrumentation
Mayo Clinic Laboratories	Monday through Friday	5 to 7 days	In Situ Hybridization (ISH)

Reference Lab

Mayo Clinic Laboratories

Test 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.

Reference Range Information

Performing Location	Reference Range
Mayo Clinic Laboratories	Results are reported as positive or negative for types 16, 18, 26, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, 68, 73, and 82.

Interpretation

This test, when not accompanied by a pathology consultation request, will be answered as either positive or negative. If additional interpretation or analysis is needed, request PATHC / Pathology Consultation along with this test.

Outreach CPTs

CPT	Modifier (if needed)	Quantity	Description	Comments
88365		1
88364			(If additional ISH)