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Test ID HPVHL Human Papillomavirus (HPV) High/Low Risk, 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: 6 Unstained glass, positively charged slides with 5 (+ or - 1)-microns formalin-fixed, paraffin-embedded tissue


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 High/Low Risk ISH

Specimen Type


Specimen Stability Information

Specimen Type Temperature Time Special Container
Special Ambient (preferred)

Clinical Information

Human papillomavirus (HPV) infections with low-risk genotypes (6, 11) can cause benign hyperplasia such as condylomas and papillomas. Persistent infections with high-risk genotypes (16, 18, 31, 33, and 51) are associated with cervical, vaginal, vulvar, and head and neck malignancies. 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.

Reference Values

Results are reported as positive or negative for types 6 and 11 (low risk), and 16, 18, 31, 33, and 51 (high risk).


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.

Clinical Reference

1. Belobrov S, Cornall AM, Young RJ, et al: The role of human papillomavirus in p16-positive oral cancers. J Oral Pathol Med. 2018 Jan;47(1):18-24

2. Ducatman BS: The role of human papillomavirus in oropharyngeal squamous cell carcinoma. Arch Pathol Lab Med. 2018 Jun;142(6):715-718

3. Windon MJ, D'Souza GD, Rettig EM, et al: Increasing prevalence of human papillomavirus–positive oropharyngeal cancers among older adults. Cancer. 2018 Jul 15;124(14):2993-2999

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


88364-If additional ISH

LOINC Code Information

Test ID Test Order Name Order LOINC Value
HPVHL HPV High/Low Risk ISH In Process


Result ID Test Result Name Result LOINC Value
71199 Interpretation 50595-8
71200 Participated in the Interpretation No LOINC Needed
71201 Report electronically signed by 19139-5
71203 Material Received 81178-6
71594 Disclaimer 62364-5
72112 Case Number 80398-1

Useful For

Detection of human papillomavirus for both low-risk (6, 11) and high-risk (16, 18, 31, 33, and 51) genotypes

Mayo Clinic Laboratories | IHC Catalog Additional Information: