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Test Code 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


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

70464

Method Name

In Situ Hybridization (ISH)

Reporting Name

HPV High/Low Risk ISH

Specimen Type

Special

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

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, 26, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, 68, 73, and 82) 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, 26, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, 68, 73, and 82(high risk).

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.

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 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

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 days

Specimen 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
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

Detecting human papillomavirus for both low-risk (6, 11) and high-risk (16, 18, 26, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, 68, 73, and 82.) genotypes