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HelpMayo 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
Method Name
In Situ Hybridization (ISH)
Reporting Name
HPV High/Low Risk ISHSpecimen Type
SpecialSpecimen 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 daysSpecimen 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