Human Papillomavirus (HPV) High Risk by in situ Hybridization, Paraffin
Also known as: HPVHR ISH
Use
This test is designed to detect high-risk subtypes of human papillomavirus (HPV) using in situ hybridization (ISH), which is valuable for assessing potential cancer risk. High-risk HPV subtypes are associated with the development of certain types of cancer, particularly cervical cancer and other anogenital or head and neck cancers. This test aids in the diagnosis and determination of the presence of high-risk HPV genotypes in formalin-fixed paraffin-embedded tissue samples.
Special Instructions
Not provided.
Limitations
This in situ hybridization technique is not cleared or approved by the FDA, and its performance characteristics are solely developed by ARUP Laboratories as a laboratory developed test. Limitations include potential signal variability due to tissue processing differences and fixation quality, which could affect result interpretation. Decalcified tissues and tissues fixed in non-standard fixatives are unacceptable as they may yield unreliable results. Frozen specimens are also unacceptable, and specimens should be protected from excessive heat during transport.
New York Approved
Methodology
Chromosomal / Cytogenetics (ISH)
Biomarkers
LOINC Codes
- 31208-2 - Specimen source
- 48767-8 - Annotation comment Imp
Result Turnaround Time
2-5 days
Related Documents
For more information, please review the documents below
Specimen
Tissue (FFPE)
Volume
Not provided
Minimum Volume
4 slides
Container
Paraffin block or slides
Collection Instructions
Transport tissue block or 5 unstained 5-micron slides in a tissue transport kit; use ARUP supply #47808.
Storage Instructions
Room temperature or refrigerated. Use a cooled container during summer months.
Causes for Rejection
Paraffin block with no tumor tissue remaining, non-standard fixatives, decalcified specimens.
Stability Requirements
| Temperature | Period |
|---|---|
| Room Temperature | Indefinitely |
| Refrigerated | Indefinitely |
| Frozen | Unacceptable |
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