Human Papillomavirus (HPV) Low Risk by in situ Hybridization, Paraffin
Also known as: HPVLR ISH
Use
This test is used to detect low-risk HPV subtypes (genotypes 6, 11, 40, 42, 43, and 44), which are associated with non-cancerous lesions and low risk of progression to cancer. It is particularly useful for assessing the potential cancer risk when a specific focus is more appropriate for high-risk HPV testing, such as in cases of suspected high-grade lesions.
Special Instructions
Not provided.
Limitations
This test has not been cleared or approved by the US Food and Drug Administration; it was developed and its performance characteristics determined by ARUP Laboratories, and should be used in a CLIA certified laboratory for clinical purposes. Results may be affected by the quality of the specimen, fixative used, and probe hybridization conditions.
Methodology
Chromosomal / Cytogenetics (CISH)
Biomarkers
LOINC Codes
- 19772-3 - Prep Tech Cvx/Vag Cyto
- 31208-2 - Specimen source
- 48767-8 - Annotation comment Imp
- 57723-9 - Unique bar code # Current sample
Result Turnaround Time
2-5 days
Related Documents
For more information, please review the documents below
Specimen
Tissue (FFPE)
Volume
Not provided
Minimum Volume
Not provided
Collection Instructions
Transport tissue block or 5 unstained positively charged, 5-micron slides in a tissue transport kit (recommended but not required).
Storage Instructions
Protect paraffin block and/or slides from excessive heat.
Causes for Rejection
Paraffin block with no tumor tissue remaining. Specimens fixed in any fixative other than 10 percent neutral buffered formalin. Decalcified specimens.
Stability Requirements
| Temperature | Period |
|---|---|
| Room Temperature | Indefinitely |
| Refrigerated | Indefinitely |
| Frozen | Unacceptable |
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