Test for human papillomavirus (HPV) genotype 16 and 18 in patients previously diagnosed with head and neck squamous cell carcinoma.
Qualitative Polymerase Chain Reaction
Within 1 week
Formalin fixed (10 percent neutral buffered formalin) and paraffin-embedded (FFPE) tissue. Transport tissue block or 5 unstained 4-5 micron slides in a tissue transport kit (ARUP supply #47808) available online through eSupply using ARUP Connect™ or contact ARUP Client Services at (800) 522-2787. (Min: 4 slides)
Room temperature. Also acceptable: Refrigerated. Ship in cooled container during summer months.
FFPE specimens without tumor tissue. FFPE specimens fixed in formalin substitutes (ie., Bouen or B5 fixatives), alternative fixatives or heavy metal fixatives (B-4 or B-5). Decalcified specimens.
Anatomic source required. Pathology report requested.
Ambient: Indefinitely; Refrigerated: Indefinitely; Frozen: Unacceptable
This test amplifies DNA of HPV16 and HPV18 associated with head and neck cancer. Sensitivity may be affected by specimen collection methods, stage of infection, and the presence of interfering substances. Results should be interpreted in conjunction with other available laboratory and clinical data. A negative result for HPV 16 or HPV 18 does not exclude the presence of other high-risk HPV types.
Compliance Statement B: For laboratory developed tests not using a RUO kit, and for FDA approved, cleared or 510(k) exempt assays with alterations. This test was developed and its performance characteristics determined by ARUP Laboratories. The U. S. Food and Drug Administration has not approved or cleared this test; however, FDA clearance or approval is not currently required for clinical use. The results are not intended to be used as the sole means for clinical diagnosis or patient management decisions.
|Component Test Code*||Component Chart Name||LOINC|
|2011935||HPV Genotype 16 by PCR||61372-9|
|3000416||HPV Genotype 18 by PCR||61373-7|
- High-risk HPV
- HPV High Risk Head and Neck Cancer, Human papilloma virus