Ordering Recommendation

Test for human papillomavirus (HPV) genotype 16 and 18 in patients previously diagnosed with head and neck squamous cell carcinoma.  

Mnemonic
HN HPV PCR
Methodology

Qualitative Polymerase Chain Reaction

Performed

Mon, Fri

Reported

Within 1 week

New York DOH Approval Status
Specimens from New York clients will be sent out to a New York DOH approved laboratory, if possible.
Specimen Required
Patient Preparation
Collect

Tissue.

Specimen Preparation

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)

Storage/Transport Temperature

Room temperature. Also acceptable: Refrigerated. Ship in cooled container during summer months.

Unacceptable Conditions

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.

Remarks

Anatomic source required. Pathology report requested.

Stability

Ambient: Indefinitely; Refrigerated: Indefinitely; Frozen: Unacceptable

Reference Interval
Interpretive Data

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.

Note
Hotline History
N/A
CPT Codes

88381; 87625

Components
Component Test Code* Component Chart Name LOINC
2002148 Block ID 57723-9
2011935 HPV Genotype 16 by PCR 77399-4
3000415 HPV Source 31208-2
3000416 HPV Genotype 18 by PCR 61373-7
* Component test codes cannot be used to order tests. The information provided here is not sufficient for interface builds; for a complete test mix, please click the sidebar link to access the Interface Map.
Aliases
  • High-risk HPV
  • HPV
  • HPV High Risk Head and Neck Cancer, Human papilloma virus
Human Papillomavirus (HPV) Genotype 16 and 18 by PCR, Head and Neck