Ordering Recommendation

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

New York DOH Approval Status

This test is not New York state approved. There are no New York state-approved laboratories available. Submit a Non-Permitted Laboratory Request Form (NPL) to the NYDOH prior to collection of specimen. If NPL is approved by NYDOH, and sample is received at ARUP, testing will be performed.

Specimen Required

Patient Preparation

Tissue containing invasive squamous cell carcinoma of the head and neck.

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.


Anatomic source required. Pathology report requested.
If multiple specimens (blocks or slides) are sent to ARUP, they must be accompanied by one of the following: an order comment indicating that the ARUP pathologist should choose the specimen most appropriate for testing (e.g., "Choose best block"), or individual orders for each sample submitted. A Pathologist Block Selection Fee (ARUP test code 3002076) will be added to orders that utilize the first option. If multiple specimens are sent to ARUP without a request for pathologist block/slide selection or individual orders, they will be held until clarification is provided.


Ambient: Indefinitely; Refrigerated: Indefinitely; Frozen: Unacceptable


Qualitative Polymerase Chain Reaction


Mon, Fri


1-7 days

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.

This test was developed and its performance characteristics determined by ARUP Laboratories. It has not been cleared or approved by the US Food and Drug Administration. This test was performed in a CLIA-certified laboratory and is intended for clinical purposes.

Compliance Category

Modified FDA


Hotline History


CPT Codes



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.


  • 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