Lab Test

HPV Genotyping, (Sample Types Other Than Cervical ThinPrep®)

Male HPV, Non-Thin Prep HPV, Squamous cell carcinoma

Test Codes



Molecular Pathology

Specimen Collection Criteria

Collect: One of the following specimen types, as described below:

  1. Fresh Specimen (i.e., anal brushing, penile brushing, cervical brushing, etc): Submit specimen obtained using a brush (such as that used for PAP tests). Place brush in ThinPrep® Vial or Cytolyte Vial and swirl vigorously to release the tissue from the brush into the fluid. Do not use a cotton swab or viral transport container. This will not yield sufficient material to perform the test.
  2. Paraffin-Embedded Tissue: A paraffin block must be submitted. (Slides or paraffin shavings are not acceptable.)

DNA will be assessed for quality. If it is deemed unacceptable, testing will be cancelled with client notification.
Specimen must be accompanied by a completed requisition and must contain the patient name, date of birth, collection date, ordering physician, and source of specimen.

Physician Office/Draw Specimen Preparation

Maintain fresh specimens in ThinPrep® or similar vial, at room temperature (20-26°C or 68-78.8°F) or refrigerated (2-8°C or 36-46°F), or paraffin-embedded tissue, at room temperature.

Preparation for Courier Transport

Transport: Fresh specimens in ThinPrep® or similar vial, at room temperature (20-26°C or 68-78.8°F) or refrigerated (2-8°C or 36-46°F), or paraffin-embedded tissue, at room temperature.

Rejection Criteria

  • Fresh specimens submitted in fluid other than ThinPrep® or Cytolyte Fluid.
  • Tissue in fixatives other than 10% formalin.
  • Improper labeling, inadequate information.

Inpatient Specimen Preparation

Specimens at Royal Oak may be sent to the Surgical Pathology tube station, #201. In-house specimens are also picked up by a Surgical Pathology assistant every hour on the hour.

In-Lab Processing

Fresh specimens must arrive in the Laboratory within 72 hours of collection. Maintain fresh specimens, in ThinPrep® or similar vials, refrigerated (2-8°C or 36-46°F) until testing. Paraffin-embedded tissue should be maintained at room temperature (20-26°C or 68-78.8°F).


Specimen Stability for Testing:

Fresh Specimens in ThinPrep® or Similar Vials
Room Temperature (20-26°C or 68-78.8°F): 24 hours
Refrigerated (2-8°C or 36-46°F): 72 hours
Frozen (-20°C/-4°F or below): Unacceptable

Paraffin-Embedded Tissue
Room Temperature (20-26°C or 68-78.8°F): Indefinitely
Refrigerated (2-8°C or 36-46°F): Unacceptable
Frozen (-20°C/-4°F or below): Unacceptable

Specimen Storage in Department Prior to Disposal:

Room Temperature (20-26°C or 68-78.8°F): 7 days


Royal Oak Clinical Molecular Pathology Laboratory


Once per week.
Results available in 10 business days. 

Reference Range

Results are reported as positive or negative for the following HPV genotypes:

High risk:  16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68

Low risk:  6/11, 42, 43, 44 

Test Methodology

Following extraction, genomic DNA is amplified via Polymerase Chain Reaction (PCR) using a primer specific for the entire HPV E3 gene. Multiplexed subtype specific primers are used in a second round PCR reaction to amplify the individual subtype. Analysis is performed via automated capillary electrophoresis, followed by pathologist interpretation.


An interpretive report will be provided. Results are reported as negative or positive for the presence of each HPV subtype(s) identified.

Clinical Utility

  • The clinical utility of this test for patient management depends of the clinical situation, morphology of the lesion, and subtype of HPV identified. The presence of high risk HPV is associated with increased risk of cervical and oropharyngeal carcinoma. The strain of high risk HPV is associated with subtype of carcinoma and a unique rate and risk of transformation.
  • Clinical Indications for Ordering Test: This assay determines the subtype of HPV in mucosal HPV-associated lesions. This assay is not a screening assay. It should not be used in place of the Roche Cobas 4800 FDA approved assay for cervical samples. This test should be ordered when knowledge of the subtype of HPV is clinically useful.


  1. Sotlar, K, Diemwer, D, Dethleffa, A, et al. Detection and Typing of Human Papillomarvirus by E6 Nested Multiplex PCR. J Clin Micro. 2004; 42:7: 3176-3184.

CPT Codes

87623, 87624


Last Updated


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