HPV Genotyping, (Non-ThinPrep<sup>®</sup> )
Specimen Collection Criteria
Collect: One of the following specimen types, as described below:
- 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.
- 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/Drawsite 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.
- Fresh specimens submitted in fluid other than ThinPrep® or Cytolyte Fluid.
- Tissue in fixatives other than 10% formalin.
- Improper labeling, inadequate information.
Monday - Friday.
Results available in 10 business days.
Results are reported as positive or negative for types 6/11, 16, 18, 31, 33, 35, 39, 42, 43, 44, 45, 51, 52, 56, 58, 59, 66, and 68.
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.
- 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 DigeneTM Capture assay. This test should be ordered when knowledge of the subtype of HPV is clinically useful. This assay was designed to assess the presence of the most common mucosal high and low risk human papillomarvirus subtypes. Individual HPV subtypes identified in this assay are 6/11, 16, 18, 31, 33, 35, 39, 42, 43, 44, 45, 51, 52, 56, 58, 59, 66, and 68.
- 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.