HPV Testing and HPV Fax Back Order Form

Other Molecular Pathology Testing

HPV Fax Request Form

HPV Testing

Methodology:
Roche cobas® 4800 System

Principle:
The cobas HPV Test is an automated test run on the cobas® 4800 System which is used to identify human papillomavirus (HPV) DNA from 14 high-risk genital HPV types that are commonly associated with cervical cancer. The test specifically identifies types HPV 16 and HPV 18 while concurrently detecting the rest of the high risk types (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68). DNA is isolated from a scrape of cells from a woman’s cervix and is subsequently mixed in reaction wells with primers and probes that specifically recognize and amplify HPV DNA. This reaction produces fluorescence, which is then measured to determine the presence of HPV in the cervical sample. ß-globin from cellular input is used as an internal control to assess specimen quality and identify specimens containing factors that inhibit the amplification process.

Specimen Requirements:
HPV testing is performed using the original SurePath vial as long as the test is ordered within 2 weeks of the collection date.  For FDA approval, the cervical broom MUST be in the SurePath vial.  A brush and/or spatula may be used in addition to the cervical broom if desired. 

Ordering HPV Testing
For recommended guidelines for ordering HPV, please visit the ASCCP website at www.asccp.org

  1. Reflexive testing based on age recommendations: HPV testing may be ordered on the pap requisition by checking the box for the reflex criteria for HPV testing.
  2. Adding on HPV testing through “Faxback”: If the provider wishes to add on HPV testing after the pap result has been finalized, the provider may do this by faxing an order to add HPV testing to the SurePath vial within 2 weeks of collection. The provider must provide the patient name, date of the SurePath pap collection, and the “G” number from the Pap report (see HPV faxback form). We will fax this form back to you as a confirmation of receipt of the order.

Ordering an “HPV only”:
If the provider wants only HPV testing, the provider will need to specify on the requisition that this test is for “HPV ONLY”.  This way, the patient will not be charged for a SurePath pap in addition to the HPV.  This should be collected in a SurePath vial.

Reporting:
Positive or negative for HPV16, 18 and/or other HR HPV genotypes (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68).