HPV typing has been approved by the U.S. Food & Drug Administration (FDA) for samples obtained using the ThinPrep® collection method. This testing may be performed concurrently with the routine processing of the cervical-endocervical sample.

The FDA has not approved HPV typing on samples obtained using the SurePath™ collection device.* However, validation studies have been performed which allow this testing to be performed concurrently with the routine processing of the cervical-endocervical sample.

If HPV typing is desired, please indicate by checking the appropriate box on the requisition.

If ThinPrep® or SurePath™ are not utilized, please call our Supply Department to obtain an HPV specimen collection kit with instructions on specimen procurement.

Do not submit a smear for HPV typing.

* Non-FDA approved testing is not covered by Medicare.
   A valid Advance Beneficiary Notice of Noncoverage (ABN) must be submitted with a
   SurePath™ sample for HPV typing.