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.