Additional Information

Clinical Information
The Roche Cobas High Risk HPV with 16/18 genotyping assay is an in vitro nucleic acid (DNA) polymerase chain reaction amplification test for qualitative detection of all high risk human papillomavirus types.

HPV Genotyping should be ordered within the Pap order as a reflex or cotest. Current ASCCP HPV triage recommendations are based on reflexing or cotesting for HPV Genotyping off of the Pap result, and patient's age. Our lab staff triage for HPV Genotyping is based on your order request within the Pap order.
ASCCP Link for Pap and HPV Testing: https://www.asccp.org/Guidelines

If HPV Genotyping is requested after the Pap has been already ordered or resulted, HPV can be added to the Pap visit encounter within 5 weeks (35 days) of collect date without collecting another Pap. We will send the aliquoted portion of the initial Pap to Mayo as soon as we received the order.

If HPV is desired after 5 weeks, a separate ThinPrep Pap is required. Please indicated you want HPV only in the order, and DO NOT want another Pap test, if indicated. Write on the Vial and/or order: HPV ONLY, NO PAP

This test should not be used as the only criterion to form a clinical conclusion; instead, results should be correlated with other test results, patient symptoms and clinical presentation.

Test Limitations A Not Detected result does not exclude the possibility of infection with HPV 16, 18 or, or any other high risk HPV type (31,33,35,39, 45, 51,52,56,58,59,66,68).
False negative or invalid results may be due to low levels of HPV infected cells, polymerase chain reaction inhibitors, concentrations of more than 1.5% whole blood (dark red to brown colored solution in the vial), inappropriate or inadequate sampling, or insufficient cellular material.
Inadequate specimen collection, processing and storage may invalidate test results.

Virus quantitation is not possible due to the nature of the specimen.

Test is only performed Monday-Friday, 0800-1630