Test Overview
Polymerase Chain Reaction (Cobas HPV Test)
Cobas® HPV for use on the cobas® 6800 System (cobas® HPV) is a qualitative in vitro test for the detection of high-risk Human Papillomavirus . This test detects the high-risk HPV types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68. Self-collected vaginal specimens, obtained in a healthcare setting, can be tested as an alternative specimen type when cervical sampling is either contraindicated or cervical samples otherwise cannot be obtained. Cobas® HPV is indicated for use for routine cervical cancer screening as per professional medical guidelines, including triage of ASC-US cytology, co-testing (or adjunctive screen) with cytology, and HPV primary screening of individuals with a cervix to assess the risk for cervical precancer and cancer.
This HPV test of self-collected vaginal specimens does not reflex to cytology for any result. Recommendations for clinical follow-up to this HPV test result are available at app.asccp.org.
Negative for HPV High Risk Profile DNA; Type 16: not detected; Type 18: not detected; Other High Risk Types: not detected.
* Reference ranges may change over time. Please refer to the original patient report when evaluating results.
Products containing carbomer(s), including vaginal lubricants, creams and gels may interfere with the test and should not be used during or prior to collecting cervical specimens. Use of over-the-counter products Replens™, RepHresh™ Vaginal Gel and RepHresh™ Clean Balance™ Kit has been associated with false-negative results. Use of Metronidazole Vaginal Gel has been associated with false-negative results. Significant amounts of blood in the ThinPrep vials may cause invalid results.
A negative high-risk HPV result does not exclude the possibility of future cytologic HSIL or underlying CIN2-3 or cancer.
The assay does not test for all HPV types known to infect anogenital tissue or for low risk types. Result should be interpreted in conjunction with clinical conditions.
Test Details
Specimen Requirements
Patient self-collected vaginal specimens, obtained in a healthcare setting, can be tested as an alternative specimen type when cervical sampling is either contraindicated or cervical samples otherwise cannot be obtained.
Self-collection instructions for either Copan FLOQSwabs® (552C.RM) or the Rovers® Evalyn® Brush will be provided to the patient by the healthcare provider and should be read and carefully followed by the patient. If the patient has any questions or difficulties with the collection process as described, they should ask their healthcare provider for more information.
The patient-collected specimen must be transferred to PreservCyt Solution by the responsible healthcare provider immediately after collection.
Swabs or brushes sent dry (not in PreservCyt transport) will be rejected.
Additional Information
The results of this assay should be used in conjunction with clinical information derived from other diagnostic and screening tests, physical exam, and full medical history, and should not be used as the sole basis for clinical assessment and treatment of patients.