Test Overview
Polymerase Chain Reaction (Cobas HPV Test)
The Cobas HPV is a qualitative in vitro test for the detection of Human Papillomavirus in clinician-collected cervical specimens using an endocervical brush/spatula or broom and placed in the ThinPrep® Pap Test™ PreservCyt® Solution. This test detects the high-risk HPV types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68.
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.
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
Collect cervical specimen and place into ThinPrep/PreservCyt vial. Store and transport at room temperature.
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.
Result Comments
16/18 positive (reflexes to cytology)
Comment: Reflex cytology testing will be performed from the same laboratory specimen. Recommendations for clinical follow-up to this HPV test result are available at app.asccp.org.
12 Other HR HPV positive (reflexes to cytology)
Comment: Reflex cytology testing will be performed from the same laboratory specimen. Recommendations for clinical follow-up to this HPV test result are available at app.asccp.org.
HPV negative
Comment: A negative high-risk HPV result does not exclude the possibility of future cytologic HSIL or underlying CIN2-3 or cancer. Recommendations for clinical follow-up to this HPV test result are available at app.asccp.org.