Important Note

*This test is orderable in Cerner as HPV Primary Screen

This test is useful for screening for infection with high-risk (HR) human papillomavirus associated with the development of cervical cancer and its precursors.

When this test is ordered, HPV genotyping is performed.  If the results are positive for Other HR HPV types and negative for HPV 16 and HPV 18, a Pap test is ordered and performed at an additional charge

Test Limitations:

• This test does not detect DNA of HPV low-risk types (e.g. 6, 11, 42, 43, 44) since there is no clinical utility for testing of low-risk HPV types
• The cobas® HPV Test for detection of human papillomavirus types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68 is not recommended for evaluation of suspected sexual abuse.
• The performance of the cobas® HPV Test for primary screening (PreservCyt® Solution specimens only) has only been established where women who are 12 other HR HPV positive have cytology results read from the same cytology vial that was used to perform the cobas® HPV Test.
• The performance of the cobas® HPV Test with ThinPrep Pap Test PreservCyt® Solution has not been adequately established for HPV vaccinated individuals.
• The cobas® HPV Test has only been validated for use with cervical specimens collected by a clinician using an endocervical brush/spatula and placed in the ThinPrep Pap Test PreservCyt® Solution.
• Detection of high-risk HPV is dependent on the number of copies present in the specimen and may be affected by specimen collection methods, patient factors, stage of infection and the presence of interfering substances.
• Infection with HPV is not an indicator of cytologic HSIL or underlying high-grade CIN, nor does it imply that CIN2, CIN3 or cancer will develop. Most women infected with one or more high-risk HPV types do not develop CIN2, CIN3 or cancer.
• A negative high-risk HPV result does not exclude the possibility of future cytologic HSIL or underlying CIN2, CIN3 or cancer, but indicates a low likelihood of CIN2, CIN3 or cancer.
• Though rare, mutations within the highly conserved regions of the genomic DNA of HPV covered by the cobas® HPV Test’s primers and/or probes may result in failure to detect the presence of the viral DNA.
• The presence of PCR inhibitors may cause false negative or invalid results.
• Cervical specimens with concentrations of whole blood exceeding 1.5% (dark red or brown coloration) in PreservCyt® Solution may have a false-negative result.

The cobas® HPV Test performance has not been validated with specimens which have been treated with glacial acetic acid for removal of red blood cells. Any such processing of specimens prior to HPV testing would invalidate the cobas® HPV Test results.