Cautions

The cobas human papillomavirus (HPV) test is US Food and Drug Administration (FDA)-approved for cervical and endocervical samples collected in PreservCyt (ThinPrep) media.

The cobas HPV test detects DNA from high-risk genotypes 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68. This test does not detect DNA of HPV low-risk types (eg, 6, 11, 42, 43, 44) since these are not associated with cervical cancer and its precursor lesions.

Prevalence of HPV infection in a population may affect performance. Positive-predictive values decrease when testing populations with low prevalence or individuals with no risk of infection.

Infection with HPV is not an indicator of cytologic high-grade squamous intraepithelial lesion (HSIL) or underlying high-grade cervical intraepithelial neoplasia (CIN), nor does it imply that CIN2-3 or cancer will develop. Most women infected with 1 or more high-risk (HR) HPV types do not develop CIN2-3 or cancer.

A negative-HR-HPV result does not exclude the possibility of future cytologic HSIL or underlying CIN2-3 or cancer.

Cervical specimens often show visibly detectable levels of whole blood as a pink or light brown coloration. These specimens are processed normally on the cobas Systems. If concentrations of whole blood exceed 10% (dark-red or brown coloration) in PreservCyt solution, there is a likelihood of obtaining a false-negative result.

The cobas HPV Test performance has not been validated with PreservCyt specimens that have been treated with glacial acetic acid for removal of red blood cells over 5%. Addition of glacial acetic acid over 5% in PreservCyt specimens prior to HPV testing would invalidate the cobas HPV Test results.

Human beta-globin amplification and detection is included in cobas HPV to differentiate HPV negative specimens from those that do not exhibit HPV signal due to insufficient cell mass in the specimen. All HPV negative specimens must have a valid beta-globin signal within a pre-defined range to be identified as valid negatives.

The cobas HPV Test performance has not been validated with PreservCyt specimens that have been filled past the maximum fill line of the primary vial. ThinPrep vials that have had any additional PreservCyt fluid volume added or any dissimilar fluid volume added to the initial specimen should not be submitted for testing.

The presence of polymerase chain reaction inhibitors may cause false-negative or invalid results.

HPV-negative cancers of the cervix do occur in rare circumstances. Also, no cancer screening test is 100% sensitive. Use of this device for primary cervical cancer screening should be undertaken after carefully considering the performance characteristics put forth in the cobas HPV Test label, as well as recommendations of professional guidelines.

The use of this test has not been evaluated for the management of women with prior ablative or excisional therapy, hysterectomy, who are pregnant, or who have other risk factors (eg, HIV positive, immunocompromised, history of sexually transmitted infections).

The effects of other potential variables (eg, vaginal discharge, use of tampons, douching) and specimen collection variables have not been evaluated.