Test Information

Patients should refrain from using feminine hygiene products for approximately 24 hours prior to self-collection of the vaginal brush. Use of carbomer-containing feminine hygiene products has been associated with invalid results by the human papillomavirus (HPV) detection/genotyping assay. Carbomer-containing products include:

-Cardinal Health Lubricating Jelly

-Conceptrol Contraceptive Gel

-DynaLybe Lubricating Jelly

-HR lubricating Jelly

-IsoLove Balancing Gel

-KY Jelly (Physician Formula)

-Labicam anti-fungal

-Lavena Moisturizer

-McKesson Lubricating Jelly

-Medline Lubricating Jelly

-Metronidazole Vaginal Gel

-Monistat 1

-Terrasil Ointment Plus Cleansing Bar

-RepHresh Clean Balance

-RepHresh Vaginal Gel prefilled

-Replens Long-Lasting Vaginal Moisturizer

-Surgilube Surgical Lubricating Jelly

-Vagisil anti-itch cream

-Vagisil creme regular strength

-Vagisil ProHydrate

-Vagisil Sensitive Cream

-VCF Contraceptive Foam

-Walgreens Clotrimazole 3

-Walgreens Clotrimazole Vaginal Cream

The vaginal HPV self-collection should not be ordered if active menstrual bleeding or vaginal product use has occurred within 2 days.

Positive HPV results (about 1 in 10) will require a follow-up visit with a speculum exam. Patient should be counseled about that and agreeable to follow-up appointment if needed.

The cobas HPV test is US Food and Drug Administration (FDA)-approved for clinician-collected cervical and endocervical samples in PreservCyt (ThinPrep) media and for patient-collected vaginal samples using an Evalyn Brush in 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.

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.

Human papillomavirus 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).

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

Test Classification

This test has been cleared, approved, or is exempt by the US Food and Drug Administration and is used per manufacturer's instructions. Performance characteristics were verified by Mayo Clinic in a manner consistent with CLIA requirements.