High Risk HPV With Reflex to Image-guided Pap

The COBAS® HPV Test detects DNA of the high-risk types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. The performance of HPV Primary screening was established in a population greater than or equal to 25 years of age. There is a possibility of false negative HPV results. Clinicians are advised to follow established professional recommendations, such as those from the ASCCP, for the most recent guidance on follow-up/additional testing after negative results are obtained from Primary HPV testing. 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.

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. 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 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. Women who are positive for high-risk HPV by the COBAS® HPV Test from a clinician-collected cervical specimen or a self-collected vaginal specimen should follow-up with a clinician to determine management.

Reliable results are dependent on adequate specimen collection, transport, storage and processing.

The effects other potential variables such as vaginal discharge, use of tampons, douching, etc., and specimen collection variables have not been evaluated.

The presence of PCR inhibitors may cause false-negative or invalid results.

Use of RepHresh® vaginal hygiene products has been associated with false-negative results.

Use of the Dove Advanced Care Clear Finish Antiperspirant Dry Spray (0% alcohol) has been associated with false-negative results.

Use of the vaginal moisturizer Replens® has been associated with false-negative results.

Though rare, mutations are within the highly conserved regions of the genomic DNA of human papillomavirus covered by the COBAS® HPV Test's primers and/or probes may result in failure to detect the presence of the viral DNA.