Additional Information

The cobas HPV assay is a qualitative real-time PCR test performed on the Roche cobas 6800 platform which detects viral DNA from HPV High Risk genotypes 16, 18 and 12 other high-risk genotypes (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68).

1. 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.
2. 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.
3. 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.
4. A negative-HR-HPV result does not exclude the possibility of future cytologic HSIL or underlying CIN2-3 or cancer.
5. This is a screening test, and results from this test should only be interpreted in conjunction with information available from clinical evaluation of the patient and patient history.

This is intended as educational information to providers for compliance with CAP regulation CYP.07582:

“There is a mechanism to educate providers that cervical cancer screening tests, including primary HPV and pap tests, are screening tests with inherent false negative results.

NOTE: The preferred mechanism is an educational note on all negative Pap test reports and all primary HPV screening tests. Other mechanisms include sending periodic educational information to providers, conference presentations, specimen collection manual, etc.”