The Self Collection HPV Test provides women with the option to self-collect a vaginal specimen that is then sent to the laboratory for testing. There is a well-documented high level of concordance between the HPV DNA results from self-collected and clinician-collected specimens.

Human Papillomavirus (HPV) is the primary cause of nearly all cervical cancer. In most cases, the HPV virus is harmless and causes no symptoms. Most women who acquire HPV are able to clear the infection through their own immune systems. Persistent presence of high-risk types of HPV can cause cervical lesions which over time may develop into cancer if untreated. Testing for HPV determines the presence, or absence, of HPV and will determine whether the HPV type present is high risk for CIN and cervical cancer.

The Self-Collection HPV Test is validated, using a CE marked sample collection device for vaginal cell collection. This sample is then sent to the laboratory for processing for 19 high risk HPV DNA subtypes.

• A negative result means that these high-risk subtypes HPV were not detected and the patient is at extremely low risk of developing high-grade cervical disease/CIN2+ before their next routine visit.

• A positive HPV result might indicate an increased risk of developing CIN/cervical cancer, and the report from the laboratory will provide a clear recommendation for follow-up/colposcopy.

The value of HPV DNA testing in cervical cancer screening and disease detection has been proven over and over again. Self-collection of specimens for HPV testing is not intended to replace existing patient management pathways but allows for:

• Those who wish to test following a change of sexual partner

• Option for identifying individual high-risk DNA subtypes

• Personal preference to self-collect vaginal samples

• An acceptable option for women who avoid having regular cervical smears

• Self-collection for HPV increases acceptability and coverage rate of cervical cancer prevention