Evaluation of the Cobas® 4800 HPV Test for the Detection of High-grade Cervical Disease
Evaluation of the Cobas® 4800 HPV Test for the Detection of High-grade Cervical Disease
This study provided data on the performance of the Cobas® 4800 HPV Test for identifying
 histologically confirmed high-grade cervical disease. The baseline, cross-sectional phase was
 conducted in approximately 45,000 women undergoing routine cervical cancer screening, of whom
 approximately 7,400 were selected to undergo colposcopy and biopsy/endocervical curettage
 (ECC) at baseline. These subjects included women with cytology that is 'not normal' and a
 selection of those with 'normal' cytology who entered a follow-up phase and underwent
 cytological evaluation annually for 3 years. In this follow-up phase, colposcopy and
 biopsy/ECC were performed only in women with cervical cytology considered 'not normal' at any
 of the annual follow-up visits.
Inclusion Criteria:

 -  Females ≥ 21 years of age presenting for routine cervical cancer screening.

 -  An intact cervix.

 -  Willing and able to undergo colposcopy and biopsy and endocervical curettage within 8
 weeks after study Visit 1.

 Exclusion Criteria:

 -  Known pregnancy at study Visit 1.

 -  Presenting for colposcopy at study Visit 1.

 -  Any condition resulting in increased risk of bleeding at biopsy.

 -  Hysterectomy.

 -  Known history of ablative or excisional therapy to the cervix within the preceding 12
 months.