To determine the diagnostic accuracy of HPV testing for detecting histologically confirmed CIN 2 or worse (CIN 2+), including adenocarcinoma in situ, in women participating in primary cervical cancer screening; and how it compares to the accuracy of cytological testing (liquid-based and conventional) at various thresholds.
To determine the diagnostic accuracy of the combination of HPV testing and cytological testing and to compare it with the accuracy of each test separately, where a positive combined test result is defined as at least one test that is positive and a negative combined result is where both tests are negative.
Sources of heterogeneity will be addressed with the study of certain subgroups such as the:
- type of cytology used (liquid based or conventional),
- type of HPV test used,
- number of HPV types detected by the HPV test,
- positivity threshold for cytology (atypical squamous cell changes (ASCUS+), low grade squamous intraepithelial lesion (LSIL+)) and HPV test,
- procedures used for reference standard verification,
- geographical location of the study.
This is a protocol.