The ATHENA human papillomavirus study: design, methods, and baseline results.

Objective: The objective of the study was to describe baseline data from Addressing the Need for Advanced HPV Diagnostics, a prospective, multicenter US cervical cancer screening trial.

Study Design: A total of 47,208 women aged 21 years or older undergoing routine screening were enrolled; liquid-based cytology and human papillomavirus (HPV) testing were performed. Women with abnormal cytology underwent colposcopy, as did high-risk HPV (hrHPV)-positive women and a random subset of women negative by both tests aged 25 years or older.

Considerations for the planning and conduct of reproducibility studies of in vitro diagnostic tests for infectious agents.

The US Food and Drug Administration (FDA) requires reproducibility studies for premarket approval of in vitro diagnostic (IVD) tests. Results of reproducibility studies provide an estimate of the variability of the IVD test among study sites, reagent lots, site operators, within a single test run, and over multiple test days. In planning the study, discuss the product registration strategy, including the intended use of the product and desired label claims, and define the study team.