Ensuring quality in cervical screening programmes based on molecular human papillomavirus testing

Abstract

The increased use of human papillomavirus testing within cervical screening programmes necessarily brings about changes to the laboratory services required to support them. A crucial element of such services is to demonstrate initial and ongoing quality of the test (and associated processes). In this review, we outline some of the quality considerations and challenges with an emphasis on the laboratory including assay and platform validation, internal quality control selection and strengths and weaknesses of external quality assurance schemes. The influence and role of key external entities, including regulatory agencies, guideline groups, programme commissioners and commercial providers, are also discussed.

Keywords: human papillomavirus; molecular testing; quality assurance; quality control; verification.