Technical Specifications Series for submission to WHO Prequalification – Diagnostic Assessment: In vitro diagnostic medical devices (IVDs) used for the detection of high-risk human papillomavirus (HPV) genotypes in cervical cancer screening

Overview

The purpose of this document is to provide technical guidance to in vitro diagnostic medical device (IVD) manufacturers that intend to seek WHO Prequalification of tests for the detection of human papillomavirus (HPV). This document is relevant to IVDs that detect HPV genotypes that are associated with cervical cancer.