Optimizing HIV testing algorithms: a generic verification protocol for selecting appropriate HIV serology assays and assessing the level of shared false-reactivity

Overview

This generic protocol contains all aspects of a research protocol including the study design, and can be used as a template for countries to adapt to their context. It aims to expedite the submission time to the local ethical review committee.

It is part of the toolkit which aims to provide countries with the tools and content needed to effectively conduct a local verification assessment to update national HIV testing algorithms following WHO recommendations on HIV testing strategies. 

A standardized HIV testing strategy and quality-assured products are critical for accurate diagnosis, while poorly chosen testing algorithms can lead to misdiagnosis. Verification of testing algorithms provides objective evidence, before widespread implementation, that a specific combination of products will accurately diagnose HIV infection, thus reducing the risk of misdiagnosis.