FIND & WHO working group on HIV incidence assays meeting report

Overview

In 2008, WHO established a Technical HIV Incidence Assay Working Group to examine the issues and challenges involved in estimating HIV incidence using assays.

The purpose of the 2016 meeting of the Working Group was to convene a group of key opinion leaders in the field to discuss critical issues outstanding after the previous Working Group meeting. The main objectives of this meeting were:

• to obtain consensus on the mean duration of recent infection (MDRI) for the CDC-derived limiting antigen (L Ag) assays (from Sedia Biosciences Corporation and Maxim Biomedical) and variability among HIV subtypes;
• to present the performance characteristics of five further incidence assays studied as part of the CEPHIA evaluation;
• to present the evaluation of recent infection testing algorithms including testing for viral load and for antiretroviral (ARV) medicines;
• to release the revised version of the sample size calculation tool by the developer, recommended by WHO;
• to determine methods for qualifying new kit lots made by commercial partners to ensure L Ag quality management systems during manufacturing processes;
• to establish a proficiency testing programme for the L Ag assay that may be expanded to other assays as the need for external quality assurance is demonstrated; and
• to obtain consensus on target product profiles for tests for recent HIV infection.