title: Moving towards a reliable HIV incidence test - current status, resources available, future directions and challenges ahead.
abstract: In 2011 the Incidence Assay Critical Path Working Group reviewed the current state of HIV incidence assays and helped to determine a critical path to the introduction of an HIV incidence assay. At that time the Consortium for Evaluation and Performance of HIV Incidence Assays (CEPHIA) was formed to spur progress and raise standards among assay developers, scientists and laboratories involved in HIV incidence measurement and to structure and conduct a direct independent comparative evaluation of the performance of 10 existing HIV incidence assays, to be considered singly and in combinations as recent infection test algorithms. In this paper we report on a new framework for HIV incidence assay evaluation that has emerged from this effort over the past 5 years, which includes a preliminary target product profile for an incidence assay, a consensus around key performance metrics along with analytical tools and deployment of a standardized approach for incidence assay evaluation. The specimen panels for this evaluation have been collected in large volumes, characterized using a novel approach for infection dating rules and assembled into panels designed to assess the impact of important sources of measurement error with incidence assays such as viral subtype, elite host control of viraemia and antiretroviral treatment. We present the specific rationale for several of these innovations, and discuss important resources for assay developers and researchers that have recently become available. Finally, we summarize the key remaining steps on the path to development and implementation of reliable assays for monitoring HIV incidence at a population level.
authors.affiliation: Public Health England,London,UK.
authors.forename: G
authors.initials: G
authors.lastname: Murphy
authors.affiliation: University of California,San Francisco,San Francisco,CA,USA.
authors.forename: C D
authors.initials: CD
authors.lastname: Pilcher
authors.affiliation: Blood Systems Research Institute,San Francisco,CA,USA.
authors.forename: S M
authors.initials: SM
authors.lastname: Keating
authors.affiliation: The South African DST/NRF Centre of Excellence in Epidemiological Modelling and Analysis (SACEMA),Stellenbosch University,Stellenbosch,South Africa.
authors.forename: R
authors.initials: R
authors.lastname: Kassanjee
authors.affiliation: University of California,San Francisco,San Francisco,CA,USA.
authors.forename: S N
authors.initials: SN
authors.lastname: Facente
authors.affiliation: The South African DST/NRF Centre of Excellence in Epidemiological Modelling and Analysis (SACEMA),Stellenbosch University,Stellenbosch,South Africa.
authors.forename: A
authors.initials: A
authors.lastname: Welte
authors.affiliation: The South African DST/NRF Centre of Excellence in Epidemiological Modelling and Analysis (SACEMA),Stellenbosch University,Stellenbosch,South Africa.
authors.forename: E
authors.initials: E
authors.lastname: Grebe
authors.affiliation: University of California,San Francisco,San Francisco,CA,USA.
authors.forename: K
authors.initials: K
authors.lastname: Marson
authors.affiliation: Blood Systems Research Institute,San Francisco,CA,USA.
authors.forename: M P
authors.initials: MP
authors.lastname: Busch
authors.affiliation: FIND,Geneva,Switzerland.
authors.forename: P
authors.initials: P
authors.lastname: Dailey
authors.affiliation: FIND,Geneva,Switzerland.
authors.forename: N
authors.initials: N
authors.lastname: Parkin
authors.affiliation: FIND,Geneva,Switzerland.
authors.forename: J
authors.initials: J
authors.lastname: Osborn
authors.affiliation: FIND,Geneva,Switzerland.
authors.forename: S
authors.initials: S
authors.lastname: Ongarello
authors.affiliation: UNAIDS,Geneva,Switzerland.
authors.forename: K
authors.initials: K
authors.lastname: Marsh
authors.affiliation: WHO,Geneva,Switzerland.
authors.forename: J M
authors.initials: JM
authors.lastname: Garcia-Calleja
mesh_terms: D004812:Epidemiologic Methods; D015658:HIV Infections / Q000188:drug therapy / Q000453:epidemiology* / Q000821:virology; D006295:Health Resources; D006801:Humans; D015994:Incidence
keywords: HIV/AIDS; incidence