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Epidemiology & Infection Epidemiology & Infection

Article contents

Moving towards a reliable HIV incidence test – current status, resources available, future directions and challenges ahead

Published online by Cambridge University Press:  22 December 2016

G. MURPHY ,
C. D. PILCHER ,
S. M. KEATING ,
R. KASSANJEE ,
S. N. FACENTE ,
A. WELTE ,
E. GREBE ,
K. MARSON ,
M. P. BUSCH  and
P. DAILEY
...Show all authors
G. MURPHY*
Affiliation:
Public Health England, London, UK
C. D. PILCHER
Affiliation:
University of California, San Francisco, San Francisco, CA, USA
S. M. KEATING
Affiliation:
Blood Systems Research Institute, San Francisco, CA, USA
R. KASSANJEE
Affiliation:
The South African DST/NRF Centre of Excellence in Epidemiological Modelling and Analysis (SACEMA), Stellenbosch University, Stellenbosch, South Africa Department of Statistical Sciences, University of Cape Town, Cape Town, South Africa
S. N. FACENTE
Affiliation:
University of California, San Francisco, San Francisco, CA, USA
A. WELTE
Affiliation:
The South African DST/NRF Centre of Excellence in Epidemiological Modelling and Analysis (SACEMA), Stellenbosch University, Stellenbosch, South Africa
E. GREBE
Affiliation:
The South African DST/NRF Centre of Excellence in Epidemiological Modelling and Analysis (SACEMA), Stellenbosch University, Stellenbosch, South Africa
K. MARSON
Affiliation:
University of California, San Francisco, San Francisco, CA, USA
M. P. BUSCH
Affiliation:
Blood Systems Research Institute, San Francisco, CA, USA
P. DAILEY
Affiliation:
FIND, Geneva, Switzerland
N. PARKIN
Affiliation:
FIND, Geneva, Switzerland Data First Consulting Inc., Belmont, CA, USA
J. OSBORN
Affiliation:
FIND, Geneva, Switzerland
S. ONGARELLO
Affiliation:
FIND, Geneva, Switzerland
K. MARSH
Affiliation:
UNAIDS, Geneva, Switzerland
J. M. GARCIA-CALLEJA
Affiliation:
WHO, Geneva, Switzerland
*
*Author for correspondence: Dr G. Murphy, Public Health England, 61 Colindale Avenue, London, UK. (Email: gary.murphy@phe.gov.uk)
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Summary

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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.

Keywords

HIV/AIDSincidence
Type
Review
Information
Epidemiology & Infection , Volume 145 , Issue 5 , April 2017 , pp. 925 - 941
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Copyright
Copyright © Crown Copyright. Cambridge University Press 2016 

Footnotes

† CEPHIA collaborators are listed in the Appendix.

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