Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Comparative Study
. 2014 Oct 23;28(16):2439-49.
doi: 10.1097/QAD.0000000000000429.

Independent assessment of candidate HIV incidence assays on specimens in the CEPHIA repository

Reshma Kassanjee  1 , Christopher D Pilcher, Sheila M Keating, Shelley N Facente, Elaine McKinney, Matthew A Price, Jeffrey N Martin, Susan Little, Frederick M Hecht, Esper G Kallas, Alex Welte, Michael P Busch, Gary Murphy; Consortium for the Evaluation and Performance of HIV Incidence Assays (CEPHIA)
Affiliations
Free PMC article
Comparative Study

Independent assessment of candidate HIV incidence assays on specimens in the CEPHIA repository

Reshma Kassanjee et al. AIDS. .
Free PMC article

Abstract

Objective: Cross-sectional HIV incidence surveillance, using assays that distinguish 'recent' from 'nonrecent' infections, has been hampered by inadequate performance and characterization of incidence assays. In this study, the Consortium for the Evaluation and Performance of HIV Incidence Assays presents results of the first independent evaluation of five incidence assays (BED, Limiting Antigen Avidity, Less-sensitive Vitros, Vitros Avidity and BioRad Avidity).

Design: A large repository of diverse specimens from HIV-positive patients was established, multiple assays were run on 2500 selected specimens, and data were analyzed to estimate assay characteristics relevant for incidence surveillance.

Methods: The mean duration of recent infection (MDRI, average time 'recent' while infected for less than some time cut-off T) was estimated from longitudinal data on seroconverters by regression. The false-recent rate (FRR, probability of testing 'recent' when infected for longer than T) was explored by measuring the proportions of 'recent' results in various subsets of patients.

Results: Assays continue to fail to attain the simultaneously large MDRI and small FRR demanded by existing performance guidelines. All assays produce high FRRs amongst virally suppressed patients (>40%), including elite controllers and treated patients.

Conclusions: Results from this first independent evaluation provide valuable information about the current performance of assays, and suggest the need for further optimization. Variation of 'recent'/'nonrecent' thresholds and the use of multiple antibody-maturation assays, as well as other biomarkers, can now be explored, using the rich data generated by the Consortium for the Evaluation and Performance of HIV Incidence Assays. Consistently high FRRs amongst those virally suppressed suggest that viral load will be a particularly valuable supplementary marker.

PubMed Disclaimer

Figures

Fig. 1
Fig. 1
Incidence assay measurements as a function of time since infection, excluding treated patients and elite controllers (1376 data points from 418 patients), for (a) LAg, (b) BED, (c) LS-Vitros, (d) Vitros Avidity and (e) BioRad Avidity.
Fig. 2
Fig. 2
Empirical distribution of incidence assay measurements for specimens drawn greater than T = 2 years after infection, excluding treated patients and elite controllers (665 data points from 316 patients), for (a) LAg, (b) BED, (c) LS-Vitros, (d) Vitros Avidity and (e) BioRad Avidity.
Fig. 3
Fig. 3
The proportion of ‘recent’ results (%) as a function of time since infection, excluding treated patients and elite controllers and stratifying by HIV subtype (A1, B, C and D) for (a) LAg, (b) BED, (c) LS-Vitros, (d) Vitros Avidity and (e) BioRad Avidity.
See this image and copyright information in PMC

References

    1. Brookmeyer R, Quinn TC. Estimation of current human immunodeficiency virus incidence rates from a cross-sectional survey using early diagnostic tests. Am J Epidemiol 1995; 141:166–172 - PubMed
    1. Mastro TD, Kim AA, Hallett T, Rehle T, Welte A, Laeyendecker O, et al. Estimating HIV incidence in populations using tests for recent infection: Issues, challenges and the way forward. J HIV AIDS Surveill Epidemiol 2010; 2:1–14 - PMC - PubMed
    1. Incidence Assay Critical Path Working Group. More and better information to tackle HIV epidemics: towards improved HIV incidence assays. PLoS Med 2011; 8:e1001045. - PMC - PubMed
    1. UNAIDS/WHO working group on global HIV/AIDS and STI surveillance. When and how to use assays for recent infection to estimate HIV incidence at a population level. 2011. www.who.int/diagnostics_laboratory/hiv_incidence_may13_final.pdf [Accessed 29 March 2014]
    1. Kassanjee R, McWalter TA, Bärnighausen T, Welte A. A new general biomarker-based incidence estimator. Epidemiology 2012; 23:721–728 - PMC - PubMed

Publication types