Skip to main content
×
Home
    • Aa
    • Aa

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

  • G. MURPHY (a1), C. D. PILCHER (a2), S. M. KEATING (a3), R. KASSANJEE (a4) (a5), S. N. FACENTE (a2), A. WELTE (a4), E. GREBE (a4), K. MARSON (a2), M. P. BUSCH (a3), P. DAILEY (a6), N. PARKIN (a6) (a7), J. OSBORN (a6), S. ONGARELLO (a6), K. MARSH (a8) and J. M. GARCIA-CALLEJA (a9)...
Summary
SUMMARY

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.

Copyright
Corresponding author
*Author for correspondence: Dr G. Murphy, Public Health England, 61 Colindale Avenue, London, UK. (Email: gary.murphy@phe.gov.uk)
Footnotes
Hide All
† CEPHIA collaborators are listed in the Appendix.
Footnotes
Linked references
Hide All

This list contains references from the content that can be linked to their source. For a full set of references and notes please see the PDF or HTML where available.

1. R Brookmeyer , TC Quinn . Estimation of current human immunodeficiency virus incidence rates from a cross-sectional survey using early diagnostic tests. American Journal of Epidemiology 1995; 141: 166172.

2. MP Busch , Beyond detuning: 10 years of progress and new challenges in the development and application of assays for HIV incidence estimation. AIDS 2010; 24: 27632771.

3. RS Janssen , New testing strategy to detect early HIV-1 infection for use in incidence estimates and for clinical and prevention purposes. Journal of the American Medical Association 1998; 280: 4248.

4. Incidence Assay Citical Path Working Group. More and better information to tackle HIV epidemics: towards improved HIV incidence assays. PLoS Medicine 2011; 8: e1001045.

5. BS Parekh , Quantitative detection of increasing HIV type 1 antibodies after seroconversion: a simple assay for detecting recent HIV infection and estimating incidence. AIDS Research and Human Retroviruses 2002; 18: 295307.

6. YT Duong , Detection of recent HIV-1 infection using a new limiting-antigen avidity assay: potential for HIV-1 incidence estimates and avidity maturation studies. PLoS ONE 2012; 7: e33328.

7. DO Kimanga , Prevalence and incidence of HIV infection, trends, and risk factors among persons aged 15–64 years in Kenya: results from a nationally representative study. Journal of Acquired Immune Deficiency Syndrome 2014; 66 (Suppl. 1): S1326.

8. T Rehle , A comparison of South African national HIV incidence estimates: a critical appraisal of different methods. PLoS ONE 2015; 10: e0133255.

11. JW Hargrove . BED estimates of HIV incidence must be adjusted. AIDS 2009; 23: 20612062; author reply 2066–2068.

12. JW Hargrove , Improved HIV-1 incidence estimates using the BED capture enzyme immunoassay. AIDS 2008; 22: 511518.

13. R Kassanjee , A new general biomarker-based incidence estimator. Epidemiology. 2012; 23: 721728.

14. JS McDougal . BED estimates of HIV incidence must be adjusted. AIDS 2009; 23: 20642065; author reply 2066–2068.

15. TA McWalter , A Welte . A comparison of biomarker based incidence estimators. PLoS ONE 2009; 4: e7368.

16. R Wang , SW Lagakos . On the use of adjusted cross-sectional estimators of HIV incidence. Journal of Acquired Immune Deficiency Syndrome 2009; 52: 538547.

17. A Welte , TA McWalter , T Barnighausen . A Simplified formula for inferring HIV incidence from cross-sectional surveys using a test for recent infection. AIDS Research and Human Retroviruses 2009; 25: 125126.

18. A Welte , TA McWalter , T Barnighausen . Reply to ‘Should biomarker estimates of HIV incidence be adjusted?’. AIDS 2009; 23: 20622063; author reply 2066–2068.

20. E Andersson , Evaluation of sequence ambiguities of the HIV-1 pol gene as a method to identify recent HIV-1 infection in transmitted drug resistance surveys. Infection, Genetics and Evolution 2013; 18: 125131.

21. SY Park , Developing high-throughput HIV incidence assay with pyrosequencing platform. Journal of Virology 2014; 88: 29772990.

22. MM Cousins , Analysis of HIV using a high resolution melting (HRM) diversity assay: automation of HRM data analysis enhances the utility of the assay for analysis of HIV incidence. PLoS ONE 2012; 7: e51359.

23. O Laeyendecker , HIV incidence determination in the United States: a multiassay approach. Journal of Infectious Diseases 2013; 207: 232239.

26. SM Keating , Lower-sensitivity and avidity modifications of the vitros anti-HIV 1 + 2 assay for detection of recent HIV infections and incidence estimation. Journal of Clinical Microbiology 2012; 50: 39683976.

28. KA Curtis , Evaluation of a multiplex assay for estimation of HIV-1 incidence. PLoS ONE 2013; 8: e64201.

29. R Kassanjee , Independent assessment of candidate HIV incidence assays on specimens in the CEPHIA repository. AIDS 2014; 28: 24392449.

30. YT Duong , Recalibration of the limiting antigen avidity EIA to determine mean duration of recent infection in divergent HIV-1 subtypes. PLoS ONE 2015; 10: e0114947.

31. A Chawla , Human immunodeficiency virus (HIV) antibody avidity testing to identify recent infection in newly diagnosed HIV type 1 (HIV-1)-seropositive persons infected with diverse HIV-1 subtypes. Journal of Clinical Microbiology 2007; 45: 415420.

32. B Suligoi , Avidity Index for anti-HIV antibodies: comparison between third- and fourth-generation automated immunoassays. Journal of Clinical Microbiology 2011; 49: 26102613.

33. F Barin , Development and validation of an immunoassay for identification of recent human immunodeficiency virus type 1 infections and its use on dried serum spots. Journal of Clinical Microbiology 2005; 43: 44414447.

34. SJ Shepherd , Development of an avidity assay for detection of recent HIV infections. Journal of Virological Methods 2015; 217: 4249.

35. KM Wilson , Incidence immunoassay for distinguishing recent from established HIV-1 infection in therapy-naive populations. AIDS 2004; 18: 22532259.

36. J Schupbach , Assessment of recent HIV-1 infection by a line immunoassay for HIV-1/2 confirmation. PLoS Medicine 2007; 4: e343.

37. H Li , A simple and inexpensive particle agglutination test to distinguish recent from established HIV-1 infection. International Journal of Infectious Diseases 2007; 11: 459465.

38. D Kothe , Performance characteristics of a new less sensitive HIV-1 enzyme immunoassay for use in estimating HIV seroincidence. Journal of Acquired Immune Deficiency Syndrome 2003; 33: 625634.

39. B Suligoi , Precision and accuracy of a procedure for detecting recent human immunodeficiency virus infections by calculating the antibody avidity index by an automated immunoassay-based method. Journal of Clinical Microbiology 2002; 40: 40154020.

Recommend this journal

Email your librarian or administrator to recommend adding this journal to your organisation's collection.

Epidemiology & Infection
  • ISSN: 0950-2688
  • EISSN: 1469-4409
  • URL: /core/journals/epidemiology-and-infection
Please enter your name
Please enter a valid email address
Who would you like to send this to? *
×

Keywords:

Metrics

Altmetric attention score

Full text views

Total number of HTML views: 23
Total number of PDF views: 158 *
Loading metrics...

Abstract views

Total abstract views: 468 *
Loading metrics...

* Views captured on Cambridge Core between 22nd December 2016 - 21st August 2017. This data will be updated every 24 hours.