1. Satellite meeting on the STARHS HIV diagnostic assay in association with the 15th International AIDS Conference July 2004, Bangkok, Thailand Robert S. Remis MD, MPH Ontario HIV Epidemiologic Monitoring Unit Department of Public Health Sciences, University of Toronto CDC HIV Diagnostics Conference Orlando, FL, March 1, 2005

2. instructional media centre, Laboratories Branch - 2000 Meeting organization Objective: To exchange data and views on the latest developments in the STARHS assay and its application Objective: To exchange data and views on the latest developments in the STARHS assay and its application Organized by Robert Remis (U of Toronto), Anne Sill and Niel Constantine (U of Maryland) Organized by Robert Remis (U of Toronto), Anne Sill and Niel Constantine (U of Maryland) Invitations to attend and present emailed to attendees of Barcelona STAHRS meeting Invitations to attend and present emailed to attendees of Barcelona STAHRS meeting Funded by Ontario HIV Treatment Network and Calypte Corporation Funded by Ontario HIV Treatment Network and Calypte Corporation Two parts: Two parts: Presentations on epidemiologic (6) and laboratory (5) aspects Presentations on epidemiologic (6) and laboratory (5) aspects Open discussion on 4 topics chosen by participants from 8 Open discussion on 4 topics chosen by participants from 8 Dr. Robert S. Remis Public Health Sciences, University of Toronto

3. instructional media centre, Laboratories Branch - 2000 Epidemiologic aspects 1 Robert S Remis et al, University of Toronto, Toronto, Canada Robert S Remis et al, University of Toronto, Toronto, Canada Objective Objective Adjust for bias due to “premature” HIV testing in calculating incidence using STAHRS Adjust for bias due to “premature” HIV testing in calculating incidence using STAHRS Methods Methods Developed algebraic formula to incorporate bias Developed algebraic formula to incorporate bias Varied bias and fit to observed HIV incidence at varying window periods Varied bias and fit to observed HIV incidence at varying window periods Key findings Key findings Achieved good fit with observed incidence and obtained adjusted incidence corrected for bias Achieved good fit with observed incidence and obtained adjusted incidence corrected for bias Dr. Robert S. Remis Public Health Sciences, University of Toronto

4. instructional media centre, Laboratories Branch - 2000 Epidemiologic aspects 2 Anne M Sill et al, Institute of Human Virology, University of Maryland, Baltimore, USA Anne M Sill et al, Institute of Human Virology, University of Maryland, Baltimore, USA Background Background Panels of specimens from seroconverting persons needed to validate STARHS assays, especially for non-B clades and from developing countries Panels of specimens from seroconverting persons needed to validate STARHS assays, especially for non-B clades and from developing countries Key findings Key findings The investigators developed a protocol to identify and collect specimens and transport them to their US laboratory; a “tool box” was presented which is now available on CD-ROM The investigators developed a protocol to identify and collect specimens and transport them to their US laboratory; a “tool box” was presented which is now available on CD-ROM Dr. Robert S. Remis Public Health Sciences, University of Toronto

5. instructional media centre, Laboratories Branch - 2000 Epidemiologic aspects 3 John V Parry et al, Health Protection Agency, London, United Kingdom John V Parry et al, Health Protection Agency, London, United Kingdom Objectives Objectives To detect a possible decrease in HIV incidence among MSM in the UK, 1995-2002 To detect a possible decrease in HIV incidence among MSM in the UK, 1995-2002 Methods Methods Tested specimens anonymously from 16 STD clinics using STARHS Tested specimens anonymously from 16 STD clinics using STARHS Key findings Key findings HIV incidence higher in London than elsewhere but showed a decrease followed by an increase with rates in 2002 similar to 1995 HIV incidence higher in London than elsewhere but showed a decrease followed by an increase with rates in 2002 similar to 1995 Dr. Robert S. Remis Public Health Sciences, University of Toronto

6. instructional media centre, Laboratories Branch - 2000 Epidemiologic aspects 4 Gary A Murphy et al, Health Protection Agency, London, United Kingdom Gary A Murphy et al, Health Protection Agency, London, United Kingdom Objectives Objectives Examine HIV incidence in a hypothetical heterosexual population infected with mixed viral subtypes (e.g. Thailand) Examine HIV incidence in a hypothetical heterosexual population infected with mixed viral subtypes (e.g. Thailand) Methods Methods Since different subtypes may have different STARHS window periods, examined possible solutions when subtyping not available Since different subtypes may have different STARHS window periods, examined possible solutions when subtyping not available Key findings Key findings Though can’t calculate HIV incidence, can examine proportions of recent infections to monitor trends Though can’t calculate HIV incidence, can examine proportions of recent infections to monitor trends Dr. Robert S. Remis Public Health Sciences, University of Toronto

7. instructional media centre, Laboratories Branch - 2000 Epidemiologic aspects 5 Martin Fisher et al, Brighton and Sussex University Hospitals, Brighton, United Kingdom Martin Fisher et al, Brighton and Sussex University Hospitals, Brighton, United Kingdom Objectives Objectives Use the STARHS assay in patients seen at a clinical service in England from 1995 to 2002 Use the STARHS assay in patients seen at a clinical service in England from 1995 to 2002 Methods Methods Explored possible reasons for false results from patients with long-standing infection Explored possible reasons for false results from patients with long-standing infection Key findings Key findings STARHS results can be used for other clinical and public health benefits besides estimating incidence STARHS results can be used for other clinical and public health benefits besides estimating incidence Dr. Robert S. Remis Public Health Sciences, University of Toronto

8. instructional media centre, Laboratories Branch - 2000 Epidemiologic aspects 6 D Puente et al, Center for Epidemiological Studies on AIDS of Catalonia, Spain D Puente et al, Center for Epidemiological Studies on AIDS of Catalonia, Spain Objectives Objectives Examine epidemiologic patterns in recently infected patients in Spain Examine epidemiologic patterns in recently infected patients in Spain Methods Methods Tested recently diagnosed patients using the STARHS assay; epidemiologic data available for 60 recent infections Tested recently diagnosed patients using the STARHS assay; epidemiologic data available for 60 recent infections Key findings Key findings Observed a mixed picture with respect to gender and exposure category Observed a mixed picture with respect to gender and exposure category Dr. Robert S. Remis Public Health Sciences, University of Toronto

9. instructional media centre, Laboratories Branch - 2000 Laboratory aspects 1 Gary A Murphy et al, Health Protection Agency, London, United Kingdom Gary A Murphy et al, Health Protection Agency, London, United Kingdom Objectives Objectives Explore limitations of two approaches for detecting recent HIV infection Explore limitations of two approaches for detecting recent HIV infection Key findings Key findings Combine information using the concept of increasing antibody titres and assays using changes in antibody quality Combine information using the concept of increasing antibody titres and assays using changes in antibody quality Dr. Robert S. Remis Public Health Sciences, University of Toronto

10. instructional media centre, Laboratories Branch - 2000 Laboratory aspects 2 Niel Constantine et al, University of Maryland School of Medicine, Department of Pathology, Baltimore, USA Niel Constantine et al, University of Maryland School of Medicine, Department of Pathology, Baltimore, USA Objectives Objectives Explore use of oral fluid to detect recent HIV infection Explore use of oral fluid to detect recent HIV infection Methods Methods Phase I study Phase I study Key findings Key findings An oral fluid S/LS EIA can be developed with high concordance with S/LS serum tests; a calibrator may be needed to better standardize the method An oral fluid S/LS EIA can be developed with high concordance with S/LS serum tests; a calibrator may be needed to better standardize the method Dr. Robert S. Remis Public Health Sciences, University of Toronto

11. instructional media centre, Laboratories Branch - 2000 Laboratory aspects 3 Elizabeth Dax, National Serology Reference Laboratory, Melbourne, Australia Elizabeth Dax, National Serology Reference Laboratory, Melbourne, Australia Objectives Objectives To develop a new approach to detect recent HIV infection To develop a new approach to detect recent HIV infection Methods Methods Use an enzyme immunoassay which detects the IgG3 isotype against p24 Use an enzyme immunoassay which detects the IgG3 isotype against p24 Key findings Key findings Preliminary data indicated the window period was around 150 days without interference in late stage infection Preliminary data indicated the window period was around 150 days without interference in late stage infection Dr. Robert S. Remis Public Health Sciences, University of Toronto

12. instructional media centre, Laboratories Branch - 2000 Laboratory aspects 4 Jean K. Carr et al, Henry M. Jackson Foundation, Rockville, USA Jean K. Carr et al, Henry M. Jackson Foundation, Rockville, USA Objectives Objectives To characterize viral HIV strains in the Caribbean To characterize viral HIV strains in the Caribbean Methods Methods Sampled archived sera from 2000-03 Sampled archived sera from 2000-03 Determined early seroconverters by detuned assay Determined early seroconverters by detuned assay Amplified, sequenced and analyzed Amplified, sequenced and analyzed Key findings Key findings 29/30 were clade B; characterized homology of 30 strains 29/30 were clade B; characterized homology of 30 strains Dr. Robert S. Remis Public Health Sciences, University of Toronto

13. instructional media centre, Laboratories Branch - 2000 Laboratory aspects 5 P Wasinrapee et al, TUC, Ministry of Public Health, Bangkok, Thailand P Wasinrapee et al, TUC, Ministry of Public Health, Bangkok, Thailand Objectives Objectives Measure HIV incidence in Thai subpopulations Measure HIV incidence in Thai subpopulations Methods Methods Used BED-CEIA assay, a competitive enzyme immunoassay that detects increasing levels of specific HIV-1 IgG, in IDUs and military conscripts Used BED-CEIA assay, a competitive enzyme immunoassay that detects increasing levels of specific HIV-1 IgG, in IDUs and military conscripts Key findings Key findings Estimates of HIV incidence comparable to those from independent studies Estimates of HIV incidence comparable to those from independent studies Dr. Robert S. Remis Public Health Sciences, University of Toronto

14. instructional media centre, Laboratories Branch - 2000 Discussion Continued concerns about test performance of the Vironostika S/LS (sensitivity, specificity); results must therefore be carefully interpreted. Need to develop better methods and possibly algorithms using multiple techniques Continued concerns about test performance of the Vironostika S/LS (sensitivity, specificity); results must therefore be carefully interpreted. Need to develop better methods and possibly algorithms using multiple techniques Validating newer methods is important and should be done in the environment (i.e. samples, equipment, reagents, personnel etc) where the test will be used Validating newer methods is important and should be done in the environment (i.e. samples, equipment, reagents, personnel etc) where the test will be used Dr. Robert S. Remis Public Health Sciences, University of Toronto

15. instructional media centre, Laboratories Branch - 2000 Discussion Whether to inform patients of results of incidence assay remains controversial Whether to inform patients of results of incidence assay remains controversial More reference panels (especially non-B clades) from carefully designed protocols required to validate new methods More reference panels (especially non-B clades) from carefully designed protocols required to validate new methods Consensus about the need to develop an active communication network to keep investigators informed of emerging issues and techniques Consensus about the need to develop an active communication network to keep investigators informed of emerging issues and techniques Dr. Robert S. Remis Public Health Sciences, University of Toronto