Program Book

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It has been 20 years since the FDA licensed the first test for HTIV-III/LAV antibody in 1985. Remarkable developments in the field of serologic and nucleic acid testing have occurred since that time; the introduction of one-step rapid HIV tests represent the largest shift in the platform for HIV diagnostic testing in two decades. However, the central question remains the same, posed during CDC’s 1987 workshop in Atlanta: what is the role of HIV diagnostic testing in the prevention and control of HIV and AIDS?
For many years, APHL’s Human Retroviral Testing Committee convened annually to consider new developments, share data, and formulate recommendations, but despite numerous strides in screening and diagnostic technology, there has been no such conclave in recent years,. It is time, therefore, for us to gather once again, share the latest information on HIV diagnostics, and consider alternatives that will best help accomplish our common goal: using the best that laboratory science has to offer to help combat and control the spread of HIV. Thank you for your interest, and welcome to the 2005 conference, HIV Testing: New Developments and Challenges.

With warm personal regards,

Bernard M. Branson, M.D.
Associate Director for Laboratory Diagnostics
Division of HIV/AIDS Prevention
Centers for Disease Control and Prevention

Acknowledgements:

On behalf of Centers for Disease Control and Prevention (CDC) we would like to express our appreciation to the following organizations for their contributions to the success of our conference:

Association of Public Health Laboratories
Biomeriuex
Calypte
Orasure
Trinity Biotech
SDS, Inc.

Meeting Programs

Monday February 28

7:30 – 8:30

Continental Breakfast, Poster Set-Up

8:30 – 8:40 Welcoming Remarks
Speaker: Bernie Branson, MD
Associate Director for Laboratory Diagnostics, CDC

Scientific Session 1:
New HIV Enzyme Immunoassays

8:40 – 9:10

Principles and Characteristics of EIAs Recently Approved by the FDA

  • Vironostika HIV-1 Plus O Microelisa System for the Detection of Antibodies to HIV-1, including Group O
    Speaker: Chamroen Chetty, PhD
    Senior manager Immunoassay R&D, bioMérieux Inc.
  • Principles and Characteristics of the Bio-Rad Genetic Systems™ HIV-1/HIV-2 Plus O EIA
    Speaker: M. Kathleen Shriver, PhD
    R&D Manager, Redmond Operations, Bio-Rad Laboratories
9:10 – 9:30

Comparing the New EIAs with Old Standbys: Validation Data from Public Health Laboratories
Speaker: Berry Bennett, MPH
Retrovirology Section Chief,
Florida Bureau of Laboratories

9:30 – 9:40

APHL Survey on HIV Assays Currently in Use
Speaker: Barbara Werner, PhD
Infectious Disease Consultant,
Massachusetts State Laboratory Institute

9:40 – 10:00

Discussion
Moderator: S. Michele Owen, PhD
Chief HIV Serology and Developmental Diagnostics Laboratory, CDC

10:00 – 10:30 Break – Poster and Exhibit Review

Scientific Session 2:
NAAT Testing for Acute HIV Infection

10:30 – 10:45

Results of donor screening with nucleic acid amplification tests (NAT) and implications for HIV research, diagnosis and surveillance
Speaker: Michael P. Busch, MD, PhD
Professor of Laboratory Medicine, UCSF
Director, Blood Systems Research Institute

10:45 – 11:00

Pooled RNA Testing of Antibody Negative High-Risk Persons: San Francisco and Los Angeles
Speaker: Sally Liska, DrPH
Director, San Francisco Public Health Laboratory

11:00 – 11:15

Alternatives for Detecting Acute HIV: RNA, p24, and
heat-dissociated p24

Speaker: Christopher D.Pilcher, MD
Assistant Professor of Medicine,
University of North Carolina at Chapel Hill

11:15 – 11:30

HIV NAAT Testing of HIV Antibody Negative Samples
Speaker: Robert Myers PhD
Deputy Director,
Maryland Dept of Health and Mental Hygiene Laboratories

11:30 – 11:40

Screening for Primary HIV Infection: The CDC Study
Speaker: Pragna Patel, MD, MPH
Medical Epidemiologist, Diagnostic Applications
Behavioral and Clinical Surveillance Branch, CDC

11:40 – 12:00 Discussion
Moderator: Amanda Smith, MPH
Epidemiologist, Diagnostic Applications
Behavioral and Clinical Surveillance Branch, CDC
12:00 – 2:00

Lunch – Poster and Exhibit Review

Scientific Session 3: Rapid HIV Testing

2:00 – 3:00

Panel: Roll-out and Implementation of Rapid Testing from a Field Perspective
Speakers:

  • Tony Falvo, CTL Program Coordinator, Florida Bureau of HIV/AIDS
  • Marianne Porter, BS MS, Director, Division of Laboratory Improvement, Pennsylvania Department of Health
  • Mara San Antonio Gaddy, RN, MSN, Director, Bureau of Direct Program Operations, New York State Department of Health
  • Susanne Norris Zanto, BS, CLS (NCA), Technical Services Manager, Montana Public Health Laboratory
  • Shelley Facente, MPH, HIV Rapid Testing Coordinator, San Francisco Department of Public Health AIDS Office
3:00 – 3:30

Discussion
Moderator: Bernie Branson, MD

3:30 – 4:00

Break – Poster and Exhibit Review

4:00 – 4:20

Resolution of Discordant Confirmatory Results after POC Reactive Rapid Tests
Speaker: Berry Bennett, MPH
Retrovirology Section Chief,
Florida Bureau of Laboratories

4:20 – 4:40

Post Marketing Surveillance of OraQuick Rapid HIV Testing
Speaker: Laura Wesolowski, MPH
Laboratory Determinants and diagnostics,
Behavioral and Clinical Surveillance Branch, CDC

4:40 – 5:00

Evaluation and Implementation of HIV Rapid Tests: The Experience in Eleven African Countries
Speaker: Stefan Wiktor, MD, MPH, Chief,
Surveillance and Infrastructure Development Branch,
Global AIDS Program, CDC

5:00 – 5:30

Implications for the Public Health Laboratory from Expansion of Rapid Testing
Speaker: Arthur Kazianis, BA
HIV/Hepatitis Laboratory Supervisor,
Massachusetts Department of Public Health

5:30 – 6:00

Discussion
Moderator: Bernie Branson, MD

6:00 – 7:30

Networking Reception – Poster/Exhibit Area

Tuesday March 1

7:30 – 8:30

Continental Breakfast – Poster and Exhibit Review

Scientific Session 4:
Options for Confirmatory Testing in Different Settings

8:30 – 8:45

Challenges for Blood Donor Confirmatory Testing Algorithms
Speaker: Susan L. Stramer, PhD
Executive Scientific Officer, American Red Cross

8:45 – 9:00

Comparison of Currently Available Assays that Detect Human Immunodeficiency Virus to Address Alternative Screening/Diagnostic Algorithms for HIV
Speaker: S. Michele Owen, PhD
Chief HIV Serology and Developmental Diagnostics Lab,
CDC

9:00 – 9:15

Performance of Rapid HIV Tests Singly and in Combination
Speaker: Kevin Delaney, MPH
Epidemiologist, Diagnostic Applications,
Behavioral and Clinical Surveillance Branch, CDC

9:15 – 9:30

HIV 1/2 Combination Screening and Outcomes of Follow-Up
Speaker: William R. Oleszko, PhD
Acting Associate Director, Public Health Laboratory,
New York City Department of Health and Mental Hygiene

9:30 – 10:00

Discussion of Next Steps:
Moderator: Sheryl Lyss, MD
Medical Officer, Diagnostic Applications,
Behavioral and Clinical Surveillance Branch, CDC

10:00 – 10:30 Break – Poster and Exhibit Review

Scientific Session 5: Dried Blood Spot Testing

10:30 – 10:50 Dried Blood Spots: An Ideal Specimen for HIV Serologic and Nucleic Acid Testing
Speaker: Joanne Mei, PhD
Lead Research Chemist
Newborn Screening Quality Assurance Program,
CDC
10:50 – 11:10 Usefulness and Application of Dried Blood Spots in HIV and HCV Epidemiology, Diagnostics and Drug Resistance Testing
Speaker: John Kim, PhD
Chief, National HIV Reference Lab
Public Health Agency of Canada
11:10 – 11:30 Early Diagnosis of HIV-1 Infection in Infants Using Dried Blood Spots and Real Time, RT-PCR
Speaker: Chin-Yih Ou, PhD
Chief, HIV Molecular Diagnostics Lab, CDC
11:30 – 11:45 Use of DBS with BED Testing for Recent Infection
Speaker: Bharat S. Parekh, PhD
Chief, HIV Incidence Laboratory, CDC
11:45 – 12:00 Use of DBS for HIV Drug Resistance Surveillance
Speaker: Diane V. Bennett, MD, MPH, M.ED.
Coordinator, Antiretroviral Drug Resistance
Surveillance, CDC
12:00 – 12:30 Discussion
Moderator: Joanne Mei, PhD
Lead Research Chemist, Newborn Screening Quality
Assurance Program, CDC
12:30 – 2:00 Lunch and Networking

Scientific Session 6: Concurrent Discussion Groups

2:00 – 2:30 Updates: Status of Tests for Recent Infection & CDC’s Plans for the Detuned IND
Speaker: Bernie Branson, MD
Associate Director for Laboratory Diagnostics, CDC
2:30 – 3:30

Panel: Tests for Recent Infection

Moderators: Niel Constantine and Anne M. Sill

  • Calibration, validation and application of the BED assay for recent HIV-1 infection in multiple subtypes
    Panelist: Bharat S. Parekh, PhD, Chief, HIV Incidence and Diagnosis
    Laboratory, CDC,
  • A Simple and Inexpensive Algorithm for Determining Recent HIV Infection: Development of a Sensitive/Less Sensitive (S/LS) Particle Agglutination Assay
    Panelist: Neil Constantine, PhD, Professor, University of Maryland School of Medicine
  • Identification of Factors Impacting the Determination of HIV Incidence in Non-Research-Based, Clinical Populations
    Panelist: Anne M. Sill, BA, Research Supervisor, Research
    Associate, Institute of Human Virology,
  • Incidence Tests for the Serological Testing Algorithm for Recent HIV Seroconversion (STARHS)
    Panelist: Joanne Mei, PhD, Lead Research Chemist, CDC,
  • Summary of STARHS meeting in Bangkok
    Panelist: Robert Remis, MD, MPH, FRCPC, Professor,
    Public Health Sciences, University of Toronto, Canada
3:30 – 4:30 IND Investigators Meeting
Scientific Session 6: Concurrent Discussion Groups
2:30 – 4:30

Panel: Rapid HIV Testing in International Settings
Moderator: Mark Rayfield, PhD, Global AIDS Program CDC

  • Arguments for the use HIV Rapid Tests on a National Scale in Resource Poor Settings
    Panelist: Kyle B. Bond, MS, Surveillance and Infrastructure Development Branch, GAP, NCHSTP, CDC
  • HIV in Botswana; Improving Lab Capacity in the Face of the AIDS Pandemic
    Panelist: Patricia Clark, MPH, Interim Virology/Immunology Section Manager, Michigan Department of Community Health
  • Rapid Testing: The Kenya Experience
    Panelist: Dr. Peter Tukei, Assistant Director Kenya Medical Research Institute, Laboratory Director, CDC/KEMRI
  • Use of Rapid HIV Assays in Vietnam and Cambodia: Challenges to improving access, quality and timeliness of HIV Testing
    Panelist: Ralph Timperi, MPH, Director Massachusetts State Laboratory Institutes
  • Quality Assurance for Rapid Testing
    Panelist: Elizabeth Dax, AM, MD, BS, PhD, Director, National Serology Reference Laboratory, Australia
4:30 – 5:30 Meeting wrap-up and discussion of next steps
Bernie Branson, MD
Associate Director for Laboratory Diagnostics, CDC
 
Last Update: April 8, 2005