Workshop on TB and HIV Diagnostics in Adult and Pediatric Populations

Silver Spring, Maryland

A workshop of the Federal TB Taskforce’s Molecular Diagnostics Working Group sponsored by the National Institute of Allergy and Infectious Diseases, Office of the Global AIDS Coordinator, Centers for Disease Control and Prevention, and the Eunice Kennedy Shriver National Institute of Child Health & Human Development

The development, evaluation, and implementation of new and improved diagnostics has been identified as a critical need by HIV and tuberculosis (TB) researchers and clinicians alike. The need is both for international and domestic settings and in adult and pediatric populations. Though there is work underway to develop diagnostic devices, including substantial investment from U.S. Government agencies, coordination of clinical evaluations and guidance for implementation are needed to accelerate appropriate uptake of these devices. Accelerated adoption of these technologies requires defining the critical path for the evaluation of these technologies and identification of potential barriers to adoption. Efficient channeling of this critical path can only occur through alignment of key stakeholders and their respective roles in the path.

This workshop addressed a wide range of issues including the following:

• Clinical Research and Development in TB Diagnostics
• Diagnostic Research Issues in the Pediatric Population
• Strategies for Implementing Molecular Point-of-care Diagnostics for HIV and TB

Agendas

Clinical Research & Development Agenda [Download]
Pediatrics Agenda [Download]
Implementation Agenda [Download]

NOTE: Presentations for which we have received presenter approval for posting are available below. Some slides have been modified by the speakers for general distribution.

OPENING SESSION PRESENTATIONS

Tuesday, June 28, 2011

01 – M. Iademarco – Building Momentum for Improved Diagnostic Tests [Download]
02 – R. Hafner – From Silos to Synergy [Download]
03 – E. Handelsman – Little People, Big Challenges [Download]

CLINICAL RESEARCH & DEVELOPMENT PRESENTATIONS

Tuesday, June 28, 2011

04 – C. Evans – Culture-based Technologies for TB Diagnosis [Download]
05 – J. Ellner – NAAT/Molecular Technologies: Current Status [Download]
06 – J. Posey – Molecular Detection of Drug Resistant M tuberculosis [Download]
07 – M. Perkins – Non-NAAT-based Diagnostics [Download]
08 – P. Nahid – What’s Needed Beyond NAAT? [Download]
09 – M. Phillips – Volatile Biomarkers of Tuberculosis in Breath [Download]
10 – D. Fergenson – Single Particle Aerosol Mass Spectrometry (SPAMS) [Download]

Thursday, June 30, 2011

11 – S. Swindells – Optimal Approaches to the Eval of TB Diagnostics [Download]
12 – C. Lienhardt – Ideas to Coordinate Research [Download]

PEDIATRICS PRESENTATIONS

Tuesday, June 28, 2011

13 – S. Graham – The Need for New TB Diagnostics in Children [Download]
14 – J. Starke – Key Issues in TB Diag in Children: The Clin-Research Perspective [Download]
15 – M. Cotton – Special Considerations in Clin TB Diag in HIV-Infected Children [Download]
16 – R. Oberhelman – Current Diagnostic Approaches to Pediatric Tuberculosis [Download]
17 – L. Dodd – Reference Standards: Problems in Eval Diag in the Ped TB Setting [Download]
18 – L. Cuevas – The WHO/TDR Diagnostic Expert Evaluation Panel [Download]

Wednesday, June 29, 2011

19 – A. Hesseling – GeneXpert: Towards Standard Eval of a TB Index Test in Children [Download]

Thursday, June 30, 2011

20 – S. Jain – Diagnosis of Pediatric TB: Need for Newer Technologies? [Download]
21 – M. Casenghi – Test Specs to Inform R&D of New TB Diag Tools in Children [Download]
22 – A. Hesseling –Standardized Approach from Collection to Results [Download]
23 – S. Nachman – Specimen and Data Repository for TB Diag Res and Dev in Children [Download]
24 – A. Walden – TB Data Standardization and Harmonization [Download]
25 – L. Cuevas – Specimen Collection Challenges and Non-sputum Specimens [Download]
26 – P. Palumbo – Combining Efforts: Multi-center Studies for TB Diag in Children [Download]
27 – C. Wingfield – Advocacy to Advance TB Diagnostics Research in Children [Download]
28 – L. Dawson – Ethical Issues in Disclosing Investigational Diag Test Results for TB [Download]

IMPLEMENTATION PRESENTATIONS

Tuesday, June 28, 2011

29 – M. Schito – Strategies for Implementing Molecular POC Diag for HIV and TB [Download]
30 – R. O’Brien – Global Laboratory Initiative (GLI) Update [Download]
31 – G. Young – Laboratory Strengthening [Download]
32 – T. Peter – Balancing Investment in POC Diag vs Conventional Lab [Download]
33 – I. Jani – Pilot Implementation of POC CD4 Counting in Mozambique [Download]
34 – K. Palamountain – Pre-Meeting Survey and Group Exercises [Download]

Wednesday, June 29, 2011

35 – M. Kimerling – Pathways for Implementing Better TB Diagnostics [Download]
36 – S. Cavanaugh – Diagnosing TB – What We Need, Where We’re Going [Download]
37 – A. Piatek – Adoption, Intro, and Implementation of New TB Diagnostics [Download]
38 – H. Alexander – Xpert MTB/RIF: An Opportunity [Download]
39 – S. Essajee – Lab Needs for Clinical Service Delivery of HIV Care [Download]
40 – D. Ellenberger – Issues to Consider in Adopting New HIV POC Testing [Download]
41 – A. Sands – WHO Prequalification of Diagnostics Programme Update [Download]
42 – E. Ermantraut – QA at POC – A Manufacturer’s Perspective [Download]
43 – B. Parekh – Ensuring Quality of HIV Rapid Testing [Download]
44 – D. Dowdy – Modeling Implementation Strategies for TB and HIV Diagnostics [Download]

CLOSING SESSION AND RAPPORTEUR PRESENTATIONS

Thursday, July 30, 2011

45 – P. Nahid – Clinical Res and Dev Rapporteur [Download]
46 – H. Menzies – Pediatrics Rapporteur [Download]
47 – W. Coggin – Implementation Rapporteur [Download]
48 – C. Hamilton – FDA Microbiology Devices Panel Meeting Rapporteur [Download]
49 – R. Hafner – Action Items and Next Steps [Download]