1. January 27, 2009

2. Paul Contestable Principal Scientist Ortho Clinical Diagnostics Second WHO Consultation: Development of a WHO Reference Panel for the Control of Chagas Diagnostic Tests January 27, 2009

3.  Variability of methods currently available or under development in the US Microwell ELISA Line Immunoassay Lateral Flow ELISA Colorimetric Reaction Chemiluminescent Reaction Fluorescent Reaction Radioactive Reaction Recombinant Antigen Whole Cell Lysate Antigen Fully Automated Testing Semi-automated Testing Manual Testing Point-of-Care Testing

4.  Variability of Intended Use Aid in Diagnosis Blood Donor Screening Cadaveric Donor Screening Confirmatory  Variability of Performance Claims Sensitivity Specificity Lot-to-lot Consistency Precision Cross-reactivity Sample Type Stability Etc.

5. AdvaMed Position on Standardization of Chagas Testing Supports the concept of an international approach to the standardization of Chagas testing. Members will continue to participate in discussions defining that standard. Members willing to evaluate/test the proposed WHO panel or standard.

6. AdvaMed Position on Standardization of Chagas Testing Provide testing results to WHO as a baseline for establishing target level of panel/standard. Support the use of the WHO panel/standard as a primary material from which secondary panels could be manufactured for use within countries or blood banks. Do not support the use of the WHO panel/standard as a Quality Control test material. Do not support the use of the WHO panel/standard to correlate results to clinical assay performance

7. Signal/Cutoff at given point in time does not correlate to clinical sensitivity Modified from Tobler LH, Stramer SL, Lee SR et al. (2003) Transfusion 1452-1459