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Blood Products Advisory Committee Meeting

Blood Products Advisory Committee Meeting. April 26, 2007 Ben Marchlewicz, Ph.D. PRISM R&D, Program Manager. Abbott’s approach to Chagas Testing PRISM Chagas Description of the assay Performance Chagas Confirmatory Description of the assay Performance.

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Blood Products Advisory Committee Meeting

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  1. Blood Products Advisory Committee Meeting April 26, 2007 Ben Marchlewicz, Ph.D. PRISM R&D, Program Manager

  2. Abbott’s approach to Chagas Testing • PRISM Chagas • Description of the assay • Performance • Chagas Confirmatory • Description of the assay • Performance

  3. Abbott’s Strategy in Blood Screeningfor Chagas Disease Develop a recombinant antigen based assay for antibodies to T. cruzi on the PRISM platform • Well-characterized antigens • Presenting multiple epitopes • Non-biohazardous Develop a recombinant antigen based Confirmatory assay for resolution of PRISM Repeat Reactive specimens.

  4. PRISM Chagas Assay

  5. PRISM Chagas Screening Assay Design Configuration Dual rAg Coated mP, Single mAb Conjugate, Two–Step Assay

  6. Multi-epitope Recombinant Antigens used in PRISM Chagas Assay

  7. Specificity Random Donors

  8. Specificity Cross Reactivity with other Parasitic Infections

  9. Sensitivity PRISM Chagas Assay SensitivityChagas Positive Specimens (confirmed by RIPA) 100% Sensitivity

  10. Chagas Confirmatory Assay

  11. Design of Chagas Confirmatory Immunostrip Anti-hIgG (Sample Addition CTL) hIgG-H CTL hIgG-L CTL (Cut-off) 4 rAgs for anti-T. cruzi detection TcF FP3 FP6 FP10 ID# Test Bands On-board CTL bands

  12. Visual Reading of Test Bands

  13. Sensitivity * Also reactive in PRISM Assay & 2 reference ELISA’s 100% Sensitivity

  14. Chagas Specimens Paneln = 410(All are confirmed RIPA positive)

  15. Specificity Unscreened Random Blood Donors * Also reactive in PRISM Assay & 2 reference ELISA’s 100% Resolved Specificity

  16. Specificity Unrelated Medical Conditions * Also reactive in PRISM Assay & 2 reference ELISA’s 100% Resolved Specificity

  17. Specificity Cross Reactivity with other Parasitic Infections

  18. Summary A fully automated blood screening assay for antibodies to T. Cruzi, on the PRISM system,is under development; Along with an Immunoblot Confirmatory assay, that can be performed on site, to confirm Repeat Reactive specimens to aid in donor management.

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