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  1. 1. Innovative, Multi-platform, Affordable CD4+ Enumeration Reagents that Need No Cold Chain: Impacting HIV/AIDS Management in Resource Poor Settings Dr.Anand Sivaraman, ReaMetrix India Pvt. Ltd. Bangalore 560092
  2. 2. HIV in India – Current Status <ul><li>HIV Prevalence rate in India 0.36% (source, NACO 2007 Bulletin) </li></ul><ul><ul><li>2.5 Million HIV Infections </li></ul></ul><ul><li>Management of HIV Infection </li></ul><ul><ul><li>Providing Anti Retroviral Therapy (ART) </li></ul></ul><ul><ul><li>Immunophenotyping </li></ul></ul><ul><ul><ul><li>CD4 T-Lymphocyte Count </li></ul></ul></ul><ul><ul><li>Viral Load Assay </li></ul></ul><ul><ul><ul><li>PCR – quantitate virus levels in blood </li></ul></ul></ul><ul><li>Role of CD4+ T-Lymphocyte Count in HIV pathogenesis </li></ul><ul><ul><li>Assessing immune status of patients </li></ul></ul><ul><ul><li>Indicating initiation of prophylactic ART therapy </li></ul></ul><ul><ul><li>Assessing patient response to therapy </li></ul></ul>
  3. 3. Current Issues with CD4 testing in Resource Poor Settings <ul><li>High cost of testing </li></ul><ul><li>Poorly developed cold chain in the transportation, storage & use of reagents </li></ul><ul><li>Aging of blood samples that are transported to centralized testing facilities </li></ul><ul><li>Complicated assay workflow with multiple critical pipetting steps leading to errors in CD4 count enumeration </li></ul>ISSUES <ul><li>Undertook a study of the anatomy of cost of CD4 testing </li></ul><ul><li>Worked on a locally relevant innovative product delivery model – dried reagents </li></ul><ul><li>Re-designed reagents to enable staining in collection centres </li></ul><ul><li>Simplified assay workflow with a single critical pipetting step – reduced chance of human error </li></ul>ReaMetrix APPROACH
  4. 4. Clinical Information Generation – Current Scenario Sample journey and cost accumulation Acquire Process Run Provide Results Transport Collection centre Path Lab Doctor Hospital Centralized Path Lab Syringe/Vacutainer/Overheads Cold chain/Courier Tech Labor + Reagent Capital Equipment Amortization Lab Infrastructure Overheads <ul><li>CD4 test example: </li></ul><ul><ul><li>~2 to 5 times cost addition from reagent manufacture to cost to patient </li></ul></ul><ul><li>Average cycle time for results ~ 48 to 72 hours </li></ul>Layers of margin at every step
  5. 5. Innovations that helped reduce the cost of CD4 testing <ul><li>Optimized the manufacturing processes to enable a two-fold increase in antibody-conjugate yield </li></ul><ul><li>Validated and standardized the use of open source bright green and red dyes </li></ul><ul><ul><li>Atto 488 (FITC equivalent) </li></ul></ul><ul><ul><li>Phycoerythrin-Dyomics 649 (PE-Cy5 equivalent) </li></ul></ul><ul><li>Development of Dried Reagents </li></ul><ul><ul><li>Uses proprietary stabilizers in formulation </li></ul></ul><ul><ul><li>Removes costs associated with maintaining cold chain in storage and transport </li></ul></ul>
  6. 6. Innovation in Product Delivery : Issue of Aging of Blood samples <ul><li>In India, the real challenge lies in transporting blood samples from remote areas to centralized testing centers. </li></ul><ul><li>Often times, this leads to “aged” blood samples (> 48 hrs), making it unusable </li></ul><ul><li>Blood collection centres need access to cold-chain to enable storage of liquid reagents, if they were to stain samples and then ship them </li></ul>CD3 capping
  7. 7. Unitized (one test per tube) dried-down format : Eliminating the Issue of Aged Samples <ul><li>Dried reagents can be stored and transported at room temperature </li></ul><ul><li>Blood can be collected, stained and fixed at the point of collection before being shipped to a central testing facility at room temperature </li></ul><ul><li>The stained samples can be stored for up to 7 days at room temperate without any statistical difference in CD4/CD8 counts on 1 st day vs. the 7 th day. </li></ul>
  8. 8. Simplification of Assay Workflow <ul><li>Methodology </li></ul><ul><li>Employ simple Lyse/no wash protocol - single platform technology </li></ul><ul><li>Unitized Format </li></ul><ul><ul><li>Pre-dispensed reagents in unitized form provided as ready to use tubes </li></ul></ul><ul><li>Convenience & Simplified Work Flow </li></ul><ul><ul><li>Just 2 pipetting steps – no separate pipetting of beads, reagents etc. </li></ul></ul>
  9. 9. ReaMetrix HIV Reagents Performance Assessment * * * * - values in cells per uL
  10. 10. Building in Robustness in Reagents: Shelf Life exceeds 1 year <ul><li>Dried Reagents are stable at room temperature for more than 12 months </li></ul><ul><li>Enables use of dried reagents in resource poor settings without cold chain/ refrigeration – enables increased penetration into remote areas . </li></ul>Stability of ReaMetrix Dried Reagents at Room Temperature : do not require Cold storage
  11. 11. ReaMetrix Reagents : Making the difference : Changing the Paradigm <ul><li>All reagents already formulated, unitized and dried </li></ul><ul><li>Steps as simple as mix & read </li></ul><ul><li>No cold chain in transportation or storage </li></ul><ul><li>Long shelf life and reduced waste </li></ul><ul><li>Less opportunity for pipetting errors – with fixed volume pipettes, sample processing is made very easy </li></ul><ul><li>All this without compromising quality or affordability. </li></ul>
  12. 12. In the words of the National Microbiology Reference Lab, Zimbabwe
  13. 13. Key Centres who have already Validated Reagents and Published Data from Validation <ul><li>National AIDS Research Institute (NARI), Pune </li></ul><ul><li>Public Health Agency of Canada, Canada </li></ul><ul><li>National Microbiology Reference Lab, Zimbabwe and CDC, Zimbabwe </li></ul>
  14. 14. Publications & Presentations <ul><li>1. Manian, BS, et al, Affordable Diagnostics — Changing the Paradigm in India , Cytometry Part B (Clinical Cytometry) 74B (Suppl. 1):S117–S122 (2008) </li></ul><ul><li>2. Bhavani Venkatkrishnan, Pratibha Malini, K.L.Ravikumar, Anand Sivaraman, Comparative Evaluation of an Indigenous CD4 Reagent Kit in a Dry Format Requiring no Cold Chain, Proceedings of the International Conference on Fundamental and Translational Research on HIV/AIDS, Mumbai, October 2008. </li></ul><ul><li>3. Rajesh Anand, Jammi Narasimham, Bhavani Venkatakrishnan, Wilson D'Souza, Sowmya </li></ul><ul><li>Narayanan, Donny Thomas, Anand Sivaraman, Multi-platform, Affordable CD4 Enumeration Reagents that need no Cold Chain: Enabling evidence-based Management of HIV/AIDS in Resource-poor Settings , Proceedings of the Association of Pathologists and Microbiologists (APCON), Chennai, December 2008. </li></ul>