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Innovation in Affordable CD4 Enumeration Diagnostics


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This presentation details the systematic processes that were employed in understanding various cost components that contribute to the high cost CD4 enumeration reagents. ReaMetrix's dried down technology that enables elimination of cold-chain in storage and shipment of reagents is also discussed.

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Innovation in Affordable CD4 Enumeration Diagnostics

  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 ReaMetrix Confidential
  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>ReaMetrix Confidential
  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 ReaMetrix Confidential <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 ReaMetrix Confidential
  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>ReaMetrix Confidential
  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 ReaMetrix Confidential
  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>ReaMetrix Confidential
  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 ReaMetrix Confidential
  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>ReaMetrix Confidential
  12. 12. In the words of the National Microbiology Reference Lab, Zimbabwe ReaMetrix Confidential
  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>ReaMetrix Confidential
  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>ReaMetrix Confidential