Innovation in Affordable CD4 Enumeration Diagnostics
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Transcript of Innovation in Affordable CD4 Enumeration Diagnostics
© 2008 Reametrix, Inc. All rights reserved.
Innovative, Multi-platform, Affordable CD4+ Innovative, Multi-platform, Affordable CD4+ Enumeration Reagents that Need No Cold Chain: Enumeration Reagents that Need No Cold Chain:
Impacting HIV/AIDS Management in Resource Poor Impacting HIV/AIDS Management in Resource Poor SettingsSettings
Dr.Anand Sivaraman, Dr.Anand Sivaraman, ReaMetrix India Pvt. Ltd.ReaMetrix India Pvt. Ltd.
Bangalore 560092Bangalore 560092
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2© 2008 Reametrix, Inc. All rights reserved.
HIV in India – Current StatusHIV in India – Current Status
HIV Prevalence rate in India 0.36% (source, NACO 2007 Bulletin)
2.5 Million HIV Infections
Management of HIV InfectionProviding Anti Retroviral Therapy (ART)Immunophenotyping
CD4 T-Lymphocyte Count
Viral Load Assay PCR – quantitate virus levels in blood
Role of CD4+ T-Lymphocyte Count in HIV pathogenesisAssessing immune status of patientsIndicating initiation of prophylactic ART therapyAssessing patient response to therapy
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Current Issues with CD4 testing in Resource Poor Current Issues with CD4 testing in Resource Poor SettingsSettings
High cost of testing
Poorly developed cold chain in
the transportation, storage &
use of reagents
Aging of blood samples that
are transported to centralized
testing facilities
Complicated assay workflow
with multiple critical pipetting
steps leading to errors in CD4
count enumeration
ISSUESUndertook a study of the
anatomy of cost of CD4 testing
Worked on a locally relevant
innovative product delivery
model – dried reagents
Re-designed reagents to enable
staining in collection centres
Simplified assay workflow with a
single critical pipetting step –
reduced chance of human error
ReaMetrix APPROACH
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Clinical Information Generation – Current ScenarioSample 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
• CD4 test example:
• ~2 to 5 times cost addition from reagent manufacture to cost to patient
• Average cycle time for results ~ 48 to 72 hours
Layers of margin at every step
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Innovations that helped reduce the cost of CD4 testing
Optimized the manufacturing processes to enable a two-fold increase in antibody-conjugate yield
Validated and standardized the use of open source bright green and red dyes
Atto 488 (FITC equivalent)Phycoerythrin-Dyomics 649 (PE-Cy5 equivalent)
Development of Dried ReagentsUses proprietary stabilizers in formulationRemoves costs associated with maintaining cold chain in storage and transport
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Innovation in Product Delivery : Issue of Aging of Blood Innovation in Product Delivery : Issue of Aging of Blood samplessamples
In India, the real challenge lies in transporting blood samples from
remote areas to centralized testing centers.
Often times, this leads to “aged” blood samples (> 48 hrs), making it
unusable
Blood collection centres need access to cold-chain to enable storage of
liquid reagents, if they were to stain samples and then ship them
CD3 cappingReaMetrix Confidential
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Unitized (one test per tube) dried-down format : Unitized (one test per tube) dried-down format : Eliminating the Issue of Aged SamplesEliminating the Issue of Aged Samples
Dried reagents can be stored and transported at room temperature
Blood can be collected, stained and fixed at the point of collection
before being shipped to a central testing facility at room temperature
The stained samples can be stored for up to 7 days at room temperate
without any statistical difference in CD4/CD8 counts on 1st day vs. the
7th day.
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Simplification of Assay WorkflowSimplification of Assay Workflow
MethodologyMethodology
Employ simple Lyse/no wash protocol - single platform technology
Unitized FormatUnitized Format
Pre-dispensed reagents in unitized form provided as ready to use tubes
ConvenienceConvenience & & Simplified Work FlowSimplified Work Flow
Just 2 pipetting steps – no separate pipetting of beads, reagents etc.
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ReaMetrix HIV Reagents Performance ReaMetrix HIV Reagents Performance AssessmentAssessment
** *
* - values in cells per uL
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Building in Robustness in Reagents: Shelf Life exceeds Building in Robustness in Reagents: Shelf Life exceeds 1 year1 year
Dried Reagents are stable at room temperature for more than 12 months
Enables use of dried reagents in resource poor settings without cold chain/ refrigeration – enables increased penetration into remote areas.
Stability of ReaMetrix Dried Stability of ReaMetrix Dried Reagents at Room Reagents at Room
Temperature : do not require Temperature : do not require Cold storageCold storage
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ReaMetrix Reagents : ReaMetrix Reagents : Making the difference : Making the difference : Changing the ParadigmChanging the Paradigm
All reagents already formulated,
unitized and dried
Steps as simple as mix & read
No cold chain in transportation or
storage
Long shelf life and reduced waste
Less opportunity for pipetting errors –
with fixed volume pipettes, sample
processing is made very easy
All this without compromising quality or
affordability.ReaMetrix Confidential
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In the words of the National Microbiology Reference Lab, Zimbabwe
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Key Centres who have already Validated Reagentsand Published Data from Validation
National AIDS Research Institute (NARI), Pune
Public Health Agency of Canada, Canada
National Microbiology Reference Lab, Zimbabwe and
CDC, Zimbabwe
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Publications & Presentations
1. Manian, BS, et al, Affordable Diagnostics — Changing the Paradigm in India, Cytometry Part B (Clinical Cytometry) 74B (Suppl. 1):S117–S122 (2008)
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.
3. Rajesh Anand, Jammi Narasimham, Bhavani Venkatakrishnan, Wilson D'Souza, Sowmya
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.
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