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© 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

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


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


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


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


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 capping


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.


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.


ReaMetrix HIV Reagents Performance ReaMetrix HIV Reagents Performance AssessmentAssessment

** *

* - values in cells per uL


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


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.


In the words of the National Microbiology Reference Lab, Zimbabwe


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


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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