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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.
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 CountViral 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 reagentsAging 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 testingWorked on a locally relevant innovative product delivery model – dried reagentsRe-designed reagents to enable staining in collection centres
Simplified assay workflow with a single critical pipetting step – reduced chance of human error
Innovation in Product Delivery : Issue of Aging of Blood samplesInnovation in Product Delivery : Issue of Aging of Blood samples
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
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 temperatureBlood 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
MethodologyMethodologyEmploy simple Lyse/no wash protocol - single platform technologyUnitized FormatUnitized FormatPre-dispensed reagents in unitized form provided as ready to use tubes
ConvenienceConvenience & & Simplified Work FlowSimplified Work FlowJust 2 pipetting steps – no separate pipetting of beads, reagents etc.
ReaMetrix Reagents : ReaMetrix Reagents : Making the difference : Making the difference : Changing the ParadigmChanging the Paradigm
All reagents already formulated, unitized and driedSteps as simple as mix & readNo cold chain in transportation or storageLong shelf life and reduced wasteLess opportunity for pipetting errors – with fixed volume pipettes, sample processing is made very easyAll this without compromising quality or affordability.
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.