POCT – Innovations

Dual Path Platform (DPP®)

Technologywww.chembio.com

National Institutes of Health – NIH

Centers for Disease Control & Prevention- CDC

The Foundation for Innovative & Novel Diagnostics- FIND

The Infectious Disease Research Institute- IDRI

The Pan American Health Organization-PAHO

World Health Organization-WHO

Fundação Oswaldo Cruz– FIOCRUZ

Guidelines + Standards+ Colaboration = Sucess

National Hospital Abuja, Nigeria

Journal Diagnostic Microbiology & Infection Disease

ORAL FLUID - HIV/AIDS IN NIGERIA

FACTS & NEEDSEndemic + StigmatizationReliable rapid testing kits & ProcedureIncrease uptake of services

STUDY AIM2004/2005 – False Positive - CDC Intervention

HIV antibodies in Blood Oral FluidSensitivity & Specificity of DPP

ConfirmatoryDetermine

Western Blot ( Discordant Cases)

Total = 645 Patients

National Hospital Abuja, Nigeria

Fall 2009

Chembio DPP® HIV 1/2 Screening AssayOral Fluid & Fingerstick Blood

228

Low

Risk

215

HIV Pos

202

High

Risk

SENSITIVITY SPECIFICITY

Oral Fluid = 100%

Fingertip Blood = 100%

Oral Fluid = 100%

Fingertip Blood = 99.5%

Oral Fluid

n=645

Fingertip Blood

n=643

True

Positive1

223 221

False

Positive

0 2

True

Negative1

422 422

False

Negative

0 0

Sensitivity 100% (95% CI =

98.3% - 100%)

100% (95% CI = 98.3% - 100%)

Specificity 100% (95% CI =

99.1% - 100%)

99.5% (95% CI = 98.3% 99.9%)

Table 1: Oral Fluid and Whole Blood Study –

Nigeria, 20091Confirmation performed by reference test and / or

Western Blot

SWAB

ORAL FLUID

FINGERPRINTSTICK

WHOLE BLOOD

SAMPLING

PHLEBOTOMY

WHOLE BLOOD

SERUM

PLASMA

Single Path Lateral Flow

Experience

Evolution

Innovation

POCT Improvement DPP

• Increased analytical and clinical sensitivity

• Outside the standard lateral flow

• Less labor intensive than EIA, PCR or WB

• Potential ideal confirmatory test

• Adaptable to multiple sample types: blood serum, oral fluid, sputum urine, feces, etc.

• Multiplex capability through elimination of aggregation issues (ie HIV/TB, HIV 1/ 2, etc.)

• Requires minimal sample volume

• Long shelf life (up to 24 months)

• Total test time < 20 minutes

• Ideally suited for POC testing

Analytical & Clinical Sensitivity > 10 X Conventional Lateral Flow

• Independent Flow Path for Sample and Conjugate

• Increased Efficiency of Binding Antibody To Immobilized Test

Antigen In The Absence Of Competing Conjugate

• Enhanced Capacity of Conjugate To Bind Specific Antibody In

The Absence of Irrelevant IgG

Sample Delivery For All Sample Types ImprovedBlood, Serum, Oral Fluid, Sputum, Feces & Urine

Multiple Parameter Tests More Feasible Due to Independent & Simultaneous Delivery Of Sample

For example: Serological Test For Multiple Disease (HIV, TB, Syphilis, HCV); Confirmatory Test For HIV (P24, Gp41, Gp120, Gp160, Gp36)

Improvement Over Antigen Detection Tests That Use Complex Sandwich System

Such As Strepavidin/Biotin Or Rapid PCR Test (Flu/RSV, Cardiac Marker, Bio Defense)

Freedom to Operate

Chembio DPP™ Technology - Advantages

Dual Path Platform (DPP®) Technology

WHOLE BLOOD

ORAL FLUID

IN USE : DOMINICA & ST KITTS AND NEVIS

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Test Line Control Line

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S2 strip

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DPP™ HIV 1/2

DPP HCV/HIV/Syphilis Assay

1 2 3 C

1- HCV

2- Syphilis

3- HIV

C- Control

HCV, HIV and Syphilis

Positive

1

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See animation for DPP HIV1/2 screen

Chembio-Branded Public Health Base

Complemented by OEM and License Programs

17

Current OEM/Licensees

Anticipated OEM/License Areas

Talita FrancoInternational Business Consultant

Chembio Diagnostic Systems Inc

Tel/Fax:+1(951)239-3139

E.mail: LatAmSales@chembio.com

Skype: tsallesusa

Homepage: www.chembio.com