poct innovation dpp
TRANSCRIPT
POCT – InnovationsDual Path Platform (DPP®)
TechnologyDr.Talita Franco – Business Development Consultant
www.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, NigeriaJournal 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 InterventionHIV antibodies in Blood Oral FluidSensitivity & Specificity of DPP
ConfirmatoryDetermineWestern Blot ( Discordant Cases)
Total = 645 Patients National Hospital Abuja, Nigeria
Fall 2009Chembio DPP® HIV 1/2 Screening Assay
Oral Fluid & Fingerstick Blood
228Low Risk
215 HIV Pos
202 High Risk
SENSITIVITY SPECIFICITY
Oral Fluid = 100%Fingertip Blood = 100%
Oral Fluid = 100%Fingertip Blood = 99.5%
Oral Fluidn=645
Fingertip Bloodn=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
SWABORAL FLUID
FINGERPRINTSTICKWHOLE BLOOD
SAMPLING
PHLEBOTOMYWHOLE BLOOD
SERUMPLASMA
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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Ag3
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ies
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ntigens
DPP™ HIV 1/2
DPP HCV/HIV/Syphilis Assay
1 2 3 C
1- HCV2- Syphilis3- HIVC- Control
HCV, HIV and Syphilis Positive
1
HIV
2
HCV
3
SYPHILIS
4
CONTROL
See animation for DPP HIV1/2 screen
Chembio-Branded Public Health Base Complemented by OEM and License Programs
17
FIOCRUZ(BRAZIL)
BIORAD
INFECTIOUS DISEASES
VETERINARY
HIV SCREEN
HCV AB-AG DUAL DPP INFLUENZASYPHILIS
Current OEM/Licensees
Anticipated OEM/License Areas
Talita FrancoInternational Business ConsultantChembio Diagnostic Systems Inc
Tel/Fax:+1(951)239-3139 E.mail: [email protected] Skype: tsallesusa Homepage: www.chembio.com