POCT Innovation Dpp
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Transcript of POCT Innovation Dpp
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
Ag1
Ag2
Ag3
Non H
IV antibodiesHIV
ant
ibod
ies
gold
goldgold
gold
gold
Test Line Control Line
S1 strip
S2 strip
PAPAPAPA
PAPA
PAPA
PAPA
PAPA
PAPA
PA
PA
PA
PA
PA
PA
PA
PA
PA
PA
PAPA
PA
PA
PAPA
PA
PAPA
gold
gold
gold
gold
gold
Antibodiesin sample
Prot
ein
A go
ld c
onju
gate
PA =
Pro
tein
AHIV A
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