poct innovations dual path platform (dpp®) technology · poct –innovations dual path platform...
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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
Ag1
Ag2
Ag3
No
n H
IV a
ntib
od
ies
HIV
an
tib
od
ies
gold
goldgold
gold
gold
Test Line Control Line
S1 strip
S2 strip
PAPA
PAPA
PAPA
PAPA
PAPA
PAPA
PA
PA
PA
PA
PA
PA
PA
PA
PA
PA
PA
PA
PAPA
PA
PA
PAPA
PA
PAPA
gold
gold
gold
gold
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Antibodies
in sample
Pro
tein
A g
old
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nju
gate
PA
= P
rote
in AH
IV A
ntig
en
s
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
H
I
V
2
H
C
V
3
S
Y
P
H
I
L
I
S
4
C
O
N
T
R
O
L
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: [email protected]
Skype: tsallesusa
Homepage: www.chembio.com