POCT – Innovations<br />Dual Path Platform (DPP®) Technology<br />Dr.Talita Franco – Business Development Consultant<br />...
National Institutes of Health –NIH<br />Centers for Disease Control & Prevention-CDC<br />The Foundation for Innovative &N...
National Hospital  Abuja, Nigeria<br />Journal Diagnostic Microbiology  & Infection Disease<br />
ORAL FLUID  -  HIV/AIDS IN NIGERIA<br />FACTS & NEEDS<br />Endemic +  Stigmatization<br />Reliable rapid testing kits  & P...
228<br />Low Risk<br />215<br />HIV Pos<br />202<br />High Risk<br />Total = 645 Patients <br />National Hospital  Abuja, ...
Table 1:  Oral Fluid and Whole Blood Study – Nigeria, 2009<br />1Confirmation performed by reference test and / or Western...
SAMPLING<br />FINGERPRINTSTICK<br />WHOLE BLOOD<br />PHLEBOTOMY<br />WHOLE BLOOD<br />SERUM<br />PLASMA<br />SWAB<br />ORA...
Single Path Lateral Flow<br />                   Evolution<br />            Innovation<br />Experience<br />
 POCT ImprovementDPP<br />Increased analytical and clinical sensitivity <br />Outside the standard lateral flow <br />Less...
ChembioDPP™ Technology -  Advantages<br />Analytical & Clinical  Sensitivity  > 10 X Conventional Lateral Flow <br /><ul><...
Increased Efficiency of Binding Antibody To Immobilized Test </li></ul>         Antigen In The Absence Of Competing Conjug...
Dual Path Platform (DPP®) Technology<br />ORAL FLUID<br />WHOLE BLOOD<br />IN USE :  DOMINICA  & ST KITTS AND NEVIS<br />
DPP™ HIV 1/2<br />Test Line<br />Control Line<br />PA<br />PA<br />PA<br />PA<br />PA<br />PA<br />gold<br />gold<br />PA<...
DPP HCV/HIV/Syphilis Assay<br /> 1    2     3   C<br />1- HCV<br />2- Syphilis<br />3- HIV<br />C- Control<br />HCV, HIV a...
See animation for DPP HIV1/2 screen<br />
Chembio-Branded Public Health Base Complemented by OEM and License Programs<br />Current OEM/Licensees<br />Anticipated OE...
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POCT Innovation Dpp

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POCT Innovation Dpp

  1. 1. POCT – Innovations<br />Dual Path Platform (DPP®) Technology<br />Dr.Talita Franco – Business Development Consultant<br />www.chembio.com<br />
  2. 2. National Institutes of Health –NIH<br />Centers for Disease Control & Prevention-CDC<br />The Foundation for Innovative &Novel Diagnostics- FIND<br />The Infectious Disease Research Institute-IDRI<br />The Pan American Health Organization-PAHO<br />World Health Organization-WHO<br />Fundação Oswaldo Cruz– FIOCRUZ <br />Guidelines + Standards+ Colaboration = Sucess<br />
  3. 3. National Hospital Abuja, Nigeria<br />Journal Diagnostic Microbiology & Infection Disease<br />
  4. 4. ORAL FLUID - HIV/AIDS IN NIGERIA<br />FACTS & NEEDS<br />Endemic + Stigmatization<br />Reliable rapid testing kits & Procedure<br />Increase uptake of services<br />STUDY AIM<br />2004/2005 – False Positive - CDC Intervention<br />HIV antibodies in Blood Oral Fluid<br />Sensitivity & Specificity of DPP<br />Confirmatory<br />Determine<br />Western Blot ( Discordant Cases)<br />
  5. 5. 228<br />Low Risk<br />215<br />HIV Pos<br />202<br />High Risk<br />Total = 645 Patients <br />National Hospital Abuja, Nigeria<br />Fall 2009<br />ChembioDPP® HIV 1/2 Screening Assay<br />Oral Fluid & Fingerstick Blood<br />SPECIFICITY<br />SENSITIVITY<br />Oral Fluid = 100%<br />Fingertip Blood = 99.5%<br />Oral Fluid = 100%<br />Fingertip Blood = 100%<br />
  6. 6. Table 1: Oral Fluid and Whole Blood Study – Nigeria, 2009<br />1Confirmation performed by reference test and / or Western Blot<br />
  7. 7. SAMPLING<br />FINGERPRINTSTICK<br />WHOLE BLOOD<br />PHLEBOTOMY<br />WHOLE BLOOD<br />SERUM<br />PLASMA<br />SWAB<br />ORALFLUID<br />
  8. 8. Single Path Lateral Flow<br /> Evolution<br /> Innovation<br />Experience<br />
  9. 9. POCT ImprovementDPP<br />Increased analytical and clinical sensitivity <br />Outside the standard lateral flow <br />Less labor intensive than EIA, PCR or WB <br />Potential ideal confirmatory test <br />Adaptable to multiple sample types: blood serum, oral fluid, sputum urine, feces, etc. <br />Multiplex capability through elimination of aggregation issues (ie HIV/TB, HIV 1/ 2, etc.) <br />Requires minimal sample volume <br />Long shelf life (up to 24 months) <br />Total test time < 20 minutes <br />Ideally suited for POC testing <br />
  10. 10. ChembioDPP™ Technology - Advantages<br />Analytical & Clinical Sensitivity > 10 X Conventional Lateral Flow <br /><ul><li>Independent Flow Path for Sample and Conjugate
  11. 11. Increased Efficiency of Binding Antibody To Immobilized Test </li></ul> Antigen In The Absence Of Competing Conjugate<br /><ul><li>Enhanced Capacity of Conjugate To Bind Specific Antibody In </li></ul> The Absence of Irrelevant IgG<br />Sample Delivery For All Sample Types Improved<br />Blood, Serum, Oral Fluid, Sputum, Feces & Urine<br />Multiple Parameter Tests More Feasible Due to Independent & Simultaneous Delivery Of Sample <br />For example: Serological Test For Multiple Disease (HIV, TB, Syphilis, HCV); Confirmatory Test For HIV (P24, Gp41, Gp120, Gp160, Gp36)<br /> Improvement Over Antigen Detection Tests That Use Complex Sandwich System <br />Such As Strepavidin/Biotin Or Rapid PCR Test (Flu/RSV, Cardiac Marker, Bio Defense)<br />Freedom to Operate<br />
  12. 12. Dual Path Platform (DPP®) Technology<br />ORAL FLUID<br />WHOLE BLOOD<br />IN USE : DOMINICA & ST KITTS AND NEVIS<br />
  13. 13. DPP™ HIV 1/2<br />Test Line<br />Control Line<br />PA<br />PA<br />PA<br />PA<br />PA<br />PA<br />gold<br />gold<br />PA<br />PA<br />Ag1 <br />gold<br />PA<br />PA<br />PA<br />gold<br />PA<br />PA<br />PA<br />PA<br />PA<br />PA<br />Ag2<br />PA = Protein A<br />gold<br />gold<br />Non HIV antibodies<br />HIV antibodies<br />Protein A gold conjugate<br />PA<br />PA<br />HIV Antigens<br />PA<br />PA<br />PA<br />gold<br />PA<br />PA<br />PA<br />PA<br />PA<br />PA<br />gold<br />Ag3 <br />gold<br />PA<br />gold<br />PA<br />PA<br />PA<br />PA<br />S2 strip<br />S1 strip<br />Antibodies<br />in sample<br />
  14. 14. DPP HCV/HIV/Syphilis Assay<br /> 1 2 3 C<br />1- HCV<br />2- Syphilis<br />3- HIV<br />C- Control<br />HCV, HIV and Syphilis Positive<br />
  15. 15.
  16. 16.
  17. 17. See animation for DPP HIV1/2 screen<br />
  18. 18. Chembio-Branded Public Health Base Complemented by OEM and License Programs<br />Current OEM/Licensees<br />Anticipated OEM/License Areas<br />FIOCRUZ(BRAZIL)<br />INFECTIOUS DISEASES <br />BIORAD<br />VETERINARY<br />HIV SCREEN<br />HCV AB-AG DUAL DPP<br />INFLUENZA<br />SYPHILIS<br />17<br />
  19. 19. Talita Franco<br />International Business Consultant<br />Chembio Diagnostic Systems Inc<br /> Tel/Fax:+1(951)239-3139<br />E.mail: LatAmSales@chembio.com<br />Skype: tsallesusa<br />Homepage: www.chembio.com<br />

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