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POCT – Innovations Dual Path Platform (DPP®) Technology Dr.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, Nigeria Journal Diagnostic Microbiology  & Infection Disease
ORAL FLUID  -  HIV/AIDS IN NIGERIA FACTS & NEEDS Endemic +  Stigmatization Reliable rapid testing kits  & Procedure Increase uptake of services STUDY AIM 2004/2005 – False  Positive  -  CDC Intervention HIV antibodies in Blood            Oral Fluid Sensitivity & Specificity of  DPP Confirmatory Determine Western Blot ( Discordant Cases)
228 Low Risk 215 HIV Pos 202 High Risk Total = 645 Patients  National Hospital  Abuja, Nigeria Fall 2009 ChembioDPP® HIV 1/2 Screening Assay Oral Fluid & Fingerstick Blood SPECIFICITY SENSITIVITY Oral Fluid = 100% Fingertip Blood = 99.5% Oral Fluid = 100% Fingertip Blood = 100%
Table 1:  Oral Fluid and Whole Blood Study – Nigeria, 2009 1Confirmation performed by reference test and / or Western Blot
SAMPLING FINGERPRINTSTICK WHOLE BLOOD PHLEBOTOMY WHOLE BLOOD SERUM PLASMA SWAB ORALFLUID
Single Path Lateral Flow                    Evolution             Innovation Experience
 POCT ImprovementDPP 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
ChembioDPP™ Technology -  Advantages Analytical & Clinical  Sensitivity  > 10 X Conventional Lateral Flow  ,[object Object]
Increased Efficiency of Binding Antibody To Immobilized Test          Antigen In The Absence Of Competing Conjugate ,[object Object],         The Absence of Irrelevant IgG Sample Delivery For All Sample Types Improved Blood, 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
Dual Path Platform (DPP®) Technology ORAL FLUID WHOLE BLOOD IN USE :  DOMINICA  & ST KITTS AND NEVIS
DPP™ HIV 1/2 Test Line Control Line PA PA PA PA PA PA gold gold PA PA Ag1  gold PA PA PA gold PA PA PA PA PA PA Ag2 PA = Protein A gold gold Non HIV antibodies HIV antibodies Protein A gold conjugate PA PA HIV Antigens PA PA PA gold PA PA PA PA PA PA gold Ag3  gold PA gold PA PA PA PA S2 strip S1 strip Antibodies in sample
DPP HCV/HIV/Syphilis Assay  1    2     3   C 1- HCV 2- Syphilis 3- HIV C- Control HCV, HIV and Syphilis Positive
See animation for DPP HIV1/2 screen
Chembio-Branded Public Health Base Complemented by OEM and License Programs Current OEM/Licensees Anticipated OEM/License Areas FIOCRUZ(BRAZIL) INFECTIOUS DISEASES  BIORAD VETERINARY HIV SCREEN HCV  AB-AG DUAL DPP INFLUENZA SYPHILIS 17

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POCT Innovation Dpp

  • 1. POCT – Innovations Dual Path Platform (DPP®) Technology Dr.Talita Franco – Business Development Consultant www.chembio.com
  • 2. 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
  • 3. National Hospital Abuja, Nigeria Journal Diagnostic Microbiology & Infection Disease
  • 4. ORAL FLUID - HIV/AIDS IN NIGERIA FACTS & NEEDS Endemic + Stigmatization Reliable rapid testing kits & Procedure Increase uptake of services STUDY AIM 2004/2005 – False Positive - CDC Intervention HIV antibodies in Blood Oral Fluid Sensitivity & Specificity of DPP Confirmatory Determine Western Blot ( Discordant Cases)
  • 5. 228 Low Risk 215 HIV Pos 202 High Risk Total = 645 Patients National Hospital Abuja, Nigeria Fall 2009 ChembioDPP® HIV 1/2 Screening Assay Oral Fluid & Fingerstick Blood SPECIFICITY SENSITIVITY Oral Fluid = 100% Fingertip Blood = 99.5% Oral Fluid = 100% Fingertip Blood = 100%
  • 6. Table 1: Oral Fluid and Whole Blood Study – Nigeria, 2009 1Confirmation performed by reference test and / or Western Blot
  • 7. SAMPLING FINGERPRINTSTICK WHOLE BLOOD PHLEBOTOMY WHOLE BLOOD SERUM PLASMA SWAB ORALFLUID
  • 8. Single Path Lateral Flow Evolution Innovation Experience
  • 9. POCT ImprovementDPP 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
  • 10.
  • 11.
  • 12. Dual Path Platform (DPP®) Technology ORAL FLUID WHOLE BLOOD IN USE : DOMINICA & ST KITTS AND NEVIS
  • 13. DPP™ HIV 1/2 Test Line Control Line PA PA PA PA PA PA gold gold PA PA Ag1 gold PA PA PA gold PA PA PA PA PA PA Ag2 PA = Protein A gold gold Non HIV antibodies HIV antibodies Protein A gold conjugate PA PA HIV Antigens PA PA PA gold PA PA PA PA PA PA gold Ag3 gold PA gold PA PA PA PA S2 strip S1 strip Antibodies in sample
  • 14. DPP HCV/HIV/Syphilis Assay 1 2 3 C 1- HCV 2- Syphilis 3- HIV C- Control HCV, HIV and Syphilis Positive
  • 15.
  • 16.
  • 17. See animation for DPP HIV1/2 screen
  • 18. Chembio-Branded Public Health Base Complemented by OEM and License Programs Current OEM/Licensees Anticipated OEM/License Areas FIOCRUZ(BRAZIL) INFECTIOUS DISEASES BIORAD VETERINARY HIV SCREEN HCV AB-AG DUAL DPP INFLUENZA SYPHILIS 17
  • 19. Talita Franco International Business Consultant Chembio Diagnostic Systems Inc Tel/Fax:+1(951)239-3139 E.mail: LatAmSales@chembio.com Skype: tsallesusa Homepage: www.chembio.com