PATENTED* DUAL PATH PLATFORM
(DPP®) TECHNOLOGY

*United States Patent #7,189,522 issued March 2007.
Patent protection is also are pending  in several foreign jurisdictions worldwide

CHEMBIO has developed a new and innovative chromatographic immunoassay technology--Dual Path Platform (DPP®)--for rapid, point-of-care diagnostic testing of a wide variety of analytes.  This technology offers significant advantages over  Lateral Flow (LF) technology.

DPP® Video Files
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CORPORATE COMMENTS:
Javan Esfandiari, Senior Vice President of R&D jesfandiari@chembio.com commented that “The independent flow paths of DPP®  sample and conjugate assays increase the efficiency of antibody binding to the immobilized antigen. This has resulted in improved sensitivity in several different assays Chembio’s R&D team is currently developing. The sample delivery efficiency for all samples has been substantially improved via DPP®. This will facilitate the development of new rapid tests using oral fluid, for example.”

DPP® TECHNOLOGICAL ADVANTAGES :

• Significantly increased analytical and clinical sensitivity.
  • DPP® HIV rapid tests results show substantially improved sensitivity, from 10-50X more sensitive than LF!
  • Independent migration paths for the sample and conjugate account for this increased sensitivity coupled with a more effective binding of the analyte to the binding site in the test zone prior to the reaction of the conjugated marker with the test zone complex.
• Decreased overall assay interaction time – It’s Faster!
  • DPP® can use either dry or liquid conjugate systems.
  • Samples such as blood, feces, and saliva are known to migrate very slowly in conventional LF assays but with separate and independent migration paths sorbent material may be utilized to permit faster migration without the concern for the conjugate migration requirements.
  • Speed of DPP® assays are enhanced, as well as sensitivity, due improved background clearance from better uniformity and consistency of migrating conjugate particles in the absence of the sample particles.
• DPP® is able to effectively resolve normal aggregation/agglutination migratory issues, a common concern  in LF assays with large particle analytes (e.g., bacteria):
  • In DPP®, the bacterial samples (after filtering) are applied directly to the test site and immobilized while the marker conjugate is free to migrate without the sample to the test zone.
  • This approach allows DPP assays to be extremely sensitive and specific.
• Enhanced multiplex capability with independent and simultaneous delivery of samples!
  • DPP® provides multiple analyte results with a high degree of sensitivity without compromising specificity due to cross-reactivity as is common in other LF methods.
  • Analytes able to migrate independently without the conjugate and reach the test zone independently and are thus able to bind equally so that the same level of sensitivity is maintained across all different analytes (e.g., HIV&TB, or HIV 1/2, etc.).
  • Easier to read results due to the fact that  different colored latex particles can be used to conjugate different antigens or antibodies provided in the conjugated pad or in the buffer solution.
  • Up to 5 test lines per cassette.
• Easier and more user friendly test procedure:
  • DPP reduces the time to results when compared to conventional LF by providing a visual color at the test site for the user to note when it disappears that then it is time to add the buffer at the test site rather than wait for a predetermined amount of time after adding the sample to add the buffer solution to the assay.
• Adaptable to multiple sample types:
  • Able to run different types of body fluids including: blood, serum, oral fluids, sputum, urine, feces, etc. and  still maintain a high level of sensitivity.
  • Able to provide highly sensitive and specific results while using minimal sample volumes.
  • Able to test for the presence of any ligand.
• Diverse potential applications for DPP®!
  • DPP® has potential applicability in a multitude of diverse applications where LF intellectual property restrictions combine with the need to provide faster and more accurate results coupled with the feasibility of expanding a multiplexed test parameter, such as:
    • Medical Diagnostics
    • Consumer OTC Diagnostics
    • Animal Health & Veterinary Diagnostics
    • Food Safety & Pathogen Screening
    • Environmental Sample Screening
    • Bioterrorism
    • Forensic Detection
    • Other Unique Agricultural & Industrial Uses

 DPP® CORPORATE BUSINESS STRATEGY:

Chembio has completed several new products and others in development utilizing its new DPP® technology.  These products include single analyte, multiplex and confirmatory assays for a number of infectious diseases includ.  TB, and other infectious diseases. These studies confirm the advantages of DPP® technology over single-path LF designs commonly employed in today’s rapid diagnostic assays. In March 2005, Chembio announced that it had filed a series of patent applications with the United States Patent and Trademark Office (USPTO) regarding the DPP® technology, and since then, has filed in several other foreign jurisdictions worldwide. In March 2007, Chembio was issued United States Patent Number 7,189,522 for its Dual Path Immunoassay device. Additional patent protection is pending in the US and worldwide. Chembio plans to develop new assays using DPP and is actively pursuing licensing agreements with several interested companies. Lawrence Siebert, President & CEO of Chembio, commented, “We believe that our Dual Path Platform is an extremely valuable technology and that we will be able to both develop new tests using the technology as well as license the technology to other companies interested in using this innovation in their test applications.”

For more information regarding this technology contact the following CHEMBIO DPP® representatives:

Research & Development:

Javan Esfandiari,
Senior VP, Research & Development
jesfandiari@chembio.com

Tel. No. (631)-924-1135 Ext. 112
Fax No. (631)-924-6033