The CLIA waived, DPP® HIV 1/2 Assay for fingerstick or venous whole blood and oral fluid was developed by Chembio Diagnostic Systems, Inc. on its patented, Next Generation DPP™ point-of-care (POC) diagnostic platform. This innovative immunochromatographic-based technology, called Dual Path Platform or DPP®, offers significant advantages over single-path lateral flow, including the ability to detect multiple analytes on a single cassette, run a variety of sample types, and deliver improved sensitivity and specificity.
On the primary flow path of DPP® devices, the sample migrates toward the immobilized immunoreagents on the horizontal strip that captures the analyte of interest, if present. Following a brief incubation to maximize analyte binding efficiency, the detector nanoparticles are released from the conjugate pad via the secondary flow path. This sequential approach resembles the traditional ELISA assay process and minimizes the potential of the prozone, or “hook,” effect.
DPP® addresses the intrinsic limitations of multiplexing by use of separate buffers for individual analyte detection. For example, Chembio’s DPP® HIV-Syphilis Assay detects antibodies to HIV 1/2 and Treponema pallidum (the causative agent of syphilis) in fingerstick or venous whole blood, serum, and plasma. This test can lead to rapid, simultaneous, independent diagnosis of two infectious diseases that have high rates of co-infection. Screening allows clinicians to streamline operations, identify infected patients, and begin treatment earlier in the course of disease, potentially improving outcomes and avoiding the health consequences that may occur in later stages. Treatment also reduces the likelihood of spread to others. Screening and early detection are keys to averting costs associated with disease progression and long-term complications.
Currently, the DPP® HIV-Syphilis Assay is approved in Mexico and Brazil with other worldwide and U.S. registrations pending.
Chembio also has unique expertise in completing and executing technology transfer agreements in the international market for rapid tests. This has resulted in agreements with Bio-Rad Laboratories, Bio-Manguinhos, RVR Diagnostics, and Labtest Diagnostica SA to establish cost-effective local public health programs.