DAKTARI DIAGNOSTICS, INC. — Department of Health and Human Services SBIR Phase II: NIAID

Description

Project Summary HIV remains a global health crisis more than million people died from the disease in While there has been significant progress in the last ten years more than million people currently receive effective antiretroviral therapy ART worldwide our ability to monitor and provide high quality care to HIV AIDS patients is still limited in part by the available diagnostics tools High quality diagnostic tools are available in the U S and developed nations However while the advent of rapid HIV diagnostic tests RDTs has catalyzed an increase in case finding rates ultimately increasing the number of people on ART low and middle income countries still suffer from the lack of simple affordable diagnostic tests to monitor treatment efficacy by measuring the amount of circulating virus Determining viral load the count of virions in the blood is critical to the determination of treatment failure due to either drug resistant strains of virus or patient non compliance Viral load testing is also critical to diagnosing infants for whom antibody tests are not sufficient Most molecular biology based tests generally using PCR are to date complex and out of reach in most global health settings The Daktari HIV VL test will build upon Daktariandapos s existing platform of POC diagnostic tests which are designed for global health environments rugged portable battery powered and with built in connectivity for secure data transmission Specifically the Daktari HIV VL test will be based on Daktariandapos s ViPr platform designed to detect circulating proteins and virions directly from whole blood The test requires a small volume of whole blood which can be drawn via fingerstick by a minimally trained healthcare worker and returns results in minutes allowing clinical decisions to be made immediately All the necessary sample preparation steps are incorporated into the automated assay eliminating hands on steps for the user The first product in the Daktari ViPr platform is a Hepatitis C HCV Viral Load Test which is well into the development phase The principle of operation of the HIV Viral Load is analogous to that of the HCV product First HIV virions are extracted from whole blood using magnetic particles which concentrate the purified virions into a small volume Next the virions are treated with lysis buffer to release the target analyte p protein and the amount of released p protein is quantified using a sandwich immunoassay that employs silver nanoparticles as the label Finally the amount of silver bound is measured using anodic stripping voltammetry At this time we have finished the proof of concept work to de risk the program ability to pull down HIV virions from blood at high efficiency and a fM limit of detection for p and have demonstrated feasibility of detecting and quantifying HIV virions from HIV samples The HIV VL program is ready to enter the development phase In this Direct to Phase II proposal we will first optimize HIV specific reagents and will combine all assay steps to show that the assay provides the required limit of detection of copies mL when starting from whole blood samples Next we will integrate the HIV VL assay into the Daktari ViPr platform cartridge and instrument Finally we will evaluate performance of the integrated HIV ViPr Viral Load system in a small field study at our Kenyan site The final deliverable of this Phase II program is a prototype HIV Viral Load system capable of quantification of HIV viral loads directly from L of whole blood and with andgt sensitivity to detect viral loads andgt copies mL and a andgt CV at copies mL Project Narrative A simple point of care diagnostic for quantifying HIV viral load is vital for monitoring over million individuals infected with HIV as well as for accurately diagnosing infants born to HIV infected mothers particularly in low resource settings in Africa Current technologies are either too large and expensive for point of care use or are not quantitative or accurate enough for clinical use We propose to adapt Daktariandapos s viral protein detection technology to develop a sensitive low cost rapid point of care HIV viral load test for use in global health settings worldwide