The ultimate aim of this project is to develop a CE-marked and/or FDA-approved diagnostic platform for viral load monitoring of HIV-1 infected patients in point-of-care (POC) and resource- limited settings. Currently available viral load tests are not suitable for such settings due to their inherent high cost, complexity and size, thus patients, especially in the developing world, are often not monitored for treatment efficacy. However, estimation of viral load in HIV-1 patients receiving anti-viral treatment (ART) is considered the best marker for the initiation and monitoring of ART. Diagnostics for the Real World (DRW) has developed a POC platform called SAMBA (Simple AMplification Based Assay) and proposed to develop a SAMBA HIV-1 semi-quantitative viral load test for plasma and whole blood samples. This semi-quantitative test will distinguish patients with viral loads above or below a predetermined clinically relevant cut-off to aid clinicians to monitor non-compliance, treatment efficacy or treatment failure due to the development of resistance. This Phase I proposal is to further develop and optimize the chemistry for plasma and low volume whole blood samples, and assess the proposed 1,000 copies/ml cut-off with in-house testing of clinical samples. The assay and the validity of the cut-off at 1,000 copies/ml will also be evaluated in-house in whole blood samples, to be followed by a field trial in Malawi in samples from patients under going ART. Confidential information: patent application in process

Public Health Relevance

A simple, high-performance, inexpensive nucleic acid-based point-of-care test for the measurement of HIV-1 viral level is being developed to enable clinicians to monitor treatment efficacy in infected patients. The results will guide clinicians to effectively dispense the appropriate anti- retroviral therapy in case treatment failure results from lack of compliance or resistance to therapy. This test is particularly appropriate for decentralized testing in sub-Saharan African countries where resources are limited and HIV prevalence is high. Rapid, on-site availability of a viral load monitoring assay is expected to reduce significantly the turn-around time from sample to result and hence loss-to- follow-up, therefore increasing the efficacy of anti-viral therapy. The test can also be useful in certain developed country settings where test throughput is low or when rapid turnaround of the results is needed. Confidential information: patent application in process

National Institute of Health (NIH)
National Institute of Allergy and Infectious Diseases (NIAID)
Small Business Innovation Research Grants (SBIR) - Phase I (R43)
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Special Emphasis Panel (ZRG1-AARR-E (11))
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Fitzgibbon, Joseph E
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Diagnostics for the Real World, Ltd
United States
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