A Rapid Portable HIV Detection and Monitoring System for Low Resource Settings

Period of Performance: 08/01/2015 - 07/31/2016

$887K

Phase 2 SBIR

Recipient Firm

Thermal Gradient, Inc.
Fairport, NY 14450
Principal Investigator

Abstract

DESCRIPTION (provided by applicant): Rapid, Portable HIV Detection and Monitoring System The long term objectives of this project are: 1. Develop a prototype of a rapid portable instrument for detecting and measuring the amount of Human Immunodeficiency Viruses (HIV's) in samples of patient blood, particularly in low resource settings. 2. Carry out a pilot study to establish the effectiveness and comparative performance of the instrument against an established reference system. The aim is to provide clinicians tools to diagnose and monitor HIV that exist in resource abundant settings but are not readily available in low resource settings. In particular, the instrument system will provide clinicians with detection methods that could be helpful in identifying acute HIV-1, early diagnosis of infection in pregnant women and infants, monitoring viral load following treatment and monitoring for the emergence of antiretroviral resistance. Viral load monitoring of patients on antiretrovirals is a good example of the difference in treatment between resource abundant and low resource settings. Routinely done in the former because of the threat to patients and community should they develop a drug resistant strain of HIV, millions of recipients of antiretroviral therapy currently are not being monitored de to its cost and complexity. These aims are congruent with those parts of the mission of DAIDS to bring an end to the HIV/AIDS epidemic by ... supporting the advancement of therapies for HIV infection and its complications.... This project will achieve its stated goals by completing the design of a compact, portable system based on the ultra-fast Thermal Gradient real-time PCR and nucleic acid sample preparation technologies developed in the original R44 089389 grant. They will be combined in an integrated test cartridge capable of carrying out a viral load test in 33 minutes and a multi-color fluorescent imaging system will be developed to measure the real time PCR output simultaneously. Finally, the performance of the system (instrument, cartridge and assay) will be validated, first in internal tests using prepared blood samples and then a significant pilot study.