Igf::ot::igf a Magnetic Microparticle Kit for Cell Removal From Blood

Period of Performance: 08/18/2015 - 08/17/2016

$225K

Phase 1 SBIR

Recipient Firm

Luna Innovations, Inc.
301 1st St Suite 200
Roanoke, VA 24011
Principal Investigator

Abstract

The rollout of antiretroviral therapy (ART) in resource-limited countries has resulted in substantial reductions in mortality and morbidity due to HIV. While ART regimens are very potent and reduce viral load (measured as HIV RNA copies/ml of plasma) to undetectable levels, virological failure still occurs in some patients. In most resource-limited settings, viral load measurement is not used to routinely monitor patients for virological failure due to cost and complexity of the test. Therefore, many patients are not switched to a second line therapy regimen in a timely manner, which can contribute to drug resistance, and many others are being switched unnecessarily to more costly treatment regimens. For this reason, current WHO recommendations include the use of viral load testing where feasible to monitor patients on ART for virological failure. Over the next several years, the use of viral load testing is expected to increase dramatically, with much of the increase due to new, simple viral load tests that can be performed at the point of care (POC). Whole blood contains both HIV RNA in plasma, as well as HIV RNA and DNA in peripheral blood mononuclear cells (PBMCs). This can cause inaccuracies in the test results, especially at the lower end of the linear range of the test, where the HIV RNA and DNA in cells can constitute a high proportion of the total HIV signal in the blood sample. A simple, inexpensive method for removing cells from very small amounts of blood is needed for use with POC HIV viral load assays. Removal of the cells must be performed very quickly in one step at the POC, without the need for electricity, and the resulting plasma must provide accurate and reproducible results in POC viral load assays. The goal of this solicitation is to develop an inexpensive, easy to use process that will remove cells from finger stick blood samples (approximately 500 ul) prior to use in POC viral load assays.