Sophisticated HIV diagnostics adapted for remote areas

PUBLIC RELEASE DATE:

1-Dec-2014

Contact: Margot Kern nibibpress@mail.nih.gov 301-496-3500 NIH/National Institute of Biomedical Imaging & Bioengineering

Diagnosing HIV and other infectious diseases presents unique challenges in remote locations that lack electric power, refrigeration, and appropriately trained health care staff. To address these issues, researchers funded by the National Institutes of Health (NIH) have developed a low-cost, electricity-free device capable of detecting the DNA of infectious pathogens, including HIV-1. The device uses a small scale chemical reaction, rather than electric power, to provide the heat needed to amplify and detect the DNA or RNA of pathogens present in blood samples obtained from potentially infected individuals.

"This highly creative technical solution brings sophisticated molecular diagnostics to underserved populations and represents a potentially groundbreaking advance in global health care for HIV as well as tuberculosis and malaria, which remain significant health challenges in many remote areas," said Roderic Pettigrew, Ph.D., M.D., director of the National Institute of Biomedical Imaging and Bioengineering (NIBIB) at NIH.

The work was performed by a team at the Seattle-based global health non-profit PATH, led by Paul LaBarre, senior technical officer, and is reported in the Nov. 26 issue of PLOS ONE. The core technology they developed and continue to improve is a system known as NINA, for non-instrumental nucleic acid amplification. The goal is to expand access to accurate diagnostics wherever they are needed, especially those areas that lack reliable electricity.

Early on-site diagnosis allows immediate treatment

LaBarre explains the problem their research endeavors to address. "In low-resource settings, the lack of on-site molecular diagnostic testing is a barrier to the control of infectious diseases. The need to transport the samples from local sites to a distant central diagnostic facility results in delays, lost results, and increased costs." One of the biggest problems, he says, is loss to follow-up, where individuals who have provided samples may fail to return to the local clinic, and therefore will not receive treatment if their test result indicates they are infected. Given these significant impediments to effective disease control, the goal of the NINA technology is to enable on-site point of care (POC) testing and subsequent treatment regardless of the available infrastructure.

A critical feature of the nucleic acid test is the ability to detect infection at very early stages. The currently available test sold over the counter is antibody-based, and cannot detect HIV until antibodies to the pathogen are produced by the body, which can take as long as several months after infection. The PATH method can detect HIV in the early stage of the disease, when the patient can be most infectious. Early detection is essential for POC medicine, where the goal is to diagnose infection and begin treatment in a single visit to the local clinic. For testing babies born to HIV-positive mothers, a nucleic acid-based test must be used because the mother's antibodies in the baby's blood can result in false positives.

Addressing the challenge one idea at a time

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Sophisticated HIV diagnostics adapted for remote areas