Single POC test detecting HIV antibodies, viral RNA in development

The NIH has awarded $335,000 to the New York University College of Dentistry for the development of a single point-of-care test able to detect HIV/AIDS antibodies and viral RNA from one specimen, according to a press release.

The funding is part of a $1.5 million Small Business Innovation Research Phase II grant previously awarded to Rheonix, Inc., a medical technology company that specializes in automated and customized molecular diagnostic devices.

“Current HIV corroborative testing requires considerable time and cost, and is often not available in remote geographic areas,” Daniel Malamud, PhD, professor of basic science and craniofacial biology and director of the HIV/AIDS Research Program at NYUCD, said in the press release. “As a result, many individuals with a positive antibody screening test opt out of taking the corroborative test. Our research aims to address this problem through the development of an affordable, easy to use POC test, capable of detecting pathogen nucleic acids and antibodies to the pathogens in less than one hour.”

Malamud and colleagues will work with Rheonix and utilize the company’s CARD cartridge system, a disposable card that holds and splits a sample of blood or saliva into two portions. Within 7 minutes, one portion of the sample runs off onto a strip to test for HIV antibodies while the other goes through an isothermal process of nucleic acid isolation and amplification, according to the release.

So far, the team has tested hundreds of samples, but for the device to be approved they will need to test thousands, Malamud said in the release.

“I’m reasonably confident that within 18 months we will have a finished product, which will allow an individual to collect a sample, insert it into the CARD, push a button, and, within 1 hour, have an accurate test result,” he said.

The NIH has awarded $335,000 to the New York University College of Dentistry for the development of a single point-of-care test able to detect HIV/AIDS antibodies and viral RNA from one specimen, according to a press release.

The funding is part of a $1.5 million Small Business Innovation Research Phase II grant previously awarded to Rheonix, Inc., a medical technology company that specializes in automated and customized molecular diagnostic devices.

“Current HIV corroborative testing requires considerable time and cost, and is often not available in remote geographic areas,” Daniel Malamud, PhD, professor of basic science and craniofacial biology and director of the HIV/AIDS Research Program at NYUCD, said in the press release. “As a result, many individuals with a positive antibody screening test opt out of taking the corroborative test. Our research aims to address this problem through the development of an affordable, easy to use POC test, capable of detecting pathogen nucleic acids and antibodies to the pathogens in less than one hour.”

Malamud and colleagues will work with Rheonix and utilize the company’s CARD cartridge system, a disposable card that holds and splits a sample of blood or saliva into two portions. Within 7 minutes, one portion of the sample runs off onto a strip to test for HIV antibodies while the other goes through an isothermal process of nucleic acid isolation and amplification, according to the release.

So far, the team has tested hundreds of samples, but for the device to be approved they will need to test thousands, Malamud said in the release.

“I’m reasonably confident that within 18 months we will have a finished product, which will allow an individual to collect a sample, insert it into the CARD, push a button, and, within 1 hour, have an accurate test result,” he said.