ITHACA, N.Y.—Global biotech and diagnostic guru Rheonix Inc. has developed and tested its microfluidic system and assay’s ability to—for the first time—simultaneously detect host anti-HIV antibodies and viral RNA, thus removing the anxiety of waiting a month before the tested individuals find out whether they actually test positive for HIV.
The researchers’ findings are outlined in the Journal of AIDS & Clinical Research, in an article entitled “A Rapid, Self-confirming Assay for HIV: Simultaneous Detection of Anti-HIV Antibodies and Viral RNA.”
The rapid Rheonix system improves HIV testing by detecting early, acute HIV infection and addressing the well-known “seroconversion window” when antibodies are not yet detectable, thus eliminating the need for multiple patient visits to healthcare providers.
The assay is performed on the Rheonix CARD (Chemistry and Reagent Device). Once a raw sample is placed on the Rheonix CARD, the automated platform runs through the process of sample extraction, purification, amplification and detection, Rheonix reports. This eliminates the need for multiple pieces of existing equipment, helping to make the testing process quicker, more efficient, less expensive and less likely to result in human error.
The global HIV/AIDS epidemic continues to be fueled by the large number of individuals who are unaware they are infected, or who have limited access to advanced diagnostics. Governments and nongovernmental organizations around the world support various programs to reduce the impact of the disease by encouraging more frequent testing. Current technologies require confirmation of a positive test result by a second, more sensitive and more specific test, according to Rheonix. However, low-resource settings often lack the sophisticated equipment, trained personnel and facilities required to effectively test clinical specimens, and they often rely on simple “dipstick-like” tests that lack sensitivity and specificity.
“Our technology meets the needs of settings with limited resources,” Gregory J. Gavin, Rheonix CEO and chairman, stated in a press release. “The assays are rapid, sensitive, specific, easy to perform and inexpensive. This combined HIV screening and confirmatory test will have a significant commercial and social impact that we’re excited to see materialize.”
Principal investigator Richard Montagna, Rheonix’s senior vice president for scientific and clinical affairs, stated, “In collaboration with scientists at NYU, we were able to demonstrate how our system can detect both the HIV antibodies and the actual viral RNA, even in the earliest stages of the disease, to immediately confirm whether or not a patient is infected. The fully automated testing system will allow resource-limited regions of the world to have their first-ever opportunity to perform simultaneous serological testing and molecular confirmation for HIV.”
“The well-known ‘seronegative window’ period is caused by the fact that the body’s immune system doesn’t produce antibodies against HIV until weeks or months after infection, but the viral RNA is essentially present immediately after infection,” Montagna told DDNews. “The ability to detect that viral RNA causes the ‘window period’ to be dramatically shortened. Theoretically, that period can be shortened to a few days.”
“Our goal was to develop a test for ‘point-of-care’ use in the developing world, and since the technical resources are limited in such settings, most current testing relies on less accurate testing methods,” Montagna continued. “Therefore, once we have approval to sell our dual assay in these settings, healthcare workers will have access to more accurate test results and be able to establish the infection status of individuals seeking care.”
In addition, “since the majority of rapid tests rely on detecting the presence of antibodies, any individuals who may have been recently infected and have not yet produced detectable antibodies, would be scored as ‘negative,’” he said.
This is complicated by the fact that many would-be HIV-positive patients fail to return to the clinic for that crucial second visit and accurate HIV test results, healthcare officials report.
Rheonix’ ability to simultaneously detect the presence of both antibodies and viral RNA will allow individuals who have been recently infected by HIV to be scored as “positive” in a day or two. Therefore, individuals who may have been unaware of their infection status may be more accurately scored as “positive” for HIV during that first visit, and thus be more amenable to accepting therapeutic intervention.
The Rheonix “smart” CARD was invented in 2005 by Peng Zhou, chief scientific officer and senior vice president of research and development at Rheonix, and Lincoln Young, an engineer at Rheonix, Montagna said, adding, efforts by a “myriad of people have further advanced the technology to its current state.”
Rheonix plans to “initiate clinical studies in the United States this year for its instrument and CARD test for the presence of three sexually transmitted infections (STIs),” according to Montagna. “The development efforts for the HIV ‘dual assay’ are currently being funded by the National Institute of Dental and Craniofacial Research of the National Institutes of Health, and those efforts will continue for at least six more months as we strive to further reduce the total time required to perform the assays.”