Quanterix Corporation announced its industry-leading single molecule array, or Simoa, technology has achieved enhanced sensitivity for the detection of acute HIV infection relative to currently approved fourth-generation antigen-antibody (Ag/Ab) combination (combo) and stand-alone p24 assays.
Led by BSRI in collaboration with several other research institutions and biotechnology companies, the study used a series of blinded panels of serial dilutions containing genetically and geographically diverse HIV clinical isolates to assess the sensitivity (p24 Ag relative to viral loads) of HIV clinical diagnostic, blood screening, and next generation p24 Ag assays. Findings illustrate similar performance across subtypes between current FDA-approved techniques and stand-alone p24 Ag immunoassays. Additionally, the study demonstrated that newer generation pre-clinical p24 Ag detection platforms, such as Simoa, achieved significantly heightened sensitivity for detection of the clinical isolates as compared to existing immunoassay methods.
Specifically, results demonstrate that Simoa was able to detect 99 percent of the diluted viral samples across diverse subtypes that had been characterized by nucleic acid testing (NAT), the gold standard for sensitive virus detection. In comparison, FDA-approved immunoassay methods detected only 30-40 percent of the samples. These results suggest the potential for a simple immunoassay blood test to provide NAT-level sensitivity for acute HIV detection. Such a test could significantly enhance the ability to detect the infection while in the acute phase when it is most infectious. While NAT is the gold standard for sensitivity, it is more complex and costly to deploy relative to immunoassays. Deployment of a simple immunoassay with NAT sensitivity, especially in lower resource settings, could positively affect HIV epidemiology though wider access to more sensitive detection of early infection.
“While significant progress has been made in the detection and treatment of HIV, there is still much work to be done,” said Kevin Hrusovsky, Chief Executive Officer, President and Chairman of Quanterix and Founder of the annual Powering Precision Health Summit. “We are excited by the results of this research, and the progress we have made in growing our reach and capabilities over the past several months. Through our expanded technology portfolio and resources, which now include a Clinical Laboratory Improvements Amendments (CLIA) certified laboratory, we look forward to empowering further diagnostic and drug development advancements.”
Approximately 36.7 million people currently live with HIV/AIDS globally, but only 60 percent know they have the disease, according to HIV.gov. The infection is widely considered to be one of the most critical health challenges facing the world community in large part due to its ability to remain dormant, going undetected for years only to emerge when it is too late to treat. To date, clinical fourth and fifth generational antigen (Ag)/antibody (Ab) combo and p24 Ag immunoassays have enhanced the ability to identify the infection, but require ongoing evaluation with currently circulating diverse subtypes.
“This type of comparative testing is essential to assessing the performance of commercially available approaches to infectious disease detection and evaluating pre-clinical methods that can play a key role in improving public health,” said Professor Michael P. Busch, MD, Ph.D, senior author of the study. “The study findings confirm the efficacy of today’s methods, but also demonstrate the great promise newer technologies hold in advancing detection of HIV at its earliest stages.”
The research joins more than 215 peer-reviewed studies across several therapeutic categories, such as oncology, neurology, cardiology, inflammation, and infectious disease, that validate Simoa’s potential to detect minute levels of biomarkers long before symptoms appear and when conditions are at their most treatable. The findings also come on the heels of Quanterix’ commercial availability of its SR-X Ultra-Sensitive Biomarker Detection System™, a benchtop instrument powered by Simoa technology, and its acceleration into pharmaceutical services following its successful IPO in December 2017.
To learn more about this research and view the poster, entitled “Comparison of Detection Limits of 4th and 5th Generation Combination HIV Antigen/Antibody, p24 Antigen and Viral Load Assays on Diverse HIV Isolates,” visit http://www.croiconference.org/sessions/relative-sensitivities-4th-and-5th-gen-combo-hiv-agab-p24-and-viral-load-assays.
To learn more about Quanterix’ HIV p24 assays, visit https://www.quanterix.com/products-technology/assays/hiv-p24.
