Point-of-care testing is a critical tool in the battle against COVID-19, and researchers in Indiana are working around the clock to deliver rapid tests with high specificity.
Point-of-care testing is a critical tool in the battle against COVID-19, and researchers in Indiana are working around the clock to deliver rapid tests with high specificity.
Since the onset of COVID-19, a number of point-of-care tests have been approved by the U.S. Food and Drug Administration under Emergency Use Authorization, including Abbott’s ID NOW RealTime SARS-CoV-2 test that has been widely used by the White House to test visitors. But, there have been concerns raised regarding the test generating a high rate of false negatives in COVID-19 cases.
As accurate testing continues to be a concern as the nation seeks to dampen the spread of the novel coronavirus, Michael Pugia, director of Bioanalytical Technologies at Indiana Biosciences Research Institute (IBRI), said the goal is to change the paradigm of testing in order to provide more accurate results. Over the years, even before COVID-19 became the chief testing concern, Pugia, a 30-year diagnostics veteran, said there have been a number of issues with point-of-care tests, including rates of false positives and even delays of testing results. Some of the failures from past attempts have occurred due to people “trying to break the laws of nature,” he said.
“If its point of care, the answer has to be within one to 30 minutes,” Pugia told BioSpace in an interview. “And you need to have a high specificity as you screen a widespread group of people.”
An ideal situation would be the ability to detect the virus in asymptomatic patients to limit the spread of COVID-19, Pugia added. And that has been a goal of Pugia and the IBRI. They have been developing a rapid test that has a high rate of specificity and can be returned in minutes as opposed to days.
IBRI has completed development of two technologies, BioMEMs (biological microelectromechanical) and SIERRA (Signal Ion Emission Reactive Release Amplification) Reagent, both of which have the potential to diagnose disease such as COVID-19 or other infections. In fact, before COVID-19, Pugia said IBRI was working with the National Institute of Allergy and Infectious Diseases to detect, among other things, the presence of antibiotic-resistant bugs. That’s the goal of the programs developed by Pugia and his colleagues.
BioMEMs uses micro-sized components to reduce cost and improve sensitivity of diagnostic tests. SIERRA Reagent helps diagnose infections and other diseases from a single cell. Used together, they are more sensitive than what is currently available and provide results faster than products on the market today. BioMEMs with SIERRA Reagent can provide results in 15 to 60 minutes.
The technology has been out-licensed to BioMEMS Analytics LLC, a third-party Indiana-based startup. Pugia said they anticipate the first systems could be available for use in December. BioMEMS Analytics will work to commercialize the technology, but IBRI retains the commercial rights and research rights to SIERRA Reagent.
“My goal was to get the technology out there so it could progress to the next stage. It’s still in its infancy and will require the more business-focused people to get it to the next level,” Pugia said.
Pugia, who joined IBRI in 2016, has been working with Indiana University-Purdue University Indianapolis, the Indiana University School of Medicine, Purdue University, University of Notre Dame, Indiana Integrated Circuits and the State of Indiana to improve diagnostic capabilities. The work of IBRI and its Indiana companions highlights the capabilities of the state as a leader in diagnostics, Pugia said.
