The first global investigation by Monash University in Australia has been able to detect positive cases of COVID-19 using blood samples in approximately 20 minutes and identify if someone has contracted the virus.
In a discovery that could advance the global effort to limit community spread of COVID-19 through robust contact tracking, the researchers were able to identify recent cases of COVID-19 using 25 microliters of plasma from blood samples.
The research team, led by BioPRIA and the Department of Chemical Engineering at Monash University, which includes researchers from the ARC Center of Excellence in BioNano Converged Science and Technology (CBNS), developed a simple agglutination test: an analysis to determine the presence and amount of a substance in blood: to detect the presence of antibodies generated in response to SARS-CoV-2 infection.
The positive cases of COVID-19 caused an agglutination or a grouping of red blood cells, which was easily identifiable with the naked eye. The researchers were able to recover positive or negative readings in approximately 20 minutes.
While current swab / PCR tests are used to identify people who are currently COVID-19 positive, the agglutination assay can determine if someone had recently been infected once the infection resolves, and could be used to detect Antibodies generated in response to vaccination to aid in clinical trials.
Using a simple laboratory setup, this discovery could see doctors around the world analyze up to 200 blood samples per hour. In some hospitals with high-grade diagnostic machines, more than 700 blood samples could be tested per hour, about 16,800 per day.
The study findings could assist high-risk countries with population detection, case identification, contact tracing, confirmation of vaccine efficacy during clinical trials, and vaccine distribution.
This first global investigation was published on Friday, July 17, 2020 in the prestigious magazine ACS Sensors.
A patent for innovation has been filed and researchers are seeking commercial and government support for luxury production.
Dr. Simon Corrie, Professor Gil Garnier and Professor Mark Banaszak Holl (BioPRIA and Chemical Engineering, Monash University), and Associate Professor Timothy Scott (BioPRIA, Chemical Engineering and Materials Science and Engineering, Monash University) led the study, with initial funding provided by the Department of Chemical Engineering and the Monash Center to impact antimicrobial resistance.
Dr. Corrie, a professor of chemical engineering at Monash University and chief investigator at CBNS, said the findings were exciting for governments and healthcare teams around the world in the race to stop the spread of COVID. -19. He said this practice has the potential to improve immediately for serological testing.
“Detection of antibodies in the patient’s plasma or serum involves pipetting a mixture of red blood cell reagent (RRBC) and serum / plasma containing antibodies onto a gel card containing separation media, incubating the card for 5-15 minutes and use a centrifuge to separate clumped cells from free cells, “said Dr. Corrie.
“This simple trial, based on the commonly used blood typing infrastructure and already manufactured to scale, can be quickly implemented in Australia and beyond. This test can be used in any laboratory that has a blood typing infrastructure, which is extremely common worldwide. “
The researchers collaborated with Monash Health doctors to collect blood samples from people recently infected with COVID-19, as well as samples from healthy people obtained before the pandemic emerged.
Tests on 10 clinical blood samples included incubating the patient’s plasma or serum with red blood cells previously coated with short peptides representing fragments of the SARS-CoV-2 virus.
If the patient’s sample contained antibodies to SARS-CoV-2, these antibodies would bind to the peptides and cause aggregation of the red blood cells. The researchers then used gel cards to separate the aggregated cells from the free cells, to see an aggregated cell line indicating a positive response. In negative samples, no aggregates were observed on the gel cards.
“We found that by producing bioconjugates of anti-D-IgG and peptides from the SARS-CoV-2 tip protein, and immobilizing them to the RRBCs, selective agglutination was observed on the gel cards in the plasma collected from patients newly infected with SARS-CoV-2 compared to healthy plasma and negative controls, “said Professor Gil Garnier, director of BioPRIA.
“Importantly, negative control reactions involving SARS-CoV-2 or RRBC negative samples and SARS-CoV-2 positive samples without bioconjugates did not reveal any agglutination behavior.”
Professor Banaszak Holl, Head of Chemical Engineering at Monash University, praised the work of talented PhD students in BioPRIA and Chemical Engineering who paused in their projects to help deliver this game that changes the COVID-19 test.
“This simple, fast, and easily scalable approach has immediate application in SARS-CoV-2 serological testing, and is a useful platform for developing trials beyond the COVID-19 pandemic. We are indebted to the work of our doctoral students to bring this to life, ”said Professor Banaszak Holl.
“Funding is required to conduct a comprehensive clinical evaluation at many samples and sites. With commercial support, we can begin to manufacture and extend this trial to the communities that need it. This can take as little as six months, depending on the assistance we receive. “
COVID-19 has caused a worldwide viral pandemic, contributing to almost 600,000 deaths and more than 13.8 million internationally reported cases. Australia has reported 10,810 cases and 113 deaths (figures from July 17, 2020)
Reference:
Alves et al. Rapid gel card agglutination assays for serological analyzes after SARS-CoV-2 infection in humans. ACS sensors, 2020; DOI: 10.1021 / acssensors.0c01050
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