A discovery that could advance global effort to limit the community spread of the rampaging COVID-19 is out.
Through robust contact tracing, researchers have been able to identify recent COVID-19 cases using 25 micro-litres of plasma from blood samples.
It is world-first research by Monash University in Australia. The university has been able to detect positive COVID-19 cases using blood samples in about 20 minutes, and identify whether someone has contracted the virus.
This is coming as 28 states in Nigeria on Saturday, shut-up their national tally to 36,107 with 653 fresh positive cases.
The Nigeria Centre for Disease Control (NCDC) that made this known also reported six new COVID-19 deaths in the country. With the latest development, the virus’ death toll in Nigeria now stands at 778.
‘’Till date, 36107 cases have been confirmed, 14938 cases have been discharged and 778 deaths have been recorded in 36 states and the Federal Capital Territory, Abuja’’, NCDC says.
Of the 653 new cases from 28 states, Lagos led the pack with 115 cases, followed by Kwara’s 85, Enugu 80, Abuja 78, Rivers 36, Ondo 35, Oyo 30, Katsina 28, Kaduna 19, Abia 19, Nasarawa 18, Plateau 17, Imo 16, Ogun nine, Ebonyi nine, Benue nine, Kano nine, Delta eight, Bauchi seven, Ekiti six, Gombe four, Bayelsa four, Adamawa four, Osun four, Cross River, Yobe, Borno, and Zamfara have one case each.
However, the research team, led by BioPRIA and Monash University’s Chemical Engineering Department, including researchers from the ARC Center of Excellence in Convergent BioNano Science and Technology (CBNS), developed a simple agglutination assay—an analysis to determine the presence and amount of a substance in the blood—to detect the presence of antibodies raised in response to the SARS-CoV-2 infection.
This is developing even as it has taken a decade or more historically to develop a vaccine. Yet some U.S. leaders say a vaccine for the new coronavirus could be ready as soon as late this year or early next.
Other experts expect a longer timetable. But together they are counting on a never-before-seen marshalling of scientific, industry, philanthropic and government forces to drive the global effort.
Director of the Vaccine Education Center at the Children’s Hospital of Philadelphia, Dr. Paul Offit, says “I think we can make a successful COVID-19 vaccine, one that’s safe and effective, likely by mid-next year. There’s never been more money, expertise or interest in making a vaccine.”
In the US, a multibillion-dollar, public-private partnership called Operation Warp Speed is aiming to compress the vaccine development timeline by overlapping parts of the process normally conducted in sequence, including pre-clinical studies and clinical trials.
To be ready for quick distribution, the federal plan also calls for manufacturing the most promising vaccines before they get Food and Drug Administration (FDA) approval. But with that comes the risk of discarding and absorbing the enormous expense of having produced vaccines that aren’t deemed safe and effective by the FDA.
The most difficult part of creating a vaccine is its manufacturing, said Offit, co-inventor of a vaccine for rotavirus, a disease that can cause severe diarrhoea, vomiting and other dangerous symptoms in infants and young children. A key challenge is manufacturers have to ensure that components such as buffering and stabilizing agents consistently protect the integrity of the vaccine, from the first to last dose produced.
“It’s hard to scale up to make millions or tens or hundreds of millions of doses”, Offit said.
For COVID-19, scientists are working toward licensing multiple safe and effective vaccines, not just one.
“We know that no single vaccine will be able to meet the needs of every population around the world, nor could enough doses be manufactured of one type of vaccine to protect the entire global population”, says virologist Dr. Larry Corey, past president and director at Fred Hutchinson Cancer Research Center in Seattle.
Vaccines will have to meet the unique needs of groups including the elderly, pregnant women, children and populations at high risk of severe illness from COVID-19, such as those with serious heart conditions, obesity and Type 2 diabetes.
At the same time, effective vaccines won’t necessarily make COVID-19 go away, Offit said.
“I think we’ll have a vaccine that’s at least 70% effective that protects against severe to moderate disease that keeps people out of the hospital and keeps them from dying”, he said. But it may not prevent mild or asymptomatic disease associated with exposure.
So far, more than 155 vaccines are being developed around the world, with 23 of them already in human trials, according to the New York Times’vaccine tracker.
A vaccine that’s safe and works in at least 50% of people in clinical trials would be considered a viable candidate, said Corey, who heads the operations centre for the COVID-19 Prevention Network.
The network is a collaboration funded by the National Institute of Allergy and Infectious Diseases to optimize execution of the very large trials needed for each candidate vaccine identified as promising.
“I’m optimistic that through randomised controlled clinical trials, enrolling up to 30,000 individuals per trial, we’ll get the necessary safety and efficacy data to allow us to evaluate each of the vaccine candidates in the program”, Corey said.
“These large-scale trials are really the only way we can define the safety and effectiveness of a vaccine candidate with enough scientific information to feel comfortable recommending the vaccine.”
Such trials, experts say, can be challenging and take time—important considerations in managing expectations for speedy results.
Vaccine candidates that make it to the large-scale trials might be a diverse bunch. There are roughly a half-dozen basic approaches to building a vaccine, plus variations on those, Offit said.
These range from using an inactivated, or killed, version of a virus to launch the body’s defences—an approach pioneered by Jonas Salk in developing a polio vaccine—to cutting-edge and not-yet-proven strategies, such as using genetic material called messenger RNA to evoke an immune response.
Given that the virus that causes COVID-19 was identified just months ago, there’s much to learn. For instance, it’s not clear whether any particular vaccine-building strategy is superior, Offit said. And scientists will have to wait and see how long the effects of any new vaccine will endure, though previous work with coronaviruses suggests protection would last at least a few years.
“Every new pathogen is a challenge”, Offit said. “You learn as you go.”
However, positive COVID-19 cases caused an agglutination or a clustering of red blood cells, which was easily identifiable to the naked eye. Researchers were able to retrieve positive or negative readings in about 20 minutes.
While the current swab / PCR tests are used to identify people who are currently positive with COVID-19, the agglutination assay can determine whether someone had been recently infected once the infection is resolved—and could potentially be used to detect antibodies raised in response to vaccination to aid clinical trials.
Using a simple lab setup, this discovery could see medical practitioners across the world testing up to 200 blood samples an hour. At some hospitals with high-grade diagnostic machines, more than 700 blood samples could be tested hourly—about 16,800 each day.
Study findings could help high-risk countries with population screening, case identification, contact tracing, confirming vaccine efficacy during clinical trials, and vaccine distribution.
This world-first research was published today (Friday 17 July 2020) in the prestigious journal ACS Sensors.
A patent for the innovation has been filed and researchers are seeking commercial and government support to upscale 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 Chemical Engineering Department and the Monash Center to Impact Anti-microbial Resistance.
Dr. Corrie, Senior Lecturer in Chemical Engineering at Monash University and Chief Investigator in the CBNS, said the findings were exciting for governments and health care teams across the world in the race to stop the spread of COVID-19. He said this practice has the potential to become upscaled immediately for serological testing.
“Detection of antibodies in patient plasma or serum involves pipetting a mixture of reagent red blood cells (RRBCs) and antibody-containing serum/plasma onto a gel card containing separation media, incubating the card for 5-15 minutes, and using a centrifuge to separate agglutinated cells from free cells”, Dr. Corrie said.
“This simple assay, based on commonly used blood typing infrastructure and already manufactured at scale, can be rolled out rapidly across Australia and beyond. This test can be used in any lab that has blood typing infrastructure, which is extremely common across the world.”
Researchers collaborated with clinicians at Monash Health to collect blood samples from people recently infected with COVID-19, as well as samples from healthy individuals sourced before the pandemic emerged.
Tests on 10 clinical blood samples involved incubating patient plasma or serum with red blood cells previously coated with short peptides representing pieces of the SARS-CoV-2 virus.
If the patient sample contained antibodies against SARS-CoV-2, these antibodies would bind to peptides and result in aggregation of the red blood cells. Researchers then used gel cards to separate aggregated cells from free cells, in order to see a line of aggregated cells indicating a positive response. In negative samples, no aggregates in the gel cards were observed.
“We found that by producing bioconjugates of anti-D-IgG and peptides from SARS-CoV-2 spike protein, and immobilising these to RRBCs, selective agglutination in gel cards was observed in the plasma collected from patients recently infected with SARS-CoV-2 in comparison to healthy plasma and negative controls”, Professor Gil Garnier, Director of BioPRIA, said.
“Importantly, negative control reactions involving either SARS-CoV-2-negative samples or RRBCs and SARS-CoV-2-positive samples without bioconjugates, all revealed no agglutination behaviour.”
Professor Banaszak Holl, Head of Chemical Engineering at Monash University, commended the work of talented PhD students in BioPRIA and Chemical Engineering who paused their projects to help deliver this game-changing COVID-19 test.
“This simple, rapid, and easily scalable approach has immediate application in SARS-CoV-2 serological testing and is a useful platform for assay development beyond the COVID-19 pandemic. We are indebted to the work of our PhD students in bringing this to life”, Professor Banaszak Holl said.
“Funding is required in order to perform full clinical evaluation across many samples and sites. With commercial support, we can begin to manufacture and roll out this assay to the communities that need it. This can take as little as six months depending on the support we receive.”
COVID-19 has caused a worldwide viral pandemic, contributing to nearly 600,000 deaths and more than 13.8 million cases reported internationally. Australia has reported 10,810 cases and 113 deaths, as of July 17, 2020.