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University of Missouri Research Team Identifies 46 Mutations Specific to the SARS-CoV-2 Omicron Variant That Could lead to Improved Clinical Laboratory Tests, Treatments, and Vaccines

Many of the mutations were found at sites on the spike protein where antibodies bind, which may explain why the Omicron variant is more infectious than previous variants

Scientists at the University of Missouri (UM) now have a better understanding of why the SARS-CoV-2 Omicron variant is more infectious than previous variants and that knowledge may lead to improved antivirals and clinical laboratory tests for COVID-19.

As the Omicron variant of the coronavirus spread across the globe, scientists noted it appeared to be more contagious than previous variants and seemed resistant to the existing vaccines. As time went by it also appeared to increase risk for reinfection.

The UM researchers wanted to know why. They began by examining the Omicron variant’s mutation distribution, its evolutionary relationship to previous COVID-19 variants, and the structural impact of its mutations on antibody binding. They then analyzed protein sequences of Omicron variant samples collected from around the world.

“We know that viruses evolve over time and acquire mutations, so when we first heard of the new Omicron variant, we wanted to identify the mutations specific to this variant,” said Kamlendra Singh, PhD, Associate Research Professor, Department of Veterinary Pathobiology at UM’s College of Veterinary Medicine (CVM), in a UM press release.

The UM scientists published their findings in the Journal of Autoimmunity, titled, “Omicron SARS-CoV-2 Variant: Unique Features and Their Impact on Pre-existing Antibodies.”

Kamlendra Singh, PhD
Kamlendra Singh, PhD (above), an associate research professor in the Department of Veterinary Pathobiology at UM’s College of Veterinary Medicine, led the team that identified 46 mutations of the SARS-CoV-2 Omicron variant. “I went to India last April and I got infected by the Delta variant. So, it then became personal to me,” he told NBC affiliate KOMU. The UM team hopes their findings lead to improvements in existing COVID-19 antivirals and clinical laboratory tests. (Photo copyright: University of Missouri.)

In their paper, the UM team wrote, “Here we present the analyses of mutation distribution, the evolutionary relationship of Omicron with previous variants, and probable structural impact of mutations on antibody binding. … The structural analyses showed that several mutations are localized to the region of the S protein [coronavirus spike protein] that is the major target of antibodies, suggesting that the mutations in the Omicron variant may affect the binding affinities of antibodies to the S protein.”

Other findings of the UM team’s research include:

  • Phylogenetically, the Omicron variant is closely related to the SARS-CoV-2 gamma variant.
  • There are a total of 46 highly prevalent mutations throughout the Omicron variant.
  • Twenty-three of the 46 mutations belong to the S protein (more than any previous variant).
  • Twenty-three of 46 is a markedly higher number of S protein mutations than reported for any SARS-CoV-2 variant.
  • A significant number of Omicron mutations are at the antibody binding surface of the S protein.

“Mutation is change in the genome that results in a different type of protein,” Singh told NBC affiliate KOMU. “Once you have different kinds of protein after the virus and the virus attacks the cell, our antibodies do not recognize that, because it has already been mutated.”

Omicron Mutations Interfere with Antibody Binding

Of the 46 Omicron variant mutations discovered by the UM researchers, some were found in areas of the coronavirus’ spike protein where antibodies normally bind to prevent infection or reinfection.

“The purpose of antibodies is to recognize the virus and stop the binding, which prevents infection,” Singh explained. “However, we found many of the mutations in the Omicron variant are located right where the antibodies are supposed to bind, so we are showing how the virus continues to evolve in a way that it can potentially escape or evade the existing antibodies, and therefore continue to infect so many people.”

These findings explain how the Omicron variant bypasses pre-existing antibodies in a person’s blood to cause initial infection as well as reinfection.

The UM team hopes their research will help other scientists better understand how the SARS-CoV-2 coronavirus has evolved and lead to future clinical laboratory antiviral treatments.

“The first step toward solving a problem is getting a better understanding of the specific problem in the first place,” Singh said. “It feels good to be contributing to research that is helping out with the pandemic situation, which has obviously been affecting people all over the world.”

Singh and his team have developed a supplement called CoroQuil-Zn designed to reduce a patient’s viral load after being infected with the SARS-CoV-2 coronavirus. The drug is currently being used in parts of India and is awaiting approval from the US Food and Drug Administration (FDA).

New discoveries about SARS-CoV-2 and its variants continue to further understanding of the coronavirus. Research such as that performed at the University of Missouri may lead to new clinical laboratory tests, more effective treatments, and improved vaccines that could save thousands of lives worldwide. 

JP Schlingman

Related Information:

MU Study Identifies Mutations Specific to Omicron Variant

Omicron SARS-CoV-2 Variant: Unique Features and Their Impact on Pre-existing Antibodies

SARS-CoV-2 Variants and Mutations

MU Researcher Identifies Mutations of the Omicron Variant

A Study to Assess the Safety and Efficacy of CoroQuil-Zn 750 in Comparison to the Standard of Care for the Treatment of Mild to Moderate COVID-19

Scientists Estimate 73% of US Population May Be Immune to SARS-CoV-2 Omicron Variant

Could Omicron Variant Have Links to HIV? Infectious Disease Experts in South Africa Say ‘Yes’

Given the large number of mutations found in the SARS-CoV-2 Omicron variant, experts in South Africa speculate it likely evolved in someone with a compromised immune system

As the SARS-CoV-2 Omicron variant spreads around the United States and the rest of the world, infectious disease experts in South Africa have been investigating how the variant developed so many mutations. One hypothesis is that it evolved over time in the body of an immunosuppressed person, such as a cancer patient, transplant recipient, or someone with uncontrolled human immunodeficiency virus infection (HIV).

One interesting facet in the story of how the Omicron variant was being tracked as it emerged in South Africa is the role of several medical laboratories in the country that reported genetic sequences associated with Omicron. This allowed researchers in South Africa to more quickly identify the growing range of mutations found in different samples of the Omicron virus.

“Normally your immune system would kick a virus out fairly quickly, if fully functional,” Linda-Gail Bekker, PhD, of the Desmond Tutu Health Foundation (formerly the Desmond Tutu HIV Foundation) in Cape Town, South Africa, told the BBC.

“In someone where immunity is suppressed, then we see virus persisting,” she added. “And it doesn’t just sit around, it replicates. And as it replicates it undergoes potential mutations. And in somebody where immunity is suppressed that virus may be able to continue for many months—mutating as it goes.”

Multiple factors can suppress the immune system, experts say, but some are pointing to HIV as a possible culprit given the likelihood that the variant emerged in sub-Saharan Africa, which has a high population of people living with HIV.

In South Africa alone, “2.2 million people are infected with HIV that is undetected, untreated, or poorly controlled,” infectious-diseases specialist Jonathan Li, MD, told The Los Angeles Times. Li is the Director of the Virology Specialty Laboratory at Brigham and Woman’s Hospital in Massachusetts, and the Director of the Harvard University Center for AIDS Research Clinical Core.

Li “was among the first to detail extensive coronavirus mutations in an immunosuppressed patient,” the LA Times reported. “Under attack by HIV, their T cells are not providing vital support that the immune system’s B cells need to clear an infection.”

Linda-Gail Bekker, PhD

Linda-Gail Bekker, PhD (above), of the Desmond Tutu Health Foundation cautions that these findings should not further stigmatize people living with HIV. “It’s important to stress that people who are on anti-retroviral medication—that does restore their immunity,” she told the BBC. (Photo copyright: Test Positive Aware Network.)

Omicron Spreads Rapidly in the US

Genomics surveillance Data from the CDC’s SARS-CoV-2 Tracking system indicates that on Dec. 11, 2021, Omicron accounted for about 7% of the SARS-CoV-2 variants in circulation, the agency reported. But by Dec. 25, the number had jumped to nearly 60%. The data is based on sequencing of SARS-CoV-2 by the agency as well as commercial clinical laboratories and academic laboratories.

Experts have pointed to several likely factors behind the variant’s high rate of transmission. The biggest factor, NPR reported, appears to be the large number of mutations on the spike protein, which the virus uses to attach to human cells. This gives the virus an advantage in evading the body’s immune system, even in people who have been vaccinated.

“The playing field for the virus right now is quite different than it was in the early days,” Joshua Schiffer, MD, of the Fred Hutchinson Cancer Research Center, told NPR. “The majority of variants we’ve seen to date couldn’t survive in this immune environment.”

One study from Norway cited by NPR suggests that Omicron has a shorter incubation period than other variants, which would increase the transmission rate. And researchers have found that it multiplies more rapidly than the Delta variant in the upper respiratory tract, which could facilitate spread when people exhale.

Using Genomics Testing to Determine How Omicron Evolved

But how did the Omicron variant accumulate so many mutations? In a story for The Atlantic, virologist Jesse Bloom, PhD, Professor, Basic Sciences Division, at the Fred Hutchinson Cancer Research Center in Seattle, described Omicron as “a huge jump in evolution,” one that researchers expected to happen “over the span of four or five years.”

Hence the speculation that it evolved in an immunosuppressed person, perhaps due to HIV, though that’s not the only theory. Another is “that the virus infected animals of some kind, acquired lots of mutations as it spread among them, and then jumped back to people—a phenomenon known as reverse zoonosis,” New Scientist reported.

Still, experts are pointing to emergence in someone with a weakened immune system as the most likely cause. One of them, the L.A. Times reported, is Tulio de Oliveira, PhD, Affiliate Professor in the Department of Global Health at the University of Washington. Oliveira leads the Centre for Epidemic Response and Innovation at Stellenbosch University in South Africa, as well as the nation’s Network for Genomic Surveillance.

The Network for Genomic Surveillance, he told The New Yorker, consists of multiple facilities around the country. Team members noticed what he described as a “small uptick” in COVID cases in Gauteng, so on Nov. 19 they decided to step up genomic surveillance in the province. One private clinical laboratory in the network submitted “six genomes of a very mutated virus,” he said. “And, when we looked at the genomes, we got quite worried because they discovered a failure of one of the probes in the PCR testing.”

Looking at national data, the scientists saw that the same failure was on the rise in PCR (Polymerase chain reaction) tests, prompting a request for samples from other medical laboratories. “We got over a hundred samples from over thirty clinics in Gauteng, and we started genotyping, and we analyzed the mutation of the virus,” he told The New Yorker. “We linked all the data with the PCR dropout, the increase of cases in South Africa and of the positivity rate, and then we began to see it might be a very suddenly emerging variant.”

Oliveira’s team first reported the emergence of the new variant to the World Health Organization, on Nov. 24. Two days later, the WHO issued a statement that named the newly classified Omicron variant (B.1.1.529) a “SARS-CoV-2 Variant of Concern.”

Microbiologists and clinical laboratory specialists in the US should keep close watch on Omicron research coming out of South Africa. Fortunately, scientists today have tools to understand the genetic makeup of viruses that did not exist at the time of SARS 2003, Swine flu 2008/9, MERS 2013.

Stephen Beale

Related Information:

Classification of Omicron (B.1.1.529): SARS-CoV-2 Variant of Concern

Full Transcript: Tulio de Oliveira on “Face the Nation,” December 12, 2021

How South African Researchers Identified the Omicron Variant of COVID

Stanford Researchers Looking at Possible Link Between Omicron COVID Variant and HIV

Did a Collision of COVID and HIV Forge the Omicron Variant?

Omicron: South African Scientists Probe Link Between Variants and Untreated HIV

How HIV and COVID-19 Variants Are Connected

Omicron’s Explosive Growth Is a Warning Sign

The Scientist in Botswana Who Identified Omicron Was Saddened by the World’s Reaction

Did HIV Help Omicron Evolve?

How Did the Omicron Coronavirus Variant Evolve to Be So Dangerous?

Why Fighting Omicron Should Include Ramping Up HIV Prevention

Network for Genomic Surveillance in South Africa (NGS-SA) to Rapidly Respond to COVID-19 Outbreaks

Does the 1918 Influenza Pandemic Teach Us Anything About How and When COVID-19 Will End?

Experts weigh-in on the new Omicron variant, how pandemics conclude, and challenges ahead for clinical laboratories

Could studying how the 1918 influenza pandemic ended teach pathologists and clinical laboratory professionals how and when the current COVID-19 pandemic may end as well? And does the new Omicron variant indicate that the SARS-CoV-2 coronavirus has mutated into an endemic form of the disease?

According to the Centers for Disease Control and Prevention (CDC), the 1918 influenza (aka, the Spanish Flu) pandemic took place worldwide between 1918 and 1919. It was caused by the H1N1 virus (A/H1N1), a subtype of the Influenza A virus, and infected approximately 500 million people worldwide (a third of the human population at the time). Fifty million people died. Many were children or otherwise healthy individuals, but people from all age groups perished.

The CDC calls the Spanish Flu the “deadliest pandemic of the 20th century.” Past pandemics have generally concluded after 2.5 to 3.5 years. That’s how long it takes for new viruses to mutate and become endemic diseases, Healthline reported.

The COVID-19 pandemic has been around for about that long. It stands to reason the natural end of the COVID-19 pandemic may be just around the corner. But is it? And is the Omicron variant an indicator that the COVID-19 pandemic is winding down?

Fighting a New Coronavirus Variant

A recent McKinsey and Company report notes that, compared to the Delta variant, the new Omicron variant is:

  • 25% more infectious,
  • 25% better at evading immunity, and
  • 25% more likely to cause less severe disease.

“Our analysis suggests that in the US, this combination of characteristics would lead to Omicron replacing Delta as the dominant variant in the next few months and to a higher peak burden of disease than the country saw in the second half of 2021 (but likely below the peak reached in the winter of 2020-21),” the report states.

McKinsey analysts also acknowledged the possible impact of new therapeutics, COVID-19 vaccine booster doses, and public health measures on Omicron spread. “In the short term, an accelerated rollout of booster doses of COVID-19 vaccines is likely to be one of the best protections against an Omicron-fueled wave of the disease,” the analysts wrote.

Does How the Spanish Flu Came to an End Mirror the COVID-19 Pandemic?

Virologists and infectious disease experts explained that the Spanish Flu virus did what viruses still do: mutate and become less dangerous. Herd immunity also helped end the 1918 pandemic. 

“The 1918 influenza virus eventually mutated to the point of not having a high number of deaths—eventually over three years or so. We may very well be witnessing this process with ongoing variants of SARS-CoV-2,” virologist Rodney Rohde, PhD, Director of the Clinical Laboratory Science Program at Texas State University, told Healthline.

Todd Ellerin, MD

Today’s flu strains have “ancestral links” to the 1918 flu, and thus, the SARS-CoV-2 coronavirus will most likely also leave its mark, The Boston Herald reported. “The coronavirus will evolve and hopefully morph into a seasonal illness to which we pay little mind, but it’s still too early to tell,” Todd Ellerin, MD (above,) Director of Infectious Diseases, South Shore Health, South Weymouth, Mass., told The Boston Herald. (Photo copyright: Greg Derr/The Patriot Ledger.)

“If you think about the way viruses behave, biologically, their reason for living is to replicate and spread, and there’s really no advantage for the virus to kill the host,” infectious disease specialist Keith Armitage, MD, Professor of Medicine, Division of Infectious Diseases at Case Western Reserve University, told Healthline. “The hope is, that if the pandemic doesn’t go away, we will get new variants that are highly contagious but don’t produce much of a clinical illness,” he added.

In “2021’s Top 10 Lab Stories Confirm Important Trends,” Dark Daily’s sister publication, The Dark Report (TDR), posed a similar question in its number one story of 2021: “COVID-19: Will it Become Endemic and a Respiratory Virus that Shows Up Every Year like Influenza?”

“The question of whether SARS-CoV-2 is a pandemic that fades, as did SARS in 2003, or becomes endemic and a respiratory virus that shows up every season like influenza and the common cold, is of major concern to clinical lab administrators. That’s because clinical labs and pathology groups must continue to serve physicians and patients with the usual menu of routine, reference, and esoteric testing,” TDR noted.

Clinical Laboratories to Continue COVID Testing

It would be most helpful for medical laboratories and pathology groups to have some idea of when the pandemic will end. Unfortunately, such predictions would not be very useful.

“Since COVID-19 infections have a high number of asymptomatic transmitters, we may not fully understand how societal and environmental pressures—masks, distancing, remote working, etc.—on the virus will allow it to evolve,” Rohde told Healthline.

For now, clinical laboratories will need to continue to remain prepared as COVID-19 cases rise and people seek SARS-COV-2 tests, vaccinations, and treatments. COVID-19 testing is likely to be in demand throughout the coming year. The current surge in demand for COVID-19 tests is putting additional stress on the supply chain.

“We know pandemics end; it’s just a matter of time,” Sara Paton, PhD, Associate Professor of Epidemiology, Wright State University, told the Journal-News. “It could be in 2022, maybe later in the year, but I can’t say for sure. It could be 2023.” 

—Donna Marie Pocius

Related Information:

CDC: 1918 Pandemic

What Can We Learn from the 1918 Flu Pandemic as the Omicron Variant Spreads?

The 1918 Pandemic: A Timeline of Events

How Did the 1918 Pandemic End, and Could the Same Thing Happen with Coronavirus?

When Will the COVID-19 Pandemic End?

Will the Pandemic End in 2022?

2021 Top 10 Lab Stores Confirm Important Trends

Researchers Identify Antibodies That Could Be Protective Against Multiple Sarbecoviruses, Including SARS-CoV-2 and Its Variants

The antibodies target portions of the SARS-CoV-2 spike protein that resist mutation, potentially leading to better treatments and vaccines

One challenge in the battle against COVID-19 is the emergence of SARS-CoV-2 variants, especially the Delta variant, which may be more resistant to neutralizing antibodies compared with the original coronavirus. But now, scientists led by researchers at the Fred Hutchinson Cancer Research Center (Fred Hutch) in Seattle say they have identified antibodies that could be broadly protective against multiple sarbecoviruses, the subgenus that contains SARS-CoV-2 as well as SARS-CoV-1, the virus responsible for the 2002-2004 severe acute respiratory syndrome (SARS) outbreak.

In “SARS-CoV-2 RBD Antibodies That Maximize Breadth and Resistance to Escape,” the researchers described how they compared 12 antibodies obtained from patients infected with either SARS-CoV-2 or SARS-CoV-1. They pointed to one antibody in particular—S2H97—that could lead to development of new vaccines and therapies against current and future variants. It might even protect against sarbecoviruses that have not yet been identified, they wrote.

Unsaid in the news release about these research findings is the fact that these particular antibodies could eventually become useful biomarkers for clinical laboratory tests designed to help physicians determine which patients have these antibodies—and the protection from infection they represent—and which do not.

So far, however, S2H97 has only been tested in hamsters. But results are promising.

“This antibody, which binds to a previously unknown site on the coronavirus spike protein, appears to neutralize all known sarbecoviruses—the genus of coronaviruses that cause respiratory infections in mammals,” said Jay Nix, PhD, an affiliate in Berkeley Lab’s Biosciences Area and Beamline Director of the Molecular Biology Consortium at Berkeley Lab’s Advanced Light Source (ALS), in a Berkeley Lab news release. “And, due to the unique binding site on mutation-resistant part of the virus, it may well be more difficult for a new strain to escape,” he added.

The research team led by biochemist Tyler Starr, PhD, a postdoctoral fellow at Fred Hutch, also included researchers from Vir Biotechnology (NASDAQ:VIR), the University of Washington in Seattle, Washington University School of Medicine in St. Louis, and Lawrence Berkeley National Laboratory in Berkeley, Calif.

Mutation Resistance

Scientists have long known that the SARS-CoV-2 virus uses the spike protein to attach to human cells. The federal Centers for Disease Control and Prevention (CDC) notes that the variants have mutations in their spike proteins that make some of them more transmissible.

The Delta variant, the CDC notes, was the predominant variant in the US as of August 28, 2021. It “has been shown to have increased transmissibility, potential reduction in neutralization by some monoclonal antibody treatments, and reduction in neutralization by post-vaccination sera,” the agency states.

The key to S2H97, the researchers wrote, is that it targets a portion of the spike protein that is common among sarbecoviruses, and that is likely to be resistant to mutations.

The researchers used a variety of techniques to analyze how the 12 antibodies bind to the virus. They “compiled a list of thousands of mutations in the binding domains of multiple SARS-CoV-2 variants,” Nature reported. “They also catalogued mutations in the binding domain on dozens of SARS-CoV-2-like coronaviruses that belong to a group called the sarbecoviruses. Finally, they assessed how all these mutations affect the 12 antibodies’ ability to stick to the binding domain.”

William Schaffner, MD

William Schaffner, MD (above), Professor of Preventive Medicine in the Department of Health Policy as well as Professor of Medicine in the Division of Infectious Diseases at the Vanderbilt University School of Medicine in Nashville, believes that “people who test positive for SARS-CoV-2 and who are at risk of progressing to severe disease—including those who are over the age of 65 years and those who have weakened immune systems—should talk with a doctor about receiving monoclonal antibody treatment,” Medical News Today reported. “[The monoclonal antibody treatment is] designed to prevent the evolution of the infection from a mild infection into a serious one,” he noted. “In other words, you’ve just [contracted the virus], but we can now give you a medication that will help prevent [you] being hospitalized and getting seriously ill.” (Photo copyright: Vanderbilt University.)

Earlier Antibody Treatment Receives an EUA from the FDA

Another antibody studied by the researchers, S309, has already led to a monoclonal antibody therapy authorized for use in the US. On May 26, the FDA issued an emergency use authorization (EUA) for sotrovimab, a therapy developed by GlaxoSmithKline (NYSE:GSK) and Vir Biotechnology, according to SciTechDaily.

In issuing the EUA for sotrovimab, the FDA cited “an interim analysis from a phase 1/2/3 randomized, double-blind, placebo-controlled clinical trial in 583 non-hospitalized adults with mild-to-moderate COVID-19 symptoms and a positive SARS-CoV-2 test result. Of these patients, 291 received sotrovimab and 292 received a placebo within five days of onset of COVID-19 symptoms.”

Among these patients, 21 in the placebo group were hospitalized or died compared with three who received the therapy, an 85% reduction.

“While preventive measures, including vaccines, can reduce the total number of cases, sotrovimab is an important treatment option for those who become ill with COVID-19 and are at high risk—allowing them to avoid hospitalization or worse,” stated Adrienne E. Shapiro, MD, PhD, of the Fred Hutchinson Cancer Research Center in a GSK news release. Shapiro was an investigator in the clinical trial.

The EUA allows use of sotrovimab in patients who have tested positive for SARS-CoV-2, have mild-to-moderate symptoms, and “who are at high risk for progression to severe COVID-19, including hospitalization or death. This includes, for example, individuals who are 65 years of age and older or individuals who have certain medical conditions.” It is not authorized for patients who are hospitalized or for those who require oxygen therapy.

The therapy was originally known as VIR-7831. The companies say they have developed a similar treatment, VIR-7832, with modifications designed to enhance T cell function against the disease.

In “The Dual Function Monoclonal Antibodies VIR-7831 and VIR-7832 Demonstrate Potent In Vitro and In Vivo Activity Against SARS-CoV-2,” published on bioRxiv, researchers from Vir Biotechnology wrote that the S309 antibody was isolated from a survivor of the earlier outbreak of SARS-CoV-1.

The antibody, they wrote, targets a region of the SARS-CoV-1 spike protein that is “highly conserved” among sarbecoviruses. Clinical laboratory testing, they wrote, also indicated that the therapy was likely to be effective against known SARS-CoV-2 variants.

“Our distinctive scientific approach has led to a single monoclonal antibody that, based on an interim analysis, resulted in an 85% reduction in all-cause hospitalizations or death, and has demonstrated, in vitro, that it retains activity against all known variants of concern, including the emerging variant from India,” stated Vir Biotechnology CEO George Scangos, PhD, in the GSK news release. “I believe that sotrovimab is a critical new treatment option in the fight against the current pandemic and potentially for future coronavirus outbreaks, as well.”

Pathologists and clinical laboratory managers working with rapid molecular tests and antibody tests for COVID-19 will want to monitor the development of monoclonal antibody treatments, as well as further research studies that focus on these specific antibodies.

Stephen Beale

Related Information:

Reduced Sensitivity of SARS-CoV-2 Variant Delta to Antibody Neutralization

SARS-CoV-2 RBD Antibodies That Maximize Breadth and Resistance to Escape

This ‘Super Antibody’ for COVID Fights Off Multiple Coronaviruses

Scientist at Berkeley Lab Played a Hand in “Inescapable” COVID-19 Antibody

Decades-Old SARS Virus Infection Triggers Potent Response to COVID Vaccines

The Dual Function Monoclonal Antibodies VIR-7831 and VIR-7832 Demonstrate Potent In Vitro and In Vivo Activity Against SARS-CoV-2

How Studies of Coronavirus Immunity Can Inform Better Vaccines, Treatments

Scientists Discover Antibodies That May Neutralize a Range of SARS-CoV-2 Variants

New Star Trek-like Handheld Device under Development That Can Detect SARS-CoV-2 in People and on Surfaces

Intriguing technology may find immediate value in assisting the detection and tracking of COVID-19 worldwide

Pathologists and clinical laboratory personnel old enough to have watched Star Trek on television will recall the tricorder, a multi-functional handheld device that could non-invasively detect any disease or medical condition that the science fiction series needed to be revealed. Fiction, yes, but so was the Star Trek communicator before the advent of smartphones.

Now, Florida-based Advanced Medical Solutions International (AMSI) anticipates bringing to market in early 2022 a similar tricorder-like handheld device that detects SARS-CoV-2 in humans and on contaminated objects and surfaces.

AMSI’s COVID Hunter™ device would be the world’s first noninvasive touchless viral detector for COVID-19, which has reportedly killed 4.55 million people worldwide. The inventors make the point that the device is simply to detect the presence of the coronavirus. It is not a diagnostic test.

For clinical laboratory scientists, this is yet another example of new technology being applied to a clinical problem that could ultimately lead to new diagnostic tools, not only for COVID-19, but ultimately for other viruses as well.

COVID hunter

Pictured above is the actual COVID Hunter device that was extensively used in testing around the world. According to AMSI, this breakthrough technology can immediately detect COVID-19 in a person’s throat, lungs, sinuses, and breath, or on skin or clothes. High-touch areas such as door handles, mobile phones, and desktops also could be routinely checked for the virus and sanitized, breaking the transmission chain. (Photo copyright: Advanced Medical Solutions International.)

According to the COVID Hunter™ website, the device’s proprietary detection method utilizes a US-patent-pending detection technology that was initially invented by Engineer Nassar Said, a partner and inventor at AMSI. The method for detecting SARS-CoV-2 (the coronavirus that causes COVID-19) utilizes the above patent-pending detection technology and was invented and developed by Nassar Said and Adeeb Al-Zoubi, PhD, immunologist, and AMSI co-founder and Chief Scientific Officer.

According to the inventors, the detection technology employed by the COVID Hunter™ utilizes a combination of radio frequency (RF) and infrared (IR) electromagnetic waves to detect the RNA and spike protein found in the SARS-CoV-2 coronavirus with greater than 99% specificity and 99% sensitivity from as far as six feet away.

Al-Zoubi described the groundbreaking technology in a January 2021 news conference introducing the device. “This patent-pending technology uses a unique combination of light waves and sound waves combined to hone in on specific physical, chemical, and biological characteristics of SARS-CoV-2,” he said.

“We are basically surrounding the virus and characterizing the virus on all its characteristics all at once,” he continued. “Through focused research and tireless work, we at AMSI and Stem Cells Arabia [a Jordanian scientific research company] analyzed and specified these physical, chemical, and biological characteristics of SARS-CoV-2 and used these characteristics as one single value to target the detection by the COVID Hunter™.

“The sum of these specific SARS-CoV-2 characteristics is not found in any other virus or any other targets and constitutes a unique thumbprint of the virus,” he added.

Nassar Said, Donald Redman and Adeeb Al-Zoubi, PhD

“The handheld COVID Hunter will revolutionize the way SARS-CoV-2 (including mutated strains) is detected, slowing the spread of the deadly virus, saving lives, and returning life to ‘normal’ in the near future,” said AMSI co-founder and CEO Donald Redman (above center), with technology inventor/AMSI partner Nassar Said (left) and AMSI co-founder/Chief Scientific Officer and COVID Hunter™ co-inventor Adeeb Al-Zoubi, PhD (right), in a news release.

The COVID Hunter™ introductory press conference noted:

  • The COVID Hunter™ showed 100% accuracy and 100% specificity to detect only SARS-CoV-2 positive samples, distinguishing COVID-19 from viruses such as SARS-CoV-1, MERS, Influenza, and HIV,
  • The COVID Hunter detected all PCR positive COVID-19 test samples among more than 4,000 nasal swabs.
  • When more than 1,000 human subjects were tested with both PCR testing and the COVID Hunter, the device confirmed as positive all confirmed COVID-19 cases.
  • 4.8% of PCR false negatives in human subjects were accurately detected by the COVID Hunter as COVID-19 positive, indicating superior sensitivity to PCR testing.
  • 76 out 94 confirmed COVID-19 positive individuals were shown to be infective, meaning they could transmit the disease.
  • The COVID Hunter was able to track the mode of transmission of COVID-19 as the virus moved from hand to mouth to other people and objects. Developers found that a healthy individual who shook hands with an infected person could transmit the virus to a third party without becoming infected themselves.
  • Researchers detected COVID-19 on the feet of domestic pets, indicating pets could transmit the virus to multiple persons within a household.

Al-Zoubi said nine months of research and development resulted in several COVID Hunter prototypes that demonstrated accuracy, specificity, and sensitivity in experiments using both nasal swab samples and confirmed COVID-19 patients residing in quarantine areas and hospitals in different countries.

“I am excited to see the COVID Hunter go from the prototype phase to a fully refined manufactured device that can be used to save lives around the world,” Al-Zoubi said in his concluding remarks.

Mass Production of COVID-Hunter

In an exclusive interview with Dark Daily, Redman and Al-Zoubi said they are seeking additional investor backing so they can shift from product refinement to high-volume manufacturing. If funding is secured this fall, their goal is to begin production in January 2022 of up to 30,000 units per month, which are projected to sell for $3,000 per device. Initially, the COVID Hunter would be marketed only as a COVID-19 detection tool under Federal Trade Commission (FTC) regulations.

Once manufacturing begins, AMSI will be able to submit the required number of COVID Hunter devices to the federal Food and Drug Administration (FDA) for review, the final step in its application for Emergency Use Authorization (EUA) of the COVID Hunter as a COVID-19 diagnostic device. The company expects its expedited EUA review to be completed by early spring.

AMSI notes that COVID Hunter can perform up to 300 scans per hour and does not use consumables other than batteries. This, according to Al-Zoubi, makes it a game-changing device for the travel industry, schools, businesses, restaurants, professional sports franchises, and concert venues seeking a return to “normal” operations.

The COVID Hunter currently is loaded with programs that can detect the various mutations of SARS-CoV-2, including the latest Delta Variant.

The COVID Hunter also will be capable of being updated online to precisely detect new virus mutations, making it a critical weapon to defeat the pandemic as new COVID-19 mutations are found.

“This device is highly tested and it’s much more accurate than PCR [testing] because it detects the virus based on the physical presence of the virus, not based on chemical reactions or antibodies,” Al-Zoubi told Dark Daily. “We have gone beyond proof-of-concept testing.”

Clinical pathologists will want to follow development of the COVID Hunter and see if it eventually receives FDA approval. It may fulfill its promise as a game-changing new technology, not just for detection, but also for diagnosis.

The inventors and developers of the COVID Hunter will present their technology and its potential uses in detection and diagnosis at the upcoming Executive War College on Laboratory and Pathology Management, which takes place at the San Antonio Hyatt Riverwalk Hotel on Nov. 2-3, 2021.

Adeeb Al-Zoubi, PhD, and Nassar Said will conduct the session titled “New Technology Preview: Meet the COVID Hunter, a Non-Invasive, Touchless, Immediate, and Portable Detection Device That Identifies the SARS-Cov-2 Virus.”

Medical laboratory professionals interested in attending this informative presentation can register by clicking here or by copying your browser.

Andrea Downing Peck

Related Information

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