Testing & Treatment | COVID-19 CENTRAL @THEU

New COVID-19 antibody test helps keep track of immunity to variants

January 26, 2023

The experts agree — the pandemic is not over. Infections are ticking up again, fueled by new variants our immune systems are ill prepared for.

That’s according to a study which found that the antibodies generated in people who were vaccinated and/or recovered from COVID-19 prior to 2022 failed to neutralize the variants circulating today.

The study was led by Shawn Owen, PhD, an assistant professor of pharmaceutics and pharmaceutical chemistry at University of Utah Health and Igor Stagljar, PhD, a professor of biochemistry and molecular genetics, at the University of Toronto’s Temerty Faculty of Medicine.

The journal Nature Communications published their findings.

The researchers say the antibody test they developed to measure immunity in the study’s participants will be a valuable tool for deciding who needs a booster and when, which will help save lives and avoid future lockdowns.

“As the pandemic stretches on, we need ways to determine if people are protected from infection or reinfection,” Owen says. “Our assay can help monitor the level of immunity a person has after they’ve been vaccinated or infected. It can also reveal the level of protection against new variants which can help guide decisions about when to get a booster or if a new vaccine is needed.”

Many antibody tests have been developed over the past two years. But only a few authorized tests are designed to monitor neutralizing antibodies, which coat the viral spike protein so that it can no longer bind its receptor and enter cells.

It’s an important distinction, as only a fraction of all Sars-CoV-2 antibodies generated during infection are neutralizing. And while most vaccines were specifically designed to produce neutralizing antibodies, it’s not clear how much protection they give against variants

“The truth is we don’t yet know how frequent our shots should be to prevent infection,” Stagljar says. “To answer these questions, we need rapid, inexpensive and quantitative tests that specifically measure Sars-CoV-2 neutralizing antibodies, which are the ones that prevent infection.”

To meet this need, the research team developed Neu-SATiN, which stands for Neutralization Serological Assay. The effort was was spearheaded by Sun Jin Kim, a postdoctoral fellow in Owen’s lab and Zhong Yao, a senior research associate in Stagljar’s lab, who are the co-first authors on the paper.

The method is as accurate as, but faster and cheaper than, the current gold standard assay, and it can be quickly adapted for new variants as they emerge, according to the researchers.

“The biggest advantage of Neu-SATiN over other surrogate assays is the modularity,” Kim says. “Each of the Neu-SATiN’s assay components are genetically engineered and recombinantly expressed making them relatively easy to modify and produce. This enables Neu-SATiN to be a truly “mix-and-read” assay.”

The pin prick test is powered by the fluorescent luciferase protein from a deep-water shrimp. It measures the ability of the viral spike protein to bind the human ACE2 receptor, each of which is attached to a luciferase fragment.

The binding brings the luciferase pieces into proximity so that they reconstitute a full-length protein, which gives off a glow of light that is captured by instrumentation. When patient blood sample is added into the mixture, the neutralizing antibodies will bind the spike protein, preventing it from contacting ACE2. Luciferase remains in pieces, with an accompanying drop in light signal.

The plug and play method can be adapted to different variants within a couple of weeks by engineering variant mutations into the spike protein.

The researchers applied Neu-SATiN to blood samples collected from 63 patients with different histories of COVID-19 infection and vaccination up to November 2021. Their antibody neutralizing capacity was assessed against the original Wuhan strain and the variants, Alpha, Beta, Gamma, Delta and Omicron.

The neutralizing antibodies were found to last about three to four months. At that time, their levels dropped by about 70 per cent irrespective of infection or vaccination status. Hybrid immunity, acquired through both infection and vaccination, produced higher antibody levels at first, but also dropped significantly four months later.

Most worryingly, infection and/or vaccination provided good protection against the previous variants, but not Omicron, or its sub-variants, BA.4 and BA.5.

The researchers stress that vaccines still confer significant protection from severe disease and death. However, that the findings from Owen’s team and others call for vigilance in the coming period, given that the more transmissible BA.4 and BA.5 sub-variants can escape immunity acquired from earlier infections with Omicron. as attested by rising reinfections.

Moving forward, the researchers hope to expand its availability.

“We are working with a few companies to assess the efficacy of their vaccine candidates against Omicron and also negotiating a license with another company to commercialize the assay,” Owen says.

The research was supported with funding from the Office of the Vice President for Research and the 3i Initiative at the University of Utah, and the Toronto COVID-19 Action Fund.

MRNA vaccines significantly reduce severity of Delta, Omicron COVID-19 infections

January 26, 2023

Original story at U of U Health.

People who have received two or three doses of an mRNA COVID-19 vaccine are significantly more likely to have milder illnesses if infected with the Delta or Omicron coronavirus variants than those who are unvaccinated, according to a nationwide study involving a team of University of Utah researchers.

The study, which examined health care personnel, first responders and other frontline workers in Utah and five other states, builds on previous research that indicates mRNA vaccines provide protection against severe health outcomes associated with COVID-19 despite the variants’ increased transmissibility.

“It’s encouraging that the mRNA vaccines hold up rather well against these variants,” said Sarang Yoon, D.O., a study co-author who leads the Utah portion of the research and is part of the Rocky Mountain Center for Occupational and Environmental Health, a partnership between the University of Utah and Weber State University. “We know that breakthrough cases are more likely with Delta and Omicron than the initial strain, but the vaccines still do a good job of limiting the severity of the infection.”

The study was published Tuesday in the Journal of the American Medical Association (JAMA). It is the latest of several peer-reviewed papers resulting from the nationwide HEROES-RECOVER project funded by the U.S. Centers for Disease Control and Prevention.

Researchers examined 1,199 participants who developed COVID-19 infections. Of the participants, 24% were infected with Delta and 62% contracted Omicron, while 14% had the original virus strain.

Delta highlights:

Participants who had received two vaccine doses were significantly less likely to be symptomatic than those who were unvaccinated (77.8% vs. 96.1%)
Symptomatic participants with a third dose were far less likely to experience fever or chills than those who were unvaccinated (38.5% vs. 84.9%) and experienced symptoms for an average of six fewer days (10.2 days vs. 16.4 days)

Omicron highlights:

The risk of symptomatic infection was similar between participants with two vaccine doses and those who were unvaccinated, while those with three doses experienced a higher risk than the unvaccinated (88.4% vs. 79.4%)
Symptomatic participants with three doses were significantly less likely to experience fever or chills (51.5% vs 79%) or seek medical care (14.6% vs 24.7%) than the unvaccinated

The authors noted that, while the study is among the largest of its kind examining COVID-19 vaccines over time and across variants, grouping participants by variant and vaccine status resulted in some combinations with relatively few people, affecting the precision of the findings. They also indicated that the study was not able to account for all factors influencing COVID-19 severity, which may skew the results. There were also results the authors characterized as “unexpected” among participants who received three doses and had symptomatic Omicron infections.

Researchers gathered data between Dec. 14, 2020, and April 19, 2022. Participants submitted self-collected nasal swabs weekly regardless of COVID-19 symptoms, as well as at the beginning of experiencing signs of illness. Participants were excluded from the study if they had infections before the study start date, or if their infections occurred: sooner than 14 days after their second vaccine dose, sooner than seven days after their third dose or more than 149 days after their third dose.

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Other co-authors associated with the University of Utah and Rocky Mountain Center for Occupational and Environmental Health include Kurt Hegmann, M.D.; Matthew Thiese, P.h.D; Andrew Phillips, M.D.; Jenna Praggastis, B.S.; and Matthew Bruner, B.S.

Proteins in saliva could aid in COVID-19 detection and predict severe illness

April 15, 2022

Reprinted with permission from the American Physiological Society.

Researchers have identified a family of proteins that is significantly elevated in the saliva of patients hospitalized with COVID-19. The proteins, known as ephrin ligands, could potentially serve as a biomarker to help doctors identify patients who are at risk for serious illness.

“Ephrins are detectable in saliva samples and could serve as adjunct markers to monitor COVID-19 disease progression,” said study author Erika Egal, DVM, PhD, a postdoctoral fellow in the laboratory of Patrice Mimche, PhD, in the Department of Pathology at University of Utah Health in Salt Lake City. “We can collect saliva without harm or discomfort for most patients, which can reveal patient responses to COVID-19 and potentially guide care.”

Egal presented the findings at the American Physiological Society annual meeting during the Experimental Biology (EB) 2022 meeting, held in Philadelphia April 2–5.

For the study, researchers analyzed saliva samples collected from patients admitted to the University of Utah Hospital emergency department with respiratory symptoms. Sixty-seven of the patients tested positive for COVID-19 while 64 patients did not. They found that the presence of ephrin ligands in saliva was strongly associated with the diagnosis of severe COVID-19.

Researchers said the study findings could help shed light on the biological processes involved in severe reactions to COVID-19 infection. Previous studies suggest ephrins play a role in injury and inflammation. The scientists say more research is needed to determine whether ephrin concentrations are linked with a higher likelihood of hospitalization, critical illness or death. In addition, as new viral variants emerge, it can be difficult to tell whether existing COVID-19 tests are able to accurately detect infections involving new variants. Looking for ephrins in saliva could offer a simple, non-invasive way to provide corroborating evidence when there is inconsistency between test results and the clinical picture, Egal said.

“Saliva is packed with information beyond detecting the COVID-19 infection itself,” said Mimche. “We demonstrate that immune cells, cytokines and soluble proteins can be reliably measured from saliva samples. Our findings provide a starting point for investigations looking into causal pathways between infection and bad medical outcomes.”

The research was overseen by Mimche in collaboration with Theodore Liou, MD and My N. Helms, PhD, from the Department of Internal Medicine at University of Utah Health, as part of a multidisciplinary project to better understand the biology of SARS-CoV-2 and how it causes serious COVID-19 infections.

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About Experimental Biology 2022

Experimental Biology (EB) is the annual meeting of five scientific societies bringing together thousands of scientists and 25 guest societies in one interdisciplinary community. With a mission to share the newest research findings shaping clinical advances, EB offers an unparalleled opportunity to tap into the latest research in anatomy, biochemistry, molecular biology, investigative pathology, pharmacology and physiology. The Experimental Biology 2022 meeting will be held April 2–5 at the Pennsylvania Convention Center in Philadelphia. www.experimentalbiology.org #expbio

About the American Physiological Society (APS)

Physiology is a broad area of scientific inquiry that focuses on how molecules, cells, tissues and organs function in health and disease. The American Physiological Society connects a global, multidisciplinary community of more than 10,000 biomedical scientists and educators as part of its mission to advance scientific discovery, understand life and improve health. The Society drives collaboration and spotlights scientific discoveries through its 16 scholarly journals and programming that support researchers and educators in their work. http://www.physiology.org

Convalescent plasma could lower hospitalization risk for newly infected COVID-19 patients

April 15, 2022

Early treatment of newly diagnosed COVID-19 patients with plasma extracted from individuals who have recovered from the disease reduces the need for hospitalization by more than 50%, according to a new nationwide clinical trial.

The researchers, including scientists at University of Utah Health, say the study provides solid evidence that the use of plasma from convalescent patients—containing high levels of antibodies against SARS-CoV-2, the virus that causes COVID-19—should be part of the treatment arsenal for the disease and other emerging viral threats to global health.

The study, led by scientists at Johns Hopkins University School of Medicine in Baltimore, appears in the April 6, 2022 issue of the New England Journal of Medicine.

During the outpatient study, conducted between June 2020 and October 2021, the researchers randomly treated 1,181 patients with either plasma containing SARS-CoV-2 antibodies taken from individuals who had recovered from the disease or a placebo plasma that contained no SARS-CoV-2 antibodies. Patients were aged 18 or older and had tested positive for SARS-CoV-2 in the previous eight days.

Emily Spivak, associate professor of medicine in the Division of Infectious Diseases at U of U Health

Of the 592 patients who received convalescent plasma, only 17 (2.9%) required hospitalization within 28 days of transfusion. In contrast, 37 of 589 patients (6.3%) who were given the placebo plasma were hospitalized within a month. Overall, the findings translated into a 54% reduction in the relative risk of hospitalization for those who received convalescent plasma.

The researchers conclude that convalescent plasma is a viable early treatment for COVID-19 that has the advantages of being low-cost and widely available, particularly in countries with little or no access to vaccines and other treatments such as monoclonal antibodies. Since each person who recovers from a variant of COVID-19 produces antibodies that subdue that specific virus, convalescent plasma treatment can potentially keep new strains of SARS-CoV-2 in check.

“In theory, if you collect plasma from donors who have recovered from omicron or another new variant, they will likely have plenty of antibodies for that variant,” says Emily Spivak, a co-author of the study and an associate professor of medicine in the Division of Infectious Diseases at U of U Health. “As a result, convalescent plasma is theoretically more adaptable and may deal with new variants faster than other treatments currently available.”

The study, “Randomized Controlled Trial of Early Outpatient COVID-19 Treatment with High-Titer Convalescent Plasma,” appears in the April 6, 2022, issue of the New England Journal of Medicine. It was supported by the U.S. Department of Defense’s (DOD) Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO- CBRND), in collaboration with the Defense Health Agency (DHA). Additional support was provided by Bloomberg Philanthropies, State of Maryland, the National Institutes of Health (NIH) National Institute of Allergy and Infectious Diseases (NIAID), NIH National Center for Advancing Translational Sciences (NCATS), Division of Intramural Research NIAID NIH, Mental Wellness Foundation, Moriah Fund, Octapharma, HealthNetwork Foundation and the Shear Family Foundation.

University of Utah Health provides leading-edge and compassionate care for a referral area that encompasses 10% of the U.S., including Idaho, Wyoming, Montana and much of Nevada. A hub for health sciences research and education in the region, U of U Health touts a $428 million research enterprise and trains the majority of Utah’s physicians, including more than 1,460 health care providers each year at its Colleges of Health, Nursing and Pharmacy and Schools of Dentistry and Medicine. With more than 20,000 employees, the system includes 11 community clinics and five hospitals. For 11 straight years, U of U Health has ranked among the top 10 U.S. academic medical centers in the rigorous Vizient Quality and Accountability Study.

Can salivary glands infected with COVID-19 increase risk for relapse or reinfection?

February 28, 2022

University of Utah Health scientists are leading an effort to determine if salivary glands infected with the virus that causes COVID-19 could diminish a person’s long-term immunity to the disease after being immunized or after recovering from the illness.

The investigation, supported by a two-year grant from the National Institutes of Health, will explore whether salivary glands that have SARS-CoV-2 can lessen the body’s ability to make antibodies that would protect it against reinfection by the virus.

A graphic drawing of a person with inflamed salivary glands injected with viruses.

A person with viral inflammation of the salivary glands. Vector illustration of sialolithiasis. Photo credit: Getty Images

Viruses like SARS-CoV-2 are commonly found in salivary glands. How SARS-CoV-2 gets there, though, is still a mystery. Typically, viruses can enter the salivary glands through the moist inner lining of the oral cavity, called mucosa, or travel there via the bloodstream, says Melodie Weller, Ph.D., an assistant professor of dentistry who is leading the new study.

Like some other parts of the body, the salivary glands have what is known as “immune privilege,” meaning that even though they are infected, the immune system may not effectively clear pathogens within the glands. As a result, the salivary glands can be a lingering repository for viruses such as SARS-CoV-2 and other viruses.

Proteins that we are exposed to in our digestive tract can trigger what is called “oral tolerance.” As a result, our immune system won’t produce antibodies to these proteins, such as those in the foods that we eat, Weller says. However, because viruses contain proteins, they too may be overlooked by the immune system in the gastrointestinal tract.

“If viral proteins are released into the saliva––and we swallow a lot of saliva every day––then they may have the capacity to decrease our ability to make antibodies,” Weller says. “That can have an impact on how long immunity will last. So, the better we can understand the role of SARS-CoV-2 in the salivary glands, the better we’ll understand how reinfection and breakthrough infections after immunization are occurring during this pandemic.”

The researchers suspect that SARS-CoV-2 released from the salivary glands may inhibit the production of antibodies—and, as a result, increase the risk of relapse or reinfection. They also could limit the long-term effectiveness of vaccines.

Weller and colleagues are testing this hypothesis in mice, expressing SARS-CoV-2 viral proteins in the salivary glands. They plan to vaccinate these animals to see how they respond.

“If they’re getting viral protein exposure in the gut through swallowing saliva, then we will likely see a decrease in immunity or a decrease in the duration of the immune response,” Weller says.

mRNA vaccines slash risk of COVID-19 infection by 91 percent

November 2, 2021

People who receive mRNA COVID-19 vaccines are up to 91 percent less likely to develop the disease than those who are unvaccinated, according to a new nationwide study of eight sites, including Salt Lake City. For those few vaccinated people who do still get an infection, or “breakthrough” cases, the study suggests that vaccines reduce the severity of COVID-19 symptoms and shorten its duration.

Researchers say these results are among the first to show that mRNA vaccination benefits even those individuals who experience breakthrough infections.

“One of the unique things about this study is that it measured the secondary benefits of the vaccine,” says Sarang Yoon, D.O., a study co-author, assistant professor at the University of Utah Rocky Mountain Center for Occupational and Environmental Health (RMCOEH), and principal investigator of the RECOVER (Research on the Epidemiology of SARS-CoV-2 in Essential Response Personnel) study in Utah.

The study, published online in the New England Journal of Medicine, builds on preliminary data released by the Centers for Disease Control and Prevention (CDC)in March.

The study was designed to measure the risks and rates of infection among those on the front lines of the pandemic.

“We gave these vaccines to some of the highest risk groups in this country—doctors, nurses, and first responders,” Yoon says. “These are the people who are getting exposure to the virus day in and day out, and the vaccine protected them against getting the disease. Those who unfortunately got COVID-19 despite being vaccinated were still better off than those who didn’t.”

Sarang Yoon, D.O., assistant professor at the University of Utah Rocky Mountain Center for Occupational and Environmental Health.

The study found that mRNA COVID-19 vaccines were:

91% effective in reducing risk for infection once participants were “fully” vaccinated, two weeks after the second dose.
81% effective in reducing risk for infection after “partial” vaccination, two weeks after the first dose but before the second dose was given.

The HEROES-RECOVER network recruited 3,975 participants at eight sites. In addition to Salt Lake City, sites included Miami, Florida; Temple, Texas; Portland, Oregon; Duluth, Minnesota; and Phoenix and Tucson, as well as other areas in Arizona. Participants submitted samples for COVID-19 testing on a weekly basis for 17 weeks between Dec. 13, 2020 and April 10, 2021. Participants also reported weekly whether they had COVID-19-like symptoms, including fever, shortness of breath, and loss of taste and smell.

Only 204 (5%) of the participants eventually tested positive for SARS-CoV-2, the virus that causes COVID-19. Of these, 156 were unvaccinated, 32 had an indeterminate vaccine status, and 16 were fully or partially vaccinated. The fully or partially vaccinated participants who developed breakthrough had milder symptoms than those who were unvaccinated:

Presence of fever was reduced 58% percent among those vaccinated with a breakthrough infection.
Days spent sick in bed were reduced by 60% among those who developed a breakthrough infection.
Detection of the virus was reduced by 70% percent among those with breakthrough infections, from 8.9 days to 2.7 days.
The three people who were hospitalized were not immunized, meaning that no one who developed a breakthrough infection was hospitalized.

These findings also suggest that fully or partially vaccinated individuals who get COVID-19 might be less likely to spread the virus to others. The researchers found that infected study participants who had been fully or partially vaccinated when infected had 40% less detectable virus in the nose and did so for six fewer days compared to those who were unvaccinated.

Overall, the researchers conclude the study’s findings support the CDC’s recommendation to get fully vaccinated as soon as possible.

“I hope these findings reassure the public that mRNA COVID-19 vaccines are safe and protect us from this severe disease,” Yoon says.

The RECOVER study is ongoing, and results from future phases will help determine how long COVID-19 vaccines protect against infection and the real-world effectiveness of newer vaccines. A new study will test the same questions in children 12 and older who are now eligible to receive the COVID-19 vaccination. The research will also investigate how well COVID-19 vaccines protect against new variants now circulating in the U.S., including the highly transmissible Delta variant of SARS-CoV-2.

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The study, “Prevention and Attenuation of Covid-19 with the BNT162b2 and mRNA-1273 Vaccines,” appears in the New England Journal of Medicine.

In addition to Dr. Yoon, Kurt Hegmann, M.D., director of RMCOEH, Matthew Thiese, Ph.D., associate professor, and Andrew Phillips, M.D., assistant professor of RMCOEH, were co-investigators on the Utah portion of the study.

COVID-19 vaccine effectiveness dips, but remains potent deterrent

November 2, 2021

COVID-19 vaccines remain effective, but their potency has diminished in recent months, according to a nationwide study at eight sites, including Salt Lake City, Utah.

Scientists calculated vaccine effectiveness to be 80% in a large group of fully vaccinated frontline workers between December 2020 and August 2021, compared to 91% in earlier surveys. The estimates were based on COVID-19 RT-PCR testing and did not measure whether there were changes in efficacy in protecting against severe disease, including hospitalization and death.

The authors say one reason for the change could be waning immunity, a decrease in the strength over time of the body’s vaccine-activated defenses against the virus. The difference may also reflect the fact that the vaccines are not as effective against the highly contagious Delta variant of the SARS-CoV-2 virus, which since June 2021, has become the most common cause of COVID-19 in the U.S.

“The vaccines are still helping save lives and keep people from getting sick despite a slight diminishing return over many months,” explains Matthew Thiese, Ph.D., associate professor at the University of Utah Rocky Mountain Center for Occupational and Environmental Health (RMCOEH). “These data, combined with other data, demonstrate that vaccinated people are much less likely to get COVID-19 and are much less likely to be hospitalized.” Thiese is co-investigator and RMCOEH assistant professor Sarang Yoon, D.O., is primary investigator of the HEROES-RECOVER (Research on the Epidemiology of SARS-CoV-2 in Essential Response Personnel) study site in Utah.

The study published on August 24 in the Morbidity Mortality Weekly Report (MMWR) from the Centers for Disease Control and Prevention (CDC). Additional study sites in the HEROES-RECOVER network are Phoenix, Tucson, and other areas in Arizona; Miami, Florida; Portland, Oregon; Duluth, Minnesota; and Temple, Texas.

The network followed 4,136 health care personnel, first responders, and essential workers who had not previously had COVID-19. Study participants submitted samples for RT-PCR testing on a weekly basis and 2,976 participants were fully vaccinated within the study period, receiving either the Pfizer-BioNtech (65%), Moderna (33%), or Johnson & Johnson (2%) vaccines. Test results from these groups between December 14, 2020, to August 14, 2021, show that:

Among unvaccinated study participants, 194 infections occurred in 181,357 person-days (combined total of number of days of testing for this group).
Among fully vaccinated participants, 34 infections occurred in 454,832 person-days.

During that time period, the vaccines were 80% effective for all fully vaccinated study participants, but preliminary data indicate that vaccines may wane in intensity over time with lower effectiveness after five or more months following full vaccination. In addition, the vaccines appeared to be less effective during the last 43 days of the study period when Delta became the predominant virus variant. However, because sample sizes were small, these results were not statistically significant. These trends will be investigated further in future studies.

“These data show that the vaccine is still quite effective against the different strains of COVID-19, including the Delta variant,” Thiese says. “The protection people get from the vaccine is keeping people from getting COVID-19 at a ratio of 14 to 1. As these data continue to come in, they are going to help chart recommendations for masking, social distancing, and booster shots.”

Test to play and to stay

June 7, 2021

When COVID-19 cases began to rise dramatically in Utah in November 2020, schools faced a difficult choice. They could maintain normal activities, giving students valuable in-person instruction and social interaction but risking spread of COVID-19. Or they could send students home, keeping them safe from disease but putting their education, emotional health and social well-being at risk.

With a goal of preserving the best of both worlds, Utah Department of Health (UDOH) implemented two COVID-19 testing programs in collaboration with local health departments and Utah schools. These programs helped students participate in extracurricular activities and stay in school while likely reducing spread of the virus.

“For most students, being able to attend school in-person and participate in extracurricular activities is best for their learning as well as their social and emotional well-being,” says Adam Hersh, senior author on the study, professor of pediatrics at University of Utah Health, and Utah HERO investigator. Hersh collaborated with UDOH to study these testing programs. “When combined with other prevention strategies, most importantly masking, these testing strategies helped keep our schools safe and open.”

Testing allowed for the completion of 95% of more than 11,000 high school extracurricular competition events and saved an estimated 109,752 in-person instruction days for students. The results were published in the Centers for Disease Control and Prevention Morbidity and Mortality Weekly Report (MMWR).

“Before the school year started, our school communities advocated for safe in-person education and participation in extracurricular activities,” says Kendra Babitz, COVID-19 State Testing Coordinator, UDOH. “Their dedication to maintaining optimal environments for learning and growth made these programs a success and kept kids in school.”

One COVID-19 testing program, “Test to Play”, was implemented in 66% (127 of 193) of Utah’s public high schools. In order to participate in extracurricular activities such as sports, students took part in mandatory, rapid antigen testing every 14 days.

“Test to Stay” was presented as an option when schools had outbreaks. Of the 28 high schools that reported outbreaks, 13 elected to conduct school-wide Test to Stay events. Students who tested positive were required to isolate for 10 days while students who tested negative could continue in-person learning.

Between November 30, 2020, and March 20, 2021, schools reported 165,078 tests. Among the 59,552 students tested, 1,886 (3.2%) had a positive result.

The study authors say that by identifying these positive cases, the testing programs likely helped reduce the spread of COVID-19 in schools and the community by enabling the students who tested positive to isolate while their close contacts could quarantine.

“Utah’s high school testing programs could not have been successful without the willingness, flexibility, and innovation of school staff,” said Commander William A. Lanier, lead author of the study and U.S. Public Health Service officer who was assigned to the UDOH to help with COVID-19 testing. “Their hard work helped preserve extracurricular and in-person learning opportunities for Utah students during a very challenging time.”

New partnership to develop a new ultra-fast test for COVID-19 antibodies

May 4, 2021

Find the original release online: https://pivotcenter.utah.edu/press-release/university-of-utah-arup-and-techcyte-develop-nanospot-ai-a-new-ultra-fast-test-for-covid-19-antibodies/

The University of Utah, ARUP Laboratories, and Techcyte Inc. announced today that they have formed a partnership to develop NanoSpot.AI, a less than five-minute, easy-to-administer SARS-CoV-2 antibody test. NanoSpot.AI is estimated to be significantly less expensive to manufacture than other SARS-CoV-2 antibody tests, so it has the potential to be considerably more affordable than currently available tests, making it possible to extend the test to every corner of the world.

The patent-pending NanoSpot.AI is performed on a spot of blood obtained through a finger prick. Individuals then receive their test results on their mobile phones. The test could be used around the globe to help prioritize who should receive SARS-CoV-2 vaccinations, or to easily and quickly detect whether individuals have some immunity against COVID-19 for travel or immigration purposes. Clinical studies validating NanoSpot.AI are currently underway.

A close up of two people's hands. One person is wearing white rubber gloves pricking an ungloved finger. The testing card is on the table.

The NanoSpot.AI rapid COVID-19 antibody test is performed on blood collected through a finger prick using a microcollection tube. Droplets of blood are then placed on three spots on a ready-to-use, synthetic, embossed card. One of the spots displays the test result, while the other two spots are positive and negative controls for the test.

“Other antibody tests are available and are very good, but it takes time to get test results back and they’re relatively expensive,” said Hans Haecker, MD, PhD, who codeveloped NanoSpot.AI with Vanessa Redecke, MD, PhD. Both are professors in the U Pathology Department Division of Microbiology and Immunology. “Based on what we know so far, we believe NanoSpot.AI checks all the boxes,” Haecker said. “Because it is simple, fast, and very affordable, it can be done anywhere without specialized equipment, creating the potential for us to have an impact on human health around the world.”

The partners in NanoSpot.AI created a video that explains the science behind the assay, demonstrates how the test is administered, and provides details about the AI used to analyze and confirm test results.

“As a national reference laboratory, ARUP has a wide view of laboratory diagnostics,” said Mark Astill, ARUP director of Research and Development. “The expertise and experience we bring enabled what may be the first instance of combining seemingly disparate elements to produce a rapid, economical, QR-code-curated, consistent, point-of-care result.”

All NanoSpot.AI test components are provided in a self-contained kit. The person administering the test places droplets of blood in three small spots on a ready-to-use card. One of the spots displays the test result while the other two confirm the test was properly run. Antibodies against SARS-CoV-2 are quickly apparent because the blood spot begins to separate within seconds when the test result is positive.

To ensure accurate results, the person administering the test uses a mobile phone to take a photograph of the card, which is then transmitted to Techcyte for analysis using the company’s AI-based image analysis tool. Techcyte, a U startup company, is a developer of artificial intelligence (AI)-based image analysis solutions for the diagnostics industry.

A white index-sized card with the nanospot website on the top. The center has three open circles that you smear blood on. The sides have a QRT code.

When blood spots collected for the NanoSpot.AI rapid COVID-19 antibody test are mixed with a predispensed, dried reagent on the test card, the blood spot on the circle displaying the test result shows agglutination that indicates SARS-CoV-2 antibodies are present.

Techcyte CEO Ben Cahoon said the company modified its digital diagnostics platform to work with images captured by mobile phones rather than microscopes for NanoSpot.AI.

“Our platform breaks each blood spot into thousands of features that the AI uses to statistically determine which specimens are positive for SARS-CoV-2 antibodies,” Cahoon said.

Haecker said the assay can be easily adapted to test for antibodies to SARS-CoV-2 variants as new mutations emerge. The test can be viewed as a platform because it and the AI can be developed to test for antibodies against other viruses.

“This has been an extremely effective partnership and collaboration between the U, ARUP and Techcyte, demonstrating how university technology can be fast-tracked by collaborating with the right partners,” said Aaron Duffy, technology manager at the U’s Partners for Innovation, Ventures, Outreach & Technology (PIVOT) Center. PIVOT Center, which manages the U’s innovations and drives them to market, is now seeking partners to launch Nanospot.AI.

For more information, contact Duffy at PIVOT Center (aaron.duffy@utah.edu); Astill at ARUP (astillme@aruplab.com); or Cahoon at Techcyte (ben.cahoon@techcyte.com).

About PIVOT Center
The Partners for Innovation, Ventures, Outreach & Technology (PIVOT) Center leads the University of Utah’s centralized and integrated strategy and operation for technology commercialization, corporate engagement, and economic development. In doing so, PIVOT Center serves as a hub for the U to foster partnerships between industry, university, and government entities. The center formalizes the U’s commitment to broaden its impact on Utah’s economy by enhancing local and global collaborations to catalyze innovation. The center’s mission is to generate economic returns for the university and the state of Utah, expand the university’s reputation for innovation, and positively impact society. The University of Utah was recently ranked second among large research universities for “innovation productivity impact.”

About ARUP Laboratories
Founded in 1984, ARUP Laboratories is a leading national reference laboratory and a wholly-owned nonprofit enterprise of the University of Utah and its Department of Pathology. ARUP offers more than 3,000 tests and test combinations, ranging from routine screening tests to esoteric molecular and genetic assays. ARUP serves clients across the United States, including many of the nation’s top university teaching hospitals and children’s hospitals, as well as multihospital groups, major commercial laboratories, group purchasing organizations, military and other government facilities, and major clinics. In addition, ARUP is a worldwide leader in innovative laboratory research and development, led by the efforts of the ARUP Institute for Clinical and Experimental Pathology®. ARUP is ISO 15189 CAP accredited.

About Techcyte
Headquartered in Orem, Utah, Techcyte Inc. is the world leader in AI-based digital diagnostics for liquids and cells. Techcyte’s use of deep machine learning to perform automated analysis of both cellphone and microscopy images is revolutionizing human, animal and environmental diagnostics.

COVID-19 vaccines as effective in real-world settings as in clinical trials

April 7, 2021

mRNA COVID-19 vaccines offer substantial protection from infection by the novel coronavirus, SARS-CoV-2, in the “real-world”, concludes a large study carried out at six regions across the U.S. including Salt Lake City, Utah. The performance of the vaccines was consistent with their performance in closely controlled clinical trials that led to their approval for emergency use.

The results are particularly noteworthy considering that participants in the study were amongst those at highest-risk for being exposed to the virus, the researchers say. These included health care workers, first responders and essential workers who routinely come in close contact with the public as a routine part of their job.

“There are usually differences in how well interventions perform in clinical trials as compared to real-world settings,” explains Sarang Yoon, assistant professor at the University of Utah Rocky Mountain Center for Occupational and Environmental Health (RMCOEH) and principal investigator of the RECOVER (Research on the Epidemiology of SARS-CoV-2 in Essential Response Personnel) study in Utah. In this case, the results support a large body of evidence, from clinical trials and other research, showing that COVID-19 vaccines are very safe and effective.

“This research is showing how well these vaccines work,” says Yoon.

Sarang Yoon, assistant professor at the University of Utah Rocky Mountain Center for Occupational and Environmental Health and principal investigator of the RECOVER (Research on the Epidemiology of SARS-CoV-2 in Essential Response Personnel) study in Utah.

The study published on March 29 in the Morbidity Mortality Weekly Report (MMWR) from the Centers for Disease Control and Prevention. Kurt Hegmann, director of RMCOEH, Matthew Thiese, associate professor and Andrew Phillips, assistant professor of RMCOEH were co-investigators on the Utah study. Additional study sites that are part of the HEROES-RECOVER network are Phoenix and Tucson, Arizona; Portland, Oregon; Duluth, Minnesota; and Temple, Texas.

The study showed the mRNA COVID-19 vaccines were:

90% effective at reducing risk for infection once participants were “fully” vaccinated, two weeks after the second dose.
80% effective at reducing risk for infection after “partial” vaccination, two weeks after the first dose (before the second dose was given).

Among those fully vaccinated, there were only 3 infections among 2,479 workers and no severe COVID-19 infections or deaths in people who were vaccinated. This is much lower when compared to the period when participants were not immunized, 161 infections were identified.

The authors note that even though the vaccines were highly effective after one dose, it is not known how long that immunity lasts. The CDC recommends two doses of the Pfizer-BioNTech and Moderna vaccines.

3,950 study participants submitted samples for COVID-19 tests on a weekly basis for 13 weeks between December 14, 2020 to March 13, 2021. During that time, 2,479 participants have been fully vaccinated, receiving two doses of either the Pfizer-BioNTech or Moderna mRNA COVID-19 vaccine. In addition to submitting samples for COVID-19 test, participants reported weekly whether they had COVID-like symptoms including fever, shortness of breath and loss of taste or smell.

Study participants were:

Health care workers (e.g. physicians, nurses, medical assistants),
First responders (e.g. firefighters, police officers, staff at correctional facilities), and
Frontline and essential workers (e.g. teachers, hospitality, retail, restaurants, airlines).

Results from COVID-19 tests and surveys also showed that among those who tested positive for SARS-CoV-2, 87.3% had COVID-19 symptoms and 10.7% were asymptomatic.

“We are incredibly grateful to our participants for their time and dedication to the study.” says Yoon. “With their help, we will be able to better understand COVID-19 vaccine efficacy and COVID-19 illness.”

The RECOVER study is ongoing and results from future phases will help determine how long COVID-19 vaccines protect against infection and the real-world effectiveness of newer vaccines.

The research will also investigate how well COVID-19 vaccines protect against new variants of the SARS-CoV-2 virus that are highly transmissible and are now circulating in the U.S.

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The research publishes as, “Interim Estimates of Vaccine Effectiveness of BNT162b2 and mRNA-1273 COVID-19 Vaccines in Preventing SARS-CoV-2 Infection among Healthcare Personnel, First Responders, and Other Essential and Frontline Workers – Six U.S. Region, December 2020-March 2021.”