Detecting immunity to different COVID variants just got a whole lot easier. And soon for Monkeypox too.

Enable Biosciences Reports Easier SARS-CoV-2 Neutralizing Antibody Assay using Dried Blood Spot Samples

July 22, 2022, South San Francisco, CA

What's New:  Neutralizing antibodies help prevent a virus from attaching and entering cells to cause infection and disease. They are generated after infection or vaccination and facilitate immunity to reinfection. Measuring neutralizing antibodies against multiple COVID variants at the same time can now be accomplished easily, accurately, and rapidly from small drops of blood collected at home or in clinics on filter paper cards. Scientists at Enable Biosciences published a new high-throughput technique, termed SONIA, that uses patented DNA-barcoding technology, in the peer-reviewed journal Nature Communications. 

This work is the product of an international collaboration with scientists from the California Department of Public Health, Mayo Clinic, Oregon Health & Science University, Swiss Red Cross, University of Basel (Switzerland), Vitalant Research Institute and Cerus Corporation. 

https://www.nature.com/articles/s41467-022-31796-1

Why it matters:  Previously, measuring neutralizing antibodies accurately required expensive and time-consuming methods that rely on handling hazardous live virus. Live virus testing is limited to a few highly-secure biolevel 3 safety labs, mostly run by a small number of public health departments. Also, live virus testing cannot evaluate multiple COVID variants simultaneously. SONIA can. As primary and booster vaccination rates slow down, breakthrough COVID infections are now at an all time high with increasing numbers of hospitalizations and deaths. CDC Director Rochelle Walensky, MD, MPH, speaking at the White House COVID Response Team briefing July 12, 2022 stated that only 28% of adults older than 50 have received second boosters and could be at risk for severe disease. 

Levels of neutralizing antibodies are an important index of immunity against COVID variants. Measuring levels of neutralizing antibodies in the same people over time can provide vital insight into the real rate of waning immunity and inform optimal revaccination timing - once levels drop below an accepted threshold of protection. Insight from SONIA testing can thus help support public health surveillance and educational efforts to combat hesitancy, spur booster vaccination and inform the need for updated variant-specific vaccines. SONIA can help vaccine manufacturers rapidly, reliably and cost effectively measure neutralizing antibodies generated by their products to help guide their development and updates.

What’s Next:  SONIA is being used to measure neutralizing antibodies against a panel of COVID variants for a Centers for Disease Control (CDC)-funded California Department of Public Health’s (CDPH) statewide COVID antibody surveillance program called CalScope (www.calscope.org). SONIA is now available for use by public health departments, vaccine manufacturers, blood banks and researchers around the world. 

Going forward, SONIA may also be used to assess smallpox and monkeypox immunity in those vaccinated against these diseases. For people born before 1972 who routinely received smallpox vaccination, SONIA may show if they still have a useful level of smallpox neutralizing antibodies that can help cross-protect them against monkeypox. Leanna Wen, Professor at George Washington University's Milken Institute School of Public Health stated in the Washington Post July 26, 2022 : “To better ration limited vaccines, we also need to understand the degree of protection against monkeypox among older individuals who were previously vaccinated against smallpox.” For those receiving the JYNNEOS Monkeypox vaccine, SONIA may help public health and other researchers confirm they indeed generated an adequate neutralizing antibody response and, by re-testing antibodies levels over time, help inform the best booster schedule for vulnerable populations. While a full course of the JYNNEOS Monkeypox vaccine, like the smallpox vaccine, may provide robust and long-lasting immunity, for the elderly or immunocompromised who may not mount a suitable and/or sustained immune response to vaccination, SONIA may help confirm this at scale and over time.

To access SONIA testing, email: info@enablebiosciences.com.

Read More:

Scientists at Enable Biosciences reported a novel method to more easily and accurately detect neutralizing antibodies against SARS-CoV-2. The new assay is named “SONIA” (Split-Oligonucleotide Neighboring Inhibition Assay). It detects levels of neutralizing antibodies from samples collected via dried blood spots. Published in Nature Communications, the peer-reviewed article was co-authored with an international team of scientists from the California Department of Public Health, Mayo Clinic, Oregon Health & Science University, Swiss Red Cross, University of Basel, Vitalant Research Institute and Cerus Corporation.

Neutralizing antibodies are a special class of antibodies that focus on disrupting virus activity. They are critically important in determining immunity to infection and in quality control for blood-based therapeutics like convalescent plasma. For viral infections like COVID, neutralizing antibodies are pivotal in defending against future infection and are therefore a common marker of protective immunity conferred by vaccination or past infection. SONIA improves upon the existing gold-standard assay for neutralizing antibodies, the Plaque Reduction Neutralization Test (PRNT), by eliminating the need for dangerous live viruses. SONIA uses Enable Biosciences patented DNA-barcoding technology to speed up testing throughput, while achieving excellent accuracy. It increases easy access to testing since it can use conveniently collected dried blood spots as well as regular fresh or banked blood samples. SONIA showed up to 97% sensitivity and 100% specificity in comparison to PRNT.

“A critical feature is the ability of SONIA to be multiplexed to detect neutralizing antibodies against different viral targets all at once, which is challenging for gold-standard assays like PRNT to do,” said Jason Tsai, PhD, CTO of Enable Biosciences and corresponding author of the article. “For a virus like SARS-CoV-2, where there may be multiple variants in a population at a single time, being able to test for neutralizing antibodies against a whole panel of variants is a powerful tool for medicine and public health.”

“We are very proud that the SONIA assay is the chosen test of the Centers for Disease Control’s (CDC) - funded California Department of Public Health (CDPH) CALSCOPE program. The SONIA assay will help determine what neutralizing antibody levels, along with other correlates of immunity, confer resistance to future SARS-CoV-2 infection,” stated David Seftel, MD, CEO of Enable Biosciences. ”We look forward to helping other public health agencies, both in the US and globally, gain unprecedented visibility into both individual and community-wide COVID immunity to help inform and inspire planning for, and participation in, updated vaccination programs and other infection mitigation efforts.” 

While the iteration of SONIA described in the article was for neutralizing antibodies against COVID, the technology can in principle be used to assess immunity to any infection, including diseases like monkeypox and smallpox.

SONIA testing services are available worldwide for public health, epidemiology and research customers at Enable Biosciences’ facilities in South San Francisco. Complete manual assay kits can also be shipped globally, or can be bundled with a dedicated robotic analyser solution provided worldwide in partnership with Hamilton robotics (https://www.hamiltoncompany.com/). In addition to the CDC and the CDPH, Enable provides services to Stanford, Mayo Clinic, Harvard’s Joslin Diabetes Center, Lund University, Sweden, Schneider Children's Hospital, Israel and the Royal Melbourne Hospital, Australia among others. Beyond COVID, Enable labs provides clinician-authorized type 1 diabetes risk testing for children and adults in 48 US states in partnership with the Juvenile Diabetes Research Fund (JDRF) via the landmark T1Detect program - https://www.jdrf.org/t1d-resources/t1detect/

The article can be found online in Nature Communications: https://www.nature.com/articles/s41467-022-31796-1

To deploy SONIA testing for your community, please email: info@enablebiosciences.com

About Enable Biosciences: Enable Biosciences is a Stanford- and UC Berkeley-spinout company based on research from Professor Carolyn Bertozzi’s laboratory. Co-founded by Professor Bertozzi, Peter Robinson, Jason Tsai, and David Seftel in 2016, Enable Biosciences provides clinical and research services and reagents for antibody testing in autoimmune and infectious disease from its College of American Pathologists (CAP) and CLIA certified high-complexity clinical reference laboratory and research facility in South San Francisco. Enable’s uses its novel Antibody Detection by Agglutination PCR (ADAP) chemistry to service global clients in the infectious disease, autoimmunity and allergy spaces. ADAP is 100 to 10,000 times more sensitive than ELISA antibody testing, enabling the earliest possible detection of multiple disease-related antibodies simultaneously for optimal treatment timing to yield the best outcomes. Enable has produces high-performance serologic tests for Type 1 diabetes and HIV in oral fluid and other infectious diseases including Zika, Dengue and COVID. 

For more information about Enable Biosciences visit www.enablebiosciences.com and follow us on Twitter (@EnableBio).

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