Quanterix Corporation, a company digitizing biomarker analysis to advance the science of precision health, has announced that researchers have developed a sensitive and specific serology test using the company’s ultra-sensitive Simoa® platform for the detection and measurement of anti-SARS-CoV-2 IgG, IgM, and IgA antibodies against four immunogenic viral proteins. Results from a recently released preprint of the study, which provide detailed information about early stages of immune response in COVID-19 positive patients, demonstrate that Simoa assays can detect seroconversion as soon as one day after symptom onset using less than a microliter of plasma.
Led by David R. Walt, Ph.D., who is a scientific founder and Board member of Quanterix, as well as the Hansjörg Wyss Professor of Biologically Inspired Engineering at Harvard Medical School and a Professor of Pathology at Brigham and Women’s Hospital, the scientific breakthrough can aid epidemiologists in determining a more accurate population prevalence of COVID-19. The manuscript, “Ultra-Sensitive High-Resolution Profiling of Anti-SARS-CoV-2 Antibodies for Detecting Early Seroconversion in COVID-19 Patients,” is posted on the medRxiv preprint server and is currently pending peer review.
The multiplex serological assay, which was licensed by Brigham and Women’s Hospital to Quanterix, has demonstrated the ability to detect antibodies against SARS-CoV-2 and identify individuals who have been infected with the virus but were asymptomatic or had mild symptoms, thereby providing a better understanding of how widespread the virus is within a population. The Simoa assay has the potential to become a new standard by which researchers can conduct COVID-19 serological profiling and will be a valuable tool for answering important questions about the heterogeneity of clinical presentation seen in the ongoing pandemic. As such, Quanterix plans to explore the potential of transitioning the assay from its current laboratory research phase of development to a commercially available product given its critical importance to population health.
“Reopening strategies will look different for every state and nation, but the undeniable fact is that they will require widespread antibody testing,” said Kevin Hrusovsky, Chief Executive Officer, President and Chairman, Quanterix and Founder, Powering Precision Health (PPH). “Recent reports indicate anywhere between 15-30% of infected people are receiving a negative test result. We must eliminate the unacceptable number of false positives and false negatives that persist today if we are to use these results to guide public health and safety decisions. Consequently, there is an acute global need for exquisitely sensitive solutions to provide a broad array of testing, from onset to immunity. Simoa’s ability to measure both innate and adaptive immune response at the earliest stages of infection with high sensitivity and precision allows researchers and clinicians to address these important testing needs. This includes detecting early signs of immune system dysfunction that can lead to cytokine release syndrome and acute cytokine storms to quantifying immunity through high-resolution antibody profiling.”
Using a combination of IgG, IgM and IgA responses to spike protein, the research team used the serological assay to test 81 plasma samples from Massachusetts General Hospital to achieve a sensitivity of 86% and a specificity of 100% during the first week of infection when comparing COVID-19 positive patients to pre-pandemic controls. This sensitivity increased to 100% and the specificity remained at 100% for COVID-19 positive patients tested one week after symptom onset. This early detection of seroconversion is unmatched by current commercial tests or published laboratory data. Furthermore, the Simoa serological platform provides a powerful analytical tool that will benefit future research in understanding the immune response to COVID-19 by enabling the analysis of antibody response at the early stages of the disease and throughout disease progression with high resolution. A comprehensive analysis of the immune response can provide critical insights necessary for the development of therapeutics, vaccines and convalescent plasma treatments.
As the COVID-19 pandemic continues to infect millions of people worldwide, the ability to curb its spread and reduce mortality requires the development of sensitive methods that can identify infected individuals and enable accurate population-wide screening of both past and present infection. Currently, nucleic acid based tests of nasopharyngeal swabs are the primary method used to detect COVID-19 infected individuals; however, these tests can only diagnose disease during a narrow window of active infection with an overall lower clinical sensitivity of 65-72%. Additional diagnostic methods, therefore, are needed to identify those who are or have been infected with the virus.
“Uncovering new insights about immune response will be essential to our next steps as a global community,” continued Hrusovsky. “Our ultra-sensitive assay technology allows for earlier, more accurate detection using less invasive, small volume samples such as dried blood spots or capillary finger pricks that can be leveraged to maximize population testing reach into home sampling, as well as large sample dilutions to minimize matrix effects and false positives and negatives. We’re proud to be working closely with experts in the forefront of their fields, such as Dr. Walt and many others within our Powering Precision Health community, to develop a robust and reliable panel of antibody tests that can be deployed on Simoa. Through our wide-reaching network we aim to put these critical tools into the hands of more frontline fighters to enhance serology testing and develop a more complete, dependable picture of immunity driven by highly specified data.”
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