Improving the clarification, characterization, and homogeneity of animal serum through Nanotrap nanoparticle technology

PROJECT SUMMARY SARS-CoV-2 is the β-coronavirus causing the current coronavirus disease 2019 (COVID-19) outbreak. Large- scale diagnostic testing and large-scale screening are key tools used to contain outbreaks, and are especially important for something as transmissible as SARS-CoV-2. While various clinical specimens—like blood, pharyngeal swabs, saliva, anal swabs, and urine—have showed the presence of the virus in infected patients, there has been a recent gravitation towards the use of saliva samples due to their ease of collection, at-home collection potential, and adaptability. Despite these advantages, the detection of SARS-CoV-2 RNA, antigen, or virus in saliva samples is variable, ranging from 30% to 100% sensitivity, due to the fact that saliva is a complex biosolution. This high variability also means that there tends to be a high background signal for almost all molecular assays tested, which obfuscates accurate testing and rapid tracking capabilities. To address this need, Ceres Nanosciences proposes a competitive 1-year supplement onto its existing Phase I SBIR grant (1R43GM135943; 02/01/2020–10/31/2020; NIGMS) to test the feasibility of using its proprietary and patented Nanotrap® technology to significantly improve the detection of SARS-CoV-2 from saliva samples using existing molecular diagnostics assays on the market today. This supplemental aim falls within the scope of the ongoing funded project, which is evaluating the feasibility of using Nanotrap particles to improve the extraction of common contaminants—including viruses—from bovine serum. The supplemental work will apply a similar workflow to evaluate the feasibility of leveraging Nanotrap particles and workflow to cost- and time-effectively screen small and large volumes of saliva and biobanked whole blood and serum specimens for the presence of SARS-CoV- 2 virus or antibody.PROJECT NARRATIVE SARS-CoV-2 is the β-coronavirus causing the current coronavirus disease 2019 (COVID-19) outbreak. Large- scale diagnostic testing and large-scale screening are key tools used to contain outbreaks such as COVID-19. While nasopharyngeal specimens are the current diagnostic matrix of choice, the time-to-result and performance (sensitivity/specificity) of current diagnostic technologies to detect SARS-CoV-2 in other biological matrices, such as blood, serum, and saliva, are highly variable. This project will explore the feasibility of using Ceres Nanosciences’ Nanotrap particle technology to capture and concentrate SARS-CoV-2 virus or related antibodies across multiple matrices, thus lowering the limit of detection, improving performance, and reducing time-to-result of the diagnostic across multiple matrices and across multiple testing platforms.