Barrett, The Honors College Thesis/Creative Project Collection

In the United States, clinical testing is monitored by the federal and state governments, held to standards to ensure the safety and efficacy of these tests, as well as maintaining privacy for patients receiving a test. In order for the ABCTL to lawfully operate in the state of Arizona, it had to meet various legal criteria. These major legal considerations, in no particular order, are: Clinical Laboratory Improvement Amendments compliance; FDA Emergency Use Authorization (EUA); Health Insurance Portability and Accountability Act compliance; state licensure; patient, state, and federal result reporting; and liability. <br/>In this paper, the EUA pathway will be examined and contextualized in relation to the ABCTL. This will include an examination of the FDA regulations and policies that affect the laboratory during its operations, as well as a look at the different authorization pathways for diagnostic tests present during the COVID-19 pandemic.

In the middle of the COVID-19 epidemic, flaws in the SARS-CoV-2 diagnostic
test were identified by the impending supply shortages of nasopharyngeal swabs and nucleic acid isolation and purification kits. The ASU Biodesign Clinical Testing Lab (ABCTL), which converted from a research lab to SARS-CoV-2 testing lab, was not an exception to these shortages, but the consequences were greater due to its significant testing load in the state of Arizona. In response to the shortages, researchers at The Department of Epidemiology of Microbial Diseases, at the Yale School of Public Health created SalivaDirect method, which is an epidemic effective test, that accounts for limitations of materials, accessibility to specialized lab equipment, time per test, and cost per test. SalivaDirect simplified the diagnostic process by collecting samples via saliva and skipping the nucleic acid extraction and purification, and did it in a way that resulted in a highly sensitive limit of detection of 6-12 SARS-CoV-2 copies/μL with a minimal decrease in positive test agreement.

The ASU Biodesign Clinical Testing Laboratory began in March 2020 after the severe acute respiratory syndrome, coronavirus 2, began spreading throughout the world. ASU worked towards implementing  its own efficient way of testing for the virus, in order to assist the university but also keep the communities around it safe. By developing its own strategy for COVID-19 testing, ASU was on the forefront of research by developing new ways to test for the virus. This process began when research labs at ASU were quickly converted into clinical testing laboratories, which used saliva testing to develop swift COVID-19 diagnostic tests for the Arizona community. The lab developed more accurate and time efficient results, while also converting Nasopharyngeal tests to saliva tests. Not only did this allow for fewer amounts of resources required, but more individuals were able to get tested at faster rates. The ASU Biodesign Clinical Testing Laboratory (ABCTL) was able to accomplish this through the adaptation of previous machines and personnel to fit the testing needs of the community. In the future, the ABCTL will continue to adapt to the ever-changing needs of the community in regards to the unprecedented COVID-19 pandemic. The research collected throughout the past year following the breakout of the COVID-19 pandemic is a reflection of the impressive strategy ASU has created to keep its communities safe, while continuously working towards improving not only the testing sites and functions, but also the ways in which an institution approaches and manages an unfortunate impact on diverse communities.

This thesis project is part of a larger collaboration documenting the history of the ASU Biodesign Clinical Testing Laboratory (ABCTL). There are many different aspects that need to be considered when transforming to a clinical testing laboratory. This includes the different types of tests performed in the laboratory. In addition to the diagnostic polymerase chain reaction (PCR) test that is performed detecting the presence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), antibody testing is also performed in clinical laboratories. Antibody testing is used to detect a previous infection. Antibodies are produced as part of the immune response against SARS-CoV-2. There are many different forms of antibody tests and their sensitives and specificities have been examined and reviewed in the literature. Antibody testing can be used to determine the seroprevalence of the disease which can inform policy decisions regarding public health strategies. The results from antibody testing can also be used for creating new therapeutics like vaccines. The ABCTL recognizes the shifting need of the community to begin testing for previous infections of SARS-CoV-2 and is developing new forms of antibody testing that can meet them.

Automated vehicles are becoming more prevalent in the modern world. Using platoons of automated vehicles can have numerous benefits including increasing the safety of drivers as well as streamlining roadway operations. How individual automated vehicles within a platoon react to each other is essential to creating an efficient method of travel. This paper looks at two individual vehicles forming a platoon and tracks the time headway between the two. Several speed profiles are explored for the following vehicle including a triangular and trapezoidal speed profile. It is discovered that a safety violation occurs during platoon formation where the desired time headway between the vehicles is violated. The aim of this research is to explore if this violation can be eliminated or reduced through utilization of different speed profiles.

Enzyme-induced carbonate precipitation (EICP) is a biocementation technique that produces comparatively fewer carbon dioxide emissions than traditional cementation. However, the use of synthetic reagents for EICP is costly, and the process produces an ammonium byproduct which is a harmful pollutant. This study utilizes fresh urine as a source of urea and calcium-rich zeolites as an ammonium adsorbent and a source of calcium ions for the EICP cementation technique. Batch hydrolysis and adsorption experiments were conducted to determine the effects of zeolite type, zeolite form, and solution composition on ammonium adsorption and calcium release. Cementation experiments were then conducted to determine the effects of different hydrolysis and adsorption times on ammonium adsorption and calcium carbonate precipitation. The results showed that calcium-rich chabazite could be used as a source of calcium ions and as an effective adsorbent of ammonium for EICP. Additionally, synthetic, fresh urine and real, fresh urine had comparable ammonium adsorption and calcium release trends. Finally, inclusion of a pre-hydrolysis step reduced the ammonium adsorption and calcium release, but longer adsorption times lead to calcium carbonate precipitation outside of the sand column, which is an undesirable outcome for soil biocementation; even with this limitation, the calcium carbonate content of sand columns ranged from 0.48% to 0.92%, which signifies the potential of the proposed process for cementation, given a higher initial concentration of urea.

As much as SARS-CoV-2 has altered the way humans live since the beginning of 2020,<br/>this virus's deadly nature has required clinical testing to meet 2020's demands of higher<br/>throughput, higher accuracy and higher efficiency. Information technology has allowed<br/>institutions, like Arizona State University (ASU), to make strategic and operational changes to<br/>combat the SARS-CoV-2 pandemic. At ASU, information technology was one of the six facets<br/>identified in the ongoing review of the ASU Biodesign Clinical Testing Laboratory (ABCTL)<br/>among business, communications, management/training, law, and clinical analysis. The first<br/>chapter of this manuscript covers the background of clinical laboratory automation and details<br/>the automated laboratory workflow to perform ABCTL’s COVID-19 diagnostic testing. The<br/>second chapter discusses the usability and efficiency of key information technology systems of<br/>the ABCTL. The third chapter explains the role of quality control and data management within<br/>ABCTL’s use of information technology. The fourth chapter highlights the importance of data<br/>modeling and 10 best practices when responding to future public health emergencies.

In mid-March of 2020, Arizona State University transformed one of its research labs into ASU Biodesign Clinical Testing Laboratory (ABCTL) to meet the testing needs of the surrounding community during the COVID-19 pandemic. The lab uses RT-qPCR, or reverse transcription polymerase chain reaction, to match the components of a biosample to a portion of the SARS-CoV-2 genome. The ABCTL uses the TaqPath™ COVID-19 Combo Kit, which has undergone many different types of efficacy and efficiency tests and can successfully denote saliva samples as positive even when an individual is infected with various emerging strains of the SARS-CoV-2. Samples are collected by volunteers at testing sites with stringent biosafety precautions and processed in the lab using specific guidelines. As the pandemic eventually becomes less demanding, the ABCTL plans to utilize the Devil’s Drop-off program at various school districts around Arizona to increase testing availability, transfer to the SalivaDirect method, and provide other forms of pathogen testing to distinguish COVID-19 from other types of infections in the ASU community.

Is there a mismatch between urban farmers’ perceptions of their farm’s environmental sustainability and its actual environmental impact? Focusing on the use of water and nutrients on each farm as described by the farmers through interviews, it is evident that there is some level of disconnect between ideals and practices. This project may aid in bridging the gap between the two in regard to the farmers’ sustainability goals. This project will move forward by continuing interviews with farmers as well as collecting soil and water from the farms in order to more accurately quantify the sustainability of the farms’ practices. This project demonstrates that there is some degree of misalignment between perception and reality. Two farms claimed they were sustainable when their practices did not reflect that, while 2 farms said they were not sure if they were sustainable when their practices indicated otherwise. Samples from two farms showed high concentrations of nutrients and salts, supporting the idea that there may be a mismatch between perceived and actual sustainability.

For our project, we explored the growth of the ASU BioDesign Clinical Testing Laboratory (ABCTL) from a standard university research lab to a COVID-19 testing facility through a business lens. The lab has pioneered the saliva-test in the Western United States. This thesis analyzes the laboratory from various business concepts and aspects. The business agility of the lab and it’s quickness to innovation has allowed the lab to enjoy great success. Looking into the future, the laboratory has a promising future and will need to answer many questions to remain the premier COVID-19 testing institution in Arizona.