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.

This thesis was conducted to study and analyze the fund allocation process adopted by different states in the United States to reduce the impact of the Covid-19 virus. Seven different states and their funding methodologies were compared against the case count within the state. The study also focused on development of a physical distancing index based on three significant attributes. This index was then compared to the expenditure and case counts to support decision making.
A regression model was developed to analyze and compare how different states case counts played out against the regression model and the risk index.

As the return to normality in the wake of the COVID-19 pandemic enters its early stages, the necessity for accurate, quick, and community-wide surveillance of SARS-CoV-2 has been emphasized. Wastewater-based epidemiology (WBE) has been used across the world as a tool for monitoring the pandemic, but studies of its efficacy in comparison to the best-known method for surveillance, randomly selected COVID-19 testing, has limited research. This study evaluated the trends and correlations present between SARS-CoV-2 in the effluent wastewater of a large university campus and random COVID-19 testing results published by the university. A moderately strong positive correlation was found between the random testing and WBE surveillance methods (r = 0.63), and this correlation was strengthened when accommodating for lost samples during the experiment (r = 0.74).

The academic environment has historically been somewhat slow to implement and adopt new technologies. However, developments in video games have created an opportunity for students to learn new skills and topics through nontraditional mediums of education. The disruption caused by the COVID-19 pandemic further highlighted the need for flexible learning opportunities. Joystick Education is our approach to addressing this need. Through online, game-based tutoring and a database of video games with high educational value, Joystick Education creates a learning environment that is effective, fun, and engaging for students. We analyzed popular, mainstream video games for educational content and selected nine games that teach concepts like history, biology, or physics while playing the game. Through promotion on social media, we generated buzz around our website which led to 103 unique visitors over our first month online and two customers requesting to book our tutoring service. We are confident that given more time to grow, Joystick Education can generate profit and become a successful business.

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.

The product our team is commercializing is a NASA designed technology designed to store waste in space. This product works on Earth as well and has applicable multi-use capabilities. Throughout the last several months, the team has identified different markets to determine which of them would experience the most value from this product. The team conducted 25 interviews to grasp the landscape of the different markets related to this product. After a thorough analysis, it was found that vendors who support the disposal of different types of waste and sludge would be the best fit for this product. Vendors like Waste Management, Sharps, Stericycle, Sludge USA, etc.,” have large contracts with hospitals, biotech firms, labs, and cities to manage a wide spectrum of waste. The companies bring value to their clients by making a difficult process easier. However, the process is not seamless and, with certain types of waste, there are significant costs associated with not following an exact process. Throughout this process and interviews with companies like Sludge USA and Waste Management, the team identified a niche market in supporting sludge processes. Caked: Sludge Management is designed to bring value to this market by making their waste disposal process seamless, and saving these institutions significant costs in the long run, while creating additional value.