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.

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.

Since the start of the COVID 19 pandemic there has undoubtedly been an increase in social distancing orders, isolation, and overall general stress. The current outbreak has been proven to have a heavy impact on issues involving mental health. Social distancing mandates contributed to isolation, which in turn caused a surge in psychiatric disorders, either newly onset or exacerbating preexisting conditions (Torales, et al, 2020). Due to significant alterations in daily life, an increase in physical inactivity has already been proven to lead to deterioration of cardiovascular health (Pecanha et al, 2020). Stay at home orders have prevented otherwise healthy people from keeping up their daily exercise and eating habits, contributing to a heightened amount of mental health and hypertensive related issues.<br/>In addition to these health concerns, the pandemic has put stress upon pharmaceutical management practices. Drug utilization surges have led to an impact on patient care and management which requires careful measures to be taken to reduce the inflow of sick patients (Badreldin and Atallah, 2020). A global drug shortage has been a result of these drug utilizations. Understanding the alterations in the usage of specific medications such as prescription psychotropics, antihypertensive drugs, and antidiabetic agents can aid in population management and drug shortages.

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.

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).

In this project, I examined the relationship between lockdowns implemented by COVID-19 and the activity of animals in urban areas. I hypothesized that animals became more active in urban areas during COVID-19 quarantine than they were before and I wanted to see if my hypothesis could be researched through Twitter crowdsourcing. I began by collecting tweets using python code, but upon examining all data output from code-based searches, I concluded that it is quicker and more efficient to use the advanced search on Twitter website. Based on my research, I can neither confirm nor deny if the appearance of wild animals is due to the COVID-19 lockdowns. However, I was able to discover a correlational relationship between these two factors in some research cases. Although my findings are mixed with regard to my original hypothesis, the impact that this phenomenon had on society cannot be denied.

In this thesis paper, the mental health consequences of the COVID-19 pandemic are discussed. Chapter 1 discusses what inspired me to write this thesis and follows with a discussion of social isolation during the COVID-19 pandemic. Chapter 2 takes a step back and discusses biological effects of social isolation in general. Chapter 3 discusses the psychological effects of social isolation. Finally, this thesis concludes with a discussion of what can be done to help those experiencing social isolation during the pandemic.

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.

Actuaries can analyze healthcare trends to determine if rates are reasonable and if reserves are adequate. In this talk, we will provide a framework of methods to analyze the healthcare trend during the pandemic. COVID-19 may influence future healthcare cost trends in many ways. First, direct COVID-19 costs may increase the amount of total experienced healthcare costs. However, with the implementation of social distancing, the amount of regularly scheduled care may be deferred to a future date. There are also many unknown factors regarding the transmission of the virus. Implementing epidemiology models allows us to predict infections by studying the dynamics of the disease. The correlation between infection amounts and hospitalization occupancies provide a methodology to estimate the amount of deferred and recouped amounts of regularly scheduled healthcare costs. Thus, the combination of the models allows to model the healthcare cost trend impact due to COVID-19.

Telehealth is the use of information and communications technology by healthcare professionals to provide care to patients. When this technology is being used specifically for genetic services, it is called telegenetics. Previous studies that examine the small-scale use of telegenetics for the field of genetic counseling have shown that the technology may provide a way to address the problem of patient access to genetic counseling services, assuming its efficacy. Patients are satisfied with telegenetics, but genetic counselors hold more reservations. Because of this and the many regulatory barriers in its way, telegenetics was only slowly being adopted when the coronavirus was declared a pandemic in March 2020. The pandemic forced a switch to telegenetics at a scale never seen before. This study begins with a literature review to assess the situation of telegenetics before and during the pandemic. It then surveys practicing genetic counselors in Arizona in order to reveal what they think about telegenetics when it is the encouraged, and sometimes only, modality. Since the literature review revealed that genetic counselors, not patients, are the ones with concerns, it is important to hear their points of view. This study reveals that genetic counselors want telegenetics as an option but not as a replacement for in-person appointments. All respondents agreed that increased patient access is the main benefit of telegenetics. There are reported challenges that must be overcome, but genetic counselors in Arizona overwhelming believe that telegenetics use will be continued in the future.