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.

Sex, Love, & Dating During the COVID-19 Pandemic is a creative thesis project that addresses two main issues: 1) the overall lack of resources and information available to the public about how to proceed with respect to sex, love, and dating during a global pandemic; and 2) my inability as director of Devils in the Bedroom (an on-campus sexual health club at ASU) to get condoms and other sexual health materials into the hands of students while in quarantine. A resource was developed, an informational pamphlet on the three main topics (sex, love, and dating), as well as a program to distribute the materials by mail, the sexual health care packages.

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.

In a healthcare system already struggling with burnout among its professionals, the COVID-19 pandemic presented a barrage of personal and occupational strife to US healthcare workers. Structural and everyday discrimination contributed to the health inequities of people of color in the US, exacerbated by COVID-19-related racism and xenophobia. There is little research regarding the effects of COVID-19 and related and/or concurring discrimination upon minority nursing staff, despite their importance in supporting the diverse American patient population with culturally competent, tireless care amid the pandemic. This cross-sectional survey study aimed to examine 1) the relationships between discrimination, social support, resilience, and quality of life among minority nursing staff in the US during COVID-19, and 2) the differences of discrimination, social support resilience, and quality of life among minority nursing staff between different racial/ethnic groups during COVID-19. The sample (n = 514) included Black/African American (n = 161, 31.4%), Latinx/Hispanic (n = 131, 25.5%), Asian (n = 87, 17%), Native American/Alaskan Native (n = 69, 13.5%), and Pacific Islander (n = 65, 12.7%) nursing staff from 47 US states. The multiple regression results showed that witnessing discrimination was associated with a lower quality of life score, while higher social support and resilience scores were associated with higher quality of life scores across all racial groups. Furthermore, while participants from all racial groups witnessed and experienced discrimination, Hispanic/Latinx nursing staff experienced discrimination most commonly, alongside having lowest quality of life and highest resilience scores. Native American/Alaskan Native nursing staff had similarly high discrimination and low quality of life, although low resilience scores. Our findings suggest that minority nursing staff who have higher COVID-19 morbidity and mortality rates (Hispanic/Latinx, Native American/Alaskan Native) were left more vulnerable to negative effects from discrimination. Hispanic/Latinx nursing staff reported a relatively higher resilience score than all other groups, potentially attributed to the positive effects of biculturality in the workplace, however, the low average quality of life score suggests a simultaneous erosion of well-being. Compared to all other groups, Native American and Alaskan Native nursing staff’s low resilience and quality of life scores suggest a potential compounding effect of historical trauma affecting their well-being, especially in contrast to Hispanic/Latinx nursing staff. This study has broader implications for research on the lasting effects of COVID-19 on minority healthcare workers’ and communities’ well-being, especially regarding Hispanic/Latinx and Native American/Alaskan Native nursing staff.

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.

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.

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.

The present study explored the relationship between desired purchasing behavior and individual differences using two nationally-representative, longitudinal samples of the U.S. population early in the COVID-19 pandemic. Past research has shown that individual differences provide information about how one might respond to threat. Therefore, we predicted changes in desired purchasing behavior across different sociodemographic variables that might reflect those differences. Specifically, we investigated hypotheses related to political orientation, age, sexual orientation, socioeconomic status, and whether or not the participant had children. We measured participants’ reported desired purchasing behavior across eleven categories of goods and investigated the connection between specific demographic variables and desired purchasing behavior. We found that conservatives desired to purchase more basic protection goods (guns/ammunition, cash, gas) and that older people desired to purchase more cleaning supplies and toiletries. These findings illustrate possible explanations for purchasing behavior during the COVID-19 pandemic and reveal directions for marketing designed to influence purchasing behavior.