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.

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.

Before the COVID-19 pandemic, there was a great need for United States’ restaurants to “go green” due to consumers’ habits of frequently eating out. Unfortunately, COVID-19 has caused this initiative to lose traction. While the amount of customers ordering takeout has increased, there is less emphasis on sustainability.<br/>Plastic is known for its harmful effects on the environment and the extreme length of time it takes to decompose. According to the International Union for Conservation of Nature (IUCN), almost 8 million tons of plastic end up in the oceans at an annual rate, threatening not only the safety of marine species but also human health. Modern food packaging materials have included a blend of synthetic ingredients, trickling into our daily lives and polluting the air, water, and land. Single-use plastic items slowly degrade into microplastics and can take up to hundreds of years to biodegrade.<br/>Due to COVID-19, restaurants have switched to takeout and delivery options to adapt to the new business environment and guidelines enforced by the Center of Disease Control (CDC) mandated guidelines. Some of these guidelines include: notices encouraging social distancing and mask-wearing, mandated masks for employees, and easy access to sanitary supplies. This cultural shift is motivating restaurants to search for a quick, cheap, and easy fix to adapt to the increased demand of take-out and delivery methods. This increases their plastic consumption of items such as plastic bags/paper bags, styrofoam containers, and beverage cups. Plastic is the most popular takeout material because of its price and durability as well as allowing for limited contamination and easy disposability.<br/>Almost all food products come in packaging and this, more often than not, is single-use. Food is the largest market out of all the packaging industry, maintaining roughly two-thirds of material going to food. The US Environmental Protection Agency reports that almost half of all municipal solid waste is made up of food and food packaging materials. In 2014, over 162 million tons of packaging material waste was generated in the states. This typically contains toxic inks and dyes that leach into groundwater and soil. When degrading, pieces of plastic absorb toxins like PCBs and pesticides, and then each piece will, in turn, release toxic chemicals like Bisphenol-A. Even before being thrown away, it causes negative effects for the environment. The creation of packaging materials uses many resources such as petroleum and chemicals and then releases toxic byproducts. Such byproducts include sludge containing contaminants, greenhouse gases, and heavy metal and particulate matter emissions. Unlike many other industries, plastic manufacturing has actually increased production. Demand has increased and especially in the food industry to keep things sanitary. This increase in production is reflective of the increase in waste. <br/>Although restaurants have implemented their own sustainable initiatives to combat their carbon footprint, the pandemic has unfortunately forced restaurants to digress. For example, Just Salad, a fast-food restaurant chain, incentivized customers with discounted meals to use reusable bowls which saved over 75,000 pounds of plastic per year. However, when the pandemic hit, the company halted the program to pivot towards takeout and delivery. This effect is apparent on an international scale. Singapore was in lock-down for eight weeks and during that time, 1,470 tons of takeout and food delivery plastic waste was thrown out. In addition, the Hong Kong environmental group Greeners Action surveyed 2,000 people in April and the results showed that people are ordering out twice as much as last year, doubling the use of plastic.<br/>However, is this surge of plastic usage necessary in the food industry or are there methods that can be used to reduce the amount of waste production? The COVID-19 pandemic caused a fracture in the food system’s supply chain, involving food, factory, and farm. This thesis will strive to tackle such topics by analyzing the supply chains of the food industry and identify areas for sustainable opportunities. These recommendations will help to identify areas for green improvement.

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.

This thesis project is the result of close collaboration with the Arizona State University Biodesign Clinical Testing Laboratory (ABCTL) to document the characteristics of saliva as a test sample, preanalytical considerations, and how the ABCTL utilized saliva testing to develop swift COVID-19 diagnostic tests for the Arizona community. As of April 2021, there have been over 130 million recorded cases of COVID-19 globally, with the United States taking the lead with approximately 31.5 million cases. Developing highly accurate and timely diagnostics has been an important need of our country that the ABCTL has had tremendous success in delivering. Near the start of the pandemic, the ABCTL utilized saliva as a testing sample rather than nasopharyngeal (NP) swabs that were limited in supply, required highly trained medical personnel, and were generally uncomfortable for participants. Results from literature across the globe showed how saliva performed just as well as the NP swabs (the golden standard) while being an easier test to collect and analyze. Going forward, the ABCTL will continue to develop high quality diagnostic tools and adapt to the ever-evolving needs our communities face regarding 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.

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).