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.

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 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.

The ASU BioDesign Clinical Testing Laboratory (ABCTL) was created to offer an accurate, less invasive, less labor intensive, and less resource draining public COVID-19 testing location in Arizona. The goal of this thesis project was to document the intra-organizational communication channels related to changing testing practices as the ABCTL evolved. This was done through a review of internal and external media, pressers, and an interview with Joshua LaBaer. By documenting internal communication channels, specifically those related to changes in testing, similar communication channels and results could be replicable in the future if an outside organization wished to transform an academic research lab into a viral testing facility.

The COVID-19 pandemic has led to high demand for testing. It also has affected minorities at disproportionate rates, and the impact is made worse due to the underlying mistrust minorities hold against medical institutions. A similar theme is observed against physicians, especially Asian American healthcare providers experiencing firsthand discrimination. Therefore, there is this reciprocal relationship between the patient and provider rooted in mistrust and discriminatory biases. This thesis aims to analyze how ASU Biodesign COVID-19 Testing Lab (ABCTL) functions to implicitly modify potential effects of a patient-provider relationship based on the concepts of health equity and cultural humility. The analysis then suggests that ABCTL accomplished the concept of health equity through community partnerships and by recruiting community healthcare workers for long-term stability, it successfully achieved cultural humility.