The Diagnostic Genomics Laboratory is housed in more than 3,000 square feet of lab
and office space in the Sumwalt College building that was extensively renovated and provided to the College of Pharmacy by university
leadership. In addition to Laboratory Director Carolyn Banister, there are two supervisors, four full-time staff, four part-time staff, and four
undergraduate assistants. The lab operates 5-7 days per week, as needed.
The Diagnostic Genomics Laboratory is a Clinical Laboratory Improvement Amendments (CLIA)-certified facility with Food and Drug Administration (FDA) Emergency Use Authorization for the SalivirDetect Test. The University of South Carolina provided the College of Pharmacy with over $6.2 million for the Diagnostic Genomics Laboratory as part of its COVID-19 related efforts to re-open campus safely for the 2020-21 academic year.
The COVID-19 Saliva-Based Testing Program was established to provide SARS-CoV-2 testing for the entire UofSC community, with results reported to the participant and South Carolina Department of Health and Environmental Control (DHEC) within 24 hours of sample collection.
Samples were collected by teams staffed through the College of Pharmacy at strategic
locations throughout campus. In addition, “GoTeams” were deployed when needed for
specific events or instances where a suspected breakout might be occurring, such as
a particular dormitory.
The SalivirDetect Test is a Quantitative Reverse Transcription Polymerase Chain Reaction (qRT-PCR) method applied to crude saliva samples, with no need for Ribonucleic Acid (RNA) isolation. Small volumes of saliva are needed for each test (20ul), however larger volumes of saliva (5ml) enable automation by robotic liquid handlers.
SalivirDetect can be broadly implemented as it does not require saliva collection tubes with preservatives and does not require specialized equipment for RNA extraction. The simplicity and flexibility of SalivirDetect means that it is less likely to be affected by supply chain bottlenecks.
We wish to recognize and credit Emergency Use Authorization 202097 - SalivaDirect, Nathan Grubaugh, Ph.D. at Yale School of Public Health - as our assay is similar to their methodology with some modifications.