Impact - Covid-19 Testing Services
COVID-19 ELISA pan-Ig Antibody Test
In response to the COVID-19 pandemic, the University of Arizona partnered with the State of Arizona to provide COVID-19 Antibody Tests developed by AZClinCore to the general public. In collaboration with UArizona researchers Deepta Bhattacharya, PhD, Janko Nikolich-Žugich, MD, PhD, Bonnie LaFleur, PhD, and Andrew P Capaldi, PhD, AZClinCore completed clinical validation of the COVID-19 ELISA pan-Ig Antibody Test on 26 April 2020 and immediately applied for Pre-Emergency Use Authorization (Pre-EUA) to the U.S. Food & Drug Administration. Official Emergency Use Authorization (EUA) was granted on 31 August 2020 by the FDA (EUA201116).
Over the course of the service, the lab continually updated the test with additional clinical validation studies as more information about the SARS-CoV-2 virus became available. In February 2021 AZClinCore implemented new assay threshold/cut-off values based on re-analysis with asymptomatic patients. In April 2021, AZClinCore reevaluated the test’s predictive value using 427 vaccinated individuals; along with the previously analyzed symptomatic and asymptomatic presumed positive individuals in the study, this resulted in a sensitivity of 96% and a specificity of 98%. From 29 April 2020 to 22 September 2021, AZClinCore provided 44,524 test results to Arizona residents.
Although AZClinCore revoked its EUA on 16 December 2022 after demand for clinical testing waned, AZClinCore continues to run the assay in a research capacity and has developed a multitude of related research assays including variant-specific quantitative titer and surrogate neutralization assays for a large scale study with the CDC, facilitated by UArizona researcher Jeff Burgess MD, MS, MPH. With its high-throughput capabilities facilitated with an array of Beckman liquid-handling robots and highly trained clinical technologists, AZClinCore has the capacity to process 5,120 qualitative reactions and 768 quantitative titer reactions per day. For this study, AZClinCore has processed over 45,000 total samples and has run over 375,000 total reactions.
SARS-CoV-2 RT-PCR Testing Service
The AZClinCore clinically validated its COVID PCR test early in the pandemic (18 April 2020) as a Laboratory Developed test (LDT) and began offering services to UArizona personnel and students on 17 June 2020. Initially testing only NP swabs, in January 2021, the AZClinCore began offering a Saline Gargle test which was later made available for TakeAway testing, greatly increasing the laboratory's capacity to process samples. At its maximum capacity, the AZClinCore processed and reported 2,893 results in a single day (29 January 2021). Over the 3 years of providing COVID testing services, the dedicated and talented technologists at the AZClinCore processed a total 258,397 clinical PCR tests for the UArizona community. On 23 June, 2023, the Arizona Molecular Clinical Core ended its SARS-CoV-2 (COVID) PCR testing service as part of UArizona's Test All Test Smart initiative.