Using an ARIES® Laboratory Developed Test for SARS-CoV-2 to Respond to the COVID-19 Pandemic in Louisville, KY

The University of Louisville Infectious Diseases Laboratory (IDL) is a high-complexity, CLIA-certified laboratory in Louisville, KY. The IDL adopted the Luminex ARIES® platform in 2016 for diagnostic testing to increase throughput while minimizing the risk of amplicon contamination. Our familiarity with the ARIES platform allowed us to pursue FDA Emergency Use Authorization for a duplex PCR assay detecting the N1 and N3 targets of the SARS-CoV-2 genome. This presentation outlines our methods, quality control material selection, the populations tested, the challenges we faced, and the future for the laboratory developed SARS-CoV-2 duplex PCR assay.

Learning Objectives:

1. Learn how a lab responded to COVID-19

2. Understand how to run a SARS-CoV-2 test on the ARIES® System

3. Gain knowledge and an understanding of creating a Laboratory Developed Test (LDT) on the ARIES® System