An Extended Laboratory Validation Study and Comparative Performance Evaluation of the Abbott ID NOW™ COVID-19 Assay in a Coastal California Tertiary Care Medical Center

The Abbott ID NOW™ COVID-19 assay is a rapid molecular diagnostic test particularly designed for on-site, rapid turnaround point of care (POC) testing. The utilization of rapid diagnostic tests is integral to optimizing workflow within the hospital and/or procedural-based clinics. The capability to provide both rapid disposition and correct patient classification during this COVID-19 pandemic is critically important with broad infection control implications for both patients and healthcare staff. A tightly controlled, extended laboratory validation was performed at our medical center to determine the negative test agreement of the Abbott ID NOW™ compared with the BD MAX™ analyzer, a laboratory-based, two target, molecular analyzer with a sensitive cycle threshold (Ct) positive cutoff value of ≤ 42. There was strict adoption of the procedures listed in the Abbott ID NOW™ Instruction for Use (IFU)¹ insert delineating preferred practices for “optimal test performance.” Under these conditions, our institution demonstrated a significant negative percent agreement with 116 out of 117 patients correlating, which equates to a 99.1% concordance similar to a recently reported correlation study2.