374. Evaluation of the ChromaCode HDPCR™ RV6 RUO Assay

Abstract

Abstract Background In December of 2019, an outbreak of pneumonia was reported to the World Health Organization. The etiology of this outbreak was identified as novel coronavirus (SARS-CoV-2), which has resulted in a global pandemic. The persistence of circulating SARS-CoV-2 leads to the need for a test that can detect and differentiate SARS-CoV-2 from common causes of respiratory illnesses such as influenza and respiratory syncytial virus (RSV). ChromaCode’s HDPCR™ RV6 RUO Assay is a real time PCR test that provides qualitative detection of SARS-CoV-2, Influenza A, Influenza B, and RSV A/B from upper respiratory specimens. An evaluation in an infectious disease molecular laboratory was performed and presented herein. Methods A combination of residual and contrived samples were used to evaluate the ChromaCode HDPCR™ RV6 RUO assay. Residual upper respiratory samples tested with the standard of care were enrolled in this study to evaluate RV6 RUO. A total of 201 samples originally tested using Diasorin Simplexa® tests were enrolled: 17 assisted mid-turbinate, 15 contrived Flu B samples, and 179 nasopharyngeal swabs. The contrived samples were made utilizing dilutions of Zeptometrix Influenza B material (PN 0810253CF LN 325137) in negative NPS matrix to achieve final concentrations of 0.02-0.04 TCID50/mL. Results The ChromaCode RV6 RUO Assay had comparable results to the standard of care test. The assays had a 99.0% concordance for the Influenza A target, 100% concordance for the Influenza B target, 97.5% concordance for the RSV A/B target, and 99.5% concordance for the SARS-CoV-2 target. Conclusion There are several tools available for distinguishing between common respiratory illnesses, which now include SARS-CoV-2. This study demonstrated the viability of the HDPCR RV6 RUO Assay to be a solution for distinguishing between common respiratory illnesses. RV6 RUO showed a high degree of concordance with the standard of care test and highlighted the flexibility of the RV6 RUO assay to be used with multiple upper respiratory sample types. The HDPCR RV6 RUO Assay and the accompanying ChromaCode Cloud software is a user-friendly solution with minimal setup time and rapid data analysis. Disclosures Kristin Fathe, PhD, ChromaCode, Inc: Work there with stock options.