SARS-CoV-2 Diagnostic Assay with Sensors of Immune Activation
T2020-344 A sequencing-based diagnostic assay for SARS-CoV-2 with sensors of immune activation and the viral microbiota.
Diagnosis of SARS-CoV-2 infection, which is responsible for COVID-19 disease, is typically performed by molecular analysis of upper respiratory sampling (e.g. nasal swab). Transcriptional-mediated amplification (TMA) and quantitative (real-time) polymerase chain reaction (qPCR) using one or more viral targets are the predominant diagnostic methodologies currently used to detect these infections. Each of these methodologies have differing sensitivities of virus detection leading to discordances, equivocal results, and possible false-positive and false-negative results. Many of these discordances are believed to result from undetected problems with sample adequacy (e.g. poor quality swabs). What are needed are new tools and methods for the complete characterization of the type and level of SARS-CoV-2 infection which provide a more clinically useful test result to understand the stage and severity of disease and the appropriate therapeutic intervention.
An Ohio State research team, led by Dr. Daniel Jones, Director of Molecular Pathology for the OSU Comprehensive Cancer Center -- Arthur G. James Cancer Hospital and Richard J. Solove Research Institute (OSUCCC – James), has developed a new molecular diagnostic assay that utilizes rapid RNA sequencing by next-generation sequencing (semi-conductor sequencing method) to detect the SARS-CoV-2 virus and also provide data on a number of interacting host and viral factors to provide more rigorous quality control than existing SARS-CoV-2 assays. The assay provides deep coverage for improved sensitivity and specificity compared to PCR/TMA platforms.
The assay provides an analysis on:
- the quality of the specimen
- the degree of host immune activation
- viral load
- viral strain typing
- changes in viral transmissibility and viral neutralizing immune responses
- viral mutations of Remdesivir resistance
- coinfection by other common respiratory viruses, including influenza A, influenza B, adenovirus, respiratory syncytial virus (RSV), and common non-SARS-like coronaviruses
The comprehensive nature of this assay is intended to compliment an in-depth analysis for specific patient populations in need. For example, this assay may be useful for the following patient populations:
- COVID-19 patients undergoing new and targeted therapies
- COVID-19 patients considering immunomodulatory therapies
- patients with low or equivocal or suspected false-negative qPCR/TMA results
- patients with prolonged infection/failure to clear SARS-CoV-2 by qPCR assays
- patients with coinfection by multiple respiratory viruses
- patients needing a more rapid method to replace full genome SARS-CoV-2 sequencing assays
Provisional Patent Application filed