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Molecular Diagnosis of SARS-CoV-2: Assessing and Interpreting Nucleic Acid and Antigen Tests.
Zimmerman, Peter A; King, Christopher L; Ghannoum, Mahmoud; Bonomo, Robert A; Procop, Gary W.
  • Zimmerman PA; Center for Global Health and Diseases, Case Western Reserve University, Cleveland, Ohio.
  • King CL; Center for Global Health and Diseases, Case Western Reserve University, Cleveland, Ohio.
  • Ghannoum M; Center for Medical Mycology and Integrated Microbiome Core, Case Western Reserve University and University Hospitals Cleveland Medical Center, Cleveland, Ohio.
  • Bonomo RA; Department of Medicine, Case Western Reserve University School of Medicine, Cleveland, Ohio; Louis Stokes Cleveland Department of Veterans Affairs Medical Center, Cleveland, Ohio; Departments of Pharmacology, Molecular Biology and Microbiology, Biochemistry, and Proteomics and Bioinformatics, Case W
  • Procop GW; Cleveland Clinic, Cleveland, Ohio.
Pathog Immun ; 6(1): 135-156, 2021.
Article in English | MEDLINE | ID: covidwho-1346785
ABSTRACT
In this review, we summarize the current status of nucleic acid and antigen testing required for diagnosing SARS-CoV-2 infection and COVID-19 disease. Nucleic acid amplification (NAAT) and antigen-detection (Ag) tests occupy a critically important frontline of defense against SARS-CoV-2 in clinical and public health settings. In early stages of this outbreak, we observed that identifying the causative agent of a new illness of unknown origin was greatly accelerated by characterizing the nucleic acid signature of the novel coronavirus. Results from nucleic acid sequencing led to the development of highly sensitive RT-PCR testing for use in clinical settings and to informing best practices for patient care, and in public health settings to the development of strategies for protecting populations. As the current COVID-19 pandemic has evolved, we have seen how NAAT performance has been used to guide and optimize specimen collection, inform patient triage decisions, reveal unexpected clinical symptoms, clarify risks of transmission within patient care facilities, and guide appropriate treatment strategies. For public health settings during the earliest stages of the pandemic, NAATs served as the only tool available for studying the epidemiology of this new disease by identifying infected individuals, studying transmission patterns, modeling population impacts, and enabling disease control organizations and governments to make challenging disease mitigation recommendations to protect the expanding breadth of populations at risk. With time, the nucleic acid signature has provided the information necessary to understand SARS-CoV-2 protein expression for further development of antigen-based point-of-care (POC) diagnostic tests. The advent of massive parallel sequencing (ie, next generation sequencing) has afforded the characterization of this novel pathogen, informed the sequences best adapted for RT-PCR assays, guided vaccine production, and is currently used for tracking and monitoring SARS-CoV-2 variants.

Full text: Available Collection: International databases Database: MEDLINE Type of study: Diagnostic study / Clinical Practice Guide / Prognostic study Language: English Journal: Pathog Immun Year: 2021 Document Type: Article

Full text: Available Collection: International databases Database: MEDLINE Type of study: Diagnostic study / Clinical Practice Guide / Prognostic study Language: English Journal: Pathog Immun Year: 2021 Document Type: Article