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The Infectious Diseases Society of America Guidelines on the Diagnosis of COVID-19: Molecular Diagnostic Testing.

Publication ,  Journal Article
Hanson, KE; Caliendo, AM; Arias, CA; Hayden, MK; Englund, JA; Lee, MJ; Loeb, M; Patel, R; El Alayli, A; Altayar, O; Patel, P; Falck-Ytter, Y ...
Published in: Clin Infect Dis
January 22, 2021

BACKGROUND: Accurate molecular diagnostic tests are necessary for confirming a diagnosis of coronavirus disease 2019 (COVID-19). Direct detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) nucleic acids in respiratory tract specimens informs patient, healthcare institution and public health level decision-making. The numbers of available SARS-CoV-2 nucleic acid detection tests are rapidly increasing, as is the COVID-19 diagnostic literature. Thus, the Infectious Diseases Society of America (IDSA) recognized a significant need for frequently updated systematic reviews of the literature to inform evidence-based best practice guidance. OBJECTIVE: The IDSA's goal was to develop an evidence-based diagnostic guideline to assist clinicians, clinical laboratorians, patients and policymakers in decisions related to the optimal use of SARS-CoV-2 nucleic acid amplification tests. In addition, we provide a conceptual framework for understanding molecular diagnostic test performance, discuss the nuance of test result interpretation in a variety of practice settings and highlight important unmet research needs in the COVID-19 diagnostic testing space. METHODS: IDSA convened a multidisciplinary panel of infectious diseases clinicians, clinical microbiologists, and experts in systematic literature review to identify and prioritize clinical questions and outcomes related to the use of SARS-CoV-2 molecular diagnostics. Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology was used to assess the certainty of evidence and make testing recommendations. RESULTS: The panel agreed on 17 diagnostic recommendations. CONCLUSIONS: Universal access to accurate SARS-CoV-2 nucleic acid testing is critical for patient care, hospital infection prevention and the public response to the COVID-19 pandemic. Information on the clinical performance of available tests is rapidly emerging, but the quality of evidence of the current literature is considered moderate to very low. Recognizing these limitations, the IDSA panel weighed available diagnostic evidence and recommends nucleic acid testing for all symptomatic individuals suspected of having COVID-19. In addition, testing is recommended for asymptomatic individuals with known or suspected contact with a COVID-19 case. Testing asymptomatic individuals without known exposure is suggested when the results will impact isolation/quarantine/personal protective equipment (PPE) usage decisions, dictate eligibility for surgery, or inform solid organ or hematopoietic stem cell transplantation timing. Ultimately, prioritization of testing will depend on institutional-specific resources and the needs of different patient populations.

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Published In

Clin Infect Dis

DOI

EISSN

1537-6591

Publication Date

January 22, 2021

Location

United States

Related Subject Headings

  • Microbiology
  • 3202 Clinical sciences
  • 11 Medical and Health Sciences
  • 06 Biological Sciences
 

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Hanson, K. E., Caliendo, A. M., Arias, C. A., Hayden, M. K., Englund, J. A., Lee, M. J., … Mustafa, R. A. (2021). The Infectious Diseases Society of America Guidelines on the Diagnosis of COVID-19: Molecular Diagnostic Testing. Clin Infect Dis. https://doi.org/10.1093/cid/ciab048
Hanson, Kimberly E., Angela M. Caliendo, Cesar A. Arias, Mary K. Hayden, Janet A. Englund, Mark J. Lee, Mark Loeb, et al. “The Infectious Diseases Society of America Guidelines on the Diagnosis of COVID-19: Molecular Diagnostic Testing.Clin Infect Dis, January 22, 2021. https://doi.org/10.1093/cid/ciab048.
Hanson KE, Caliendo AM, Arias CA, Hayden MK, Englund JA, Lee MJ, et al. The Infectious Diseases Society of America Guidelines on the Diagnosis of COVID-19: Molecular Diagnostic Testing. Clin Infect Dis. 2021 Jan 22;
Hanson, Kimberly E., et al. “The Infectious Diseases Society of America Guidelines on the Diagnosis of COVID-19: Molecular Diagnostic Testing.Clin Infect Dis, Jan. 2021. Pubmed, doi:10.1093/cid/ciab048.
Hanson KE, Caliendo AM, Arias CA, Hayden MK, Englund JA, Lee MJ, Loeb M, Patel R, El Alayli A, Altayar O, Patel P, Falck-Ytter Y, Lavergne V, Morgan RL, Murad MH, Sultan S, Bhimraj A, Mustafa RA. The Infectious Diseases Society of America Guidelines on the Diagnosis of COVID-19: Molecular Diagnostic Testing. Clin Infect Dis. 2021 Jan 22;
Journal cover image

Published In

Clin Infect Dis

DOI

EISSN

1537-6591

Publication Date

January 22, 2021

Location

United States

Related Subject Headings

  • Microbiology
  • 3202 Clinical sciences
  • 11 Medical and Health Sciences
  • 06 Biological Sciences