The Infectious Diseases Society of America Guidelines on the Diagnosis of COVID-19: Molecular Diagnostic Testing.
Abstract
<h4>Background</h4>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.<h4>Objective</h4>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.<h4>Methods</h4>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.<h4>Results</h4>The panel agreed
on 17 diagnostic recommendations.<h4>Conclusions</h4>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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Journal articlePermalink
https://hdl.handle.net/10161/22465Published Version (Please cite this version)
10.1093/cid/ciab048Publication Info
Hanson, Kimberly E; Caliendo, Angela M; Arias, Cesar A; Hayden, Mary K; Englund, Janet
A; Lee, Mark J; ... Mustafa, Reem A (2021). The Infectious Diseases Society of America Guidelines on the Diagnosis of COVID-19:
Molecular Diagnostic Testing. Clinical infectious diseases : an official publication of the Infectious Diseases
Society of America. 10.1093/cid/ciab048. Retrieved from https://hdl.handle.net/10161/22465.This is constructed from limited available data and may be imprecise. To cite this
article, please review & use the official citation provided by the journal.
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Mark Jae Lee
Assistant Professor in Pathology

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