1. The Infectious Diseases Society of America Guidelines on the Diagnosis of COVID-19: Molecular Diagnostic Testing (December 2023).
- Author
-
Hayden MK, Hanson KE, Englund JA, Lee MJ, Loeb M, Lee F, Morgan DJ, Patel R, El Mikati IK, Iqneibi S, Alabed F, Amarin JZ, Mansour R, Patel P, Falck-Ytter Y, Morgan RL, Murad MH, Sultan S, Bhimraj A, and Mustafa RA
- Subjects
- Humans, United States, Molecular Diagnostic Techniques standards, Molecular Diagnostic Techniques methods, COVID-19 Testing methods, COVID-19 Testing standards, Nucleic Acid Amplification Techniques standards, Nucleic Acid Amplification Techniques methods, COVID-19 diagnosis, SARS-CoV-2 genetics, SARS-CoV-2 isolation & purification, COVID-19 Nucleic Acid Testing standards, COVID-19 Nucleic Acid Testing methods
- Abstract
Accurate molecular diagnostic tests are necessary for confirming a diagnosis of coronavirus disease 2019 (COVID-19) and for identifying asymptomatic carriage of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The number of available SARS-CoV-2 nucleic acid detection tests continues to increase as does the COVID-19 diagnostic literature. Thus, the Infectious Diseases Society of America (IDSA) developed 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 nuances of test result interpretation in a variety of practice settings, and highlight important unmet research needs related to COVID-19 diagnostic testing. 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. The panel agreed on 12 diagnostic recommendations. Access to accurate SARS-CoV-2 nucleic acid testing is critical for patient care, hospital infection prevention, and the public health response to COVID-19 infection. Information on the clinical performance of available tests continues to grow, but the quality of evidence of the current literature to support this updated molecular diagnostic guideline remains 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 suggested for asymptomatic individuals with known or suspected contact with a COVID-19 case when the results will impact isolation/quarantine/personal protective equipment (PPE) usage decisions. Evidence in support of rapid testing and testing of upper respiratory specimens other than nasopharyngeal swabs, which offer logistical advantages, is sufficient to warrant conditional recommendations in favor of these approaches., Competing Interests: Potential conflicts of interest. The following list displays what has been reported to the IDSA. To provide thorough transparency, the IDSA requires full disclosure of all relationships, regardless of relevancy to the guideline topic. Evaluation of such relationships as potential conflicts of interest is determined by a review process which includes assessment by the Board of Directors’ liaison to the Standards and Practice Guideline Committee and, if necessary, the Conflicts of Interest (COI) and Ethics Committee. The assessment of disclosed relationships for possible COI is based on the relative weight of the financial relationship (ie, monetary amount) and the relevance of the relationship (ie, the degree to which an association might reasonably be interpreted by an independent observer as related to the topic or recommendation of consideration). The reader of these guidelines should be mindful of this when the list of disclosures is reviewed. M. K. H. receives research funding from the Centers for Disease Control and Prevention (CDC); and served as a member of Clinical Adjudication Panel for an investigational COVID-19 vaccine made by Sanofi Pasteur. K. E. H. served an advisor to Quidel, BioFire, Pfizer, and Takeda; received other numerations from Quidel, Pfizer, and Takeda; served as Editor to the American Society of Microbiology (ASM) and member of the Clinical and Laboratory Standards Institute Antifungal Committee; received research funding from the National Institutes of Health (NIH); and served on the exam committee for the American Board of Internal Medicine and associate editor for Open Forum Infectious Diseases. J. A. E. serves as a consultant for Sanofi Pasteur, Pfizer, and AstraZeneca and reports consulting fees from Moderna and Meissa Vaccines; is an advisor/consultant for Meissa Vaccines; receives research funding from the CDC, Pfizer, Brotman Baty Research Institute, Merck, Novavax, GlaxoSmithKline, and AstraZeneca; served as an advisor to Teva Pharmaceuticals; and served as a member of the Pediatric Infectious Diseases Society (PIDS) Publication Committee and Transplant ID Committee, and reports support for travel to the 2022 European Society for Paediatric Infectious Diseases (ESPID) meeting to present from ESPID/AstraZeneca. M. J. L. serves as an advisor for Sanofi, Seqirus, Medicago, GSK, Janssen, Novavax, Pfizer, and MD Brief; receives research funding from the Canadian Institutes of Health Research, World Health Organization (WHO), and Medical Research Council (United Kingdom); has received an in-kind supply of vaccine from Sanofi; has been paid for expert testimony on institutional and workplace vaccine policy; and has served on the DSMB for CanSino Biologics and an advisor to Merck. R. P. has a patent on a Bordetella pertussis/parapertussis PCR issued, a patent on a device/method for sonication with royalties paid by Samsung to Mayo Clinic, and a patent on an anti-biofilm substance issued; serves as a consultant to PhAST, Torus Biosystems, Day Zero Diagnostics, Mammoth Biosciences, Netflix, Abbott Laboratories, Oxford Nanopore Technologies, CARB-X, Qvella, and HealthTrackRx; receives other numeration (honoraria) from NBME, UpToDate, and the Infectious Disease Board Review Course; received grants from CD Diagnostics, Merck, Hutchison Biofilm Medical Solutions, Accelerate, ContraFect, TenNor Therapeutics Limited, Shionogi, NIH, Biofire, Adaptive Phage Therapeutics, National Science Foundation, and the Department of Defense; has served as a consultant to Curetis, Specific Technologies, NextGen Diagnostics, Pathoquest, Selux Diagnositcs, and 1928 Diagnostics; and reports support for attending meetings and/or travel from ASM Biofilms and ISAC and roles as Chair of ASM Governance Committee and as a member of the ASM Finance Committee. S. S. serves as a Board member for the Evidence Foundation; receives honoraria for evidence reviews, methodological support, and teaching from the Evidence Foundation; serves on guideline panels for the American Gastroenterological Association (AGA); reports unpaid roles as Co-Director for the Evidence Foundation and US Grade Network and former Chair Clinical Guidelines Committee for the AGA; and receives research funding from the Department of Veterans Affairs Evidence Synthesis Program. Y. F.-Y. serves as a Board member for the Evidence Foundation; receives honoraria for evidence reviews, methodological support, and teaching from the Evidence Foundation, the AGA for evidence reviews, and the Institute for Clinical and Economic Review (ICER) for committee meetings; serves as a Director for the Evidence Foundation and for the US GRADE Network; and served on an Independent Appraisal Committee for ICER. R. L. M. serves as a Board member for the Evidence Foundation and receives honoraria for evidence reviews, methodological support, and teaching from the Evidence Foundation. M. H. M. serves as a Board member for the Evidence Foundation; receives honoraria for evidence reviews, methodological support, and teaching from the Evidence Foundation; receives research funding from the Agency for Healthcare Research and Quality (AHRQ), the Endocrine Society, and the Society for Vascular Surgery; has received research funding from the American Society of Hematology and the WHO; and has served as a guideline methodologist for the WHO. A. B. received an honorarium from the ICER (clinical expert at an ICER public meeting [discussion in 2022 re: COVID-19 oral drug costs], honorarium $750). R. A. M. serves as a Board member for the Evidence Foundation; receives honoraria for evidence reviews, methodological support, and teaching from the Evidence Foundation and ICER for committee meetings; receives research funding from the NIH, the WHO, the American College of Rheumatology, the American Society of Hematology, and Bohringer Ingelheim; serves as Chair of the Midwest Comparative Effectiveness Public Advisory Council of the ICER; serves on the Methods Committee for Kidney Disease Improving Global Outcomes Work Group; serves on the Clinical Guidelines Committee for the Canadian Society of Nephrology; and previously served on the Clinical Guidelines Committee for the American College of Physicians (ACP). D. J. M. reports an NIH DP2 award, Shepherd contract, and is Co-Investigator on an Epicenter award from CDC, R01 on C. difficile from the AHRQ, and IIR on Diagnostic Stewardship from VA HSRD; support for conference planning and speaking from SHEA/IDSA; and an unpaid role as co-lead on the task force on diagnostic stewardship. All other authors report no potential conflicts. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed., (© The Author(s) 2023. Published by Oxford University Press on behalf of Infectious Diseases Society of America. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)
- Published
- 2024
- Full Text
- View/download PDF