The Infectious Diseases Society of America Guidelines on the Diagnosis of Coronavirus Disease 2019 (COVID-19): Molecular Diagnostic Testing

Mary K Hayden; Kimberly E Hanson; Janet A Englund; Mark J Lee; Mark Loeb; Francesca Lee; Daniel J Morgan; Robin Patel; Ibrahim K El Mikati; Shahad Iqneibi; Farouk Alabed; Justin Z Amarin; Razan Mansour; Payal Patel; Yngve Falck-Ytter; Rebecca L Morgan; M Hassan Murad; Shahnaz Sultan; Adarsh Bhimraj; Reem A Mustafa

doi:10.1093/cid/ciad646

The Infectious Diseases Society of America Guidelines on the Diagnosis of Coronavirus Disease 2019 (COVID-19): Molecular Diagnostic Testing

Clin Infect Dis. 2023 Dec 19:ciad646. doi: 10.1093/cid/ciad646. Online ahead of print.

Authors

Mary K Hayden^{1

2}, Kimberly E Hanson³, Janet A Englund⁴, Mark J Lee⁵, Mark Loeb⁶, Francesca Lee⁷, Daniel J Morgan⁸, Robin Patel⁹, Ibrahim K El Mikati¹⁰, Shahad Iqneibi¹¹, Farouk Alabed¹², Justin Z Amarin¹³, Razan Mansour¹⁴, Payal Patel¹⁵, Yngve Falck-Ytter¹⁶, Rebecca L Morgan¹⁷, M Hassan Murad¹⁸, Shahnaz Sultan¹⁹, Adarsh Bhimraj²⁰, Reem A Mustafa²¹

Affiliations

¹ Division of Infectious Diseases, Department of Medicine, Rush University Medical Center, Chicago, Illinois, USA.
² Department of Pathology, Rush University Medical Center, Chicago, Illinois, USA.
³ Divisions of Infectious Diseases and Clinical Microbiology, University of Utah, Salt Lake City, Utah, USA.
⁴ Department of Pediatrics, University of Washington, Seattle Children's Research Institute, Seattle, Washington, USA.
⁵ Department of Pathology and Clinical Microbiology Laboratory, Duke University School of Medicine, Durham, North Carolina, USA.
⁶ Division of Pathology and Molecular Medicine, McMaster University, Hamilton, Ontario, Canada.
⁷ Departments of Pathology and Internal Medicine, University of Texas Southwestern Medical Center, Dallas, Texas, USA.
⁸ Department of Epidemiology and Public Health, University of Maryland School of Medicine, Baltimore, Maryland, USA.
⁹ Division of Clinical Microbiology and Division of Public Health, Infectious Diseases, and Occupational Medicine, Mayo Clinic, Rochester, Minnesota, USA.
¹⁰ Outcomes and Implementation Research Unit, Department of Internal Medicine, University of Kansas Medical Center, Kansas City, Kansas, USA.
¹¹ Faculty of Medicine, University of Jordan, Amman, Jordan.
¹² School of Medicine, The University of Kansas, Kansas City, Kansas, USA.
¹³ Division of Pediatric Infectious Diseases, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
¹⁴ Department of Internal Medicine, University of Kansas Medical Center, Kansas City, Kansas, USA.
¹⁵ Department of Pulmonary, Allergy, Critical Care, and Sleep Medicine and Department of Medicine, Emory University, Atlanta, Georgia, USA.
¹⁶ Department of Medicine, Case Western Reserve University, School of Medicine, Cleveland, Ohio, USA.
¹⁷ Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, Ontario, Canada.
¹⁸ Division of Public Health, Infectious Diseases and Occupational Medicine, Mayo Clinic, Rochester, Minnesota, USA.
¹⁹ Division of Gastroenterology, Hepatology, and Nutrition, University of Minnesota, Minneapolis VA Healthcare System, Minneapolis, Minnesota, USA.
²⁰ Houston Methodist Hospital, Center of Excellence for Infectious Diseases, Houston Methodist Research Institute, Houston, Texas, USA.
²¹ Division of Nephrology and Hypertension, Department of Internal Medicine, University of Kansas Medical Center, Kansas City, Kansas, USA.

PMID: 38112284
DOI: 10.1093/cid/ciad646

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.

Keywords: COVID-19; SARS-CoV-2; diagnosis; nucleic acid amplification tests; polymerase chain reaction.

Abstract

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