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Peer reviewedOpen accessCOVID-19SARS

The Infectious Diseases Society of America Guidelines on the Diagnosis of COVID-19: Antigen Testing (January 2023)

Clinical Infectious Diseases·

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

DOI
10.1093/cid/ciad032
PMID
PMCID
OpenAlex
W4318192713
Study type
Systematic review
Publisher
Oxford University Press (OUP)
Article type
journal-article
Integrity
current

Why this research matters now

The guideline assists clinicians, laboratories, patients, public health authorities, administrators, and policymakers in decisions regarding optimal deployment of SARS-CoV-2 antigen testing for COVID-19 diagnosis when molecular methods are not readily accessible.

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Structured evidence summary

Research question

The panel sought to develop evidence-based recommendations for the optimal use of SARS-CoV-2 antigen tests in medical and nonmedical settings, addressing testing in symptomatic and asymptomatic individuals and single versus repeat testing strategies.

Study design

This guideline represents a systematic review of peer-reviewed literature through April 1, 2022, using GRADE methodology to assess certainty of evidence and formulate testing recommendations. The multidisciplinary panel included infectious diseases clinicians, clinical microbiologists, and systematic review experts.

Population and setting

The guideline addresses use of SARS-CoV-2 antigen tests for symptomatic and asymptomatic individuals in both medical and nonmedical settings within the United States.

Main findings

FDA Emergency Use Authorization SARS-CoV-2 antigen tests demonstrate high specificity but low to moderate sensitivity relative to nucleic acid amplification testing, with sensitivity varying by symptom presence and timing after symptom onset. Positive antigen results generally do not require confirmation, and point-of-care testing performs comparably to laboratory-based testing. The panel produced 10 diagnostic recommendations and concluded that rapid RT-PCR or laboratory-based NAAT remain preferred methods, though antigen testing aids identification when timely molecular testing is unavailable or infeasible.

Public-health relevance

The guideline assists clinicians, laboratories, patients, public health authorities, administrators, and policymakers in decisions regarding optimal deployment of SARS-CoV-2 antigen testing for COVID-19 diagnosis when molecular methods are not readily accessible.

Important limitations

The overall quality of available evidence supporting antigen testing use was graded as very low to moderate. Insufficient data prevented a recommendation about using antigen testing to guide release from isolation, and no empirical data were available to inform repeat testing strategies, which relied on modeling. This summary is limited to the supplied single-article abstract and metadata and requires the original paper for decision-grade interpretation.

GIDS interpretation

The article was classified under COVID-19 and SARS diseases, United States country context, and diagnostics and health policy topics, reflecting its focus on diagnostic test performance and guideline development for a respiratory pathogen of public health importance.

02

Related GIDS surveillance

Literature context does not validate, explain, or change a surveillance signal. Exact and contextual relationships are shown separately.

03

Evidence relationships

This article has 10 auditable classifier relationships to diseases, places, topics, and study design.

about diseaseabout diseaseaddresses topicaddresses topicevaluates interventionhas pathogen typeinforms policy domainstudied population settingstudies pathogenuses study design