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

Publication ,  Journal Article
Hayden, MK; Hanson, KE; Englund, JA; Lee, F; Lee, MJ; Loeb, M; Morgan, DJ; Patel, R; El Alayli, A; El Mikati, IK; Sultan, S; Falck-Ytter, Y ...
Published in: Clin Infect Dis
June 27, 2024

Immunoassays designed to detect SARS-CoV-2 protein antigens (Ag) are commonly used to diagnose COVID-19. The most widely used tests are lateral flow assays that generate results in approximately 15 minutes for diagnosis at the point-of-care. Higher throughput, laboratory-based SARS-CoV-2 Ag assays have also been developed. The number of commercially available SARS-CoV-2 Ag detection tests has increased rapidly, as has the COVID-19 diagnostic literature. The Infectious Diseases Society of America (IDSA) convened an expert panel to perform a systematic review of the literature and develop best-practice guidance related to SARS-CoV-2 Ag testing. This guideline is an update to the third in a series of frequently updated COVID-19 diagnostic guidelines developed by the IDSA. IDSA's goal was to develop evidence-based recommendations or suggestions that assist clinicians, clinical laboratories, patients, public health authorities, administrators, and policymakers in decisions related to the optimal use of SARS-CoV-2 Ag tests in both medical and nonmedical settings. A multidisciplinary panel of infectious diseases clinicians, clinical microbiologists, and experts in systematic literature review identified and prioritized clinical questions related to the use of SARS-CoV-2 Ag tests. A review of relevant, peer-reviewed published literature was conducted through 1 April 2022. Grading of Recommendations Assessment, Development, and Evaluation (GRADE) methodology was used to assess the certainty of evidence and make testing recommendations. The panel made 10 diagnostic recommendations that address Ag testing in symptomatic and asymptomatic individuals and assess single versus repeat testing strategies. US Food and Drug Administration (FDA) SARS-CoV-2 Ag tests with Emergency Use Authorization (EUA) have high specificity and low to moderate sensitivity compared with nucleic acid amplification testing (NAAT). Ag test sensitivity is dependent on the presence or absence of symptoms and, in symptomatic patients, on timing of testing after symptom onset. In most cases, positive Ag results can be acted upon without confirmation. Results of point-of-care testing are comparable to those of laboratory-based testing, and observed or unobserved self-collection of specimens for testing yields similar results. Modeling suggests that repeat Ag testing increases sensitivity compared with testing once, but no empirical data were available to inform this question. Based on these observations, rapid RT-PCR or laboratory-based NAAT remain the testing methods of choice for diagnosing SARS-CoV-2 infection. However, when timely molecular testing is not readily available or is logistically infeasible, Ag testing helps identify individuals with SARS-CoV-2 infection. Data were insufficient to make a recommendation about the utility of Ag testing to guide release of patients with COVID-19 from isolation. The overall quality of available evidence supporting use of Ag testing was graded as very low to moderate.

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Published In

Clin Infect Dis

DOI

EISSN

1537-6591

Publication Date

June 27, 2024

Volume

78

Issue

7

Start / End Page

e350 / e384

Location

United States

Related Subject Headings

  • United States
  • Sensitivity and Specificity
  • SARS-CoV-2
  • Microbiology
  • Immunoassay
  • Humans
  • COVID-19 Testing
  • COVID-19 Serological Testing
  • COVID-19
  • Antigens, Viral
 

Citation

APA
Chicago
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MLA
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Hayden, M. K., Hanson, K. E., Englund, J. A., Lee, F., Lee, M. J., Loeb, M., … Mustafa, R. A. (2024). The Infectious Diseases Society of America Guidelines on the Diagnosis of COVID-19: Antigen Testing (January 2023). Clin Infect Dis, 78(7), e350–e384. https://doi.org/10.1093/cid/ciad032
Hayden, Mary K., Kimberly E. Hanson, Janet A. Englund, Francesca Lee, Mark J. Lee, Mark Loeb, Daniel J. Morgan, et al. “The Infectious Diseases Society of America Guidelines on the Diagnosis of COVID-19: Antigen Testing (January 2023).Clin Infect Dis 78, no. 7 (June 27, 2024): e350–84. https://doi.org/10.1093/cid/ciad032.
Hayden MK, Hanson KE, Englund JA, Lee F, Lee MJ, Loeb M, et al. The Infectious Diseases Society of America Guidelines on the Diagnosis of COVID-19: Antigen Testing (January 2023). Clin Infect Dis. 2024 Jun 27;78(7):e350–84.
Hayden, Mary K., et al. “The Infectious Diseases Society of America Guidelines on the Diagnosis of COVID-19: Antigen Testing (January 2023).Clin Infect Dis, vol. 78, no. 7, June 2024, pp. e350–84. Pubmed, doi:10.1093/cid/ciad032.
Hayden MK, Hanson KE, Englund JA, Lee F, Lee MJ, Loeb M, Morgan DJ, Patel R, El Alayli A, El Mikati IK, Sultan S, Falck-Ytter Y, Mansour R, Amarin JZ, Morgan RL, Murad MH, Patel P, Bhimraj A, Mustafa RA. The Infectious Diseases Society of America Guidelines on the Diagnosis of COVID-19: Antigen Testing (January 2023). Clin Infect Dis. 2024 Jun 27;78(7):e350–e384.
Journal cover image

Published In

Clin Infect Dis

DOI

EISSN

1537-6591

Publication Date

June 27, 2024

Volume

78

Issue

7

Start / End Page

e350 / e384

Location

United States

Related Subject Headings

  • United States
  • Sensitivity and Specificity
  • SARS-CoV-2
  • Microbiology
  • Immunoassay
  • Humans
  • COVID-19 Testing
  • COVID-19 Serological Testing
  • COVID-19
  • Antigens, Viral