Infectious Disease

IDSA publishes guidelines for SARS-CoV-2 antigen testing

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Hanson does not report any relevant financial information.

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The Infectious Diseases Society of America has published new guidelines for the use of SARS-CoV-2 antigen tests.

“Antigen tests have really become more and more available over the course of the pandemic and have helped us meet the need for more universal and faster access to diagnostic tests for SARS-CoV-2.” Kimberly E. Hanson, MD, MHS, Associate Professor of Internal Medicine and Associate Associate Professor of Pathology at the University of Utah School of Medicine, said during an IDSA news conference. “These tests can be used in a variety of environments.”

IDSA antigen test

Source: IDSA. IDSA Guidelines for Diagnosing COVID-19: Antigen Testing. https://www.idsociety.org/practice-guideline/covid-19-guideline-antigen-testing/. Retrieved June 2, 2021.

The guidelines were based on a systematic literature review by infectious disease clinicians and clinical microbiologists who found that clinical performance data on FDA-approved rapid antigen tests are “mostly limited to one-time, one-time” test versus standard nucleic acid -Amplification test (NAAT) as the reference standard, ”wrote the guideline panel.

“Rapid antigen tests have a high specificity and low to moderate sensitivity compared to NAAT reference methods. The sensitivity of the antigen test is highly viral load-dependent, with differences observed between symptomatic and asymptomatic individuals and the timing of the test after the onset of symptoms, ”the panel wrote.

“Based on these observations, rapid RT-PCR or laboratory-based NAAT remain the diagnostic methods of choice for diagnosing SARS-CoV-2 infection,” the panel continued. “However, when molecular testing is not readily available or logistically impractical, antigen testing can help identify some people with SARS-CoV-2 infection.”

The guidelines, which are based on evidence graded “very low to moderate”, include five diagnostic recommendations:

  • Symptomatic individuals with suspected COVID-19 should be tested with NAAT (either rapid RT-PCR or laboratory-based NAAT) via antigen testing.
  • Asymptomatic individuals at risk for exposure to SARS-CoV-2 should be tested via a single standard NAAT (either rapid RT-PCR or laboratory-based NAAT) using a single rapid antigen test.
  • Asymptomatic individuals at risk for SARS-CoV-2 exposure should receive a single standard NAAT (either rapid RT-PCR or laboratory-based NAAT) instead of two consecutive rapid antigen tests.
  • The panel does not advise for or against individual rapid antigen tests, as opposed to not testing asymptomatic individuals at risk for SARS-CoV-2 exposure.
  • The IDSA does not advocate or oppose the use of repeated rapid antigen tests in lieu of not using tests for asymptomatic individuals at risk for SARS-CoV-2 exposure.

“When we looked through the literature and made our recommendations and suggestions, high-potency vaccines were not yet widely available and there was no significant coverage of the vaccinated adult population,” said Hanson. “It is likely that the role of tests will change as we see more vaccination protection in the population and the prevalence of infections in communities decreases – which we are already seeing.”

IDSA said the guidelines were endorsed by the American Society for Microbiology, the Society for Healthcare Epidemiology of America, and the Pediatric Infectious Diseases Society.

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