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Considerations for use of SARS-CoV-2 antigen testing in nursing homes
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  • Description:
    Updated Oct. 23, 2020

    This document provides a summary of considerations for use of SARS-CoV-2 (the virus that causes COVID-19) antigen testing in nursing homes and is intended for nursing home providers and state and local public health departments.

    Antigen tests are available as point-of-care (POC) diagnostics for SARS-CoV-2. They have a rapid turnaround time, which is critical to the identification of SARS-CoV-2 infection and rapid implementation of infection prevention and control strategies. These tests can augment other testing efforts, especially in settings where RT-PCR testing capacity is limited or testing results are delayed (e.g., >48 hours). In general, these POC antigen tests have a lower sensitivity, but similar specificity, for detecting SARS-CoV-2 compared to reverse-transcriptase polymerase chain reaction (RT-PCR) tests.

    This document pertains to antigen tests that have been granted a US Food and Drug Administration’s Emergency Use Authorization (FDA EUA) to detect SARS-CoV-2. The first two SARS-CoV-2 antigen tests to receive FDA EUA are authorized for testing symptomatic persons within 5 days of symptom onset and there are limited data on antigen test performance in asymptomatic persons. However, given the transmission of SARS-CoV-2 from asymptomatic and presymptomatic nursing home residents and healthcare personnel (HCP) with SARS-CoV-2 infection, CDC is providing considerations for the use of antigen tests in asymptomatic persons during this public health emergency. Facilities should be aware of the FDA EUAexternal icon for antigen testsexternal icon and potential implications for the Clinical Laboratory Improvement Amendments (CLIA)external icon certificate of waiver when using antigen tests in asymptomatic individuals and in persons >5 days from symptom onset.

  • Content Notes:
    Overview of Testing for SARS-CoV-2 -- Interim Guidance for Rapid Antigen Testing for SARS-CoV-2 -- Interim SARS-CoV-2 Testing Guidelines for Nursing Home Residents and Healthcare Personnel -- Interim Guidance on Testing Healthcare Personnel for SARS-CoV-2 -- Interpreting Results of Diagnostic Tests.
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