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Interim Guidance on Antigen Testing for COVID-19 in Long-Term Care
This interim guidance addresses the use of COVID-19 antigen testing in long-term care (LTC) facilities and is aligned with guidance released by the Centers for Disease Control and Prevention (CDC). The U.S. Food and Drug Administration (FDA) has granted emergency use authorization to antigen point-of-care (POC) testing systems to detect the presence of SARS-CoV-2 viral protein.
- Lab-based nucleic acid amplification tests (NAATs), which detect the genetic material (RNA) of the virus, are considered the “gold standard” for diagnostic accuracy and are preferred. In contrast, COVID-19 POC tests, including antigen tests, are less sensitive but have the advantage of providing results in approximately 15 minutes and at lower cost.
- If an LTC facility cannot access NAAT testing with less than a 48-hour turn-around time, then antigen testing should be considered for diagnostic purposes and to meet repeat screening testing requirements from the Centers for Medicare and Medicaid Services (CMS) and Illinois Department of Public Health (IDPH).
A Clinical Laboratory Improvement Amendment (CLIA) Waiver Is Required for POC Testing
According to CMS Rules, in order to conduct POC antigen testing, a facility must first obtain a CLIA Certificate of Waiver. COVID-19 POC antigen test systems are authorized for use in patient care settings that operate under a CLIA Certificate of Waiver. Facilities can find information on how to obtain a CLIA waiver at: https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/HowObtainCertificateofWaiver.pdf. More information can be found at the IDPH CLIA program website located at http://www.dph.illinois.gov/topics-services/health-care-regulation/CLIA.
Under CLIA rules, staff who perform POC tests must be appropriately trained to perform the test and must use appropriate personal protective equipment when handling samples. Facility administrators and testing personnel new to CLIA-waived testing will find it useful to complete CDC’s online training module (continuing education available) at https://www.cdc.gov/labtraining/training-courses/ready-set-test.html.
Considerations for COVID-19 POC Antigen Testing and Interpreting Results
Results from COVID-19 POC antigen testing should be interpreted based upon the test sensitivity and specificity, whether the individual being tested has symptoms, and level of transmission in the community and the facility. Refer to CDC’s guidance on when a confirmatory NAAT test may be needed and how to interpret results.
LTC Facilities Must Report Testing to Public Health Authorities
LTC facilities that perform POC testing must report each individual positive test result per federal requirements. Starting April 4, 2022, facilities will no longer need to report NEGATIVE antigen test results. Nursing homes and LTC facilities with SAMS Level 3 access to the CDC’s National Healthcare Safety Network (NHSN) may report patient-level COVID-19 antigen POC results to NHSN. Otherwise, nursing homes and other LTC facilities must report results to CDC’s SimpleReport system.
Regardless of the testing method employed, facilities must report each positive test result to their certified local health department and follow their guidance.
Contact. Questions regarding COVID-19 testing can be directed to DPH.LTCtesting@illinois.gov.