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DOH Releases Guidance on Use of COVID-19 Antigen Tests

Guidance issued by the Department of Health (DOH) on Oct. 19th clarifies the recommended uses of antigen tests for COVID-19 and the circumstances in which confirmatory PCR testing must be conducted. The guidance documents, which include an Interim Recommendations memorandum, Frequently Asked Questions (FAQs), and a confirmatory testing algorithm, indicate that antigen tests may be used to test individuals when there is an outbreak in a public setting or environment and to test residents and employees in nursing homes, adult care facilities (ACFs), and other congregate facilities regardless of outbreak status. The FAQs confirm that, notwithstanding a requirement in prior guidance that nursing homes have an arrangement with a lab to conduct testing with a specified sensitivity, antigen tests may be used to satisfy staff testing requirements in nursing homes. In addition, the FAQs state that antigen tests may be used to satisfy the visitor test result requirement in nursing homes.

The FAQs note that COVID-19 antigen tests are generally less sensitive than PCR tests, resulting in a higher percentage of false negatives. The specificity of antigen tests is generally as high as the PCR tests, resulting in few false positives. However, the predictive value of any test varies based on pre-test probability (i.e., prevalence in the community and presence of symptoms). When community prevalence is low, false positives are more likely. When community prevalence is high, false negatives are more likely.

Given the lower sensitivity of antigen tests and potential for erroneous results, the guidance requires confirmatory PCR testing under specified circumstances and includes a graphic algorithm to assist providers with decisions regarding confirmatory testing. The graphic includes one decision tree for "public settings" and another for nursing homes, ACFs, and other congregate settings. The requirement of a confirmatory test in nursing homes and ACFs depends on whether a facility is having an outbreak and whether the test subject is symptomatic. For example, if an individual is symptomatic and receives a positive antigen test result, no confirmatory test is required, the individual must be isolated, and outbreak response must be initiated. On the other hand, if an individual is asymptomatic and receives a positive antigen test result in a facility without an outbreak, confirmatory testing must be performed within 48 hours. The individual must be isolated and excluded from work pending the PCR result. If the PCR test result is not available within three days after the antigen test, the facility is instructed to "proceed with other appropriate actions (e.g., contact tracing, furlough and/or quarantine)." 

The FAQs clarify that antigen tests may be used to test visitors to nursing homes. They instruct facilities to prioritize resident and staff testing and have adequate testing supplies to meet those requirements prior to testing visitors. Nursing homes that test visitors must meet all requirements for testing, including having the test ordered by an authorized ordering source and reporting of results. LeadingAge NY has been informed by the Department of Health's (DOH) Wadsworth Clinical Laboratory Evaluation Program (CLEP) that the health care provider who is serving as the limited service laboratory director may act as the authorized ordering source for visitors.

The FAQs also remind all facilities that, in order to perform point-of-care (POC) testing, they must be approved as a limited service laboratory by DOH. Information about the application process is available here. In addition, facilities that already have a limited service lab registration certificate must secure approval to add the antigen tests to their approved tests. The application to add or delete test procedures is available here. For more information about the approval process, email CLEP here. Facilities that perform testing must comply with reporting requirements and report results through the Electronic Clinical Laboratory Reporting System (ECLRS) within three hours. For more information about reporting, email ECLRS here or call the help desk at 866-325-7743.

LeadingAge NY members may be aware of the new POC test result reporting pathway introduced by the Centers for Disease Control and Prevention (CDC) through the National Healthcare Safety Network (NHSN). This reporting pathway is optional, and it is unclear at this time whether New York State will accept this reporting process. Until further information is provided, members conducting POC testing are advised to continue to report through ECLRS.

Finally, the Department of Health and Human Services (HHS) has announced that it is distributing POC devices to 1,300 nursing homes, including many LeadingAge NY members, that have not yet received distributions. The shipments are beginning now, with deliveries anticipated by Nov. 2nd. Nursing homes that were identified for a shipment should have received an email with additional information.

Contact: Karen Lipson, klipson@leadingageny.org, 518-867-8838