New York Nursing Homes Selected by CMS to Receive Point-of-Care COVID-19 Tests
The Centers for Medicare and Medicaid Services (CMS) announced several weeks ago that it will be distributing COVID-19 point-of-care testing instruments and tests to nursing homes nationwide for testing of staff and residents. Facilities have been selected for the distribution based on data reported through the Centers for Disease Control and Prevention's (CDC) National Healthcare Safety Network (NHSN) survey. An updated list of facilities that will receive tests was posted on Aug. 6th and includes several dozen New York nursing homes. CMS has also posted Frequently Asked Questions (FAQs) about the distribution of the tests.
Facilities that are selected to receive the free testing devices are advised to seek an amendment to their New York State Limited Service Laboratory Registration to add the following COVID-19 antigen tests:
- Becton, Dickinson (BD) Veritor System for Rapid Detection of SARS-CoV-2
- Quidel Sofia 2 SARS Antigen FIA
Information about how to add tests is available here. Facilities may add both tests even if they are unsure which one they will use. Laboratory registrations may be amended by submitting a "Limited Service Laboratory Registration Notification to Add and/or Delete Test Procedure(s)" form via email. Officials at the New York State Clinical Laboratory Evaluation Program request that applicants provide the following information in the subject line of the email: PFI number and the test(s) to be added (e.g., PFI#: ____ - Request to Add COVID-19). The "PFI number" refers to the laboratory certificate PFI, not the nursing home's PFI. It can be found in the upper left-hand corner of the Limited Service Laboratory Registration.
While the rapid point-of-care tests appear to be highly accurate in reporting positive results, concerns have been raised about the potential for false negative results with these tests. The CDC recognizes that:
Antigen tests for SARS-CoV-2 are generally less sensitive than viral tests that detect nucleic acid using reverse transcription polymerase chain reaction (RT-PCR)......Rapid antigen tests are particularly helpful if the person is tested in the early stages of infection with SARS-CoV-2 when viral load is generally highest. They also may be informative in diagnostic testing situations in which the person has a known exposure to a confirmed case of COVID-19. Rapid antigen tests can be used for screening testing in high-risk congregate settings in which repeat testing could quickly identify persons with a SARS-CoV-2 infection to inform infection prevention and control measures, thus preventing transmission throughout the congregate setting. In this case, there may be value in providing immediate results with antigen tests even though they may have lower sensitivity than RT-PCR tests, especially in settings where a rapid turnaround time is required.
CDC, Interim Guidance for Rapid Antigen Testing for SARS-CoV-2
Nursing homes that decide to conduct COVID-19 point-of-care testing should familiarize themselves with reporting requirements for these tests. Department of Health (DOH) advisories are available here and here.
Contact: Karen Lipson, klipson@leadingageny.org, 518-867-8838