The Centers for Disease Control and Prevention has released interim guidance on rapid antigen testing as nursing homes across the country begin receiving and using the point-of-care devices for COVID-19.
The point-of-care antigen testing devices started to arrive for some nursing home operators earlier this month — about two weeks after federal health officials announced plans to deploy the testing devices in facilities. The Trump administration on Thursday announced it’s leveraging the Defense Production Act to help expedite the delivery of the systems to nursing homes.
The guidance, which was released early this week, notes that two tests providers are receiving from the federal government — either the Quidel Sofia 2 Instrument or a Becton, Dickinson and Company (BD) Veritor™ Plus System — are intended to be used as diagnostic tests for symptomatic residents within five days of symptom onset, the American Health Care Association explained. It also lays out testing strategies for diagnostic, screening and surveillance uses of the materials.
“Rapid antigen tests are particularly helpful if the person is tested in the early stages of infection with [COVID-19] 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,” according to the guidance.
“Rapid antigen tests can be used for screening testing in high-risk congregate settings in which repeat testing could quickly identify persons with a [COVID-19] infection to inform infection prevention and control measures, thus preventing transmission throughout the congregate setting,” it added.
The CDC also noted that laboratories and testing professionals who conduct diagnostic or screening for COVID-19 with rapid antigen tests must also comply with Clinical Laboratory Improvement Amendment (CLIA) regulations, while those who don’t surveillance testing with the devices are not obligated to comply with CLIA requirements.
Providers should take into account several factors when evaluating the test results, including the test’s performance characteristics, the prevalence of COVID-19 in its community and the clinical and epidemiological context of the person who was tested.
The AHCA added that providers must defer to state or local guidance on their use, but if no such guidance exists, they can consider following the CDC guidance.