FDA web page outlines strategy for testing asymptomatic people for SARS-CoV-2

Aug. 25, 2020

The U.S. Food and Drug Administration has posted a new web page that provides an overview of available resources related to screening asymptomatic people for SARS-CoV-2 and testing using pooled samples, the agency said in a press release.

The web page, which acts as a central repository, also includes access to information on surveillance testing, answers to frequently asked questions, and links to templates to apply for emergency use authorization.

In addition to information for test developers, the web page also provides recommendations to CLIA-certified labs for screening asymptomatic people for SARS-CoV-2.

Noting that “there is limited data on the distribution of viral loads in individuals with and without symptoms across demographics, different settings, and specimen types,” the agency recommends that labs use “a highly sensitive test, especially if rapid turnaround times are available. If highly sensitive tests are not feasible, or if turnaround times are prolonged, health care providers may consider use of less sensitive point of care tests, even if they are not specifically authorized for this indication (commonly referred to as "off label"). For congregate care settings, like nursing homes or similar settings, repeated use of rapid point of care testing may be superior for overall infection control compared to less frequent, highly sensitive tests with prolonged turnaround times,” the agency said.

“If less-sensitive tests, such as some rapid point-of-care tests, are used, healthcare providers should be aware of the performance of the tests and may want to consider different testing approaches, such as serial testing,” the FDA said.

In discussing laboratories use of pooled sampling techniques, for example, the FDA discusses how to report results. The agency said labs must report diagnostic or screening negative test results to appropriate federal, state, and local public health agencies in accordance with applicable federal, state, and local laws.

However, the laboratories should not report positive or indeterminate results of a pooled test to either the individuals in the pool, or the local, state, tribal, or territory health department. Instead, those specimens should be retested separately, and the subsequent individual diagnostic or screening results should then be reported to the local, state, tribal, or territory health department as well as to the individuals tested.

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