What was the recent FDA announcement about regarding COVID-19 screening strategies?
The recent announcement by FDA to help with establishing testing programs call particular attention to tests that have been designated for screening. To identify these types of tests, visit the FDA In Vitro Diagnostics EUA website and search for the term "screening" under test attributes. https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/screening-covid-19-deciding-which-test-use-when-establishing-testing-programs
What if a test is not listed as "screening?" Can I still use it?
Per the FDA press release, tests can still be used as a screening tool, but the FDA also recommends other systems in place to avoid false negatives/positives:
When using a test that is not specifically authorized for screening, it is particularly important to understand what you know and don't know about the test's performance and combine it with other strategies, taking the following into consideration:
- Consider using a highly sensitive authorized test, especially if rapid turnaround times are available. If highly sensitive authorized tests are not feasible, or if turnaround times are prolonged, consider using a less sensitive authorized point-of-care test, such as an antigen test.
- Consider using a pooling strategy to conserve testing supplies. Several tests have been authorized for pooling.
- Consider frequent serial testing, such as the repeated use of rapid point-of-care or at-home tests for self-testing at a predetermined testing interval.
- Negative results should be considered as "presumptive negative," and health care providers should consider them in the context of clinical observations, patient history, and epidemiological information. If there is a concern that an individual with a negative antigen, other point-of-care or at-home test result may have COVID-19 (e.g., because of a new outbreak in a congregate setting), consider retesting the individual with a highly sensitive authorized molecular test.