FDA updates COVID-19 testing guidelines to allow self-swab tests

Darrell Etherington

The FDA has updated its guidelines for COVID-19 testing procedures to make the process easier and less uncomfortable for patients, as well as to help limit the impact of testing on the supply of personal protective equipment (PPE) used by healthcare workers, including protective masks, face shields, gloves and gowns.

The change means that people taking a test will be able to conduct their own swab, which will involve swabbing shallowly in their nose. The existing process required a healthcare professional to take the swab, and to collect a sample from further up in the nasal cavity. This change does not mean there's any difference in the FDA's guidance regarding at-home sample collection – that is still specifically disallowed by the agency's rules, something the FDA clarified over the weekend in order to put an end to at-home test collection kits being distributed by diagnostic startups.

Individuals will still have to go to authorized clinical or drive-through testing sites, and will still have to meet the Centers for Disease Control and Prevention (CDC)'s screening requirements in order to get tested in the first place. But Vice President Mike Pence said that this will mean that testing conditions are safer for frontline medical personnel in addition to lowering the drain on PPE resources.

Pence also added that all state and private labs now required by law to report all of their results by law to the CDC, whereas previously, some states were reporting only positive results, which obviously skewed the data in terms of the number of people in the U.S. tested and the resulting positive diagnoses.