Study behind updated FDA guidance shows self-swab tests are as effective as those done by clinicians
Earlier this week, the U.S. Food and Drug Administration (FDA) announced that it would be updating its guidance to allow self-swab tests for COVID-19, in which a patient collects a sample from their own nose for a health professional to test. On Wednesday, UnitedHealth Group revealed the results of a peer-reviewed large-scale study that provided the science behind the decision to switch to the less-invasive sample collection method.
The self-swab process doesn’t change where FDA-approved testing can happen — this expanded guidance only applies to the method of collection, meaning at-home swab-based PCR tests that many startups had hoped to bring to market are still on hold. But even though people still have to go to either clinics or drive-through testing sites to get a COVID-19 test done, the ability to self-swab offers more comfort, as well as real advantages when it comes to the health and safety of the clinicians and front-line healthcare workers staffing the sites.
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This new study shows that not only does self-swabbing lessen the chance of someone with COVID-19 passing on their infection to a healthcare worker, it’s also just as effective as a test where clinicians collected the sample from much deeper inside a person’s nasal cavity. UnitedHeatlh worked with the Bill & Melinda Gates Foundation, as well as Quest Diagnostics and the University of Washington to conduct the study, which covered almost 500 patients who received tests at OptumCare diagnostic facilities in the state of Washington.
There are other benefits to the self-swab method as well, including eliminating the need for specifically trained medical professionals who have to administer the tests at point-of-care. This should help with clearing up backlogs owing to staffing, at least, though supplies and bottlenecks due to demand are going to persist as more people seek diagnosis.