FRIDAY, May 8, 2020 — The first COVID-19 test using saliva samples that patients collect at home has been approved by the U.S. Food and Drug Administration.
The emergency use authorization was issued to Rutgers Clinical Genomics Laboratory for the diagnostic test using home-collected samples. Patients return their sample to the New Jersey-based lab in a sealed package for analysis.
The screening is the only authorized test that uses saliva samples to check for the new coronavirus that causes COVID-19. It is available only with a prescription.
Last month, the FDA gave emergency authorization for the first at-home COVID-19 test using a sample taken from the patient’s nose with a nasal swab and saline.
“Authorizing additional diagnostic tests with the option of at-home sample collection will continue to increase patient access to testing for COVID-19,” FDA Commissioner Dr. Stephen Hahn said in an agency news release. “This provides an additional option for the easy, safe and convenient collection of samples required for testing without traveling to a doctor’s office, hospital or testing site.”
At-home saliva testing has several advantages over traditional nasal testing, in which a health care worker inserts a swab deep into the patient’s nose and rotates it to extract a sample.
Besides being invasive and uncomfortable, the nasal test requires a potentially contagious patient to leave home and the person administering the test to don personal protective gear.
Since the start of the pandemic, Hahn said FDA has authorized more than 80 COVID-19 tests, and adding more options for at-home sample collection is an important advance.
“It is important to note that this is not a general authorization for at-home collection of patient samples using other collection methods, saliva collection devices, or tests, or for tests fully conducted at home,” the FDA news release said.
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Posted: May 2020