FDA approved updated 2026-2027 COVID-19 vaccines from Pfizer-BioNTech, Moderna, and Novavax's partners, all reformulated to target the XFG variant, giving clinicians several options ahead of the fall respiratory virus season.
|Articles|May 8, 2020
FDA Authorizes At-Home Sample Collection for COVID-19 Testing
Author(s)Kevin Kunzmann
The device, which uses a sample collected from the patient’s nose with a nasal swab and saline, will allow patients to collect their own sample and return it to a Rutgers laboratory in a sealed package for testing.
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The US Food and Drug Administration (FDA) has authorized the first diagnostic test providing a home-collected saliva sample option for individuals with potential
The Emergency Use Authorization (EUA) was issued to Rutgers Clinical Genomics Laboratory for their laboratory developed test, the Spectrum Solutions LLC SDNA-1000 Saliva Collection Device. It is now permitted for at-home sample collection, after having received an EUA last month for sample collection at a laboratory.
The device, which uses a sample collected from the patient’s nose with a nasal swab and saline, will allow patients to collect their own sample and return it to the Rutgers laboratory in a sealed package for testing.
In a statement accompanying the authorization, the FDA emphasized that this is not a general approval for at-home collection of patient samples using other collection methods, saliva collection devices, or tests—or for tests fully conducted at home.
Nonetheless, FDA Commissioner Stephen M. Hahn, MD, called the authorization a continuation of increased patient access to COVID-19 testing.
“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,” Hahn said in a
As of May 8, the FDA has authorized 80-plus tests for COVID-19 diagnosis. The addition of an at-home sample collection option is a critical step forward in public health emergency response, Hahn added.
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