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.
The US Food and Drug Administration (FDA) has authorized the first diagnostic test providing a home-collected saliva sample option for individuals with potential coronavirus 2019 (COVID-19).
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 statement. “We will continue to work around the clock to support the development of accurate and reliable tests, as we have done throughout this pandemic.”
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.