The Rutgers laboratory is now authorized to receive and test collected, prescribed samples of either nasal or saliva samples for possible COVID-19.
The US Food and Drug Administration (FDA) has expanded the existing Emergency Use Authorization (EUA) for the Rutgers Clinical Genomics Laboratory to now include the at-home collection of saliva samples for coronavirus 2019 (COVID-19) testing.
The extension of the EUA, originally granted last week, indicates the Spectrum Solutions SDNA-1000 saliva collection can be used for self-collection at home. This is the first and currently only FDA authorization of at-home saliva collection for physician-prescribed COVID-19 testing.
The new approval for direct-to-patient delivery using the SDNA-1000 saliva collection kit could hopefully relieve healthcare facilities burdened with in-person testing rates, Stephen Fanning, chief executive officer at Spectrum, said in a statement.
“The FDA recognized that current methods of obtaining biosamples for COVID-19 testing were limiting in scope and scale due to supply shortages and the current testing methods were also constantly putting healthcare workers at risk of exposure,” he said. “We’ve developed a better, more innovative solution.”
The FDA granted original EUA to Rutgers Clinical Genomics Laboratory for the Spectrum Solutions SDNA-1000 Saliva Collection Device with at-home nasal and saline collection capability on May 8. At the time of the authorization, FDA commissioner Stephen Hahn, MD, said the administration would continue to work “around the clock” to support the development and expansion of available COVID-19 tests.
“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,” he said.
Individuals interested in purchasing the at-home COVID-19 test are advised to contact their physician or visit the Spectrum website for an approved seller list. They should then arrange an appoint with a physician, where they will be determined for COVID-19 test candidacy.
If approved and prescribed, patients can have the test delivered to their homes, where they then follow the simple collection instructions on the kit before returning the kit. Physicians will be able to review the results with the patient once assessed.