WASHINGTON – The Food and Drug Administration (FDA) authorized the use of the first diagnostic test that uses home-collected saliva samples to detect COVID-19.
In a statement, the FDA granted the emergency permit to the Rutgers Clinical Genomics Laboratory at Rutgers University School of Medicine in New Jersey for use of the device called SDNA-1000 from Spectrum Solutions LLC.
The $ 100 kit may be sent to the patient’s home. The laboratory says that it can process more than 10,000 tests daily and with results in 48 hours and hopes that other laboratories will adopt this type of test. The authorization is only limited to the aforementioned test from said laboratory and the test continues to only be provided with a doctor’s prescription.
“Authorizing additional diagnostic testing with the home sample collection option will continue to increase patient access to COVID-19 testing. This provides an additional option for the easy, safe and convenient collection of samples required for testing without having to go to a doctor’s office, hospital or test site, “said FDA Commissioner Stephen M. Hahn.
Rutgers’ RUCDR Infinite Biologics has received emergency approval from the FDA for an at-home coronavirus test that will allow people to collect their own saliva and send it to a lab for results — all from the comfort of their own home.https: // t.co/xw4K69BmmM
– Rutgers University – New Brunswick (@RutgersNB) May 8, 2020
It is important to note that this is not a general authorization for any other home collection tests of samples from patients with saliva collection devices, or for tests performed entirely at home, the FDA clarified. The authorization is only limited to the aforementioned test from said laboratory and the test continues to only be provided with a doctor’s prescription.
During collection, a person spits into a container containing a preservative liquid developed by medical equipment manufacturer Spectrum Solutions, Rutgers explains.
This new approach could help expand testing options and reduce the risk of infection in healthcare workers. The FDA has authorized more than 80 COVID-19 tests.
Three weeks ago, researchers at Rutgers University received the green light from the United States government for the first saliva tests that were used at test sites.
The FDA then authorized the test under its emergency powers to quickly approve new tests and therapies to combat the outbreak. At first, the method was available in hospitals and clinics affiliated with the faculty of this university.
The current system for detection of COVID-19 requires the healthcare provider to remove a sample from the patient’s nose or throat. To reduce the risk of infection, many hospitals and clinics ask their staff to throw away gloves and masks after being around an infected person or someone who may have contracted the virus. And many institutions are short of basic supplies like gloves, masks, and swabs.
With the new saliva test, patients receive a plastic tube into which they must spit multiple times. They then return the tube to the Rutgers Clinical Genomics Laboratory.
“This prevents health professionals from having to face someone asymptomatic,” said Andrew Brooks, director of the Rutgers laboratory that developed the test.
An infectious disease expert who was not involved in the new test, said it would help overcome the discomfort and difficulties for the patient in taking a swab sample.
Rutgers tested the accuracy of his method by taking saliva and swab samples from 60 patients. In 100% of the cases, both results coincided.
The University developed the method with saliva collection kits from Spectrum Solutions, a Utah company that provides similar devices for DNA-based ancestry testing.